Gardasil 9
Prejudicial Distribution of the HPV Vaccine (thorough overview) Gardasil is a vaccine designed to prevent infections caused by certain types of human papillomavirus (HPV), specifically HPV types 6, 11, 16 and 18. HPV types 16 and 18 have been associated with cervical cancers and strains HPV types 6 and 11 have been associated with genital warts cases. Since its release in 2006, Gardasil has had more reports of adverse events than any other vaccine.
- GARDASIL 9 vaccine package insert contains approximately 500 mcg of aluminum (provided as AAHS), 9.56 mg of sodium chloride.
- Found 11140 cases where Vaccine is HPV9 and Manufacturer is MERCK & CO. INC.
- VAERS Report Male Death After Gardasil
March 17, 2020 - Adjuvant-containing control arms in pivotal quadrivalent human papillomavirus vaccine trials: restoration of previously unpublished methodology (pdf) "We obtained 14 trials from the EMA (eight qHPV vaccine, six nonavalent HPV vaccine), of which five met our prespecified inclusion criteria (V501-012, V501-013, V501-015, V501-019 and V501-020; figure 1). All included trials compared qHPV vaccine to aluminium-containing adjuvant. Corresponding register and publication information for each trial are listed in table 1.
December 2019 - Is one dose of human papillomavirus vaccine as effective as three?: A national cohort analysis (full text) "We believe that one dose HPV vaccination should be considered a viable strategy as part of the recent WHO call for action to develop strategies, which will include vaccination, screening, early diagnosis and treatment, and palliative care, to achieve the elimination of cervical cancer as a public health problem. Requiring only one dose of vaccine greatly reduces program costs and requirements, and may open the way for a global mass vaccination campaign. It may make the difference for many countries, and at the moment for cohorts of girls who may otherwise miss out altogether due to supply constraints, especially those countries who are otherwise unable to afford either screening or vaccination and are therefore suffering what is now a largely preventable burden of cervical cancer."
May 1, 2019 - On the contextual nature of vaccine safety monitoring: Adverse events reporting after HPV-vaccination in Denmark, 2015 "Despite an official aim of homogenous case management, reporting of suspected AEFI was incomplete with large regional differences. The qualitative study corroborated that reporting behaviour was contextual. This observation represents an important caveat in interpreting data from AEFI reporting, in particular when these data are used for research or policymaking."
January 29, 2019 - Evidence of decreased HPV vaccine acceptance in Polish communities within Scotland “Despite higher rates of HPV vaccine uptake compared to those residents in Poland, this study demonstrates significantly lower rates of HPV vaccine uptake in girls of Polish and Eastern European ethnicity compared to others in Scotland. We have conducted an explorative qualitative study with Polish families, which suggest that vaccine trust in medical/healthcare practitioners, and cultural influences may be important drivers of acceptance. Furthermore, this qualitative study has revealed that Polish women expressed fears in relation to the side-effects of the HPV vaccine, an independent predictor of parental willingness to have their child vaccinated.
January 2019 - Ongoing inadequacy of quadrivalent HPV vaccine safety studies "Although 92% of women with premature ovarian failure describe an altered menstrual cycle as their initial symptom, the authors did not include the International Classification of Diseases-Ninth Revision codes of amenorrhoea, dysfunctional uterine bleeding and oligomenorrhoea and omit to describe the 13% of ‘presumed idiopathic POI’ cases they excluded. Inadequate medical records were classed ‘not POI’ and 1.7% ‘POI diagnosis code’ records were missing. Vaccine dosage numbers are premised irrelevant and are omitted. Failure to record hormonal usage including long-acting reversible contraception lasting several years disables ovarian function observation, reduces the pool of observable enrollees to an unknown number and reduces the power of this study. All presumptive cases were abstracted by the three authors with a declared conflict of interest. There was no acknowledged gynaecologist input. ... Since only 39% of women developing amenorrhoea consult a doctor, ovarian safety research would be better served by menses recording in vaccinated and unvaccinated cohorts for at least 5 years from completed vaccination or anti-Mullerian hormone measurement before and at appropriate interval after vaccination. Rat ovary histology or ongoing fecundity would investigate the issue better than industry-devised studies."
November 12, 2018 – Immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent and one dose of bivalent HPV vaccine versus two doses of nonavalent vaccine – A randomized clinical trial (full text) “A higher proportion of subjects who received 2vHPV reported local or systemic adverse events than those who received 9vHPV as the first dose. Post-second dose there were no differences in reported adverse events between the two vaccines.”
July 2018 -Risk of Spontaneous Abortion After Inadvertent Human Papillomavirus Vaccination in Pregnancy "Among women with distant HPV vaccination exposure, 96' (10.4%) experienced a spontaneous abortion. For peri-pregnancy and during pregnancy exposures, spontaneous abortions occurred in 110 (11.2%) and 77 (8.6%), respectively. The risk of spontaneous abortion was not increased among women who received 4vHPV (Gardasil) during pregnancy or peri-pregnancy."
June 2018 -Invited Commentary: Moving From Evidence to Impact for Human Papillomavirus Vaccination: The Critical Role of Translation and Communication in Epidemiology "The authors were able to review these patients’ medical records, and they found that the majority of the patients experiencing “other complications” had had at least '1 other vaccine administered on the same day as the HPV' vaccine, 'lessening the causal link' to the HPV vaccine specifically. Comment: This is why giving multiple vaccines on the same day is advantageous to the Industry but disadvantageous to the patient/petitioner.
May 15, 2018 -Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants From Asian Countries "Conclusions The 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Asian participants. Data support 9vHPV vaccination programs in Asia." Comment:From the CDC Pink Book December 2016: Gardasil 9 contains twice the amount of aluminum adjuvant than Gardasil. Each 0.5-mL dose of the Gardasil 9 vaccine contains approximately 500 mcg of aluminum See here. Each 0.5-mL dose of Gardasil vaccine contains approximately 225 mcg of aluminum here.
May 3, 2018 -Systematic review of cost-effectiveness studies of human papillomavirus (HPV) vaccination: 9-Valent vaccine, gender-neutral and multiple age cohort vaccination "The inclusion of adolescent boys in vaccination program was found to be cost-effective if vaccine price and coverage was low. When coverage for female was above 75%, gender-neutral vaccination was less cost-effective than when targeting only girls aged 9–18 years. Current evidence does not show conclusive proof of greater cost-effectiveness of 9-valent vaccine compared to the older HPV vaccines as the price for 9-valent vaccine was still uncertain. COMMENT: Adding boys to receive Gardasil was always about doubling the market share.
May 3, 2018 -Systematic review of cost-effectiveness studies of human papillomavirus (HPV) vaccination: 9-Valent vaccine, gender-neutral and multiple age cohort vaccination "The inclusion of adolescent boys in vaccination program was found to be cost-effective if vaccine price and coverage was low. When coverage for female was above 75%, gender-neutral vaccination was less cost-effective than when targeting only girls aged 9–18 years. Current evidence does not show conclusive proof of greater cost-effectiveness of 9-valent vaccine compared to the older HPV vaccines as the price for 9-valent vaccine was still uncertain.
April 25, 2018 - Human papillomavirus vaccination coverage in Luxembourg – Implications of lowering and restricting target age groups (full text) "In Luxembourg, all childhood vaccines are administrated by private and hospital physicians. The coverage of HPV vaccination is relatively low compared to other vaccinations: immunization coverage for other childhood vaccines is approximately 95%. One of the reasons behind the difference in vaccination rates could be physicians’ hesitancy to recommend the HPV vaccine. Physician’s hesitancy to vaccinate has already been known in the past to have caused localized outbreaks of measles in northern Luxembourg. We also observed lower HPV vaccination rates in some northern parts of the country. Introducing HPV vaccination at school level would represent a major challenge, as there is currently no public infrastructure or personnel for vaccine administration."
March 22, 2018 - The New HPV Vaccination Policy in France "Since the beginning of January 2018, a total of 11 vaccines have been mandatory in Franc'e. 'This is a true revolution. Nonetheless, the problems of ambiguity and low confidence remain regarding the use of many non-mandatory vaccines, including those against influenza, varicella, hepatitis A virus, and especially human papillomavirus (HPV). The level of coverage against HPV remains singularly low in France, with a 19% complete vaccination rate among 16-year-old girls in 2016. ... "The lack of comprehensive general and medical information and the flood of disinformation from antivaccine lobbies are major obstacles to HPV vaccination in France. This ambient suspicion affects doctors, themselves citizens, who can no longer find the arguments to defend the use of this vaccine."
March 14, 2018 - Two Cases of Pediatric Multiple Sclerosis after Human Papillomavirus Vaccination (Enter P088 in find) "14-year-old male presented with left retro-orbital pain and blurry vision in the left eye, diagnosed with left optic neuritis. ... 17-year-old female presented with blurry vision in the right eye, diagnosed with right optic neuritis. MRI brain showed right frontal enhancing lesion. The first dose of Gardasil was given two weeks prior to presentation. ... These 2 cases and the others that have been previously reported suggest a temporal association between HPV vaccination and the onset of MS. Although live, attenuated vaccines are generally not recommended in MS patients, Gardasil® is an inactivated and recombinant vaccine, and does not contain any viral DNA."
March 7, 2018 - Improving human papillomavirus vaccination rates throughout military treatment facilities "The Centers for Disease Control and Prevention and the President’s Cancer Panel have identified several interventions that can increase vaccine rates: (1) strengthening healthcare provider recommendations, (2) providing in-person and webinar-based vaccine education for clinic champions who are dedicated to monitoring vaccine rates and ensuring implementation efforts, (3) educating parents and adolescents about vaccines, (4) implementing reminder/recall systems, and using every office visit to administer vaccinations. Improving healthcare provider recommendations has been targeted as a key strategy to increase HPV immunization coverage."
March 7, 2018 - The National Vaccine Advisory Committee at 30: Impact and opportunity "Notably, in 1988 ACIP recommended vaccination of all children against 8 diseases (i.e., diphtheria, tetanus, pertussis, polio, measles, mumps, rubella, and Haemophilus influenzae type b), and 30 years later the recommendations cover 16 diseases (i.e., the 8 above plus hepatitis B, hepatitis A, rotavirus, pneumococcal disease, influenza, meningococcal disease, HPV, and varicella). ... Further, despite substantial progress in reducing vaccine-preventable diseases of childhood (due to very high coverage with highly effective vaccines), the significant effort remains to achieve the same for adults. NVAC will most likely need to focus on overcoming barriers and facilitating vaccine uptake of recommended vaccines for adults. In addition, vaccine hesitancy and vaccine confidence will likely continue to represent priorities, for which NVAC will likely play a continued role in addressing public and professional concerns."
March 2018 - Provider Communication, Prompts, and Feedback to Improve HPV Vaccination Rates in Resident Clinics "The primary outcome measure was eligible visits with vaccination divided by vaccine-eligible visits (captured HPV vaccination opportunities). Practices performed chart audits that were fed into monthly performance feedback on captured HPV vaccination opportunities. We used conditional logistic regression (conditioning on practice) to assess captured vaccination opportunities, with the time period of the study (before and after the QI intervention) as the independent variable. RESULTS: Overall, captured opportunities for HPV vaccination increased by 16.4 percentage points, from 46.9% to 63.3%. Special cause was demonstrated by centerline shift, with 8 consecutive points above the preintervention mean." Comment: Captured opportunities? More like fear mongering and bullying.
February 23, 2018 - Response to commentary by Drs. Rositch and Krakow, “Moving from evidence to impact for HPV vaccination: the critical role of translation and communication in epidemiology” "At the same time, we find it necessary to reiterate two possibly important limitations of our evaluation: 1) We looked for increased risks of potential adverse events presenting only within the first 42 days after vaccination; thus, potential adverse events with longer latency periods and/or with insidious onset could have been missed. 2) The hierarchical tree of diagnoses we used was organized by ICD-9 codes and body system; thus, potential adverse events characterized by physiologically diverse symptoms (for example, postural orthostatic tachycardia syndrome (POTS), which manifests as ORIGINAL neurological, gastrointestinal, and/or cardiovascular symptoms) could have been missed due to the possibility of diagnosis codes for patients with the same syndrome being dispersed among multiple branches of the tree. Ultimately, in order to win and deserve the public's trust in vaccines, we will need to communicate clearly not only about key safety findings, including from studies such as this one that evaluate a whole range of potential adverse events with high statistical power, but also about which kinds of health outcomes have been thoroughly assessed as possible vaccine-associated adverse events and which have not.
February 23, 2018 - Cross-sectional associations between psychological traits, and HPV vaccine uptake and intentions in young adults from the United States "The limitations of this study indicate the need for continued research on the psychological traits associated with HPV vaccine uptake. While this study highlights the importance of considering psychological traits, a follow-up study could provide a more rigorous test by utilizing medical records to identify young adults who have received the HPV vaccine and those who have not and sending surveys that includes the measures from the current study. As previously mentioned, another follow-up study could be conducting a modified version of the current study with parents to examine the extent to which the current results extend to surrogate decision-making for HPV vaccination."
February 1, 2018 - Multiple Sclerosis Development in Two Teens After HPV Vaccination "Researchers from the University of Miami presented 2 cases of multiple sclerosis (MS) developing in teens after receiving Gardasil, a human papillomavirus (HPV) vaccine."
January 25, 2018 - Parent perceptions of dentists’ role in HPV vaccination "Parents in this sample had low comfort with dentists as HPV vaccinators. Findings from this study highlight potential concerns to be addressed before dental practices consider offering HPV vaccination in the future. Further research should assess dentists’ perspectives and explore alternative roles for dental providers in HPV prevention efforts." Comment: This is the latest push - to teach dentists/dentist offices to administer vaccines.
January 11, 2018 -A Physician’s Recommendation for HPV Vaccination: What Makes African American Mothers Compliant? "A physician’s recommendation should advise African American mothers on the risk of HPV and the importance of HPV vaccination at an early age to reduce cervical cancer risk. It should further address mothers’ 'perceived disadvantages of HPV' vaccination (e.g., side effects). Comment: The disadvantages are not perceived - mothers know.
December 14, 2017 - Bad news: The influence of news coverage and Google searches on Gardasil adverse event reporting "The present study sought to assess the influence of news coverage (number of news articles per month) on adverse event reporting in response to Gardasil vaccination in New Zealand over a 7.5-year period, and whether the influence of news coverage was mediated by internet search activity (Google search volumes). ... News coverage in the previous month, and Google search volumes in the same month were significant predictors of adverse event reporting, after accounting for vaccination rates and year. Concurrent Google search volumes partially mediated the effect of prior news coverage. Conclusion: The results suggest that some of the adverse events reported were not related to the vaccination itself, but to news coverage and internet search volumes, which may have contributed to public concerns about potentially unpleasant or harmful outcomes. These findings have implications for the importance of psychological and social factors in adverse event reporting, and the role of the news media in disseminating health information. Comment: Could it be that reporting of the adverse events suddenly allowed parents to connect-the-dots and recognize what had happened to their child?
October 27, 2017 - Using the 4 Pillars™ Practice Transformation Program to increase adolescent human papillomavirus, meningococcal, tetanus-diphtheria-pertussis and influenza vaccination "To report the results of an intervention using the 4 Pillars™ Practice Transformation Program (4 Pillars™ Program) to increase adolescent vaccinations including human papillomavirus vaccine (HPV) and influenza vaccines, which remain underutilized in this population. Comment: 4 Pillars™ Practice Transformation Program is a step-by-step guide to improving vaccine uptake in outpatient settings. Allegheny County in Pittsburgh PA tried to make HPV mandatory. In 2017, it was relatively unheard of for a county to try and mandate a vaccine. This particular study was done in part by the University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
August 9, 2016 - Severe somatoform and dysautonomic syndromes after HPV vaccination: case series and review of literature (full text) "We retrospectively described a case series including 18 girls (aged 12–24 years) referred to our “Second Opinion Medical Network” for the evaluation of “neuropathy with autonomic dysfunction” after HPV vaccination. All girls complained of long-lasting and invalidating somatoform symptoms (including asthenia, headache, cognitive dysfunctions, myalgia, sinus tachycardia and skin rashes) that have developed 1–5 days (n = 11), 5–15 days (n = 5) and 15–20 days (n = 2) after the vaccination. These cases can be included in the recently described immune dysfunction named autoimmune/inflammatory syndrome induced by adjuvants (ASIA). ... Moreover, the HPV vaccine formula, containing also high polysorbate 80 (50 mcg) concentration, might also induce a greater meningeal permeability leading to a facilitated entrance of many substances to the central nervous system. Based upon these observations, it might be speculated that this vaccine—and not others—could induce some abnormal activation of immune competent cells in the central nervous system, such as the glia." Comment: If it can't be diagnosed by a conventional testing methodology, then the person is crazy and their symptoms are all in their head.
July 7, 2016 - Immunological studies of cerebrospinal fluid from patients with CNS symptoms after human papillomavirus vaccination "These results suggest biological, mainly immunological, changes in the CSF of patients after HPV vaccination."
April 2016 - Postural Orthostatic Tachycardia Syndrome (POTS) – A novel member of the autoimmune family (pdf) "There are several plausible explanations for the appearance of abnormal cardiac including death, following HPV vaccination. Namely, in exploring the primary sequence of the HPV major capsid L1 protein (one of the four antigens in Gardasil) for peptide sharing with human proteins, Kanduc found that pentamers from the HPV viral capsid protein are shared with human proteins that, when altered, have been linked to arrhythmias, cardiovascular diseases, 'and sudden death. In particular, out of the viral pentamers are present in the human protein, Titin, alterations of which have been linked to cardiac failure and sudden cardiac death.
March 4, 2016 - Motor and sensory clinical findings in girls vaccinated against the human papillomavirus from Carmen de Bolivar, Colombia. "There were also sensory and motor syndromes with upper and lower limb numbness and tingling (paraesthesia), muscle weakness and difficulty walking (paresis) accompanied by tremors, muscle spasms and twitches (abnormal movements). Most symptoms appeared after the second vaccine dose, which agrees with greater antibody titers seen in booster dose immunizations. A severely ill 13-year old girl with similar complaints and history of immunization had high serum auto-antibody titers against nerve tissue as well as a marked clinical improvement after anti-inflammatory and antibody removal therapy (plasmapheresis and IVIg). This evidence prompts me to propose an autoimmune hypersensitivity type II reaction was triggered by 'Gardasil whose batch-specific antigens await further research."
February 9, 2016 - The Impact and Cost-Effectiveness of 3 doses of 9-Valent Human Papillomavirus (HPV) Vaccine among US Females Previously Vaccinated with 4-Valent HPV Vaccine "The average cost per QALY gained by additional 9vHPV vaccination exceeded $100,000 in both models. However, the results varied considerably in sensitivity and uncertainty analyses. Additional 9vHPV vaccination is likely not as efficient as many other potential HPV vaccination strategies, such as increasing primary 9vHPV vaccine coverage."
February 3, 2016 - General practitioners’ attitudes and behaviors toward HPV vaccination: A French national survey "Overall, 72% of participants reported frequently recommending HPV vaccination; 60% considered that not enough is known about its risks. The model averaging showed that the factors most associated with infrequent recommendation of this vaccine by GPs were: unfavorable perceptions of its risk-benefit balance, a decision not to vaccinate one's own daughter(s) with this vaccine, and doubts about vaccine utility in general."
September 2015 - Monitoring Effect of Human Papillomavirus Vaccines in US Population, Emerging Infections Program, 2008–2012 "Because of the slow natural history of HPV oncogenesis, the effect of vaccination on invasive cancers will not be evident for decades."
August 26, 2015 '- Human papillomavirus vaccines: WHO position paper, October 2014—Recommendations (full text) "Breastfeeding is not a contraindication for HPV vaccination. Available evidence does not indicate an increased risk of adverse events linked to the vaccine in either the mothers or their babies after administration of HPV vaccine to lactating females. HPV vaccines should not be given to anyone who has experienced a severe allergic reaction after a previous vaccine dose, or to a component of the vaccine. Travellers and health-care workers: Travellers and health-care workers are not at special risk of contracting HPV infection and there are no specific vaccination recommendations for these groups." Comment: HPV isn't infectious with normal contact, "like those in a classroom."
August 10, 2015 - Interventions to Improve Adolescent Vaccination: What May Work and What Still Needs to Be Tested (full text) "Some groups have recently begun to explore the potential for pharmacies to improve adolescent vaccination, particularly for HPV. Multiple barriers have been identified, including reimbursement for vaccination and tracking of provided vaccines. However, given the proven success of pharmacists as vaccinators of adults, finding ways to implement a similar approach for adolescent vaccination may be a fruitful area for future study."
August 7, 2015 - A model of health care provider decision making about HPV vaccination in adolescent males "Most providers agreed with the ACIP recommendations, however, several expressed that providers’ preexisting opinions might remain unchanged despite the recommendations. Consistent with the literature on determinants of HPV vaccination, providers believed that their own recommendation was a major factor in a family's decision to vaccinate. Barriers to vaccination included the “newness” and sexual nature of the vaccine, lack of insurance coverage, and the vaccine not being mandated." Comment: Parents and some providers are against the HPV vaccine, so why not mandate the vaccine by law, taking the choice away from parents and providers. Pharma can triple profits.
August 3, 2015 - Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines "This study in 11- to 15-year-old boys and girls compared the immunogenicity and safety of GARDASIL 9 (9-valent human papillomavirus [9vHPV] vaccine) administered either concomitantly or non-concomitantly with 2 vaccines routinely administered in this age group (Menactra [MCV4; Neisseria meningitidis serotypes A/C/Y/W-135] or Adacel [Tdap; diphtheria/tetanus/acellular pertussis])."..."Concomitant administration of 9vHPV vaccine with MCV4/Tdap was generally well tolerated and did not interfere with the antibody response'' to any of these vaccines. This strategy would minimize the number of visits required to deliver each vaccine individually."
August 2015 - Early Defensive Mechanisms against Human Papillomavirus Infectio[ n] (full text) "The fact that 90% of HPV infections are cleared within 2 years speaks to the success of immune effector mechanisms. Nevertheless, some women harbor persistent HPV infections for years. A prospective study by Scott et al."
August 2015 - Physician communication about adolescent vaccination: How is human papillomavirus vaccine different? "Our findings suggest that primary care physicians perceived HPV vaccine discussions to be burdensome, requiring more time and engendering less parental support than other adolescent vaccines. Perhaps for this reason, physicians in our national study recommended HPV vaccine less strongly than other adolescent vaccine, and often chose to discuss it last. Communication strategies are needed to support physicians in recommending HPV vaccine with greater confidence and efficiency."
August 2015 - Early Defensive Mechanisms against Human Papillomavirus Infectio[ n] (full text) "The fact that 90% of HPV infections are cleared within 2 years speaks to the success of immune effector mechanisms. Nevertheless, some women harbor persistent HPV infections for years. A prospective study by Scott et al."
August 2015 - Implementation and Evaluation of a School-Based Human Papillomavirus Vaccination Program in Rural Kentucky "At the beginning of the school year, all 935 students at the two schools were given HPV vaccination parental consent forms. Five hundred eleven students returned consent forms (55% return rate), and 447 of these students were HPV vaccine naïve (87%). Of these students, 315 (70%) initiated the vaccine series, with 276 (62%) completing the entire three-dose series, so that 88% of students initiating the vaccine series successfully completed the series. In estimating rates for the entire school body, 45% of students had received all three doses by the end of the project. Conclusions Despite study design limitations, results of this project provide further evidence about school-based immunization programs as an effective strategy for improving HPV vaccination rates among 'Kentucky and U.S. adolescents.
August 2015 - Organizational Variation in Implementation of an Evidence-Based Human Papillomavirus Intervention "Although analysi
August 2015 - Physician communication about adolescent vaccination: How is human papillomavirus vaccine different? "Our findings suggest that primary care physicians perceived HPV vaccine discussions to be burdensome, requiring more time and engendering less parental support than other adolescent vaccines. Perhaps for this reason, physicians in our national study recommended HPV vaccine less strongly than other adolescent vaccines, and often chose to discuss it last. Communication strategies are needed to support physicians in recommending HPV vaccine with greater confidence and efficiency."
July 15, 2015 - Do Vitamin D Levels Affect Antibody Titers Produced in Response to HPV Vaccine? "In linear regression analyses, antibody titers for all HPV strains were significantly higher among those with lower vitamin D levels and among younger participants (P<0.05). These relationships add to the body of knowledge of the complex role of vitamin D in immunoregulation."
July 9, 2015 - Immunogenicity and safety of the human papillomavirus vaccine in patients with autoimmune diseases: A systematic review "The results of our literature revision suggest that the HPV vaccines are efficacious and safe in most of the patients affected by autoimmune diseases. Yet, some points of concern remain to be tackled, including the effects of concomitant therapies, the risk of disease exacerbation and the cost-effectiveness of such immunisation programmes in these populations."
July 7, 2015 - ‘I didn't even know boys could get the vaccine’: Parents' reasons for human papillomavirus (HPV) vaccination decision making for their sons "Using the precaution adoption process model (PAPM), parents were classified according to one of six stages of decision making: unaware, unengaged, undecided, decided not to vaccinate, decided to vaccinate, or vaccinated. Parents responded to an open-ended question: ‘What would influence your decision to have your son vaccinated or not against HPV?’
June 10, 2015 - Associations Between Exposure to and Expression of Negative Opinions About Human Papillomavirus Vaccines on Social Media: An Observational Study (full text) "Conclusions: The heterogeneous community structure on Twitter appears to skew the information to which users are exposed in relation to HPV vaccines. We found that among users that tweeted about HPV vaccines, those who were more often exposed to negative opinions were more likely to subsequently post negative opinions." Comment: Wonder how much money went into this conclusion?
June 2015 - The first steps towards the era of personalized vaccinology: predicting adverse reactions (full text) "As an example, we estimated recently the incidence of post-HPV vaccine ADEM to be of 0.26/106 vaccinations (CI 95%: 0.16/106–0.37/106). Even assuming a 10-fold higher incidence because of biases such under-reporting to the surveillance databases, still the retrieving of a number of case large enough would require a large scale, national or international study."..."On the basis of the data reviewed above, we feel that a correlation between vaccine adverse reactions and genetics exists and deserves further studies. The idea of identifying the genetic variants predictive for vaccine adverse events and suitable for the introduction in clinical practice is, in our opinion, feasible as the cost of genotyping is falling rapidly and large-scale genotyping at birth is not too far off the horizon."
June 2015 - An Open-Label, Randomized Study of a 9-Valent Human Papillomavirus Vaccine Given Concomitantly with Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccines to Healthy Adolescents 11–15 Years of Age (full text)
June 2015 - Associations Between Exposure to and Expression of Negative Opinions About Human Papillomavirus Vaccines on Social Media: An Observational Study "During the 6-month period, 25.13% (20,994/83,551) of tweets were classified as negative; among the 30,621 users that tweeted about HPV vaccines, 9046 (29.54%) were exposed to a majority of negative tweets. The likelihood of a user posting a negative tweet after exposure to a majority of negative opinions was 37.78% (2780/7361) compared to 10.92% (1234/11,296) for users who were exposed to a majority of positive and neutral tweets corresponding to a relative risk of 3.46 (95% CI 3.25-3.67, P<.001)."
June 2015 - The first steps towards the era of personalized vaccinology: predicting adverse reactions (full text) "As an example, we estimated recently the incidence of post-HPV vaccine ADEM to be of 0.26/106 vaccinations (CI 95%: 0.16/106–0.37/106). Even assuming a 10-fold higher incidence because of biases such under-reporting to the surveillance databases, still the retrieving of a number of case large enough would require a large scale, national or international study."..."On the basis of the data reviewed above we feel that a correlation between vaccine adverse reactions and genetics exists and deserves further studies. The idea of identifying the genetic variants predictive for vaccine adverse events and suitable for the introduction in clinical practice is, in our opinion, feasible as the cost of genotyping is falling rapidly and large-scale genotyping at birth is not too far off the horizon."
June 2015 - Updated, augmented vaccines compete with original antigenic sin "What worries some researchers is that individuals who already received vaccination against HPV will not respond to the augmented vaccine version with more strains because of an immunological concept known as ‘original antigenic sin.’?
June 2015 - Updated, augmented vaccines compete with original antigenic sin "What worries some researchers is that individuals who already received vaccination against HPV will not respond to the augmented vaccine version with more strains because of an immunological concept known as ‘original antigenic sin.’
June 2015 - Cost-effectiveness of Chlamydia Vaccination Programs for Young Women "Models of the effect and cost-effectiveness of human papillomavirus (HPV) vaccine were developed before HPV vaccines were approved for use in the United States. These models, as well as subsequent models they helped to inform, proved valuable to public health officials and policymakers. Our exploratory model is intended to help advance the discussion surrounding the development of a successful chlamydia vaccine, to inform the business case for investing in research and development of chlamydia vaccines, and to promote development of more detailed models so that the necessary tools are in place for chlamydia vaccine recommendations."
June 2015 - Associations Between Exposure to and Expression of Negative Opinions About Human Papillomavirus Vaccines on Social Media: An Observational Study "During the 6-month period, 25.13% (20,994/83,551) of tweets were classified as negative; among the 30,621 users that tweeted about HPV vaccines, 9046 (29.54%) were exposed to a majority of negative tweets. The likelihood of a user posting a negative tweet after exposure to a majority of negative opinions was 37.78% (2780/7361) compared to 10.92% (1234/11,296) for users who were exposed to a majority of positive and neutral tweets corresponding to a relative risk of 3.46." Comment: Wonder how much money went into this conclusion?
May 15, 2015 - Actions improving HPV vaccination uptake – Results from a national survey in Italy "The synergy of multiple interventions is necessary for a successful vaccination programme. Practices such as pre-assigning vaccination date and repeatedly recalling non-respondents could improve vaccination uptake. Efforts are required to strengthen the training of different professional profiles and services and encourage their collaboration. Economical resources are needed to promote vaccination."
May 2015 - Seroprevalence and Seroincidence of Herpes Simplex Virus (2006–2010), Syphilis (2006–2010), and Vaccine-Preventable Human Papillomavirus Subtypes (2000–2010) Among US Military Personnel "Conclusions: Sexually transmitted infections in military populations are highly prevalent, incident, and epidemiologically distinct. Our data show the rates of HPV and HSV-1/2 acquisition that are higher than those seen in the general public, again highlighting the need for continued preventive efforts. Consideration of universal HPV vaccination among men is warranted."
May 2015 - Association between mother-child sexual communication and HPV vaccine uptake
- Mother–child communication on sexual topics was associated with HPV vaccine uptake.
- For daughters, the association was for discussing sex, STDs and contraception.
- For sons, the association was for discussing STDs and condoms, but not sex.
- These positive associations were for child HPV vaccine initiation, not completion.
- Teaching mothers how to discuss sexual topics may improve child HPV vaccine uptake.
April 24, 2015 - Determination of freeze damage on HPV vaccines by use of flow cytometry "Additional experiments showed that the HPV vaccines could be degraded to smaller particles by citric acid/phosphate buffer treatment. The majority of particles detected in degraded Gardasil were very small indicating that the particles are HPV virus like particle (VLPs) labeled with antibodies, but Cervarix could only be degraded' partially 'due to the presence of another type adjuvant in this vaccine."
April 8, 2015 - Acceptability of using standing orders to deliver human papillomavirus vaccines in the outpatient obstetrician/gynecologist setting "Acceptability of standing orders for HPV vaccines was higher for series completion than initiation (88% vs. 70%, p < 0.001) and was more commonly supported for adult patients (79%) than for adolescents (43%). Acceptability of standing orders increased if the patient was first told that the provider ‘strongly recommended the vaccine’, even for a majority (52%) of those who generally were not comfortable receiving the vaccine using standing orders."
March–April, 2015 - Why Are U.S. Girls Getting Meningococcal But Not Human Papilloma Virus Vaccines? Comparison of Factors Associated with Human Papilloma Virus and Meningococcal Vaccination Among Adolescent Girls 2008 to 2012 "However, White girls were 10% more likely to report provider recommendatio'n than Black or Hispanic girls, yet did not have higher vaccination rates, 'implying a role for parental refusal. No factors predicted consistently the completion of the HPV vaccine series among those who started."..."Improving provider recommendation for co-administration of HPV and meningococcal vaccines would reduce missed opportunities for initiating the HPV vaccine series. However, different interventions may be necessary to improve series completion."
March 31, 2015 - An Open-Label, Randomized Study of a 9-Valent Human Papillomavirus Vaccine Given Concomitantly with Diphtheria, Tetanus, Pertussis, and Poliomyelitis Vaccines to Healthy Adolescents 11 to 15 Years of Age. "There were no vaccine-related serious AEs. Conclusion: Overall, concomitant administration of 9vHPV vaccine and REPEVAX was generally well tolerated and did not interfere with the immune response to either vaccine. This strategy would minimize the number of visits required to deliver each vaccine individually. NCT01073293" "'Sponsor: Merck Sharp & Dohme Corp." Comment: The statement there were no vaccine-related serious AE's is a 'bald-faced' lie. How do they get away with this? What is their criteria? See here Other Adverse Events
March 30, 2015 - Vaccine hesitancy among parents of adolescents and its association with vaccine uptake "We determined the vaccination status of the parents’ adolescents for 3 vaccines (Tetanus–diphtheria–acellular pertussis [Tdap], meningococcal conjugate [MCV4], and human papillomavirus [HPV] vaccines). We used Fisher's exact tests to compare vaccination status with each survey item and with an overall general hesitancy scale that we constructed. Results We analyzed 363 surveys. At the time of the visit, vaccination coverage was 84% for Tdap, 73% for MCV, and 45% for any dose of HPV. Thirty-nine percent of parents expressed concern about vaccine efficacy and 41% expressed concern about side effects. Nearly 45% 'of parents disagreed with the statement that “teens can get all of the vaccines that are due at a single visit.”
March 14, 2015 - The impact of non-financial and financial encouragements on participation in non-school-based human papillomavirus vaccination: a retrospective cohort study "The combined personal information and 'financial incentive campaign' increased vaccination initiation among certain age groups. One year after the campaign the difference in percentage points for HPV vaccination initiation between intervention and control groups varied between 18.5 % (z = 3.65, p = 0.0002) and 5.1 % (z = 1.12, p = 0.26)."
January 29, 2015 - Age at HPV vaccine initiation and completion among US adolescent girls: Trend from 2008 to 2012 "Additional efforts are needed to increase HPV vaccine uptake among adolescent girls as only half of them receive this vaccine at ACIP recommended age."
January 15, 2015 - The Cost-effectiveness of Human Papillomavirus Vaccine Catch-up Programs for Women (full text) "For example, what if the population of young adult women who have acquired and cleared HPV consists disproportionately of those who are predisposed not to develop HPV-related sequelae? In such instances, the cost-effectiveness of vaccinating these young adults might be less favorable than suggested by models that do not allow for this possibility."
January 15, 2015 - Too Late to Vaccinate? The Incremental Benefits and Cost-effectiveness of a Delayed Catch-up Program Using the 4-Valent Human Papillomavirus Vaccine in Norway "The incremental benefits and cost-effectiveness decreased as the upper age limit for catch-up increased. Assuming a vaccine cost of $150/dose, vaccination up to age 20 years remained below Norway's willingness-to-pay threshold (approximately $83 000/quality-adjusted life year gained); extension to age 22 years was cost-effective at a lower cost per dose ($50–$75)."
MEDINFO 2015 - Using social connection information to improve opinion mining: Identifying negative sentiment about HPV vaccines on Twitter "The manner in which people preferentially interact with others like themselves suggests that information about social connections may be useful in the surveillance of opinions for public health purposes. We examined if social connection information from tweets about human papillomavirus (HPV) vaccines could be used to train classifiers that identify anti-vaccine opinions."
December 29, 2014 - FDA Summary Basis for Regulatory Action Gardasil 9 (pdf) - Summary of Bias for regulatory action for Gardasil:
- "Thus, compared with GARDASIL, GARDASIL 9 contains 2.25-fold more total protein antigen (270 µg vs. 120 µg) and 2.22-fold more aluminum adjuvant (500 µg vs. 225 µg)."...
- "GARDASIL 9 and GARDASIL treatment groups except for multiple sclerosis (MS); there were '5 cases of MS' in the GARDASIL 9 group compared with 2 cases in the GARDASIL group. The clinical significance of this apparent imbalance is unclear due to the small case numbers involved. The incidence rate of MS in the GARDASIL 9 group is within the limits of the population background. Post-marketing assessment for immune-mediated medical conditions will be conducted using the FDA Mini-Sentinel surveillance system."...
- "Spontaneous abortions and other pregnancy-related outcome data for GARDASIL 9 will be collected through a post-marketing pregnancy registry 'conducted by Merck (using the same methodology as the pregnancy registry for GARDASIL). In addition, a post-marketing targeted observational study through the Vaccine Safety Datalink (VSD) administered by the Centers for Disease Control and Prevention (CDC) is being considered. Consultations are ongoing between CBER and CDC on a VSD study protocol for assessing SA in recipients of GARDASIL 9'."
December 26, 2014 - Vaccinating Sons against HPV: Results from a U.S. National Survey of Parents - Previous publications representing data on both males and females suggest that having health 'insurance is related to increased HPV vaccine initiation which may be related to public vaccine programs such as the Vaccines for Children Program.
December 12, 2014 - Anti-Cancer Vaccines — A One-Hit Wonder? (full text) "In terms of drawbacks to the vaccines themselves, there have been side effects reported after vaccine administration. One of the biggest fears is the lack of selectivity of TAAs that can potentially lead to autoimmunity occurring in the patient. For example, cases of vitiligo (a condition that results in blotches of pigmentation loss in the skin) have been reported in patients receiving a melanoma vaccine."..."Examples of anti-cancer vaccine adjuvants currently approved for use in clinical practice include aluminum salts (alum), monophosphoryl lipid A (MPL) in an oil-in-water emulsion (known as MF59), and a combination of MPL and alum known as AS04. Alum and oil-in-water emulsions both act as a vehicle, delivering and controlling the release of the vaccine antigen to the host immune system. They can also directly stimulate the innate immune system through an inflammatory response, which, in turn, facilitates and amplifies a cell-mediated or humoral immune response. MPL is derived from lipopolysaccharide (LPS), a pattern-associated molecular pattern (PAMP) recognized by a pattern recognition receptor (PRR), T'oll-like receptor 4 (TLR4). AS04 is licensed for use as an adjuvant in Fendrix (a HBV vaccine) and Cervarix (a HPV vaccine).
November 13, 2014 - Docosahexaenoic acid induces the degradation of HPV E6/E7 oncoproteins by activating the ubiquitin-proteasome system (full text) "Docosahexaenoic acid (DHA), the most unsaturated omega-3 fatty acid, has been demonstrated to possess pro-apoptotic activity against tumor cells."
October 29, 2014 - Invited Commentary: Multiple Human Papillomavirus Infections and Type Replacement—Anticipating the Future After Human Papillomavirus Vaccination "In this issue of the Journal, Yang et al. (Am J Epidemiol. 2014;000(00):000–000) report on concurrent infections with multiple HPV types in unvaccinated women who underwent cervical screening in New Mexico (December 2007–April 2009) to identify possible interactions between HPV types, which if present could suggest the possibility of type replacement.
October 20, 2014 - Vaccines and the Risk of Multiple Sclerosis and Other Central Nervous System Demyelinating Disease[ s] "The short-term increase in risk suggests that vaccines may accelerate the transition from subclinical to overt autoimmunity in patients with existing disease. Our findings support clinical anecdotes of CNS ADS symptom onset shortly after vaccination but do not suggest a need for a change in vaccine policy."Type replacement may be of less concern with the introduction of multivalent vaccines that include most of the carcinogenic HPV types; continued surveillance postvaccination should improve our understanding of the impact of HPV vaccination on type distribution and screening performance
October 21, 2014 - Parent perceptions important for HPV vaccine initiation among low income adolescent girls "Compared to parents without recommendations, parents with strong recommendations had 2 to 7 times higher odds of agreeing that: vaccines are safe, the HPV vaccine is safe, not concerned about side effects, and the vaccine prevents cervical cancer. Even when considering provider recommendation strength, HPV vaccine series initiation was more likely among girls of parents who agreed rather than disagreed that the HPV vaccine was safe" Comment: Note "low" income. Why are they breaking this down by income? It's been proven in studies before higher income, and higher education = less HPV vaccination.
October 19, 2014 - Human papillomavirus vaccine uptake among males 11–26 years in United States: Findings from the National Health and Nutrition Examination Survey, 2011–2012 "The corresponding HPV vaccine completion rates were 39.3% (16.7–67.7%) for the 11–17 year=old males and 59.1% (37.2–77.6) for the 18–26-year-old males. Despite a slight increase, HPV vaccine uptake remained low among males. These findings can help in HPV vaccination policy in the United States, with a focus on informational messages directed toward 'young males and their parents' in order 'to increase uptake of HPV vaccine."
October 12, 2014 - Individual- and Regional-level determinants of Human Papillomavirus (HPV) vaccine refusal: the Ontario grade 8 HPV vaccine cohort study (pdf) "Our cohort consisted of 144,047 girls, 49.3% of whom refused HPV vaccination. Factors associated with refusal included a previous diagnosis of Down’s syndrome. or autism, Few physician visits and previous refusal of mandatory and optional vaccines. Refusal was highest among the lowest and highest income levels."
October 7, 2014 - Comparing the cost-effectiveness of two- and three-dose schedules of human papillomavirus vaccination: A transmission-dynamic modelling study (full text) "Two-dose HPV vaccination is likely to be cost-effective 'if its duration of protection is at least 10 years. A third dose of HPV vaccine is unlikely to be cost-effective if two-dose duration of 'protection is longer than 30 years. Finally, two-dose girls & boys HPV vaccination is 'unlikely to be cost-effective unless the cost per dose for boys is substantially lower than the cost for girls."
October 6, 2014 - Adult Vaccination Disparities Among Foreign-Born Populations in the U.S., 2012 "Among the foreign born, vaccination coverage was generally lower for non-U.S. citizens, recent immigrants, and those interviewed in a language other than English. Foreign-born individuals were less likely than U.S.-born people to be vaccinated for pneumococcal (≥65 years), tetanus, Tdap, and HPV (women) after adjusting for confounders. Conclusions: Vaccination coverage is lower among foreign-born adults than those born in the U.S. It is important to consider foreign birth and immigration status when assessing vaccination disparities and planning interventions."
October 3, 2014 - Effective Nonvaccine Interventions to Be Considered Alongside Human Papilloma Virus Vaccine Delivery "World Health Organization recommends that girls, ages 9–13 years, get the human papilloma virus (HPV) vaccine. Global Alliance for Vaccines Initiative, which provides low-cost vaccine to eligible countries, requires that an additional intervention to be offered alongside the vaccine. We systematically searched and assessed the published literature in lower- and middle-income countries to identify effective interventions."
October 2, 2014 -Evaluation of Human Papillomavirus Type Replacement Post-vaccination Must Account for Diagnostic Artifacts: Masking of HPV52 by HPV16 in Anogenital Specimens "We observed a positive association between HPV16 viral load (tertiles) and detection of HPV52 (P for trend=0.003). These results indicate that diagnostic artifacts, resulting from unmasking of HPV52, may occur in some settings in the evaluation of HPV type replacement. Additional studies exploring the extent and severity of unmasking are needed." Comment: There are more than 100 strains of HPV. Will this become the next adult pneumococcal vaccine, with 23 antigens? Nature abhors a vacuum. As the viruses are pushed out of the way, more aggressive and virulent viruses fill in the gap. Hey! I have a novel idea: Instead of striving to eliminate a virus, why not improve the underlying health of the cervix? As an exposed organ, it can develop nutritional and hormone deficiencies. If the organ was healthy, the virus would not adhere. Oh, silly me. I forgot that the money is in the cure, not in eliminating the cause. Back to more vaccines and drugs. Health be damned…
September 15, 2014 - Parent and Adolescent Knowledge of HPV and Subsequent Vaccination "Those with higher levels of knowledge were 'not' more likely to obtain vaccination for themselves or their daughters. Ideally, future interventions will target factors related to vaccination.
September 2, 2014 - Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 4-year interim follow-up of the phase 3, double-blind, randomised controlled VIVIANE study "Serious adverse events occurred in 285 (10%) of 2881 women in the vaccine group and 267 (9%) of 2871 in the control group; five (<1%) and eight (<1%) of these events, respectively, were believed to be related to vaccination." Comment: Please look at the full study results here. The control group was given 3 doses of Aluminum Hydroxide.
September 2014 - Immune Responses in Macaques to a Prototype Recombinant Adenovirus Live Oral Human Papillomavirus 16 Vaccine "Here, we characterize the immune response to the recombinant after dual oral and 'intranasal immunization' of pigtail macaques, in which the virus replicates as it would in' 'immunized humans. The immunization of macaques induced vigorous humoral responses to adenovirus capsid and nonstructural proteins, although, surprisingly, not against HPV L1. In contrast, immunization elicited strong T-cell responses to HPV VLPs as well as adenovirus virions. T-cell responses arose immediately after the primary immunization and were boosted by a second immunization with a recombinant virus"
August 23, 2014- HPV catch-up vaccination of young women: a systematic review and meta-analysis (full text) "We examined also adverse events possibly linked to HPV vaccination. We considered only adverse events reported as serious adverse events in the included publications." Comment in the table below study group Patricia had the most serious events. This study is posted in full here Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18
August 18, 2014 - Missed Opportunities for HPV Vaccination in Adolescent Girls: A Qualitative Study "In contrast, providers with high vaccination rates presented HPV vaccination as a 'routine vaccine with proven safety' to prevent cancer, and parents responded positively to these messages."..."Routinely recommending HPV vaccination as cancer prevention to be coadministered with other vaccines at age 11 years can improve vaccination rates."
August 15, 2014 - Naturally Acquired Immunity Against Human Papillomavirus (HPV): Why It Matters in the HPV Vaccine Era "The measurement of HPV antibodies is also important for identifying unvaccinated women who have mounted an antibody response following previous exposure to HPV infection and may, therefore, be naturally protected. However, only approximately half of women seroconvert within 18 months after HPV infection. The interpretation of HPV serology is additionally complicated by substantial differences across assays used in different studies (eg, detection ranges, targeted HPV types, and epitopes). Comment: If women that have already had HPV do not attain immunity by 18 months after the vaccination clearly it isn't working in these women. How many women are getting the vaccine with immunity from natural infection who don't know they even had HPV?
August 15, 2014 - Risk of Newly Detected Infections and Cervical Abnormalities in Women Seropositive for Naturally Acquired Human Papillomavirus Type 16/18 Antibodies: Analysis of the Control Arm of PATRICIA (full text) "In conclusion, this study confirms the utility of control arm data from vaccine efficacy trials in understandingthe acquisition and progression of HPV infections and related cervical abnormalities. The results suggest that naturally acquired antibodies to HPV-16, and to a lesser extent HPV-18, reduce the risk of subsequent infection and associated cervical abnormalities with the same HPV type."
August 6, 2014 - Engaging parents and schools improves uptake of the human papillomavirus (HPV) vaccine: Examining the role of the public health nurse "HPV vaccine initiation was significantly associated with Public Health Nurses providing reminder calls for: consent return (p = 0.017) and missed school clinic (p = 0.004); HPV education to teachers (p < 0.001), and a thank-you note to teachers (p < 0.001). Completion of the HPV series was associated with vaccine consents being returned to the students’ teacher (p = 0.003), and a Public Health Nurse being assigned to a school (p = 0.025). Conclusions These findings can be used to help guide school-based immunization programs for optimal uptake of the HPV vaccine among the student population.
July 31, 2014 - Achieving high uptake of human papillomavirus vaccine in Cameroon: Lessons learned in overcoming challenges "With adequate education of all 'stakeholders, HPV vaccination is acceptable and feasible in Cameroon. Following this demonstration project, in 2014 the Global Access to Vaccines and Immunization (GAVI) Alliance awarded the Cameroon MOH HPV vaccine at a price of US$4.50 per dose to immunize sixth grade girls and girls aged 10 years who are not in school in two districts of Cameroon."
July 25, 2014 - National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13–17 Years — United States, 2013 (full text) 'Finally, some of the state-specific and racial/ethnic-specific analyses might be unreliable because of small sample sizes. Estimates with confidence half-widths wider than 10 are less reliable, and this impacts estimates for some racial and ethnic populations. For HPV coverage analyses by state and sex, small sample sizes decrease the power to detect differences. High Tdap coverage levels among adolescents aged 13–17 years indicate that similar coverage levels are attainable for other vaccines recommended for adolescents. Improved adherence of clinicians and parents to the ACIP recommendation to administer all age-appropriate vaccines during a single visit could substantially increase lagging vaccination coverage levels." Comment: High Tdap coverage levels are high because the vaccinations are mandatory for school attendance. The intention is implied all adolescent vaccines should be mandatory.
July 24, 2014 - The Cost-effectiveness of Human Papillomavirus Vaccine Catch-up Programs for Women "HPV vaccination of young women becomes less cost-effective as the age of vaccination increases, although the importance of age at vaccination can vary considerably across models and there is no consensus on a threshold age at which HPV vaccination ceases to be cost-effective. Third, adding males to a female-only vaccination program is not as cost-effective as female-only vaccination."
July 16, 2014 -Intervention effects from a social marketing campaign to promote HPV vaccination in preteen boys "The Cox model showed an intervention effect (β = 0.29, HR = 1.34, p = .0024), indicating that during the intervention the probability of vaccination increased by 34% in the intervention counties relative to the control counties. Comparisons with HPV vaccination in girls and Tdap and meningococcal vaccination in boys suggest a unique boost for HPV vaccination in boys during the intervention."
July 16, 2014 -Identifying human papillomavirus vaccination practices among primary care providers of minority, low-income and immigrant patient populations "Of 156 physicians randomly selected, 121 eligible providers responded to the survey; 64% were pediatricians, 19% were internists and 17% were family practitioners. Thirty-four percent of respondents reported that they routinely offered HPV vaccine to their eligible patients. Seventy percent of physicians reported that the lack of preventive care visits for patients in the eligible age group limited their ability to recommend the HPV vaccine and 70% of those who reported this barrier do not routinely recommend HPV vaccine."
July 15, 2014 - Physicians' Human Papillomavirus Vaccine Recommendations in the Context of Permissive Guidelines for Male Patients: A National Study "The purpose of this study was to examine and explore factors associated with U.S. physicians' HPV vaccine recommendations to early (ages 11-12), middle (13-17), and late adolescent/young adult (18-26) males."..."Less than 15% of physicians surveyed reported "always" recommending HPV vaccine to male patients following national guidelines for permissive vaccination. Vaccine financing may have affected physicians' vaccine recommendations. Impact: If these recommendation practices continue following the ACIP's routine recommendation for males in October 2011, then interventions designed to increase recommendations should target family physicians and possibly utilize early adopters to encourage support of HPV vaccination guidelines."
July 9, 2014 - Effect on HPV vaccination in Japan resulting from news report of adverse events and suspension of governmental recommendation for HPV vaccination "The recognition rate of the news of the vaccine’s adverse events was 80 %; it was 68 % for awareness of the government’s announcement of the suspension of its recommendation for the vaccine. Among those who had a chance to hear or see the negative news during their vaccination period, 46 (60 %) continued vaccination while knowing of the news, 22 (29 %) discontinued vaccination, and 9 (11 %) continued vaccination without an awareness of the news. Reports of the vaccine’s adverse events were the main reason for not continuing the vaccination series." Comment: After knowing the vaccine was suspended how could you still receive it?
July 9, 2014 - Barriers and facilitators to HPV vaccination of young women in high-income countries: a qualitative systematic review and evidence synthesis (pdf) "In the USA, routine HPV vaccination was recommended for girls between ages 11 and 12 by the National Advisory Committee on Immunisation Practices (ACIP) in 2006. However, whether a vaccine should be mandatory for school attendance is predominantly decided by state legislatures and is subject to debate. At the time the studies were undertaken, policymakers in the USA were not clear that a school-based mandate for the HPV vaccine was appropriate. Lack of transmissibility in the school-setting was felt to undermine the need to a mandate: “I can completely support it in certain kinds of infectious diseases that are a threat in terms of morbidity and mortality and are easily transmitted within a classroom, for example, but HPV is not one of the things” [Policy maker, USA]. Policy makers also considered likely opposition from ‘anti-vaccination’ groups."
July 7, 2014 - Increasing Provision of Adolescent Vaccines in Primary Care: A Randomized Controlled Trial "At the 5-month follow-up, AFIX consultations increased vaccine coverage among younger adolescents. Patients in the in-person arm experienced coverage changes that exceeded those in the control arm for Tdap (3.4% [95% confidence interval (CI): 2.2 to 4.6]), meningococcal (4.7% [95% CI: 2.3 to 7.2], and HPV (1.5% [95% CI: 0.3 to 2.7]) vaccines. Patients in the webinar versus control arm also experienced larger changes for these vaccines. AFIX did little to improve coverage among older adolescents."..."AFIX consultations for adolescents need improvement to have a stronger and more durable impact, especially for HPV vaccine."
June 30, 2014 - Acceptability of the human papillomavirus vaccine and reasons for non-vaccination among parents of adolescent sons "Parents citing only logistical reasons for non-vaccination (e.g., lack of recommendation, access, or education, n = 384) reported significantly higher vaccine acceptability than parents reporting a combination of attitudinal (e.g., concerns about vaccine safety or efficacy) and logistical barriers (n = 92), while parents citing only attitudinal barriers (n = 73) reported the lowest level of vaccine acceptability." Comment: Smart parents would give a benign short answer to a question about HPV for boys, and have no intentions of considering the vaccine for their son.
June 26, 2014 - Costs of Introducing and Delivering HPV Vaccines in Low and Lower Middle Income Countries: Inputs for GAVI Policy on Introduction Grant Support to Countries (full text) "Average recurrent financial costs for nationwide introduction ranged from $3.51 per eligible girl for implementation of HPV vaccination through health facilities in Tanzania to $4.78 for HPV vaccination through schools in Tanzania. Similar to introduction costs, the recurrent costs for nationwide scale-up differed from those of pilot projects, since more national costs such as supervision and monitoring and evaluation are included than would be found in pilot projects. In addition, two out of three of these countries are African and have lower population density, driving up the recurrent costs." Comment: Consider this, in the US, the government pays $91.20 for 10 doses of Gardasil; the private sector pays $141.38. For Cervarix, the government pays $86.59 for 10 doses; private sector doctors pay $128.75. The only reason it is possible to manufacture, distribute and administer this expensive, toxic vaccine for less than $5/dose is through an expenditure of the US Government (taxpayer money) and US medical patients (insurance)…and the money put into country-wide programs by GAVI and the Gates Foundation. Bottom line? Pharma wins and children around the world are put at risk of side effects and infertility in countries with marginal medical services to care for serious reactions if they are even recognized.
June 26, 2014 - Is expanding HPV vaccination programs to include school-aged boys likely to be value-for-money: a cost-utility analysis in a country with an existing school-girl program (pdf) "At an assumed local willingness-to-pay threshold of US$29,600, vaccination of 12-year-old boys to achieve the current coverage for girls would not be cost-effective, at US$61,400/QALY gained (95% UI $29,700 to $112,000; OECD purchasing power parities) compared to the current girls-only program, with an assumed vaccine cost of US$59 (NZ$113)."
June 26, 2014 - Costs of Introducing and Delivering HPV Vaccines in Low and Lower Middle Income Countries: Inputs for GAVI Policy on Introduction Grant Support to Countries (full text) "Average recurrent financial costs for nationwide introduction ranged from $3.51 per eligible girl for implementation of HPV vaccination through health facilities in Tanzania to $4.78 for HPV vaccination through schools in Tanzania. Similar to introduction costs, the recurrent costs for nationwide scale-up differed from those of pilot projects, since more national costs such as supervision and monitoring and evaluation are included that would be found in pilot projects. In addition, two out of three of these countries are African and have lower population density, driving up the recurrent costs."Comment: Consider this - in the US, the government pays $91.20 for 10 doses of Gardasil; the private sector pays $141.38. For Cervarix, the government pays $86.59 for 10 doses; private sector doctors pay $128.75. It is only possible to manufacture, distribute and administer this expensive vaccine for less than $5/dose throughout the world is through the expenditure of the US Government (taxpayer money) and US medical patients (insurance)…and the money put into country-wide programs by GAVI and the Gates Foundation. Bottom line? Pharma wins (again) and children around the world are put at risk of side effects, including primary ovarian failure and infertility in countries with marginal medical services to care for other autoimmune and neurological reactions.
June 24, 2014 - Mind the gaps: What's missing from current economic evaluations of universal HPV vaccination? "Decisions to invest in universal HPV vaccination need to be based on a complete assessment of the value that it generates. This is not provided by existing economic evaluations. Further work is required to understand this value. First, research is required to understand how HPV-related health outcomes impact on society including, for instance, their impact on productivity. Second, consideration should be given to alternative approaches to capture this broader set of values in a manner useful to decisions-makers, such as multi-criteria decision analysis."
June 19, 2014 - Uptake of Human Papillomavirus Vaccine Among Adolescent Males and Females: Immunization Information System Sentinel Sites, 2009–2012 "HPV vaccination coverage increased among adolescents between 2009 and 2012. However, increases among girls were small, and coverage for boys and girls remained below target levels."
June 11, 2014 - Early Policy Responses to the Human Papillomavirus Vaccine in the United States, 2006–2010 "All but five states (Alaska, Delaware, Idaho, New Hampshire, and Wyoming) introduced HPV vaccine bills between 2006 and 2010. Two-thirds of all bills were introduced in 2007. In all, 141 bills were introduced and 23% or 32 bills were enacted. Of the bills that were enacted, 43.8% provided information for parents and schools about the vaccine; 37.5% provided public financing for HPV vaccines; '34.4% were classified as other policies'; 25% created awareness campaigns; 25% required private insurance coverage of the HPV vaccination; 12.5% included voluntary vaccination, and 9.4% mandated vaccination for school entry. One bill reversed prior mandatory vaccination policies. Overall, 91% of enacted HPV vaccine bills did not refer to mandated vaccinations but adopted alternate policy strategies in response to the availability of the new HPV vaccine."
May 28, 2014 - School-Based Vaccination Programs and the HPV Vaccine in 16 Appalachian Kentucky School Districts: Results from a Pilot Study "Results suggest that few schools have school-based vaccination programs, and of those that do, very few programs include the HPV vaccine. A majority of respondents reported that information leaflets about HPV are available in the schools, whereas 'few schools include discussions of HPV in their health programs. Almost all respondents reported an excellent relationship with their county health departments, school nurses, and school social workers, although most schools lacked the presence of a school social worker. Implications for social work practice and policy and directions for future research are also discussed." Comment: Will more parents be reported to Child health services who refuse the vaccine?
May 1, 2014 - Staying on track: A cluster randomized controlled trial of automated reminders aimed at increasing human papillomavirus vaccine completion ? "Intervention participants selected their preferred method of reminders – text, e-mail, phone, private Facebook message, or standard mail. We compared vaccine completion rates between groups over a period of 32 weeks."..."The study intervention did not increase HPV vaccine series completion. Despite great public health interest in HPV vaccine completion and reminder technologies, completion rates remain low."
May 2014 - Vaccination Interest and Trends in Human Papillomavirus Vaccine Uptake in Young Adult Women Aged 18 to 26 Years in the United States: An Analysis Using the 2008–2012 National Health Interview Survey "Conclusions. Uptake of HPV vaccine has increased from 2008 to 2012 in young women. Yet vaccination rates remain low, especially among women with limited access to care. However, unvaccinated women with 'limited health care' access were 'more likely to be interested in receiving the vaccine."
April 19, 2014 - Pre-vaccine era human papillomavirus types 6, 11, 16 and 18 seropositivity in the USA, National Health and Nutrition Examination Surveys, 2003–2006 "Background: A vaccine is available to prevent human papillomavirus (HPV) 6, 11, 16 and 18; in the prevaccine era, seropositivity to vaccine types is a measure of natural exposure."..."Almost 25% of the participants were seropositive to any HPV vaccine type but few were seropositive to at least three vaccine HPV types in the prevaccine era. Further study is needed to assess if seropositivity would be useful as a biological marker of vaccination."
April 7, 2014 - HPV vaccination: Are we initiating too late? "Of the subcohort, 36.9% underwent Chlamydia screening before HPV1 receipt (19.1% with ≥1 positive result). Of those with prior Pap screening (16.6%), 32.1% had ≥1 abnormal result. These low-income, minority females frequently delayed initiation of HPV vaccination. Many had evidence of prior sexual experience and associated morbidity, placing them at risk of HPV-related complications. Promoting timely HPV vaccination and reducing missed vaccination opportunities are crucial.
March' 25,' 2014 - Effects of varying antigens and adjuvant systems on the immunogenicity and safety of investigational tetravalent human oncogenic papillomavirus vaccines: Results from two randomized trials "One month after the third injection (Month 7), there was a consistent trend for lower anti-HPV-16 and -18 geometric mean antibody titers' (GMTs) f'or tetravalent AS04-adjuvanted vaccines compared with control. GMTs were statistically significantly lower for an HPV-16/18/31/45 AS04 vaccine containing 20/20/10/10 μg VLPs for both anti-HPV-16 and anti-HPV-18 antibodies, and for an HPV-16/18/33/58 AS04 vaccine containing 20/20/20/20 μg VLPs for anti-HPV-16 antibodies. There was also a trend for lower HPV-16 and -18-specific memory B-cell responses for tetravalent AS04 vaccines versus control."
March 20, 2014 - Toward global prevention of sexually transmitted infections (STIs): The need for STI vaccines (full text) "A great deal will be learned from current implementation of HPV vaccine to inform delivery of future STI vaccines. Most STI vaccines are being developed for early adolescents, to provide maximal protection before and during the time of highest risk. For some vaccines, there may be compelling reasons for infant vaccination in addition to implementation issues, for example, an HSV vaccine that would also protect against HSV-1 infection. Nonetheless, new adolescent platforms for health intervention delivery are needed to respond to a global agenda to improve adolescent health, especially sexual and reproductive health. HPV vaccine implementation is an opportunity to develop these adolescent platforms, which can be used not only for currently recommended prevention services, but also for future STI vaccines. Given common risk factors, high rates of co-infection, and epidemiologic overlap in STI-related complications, combination STI vaccines for adolescents would be an important future goal. HPV vaccine implementation will also provide insight on monitoring vaccine impact, which will need to be considered for other STI vaccines well in advance of vaccine availability."
March 20, 2014 - Microbiome, sex hormones, and immune responses in the reproductive tract: Challenges for vaccine development against sexually transmitted infections (full text) "The success of the HPV vaccine' has re-energized the field of STI vaccine research after earlier disappointing results with HSV and gonorrhea vaccines. There are currently several new candidate HSV and chlamydia vaccines in various stages of development and recent advances in the fields of immunology and vaccine design offer hope for the development of vaccines targeting gonorrhea and syphilis. To optimize vaccine responses against STIs, in addition to optimizing antigen types, formulations, adjuvants, and delivery methods, we need a clear understanding of the interactions taking place at the mucosal surfaces. Vaccine development must take into account the differences between the systemic and mucosal immune responses, the compartmentalization of the mucosal immune responses, the unique characteristics of the reproductive tract mucosae, the role of the microbiome, the impact of sex hormones, and the interactions among all of these factors. We are just beginning to decipher these complex relationships.
March 18, 2014 - Postural Orthostatic Tachycardia With Chronic Fatigue After HPV Vaccination as Part of the “Autoimmune/Auto-inflammatory Syndrome Induced by Adjuvants” - Case Report and Literature Review (full text) "Ours is the seventh case of POTS associated with the qHPV vaccine Gardasil reported in the literature. In addition, POTS following administration of the novel H1N1 influenza vaccine was reported recently. Recently, Blitshteyn reported six cases of POTS following HPV vaccination. In this case series, all six previously healthy young women (aged 12 to 22 years) developed symptoms of POTS within 6 days to 2 months after vaccination with the Gardasil HPV vaccine."..."It is of further relevance to note that the safety trials for Gardasil (which is an aluminum-adjuvanted vaccine) did not include a true inactive placebo but rather an aluminum-adjuvant-containing placebo, despite much data showing that aluminum in vaccine-relevant exposures can be toxic to humans.
March 2014 - The spectrum of post-vaccination inflammatory CNS demyelinating syndromes "In terms of the clinical presentation and the affected CNS areas, there is a great diversity among the reported cases of post-vaccination acute demyelinating syndromes. Optic neuritis was the prominent clinical presentation in 38 cases, multifocal disseminated demyelination in 30, myelitis in 24 and encephalitis in 17. Interestingly in 'a rather high proportion of the patients (and 'especially following influenza and human papiloma virus vaccination-HPV') the dominant localizations of demyelination were the optic nerves and the myelon, presenting as optic neuritis and myelitis (with or without additional manifestations of ADEM), reminiscent to neuromyelitic optica - NMO (or, more generally, the NMO-spectrum of diseases). Seven patients suffered an NMO-like disease following HPV and we had two similar cases in our Center. One patient with post-vaccination ADEM, subsequently developed NMO."
February 3, 2014 - Overcoming barriers to HPV vaccination: Non-inferiority of antibody response to human papillomavirus 16/18 vaccine in adolescents vaccinated with a two-dose vs. a three-dose schedule at 21 months "The reduction in the number of doses from the current three-dose schedule may lower overall costs associated with the vaccination and increase accessibility and compliance with the recommended dosing of the HPV vaccine."
February 1, 2014 - Multiple evanescent white dot syndrome after human papillomavirus vaccination (full text) "This case of MEWDS after HPV vaccination showed progressive concentric visual field loss. FA revealed a dramatic response to immunosuppressive therapy. This supports the hypothesis that the cause of MEWDS is related to immune function.
January 31, 2014 -School-based vaccination of young US males: Impact of health beliefs on intent and first dose acceptance "Little is known about adolescent males and their parents with respect to intent and first dose uptake of the human papillomavirus (HPV) vaccine outside of primay care settings. The purpose of this study was to evaluate potential predictors of parental intent to vaccinate (study was conducted in November 2010–December 2012) and of first dose uptake of HPV vaccine among a sample of young adolescent males, 11–15 years of age, who received care 'at a school-based health center' (SBHC)."
January 24, 2014 - On the relationship between human papilloma virus vaccine and autoimmune diseases "We have thus analysed and reviewed comprehensively all case reports and studies dealing with either the onset of an autoimmune disease in vaccinated subject or the safety in patients with autoimmune diseases to define the role of the HPV vaccines in these diseases and hence its safety. A solid evidence of causal relationship was provided in few cases in the examined studies, and the 'risk vs. benefit of vaccination is still to be solved. The on-going vigilance for the safety of this vaccine remains thus of paramount importance.
January 24, 2014 - Delay and Refusal of Human Papillomavirus Vaccine for Girls, National Immunization Survey-Teen, 2010 "A significantly higher proportion of parents of girls who were non-Hispanic white, lived in households with higher incomes, and had mothers with higher education levels, delayed and/or refused vaccination. The most common reasons for non-vaccination were concerns about lasting health problems from the vaccine, wondering about the vaccine’s effectiveness, and believing the vaccine is not needed."
January 2014 - Physicians’ Human Papillomavirus Vaccine Recommendations, 2009 and 2011 "Results suggest a modest increase in recommendations for HPV vaccination of girls aged 11 or 12 years over a 2-year period; however, recommendations remain suboptimal for all age groups despite national recommendations for universal immunization."
December 31, 2013 - Human Papillomavirus Prevalence and Type-Distribution, Cervical Cancer Screening Practices and Current Status of Vaccination Implementation in Central and Eastern Europe "The key reasons for lack of implementation of HPV vaccination into the national immunization programme are high vaccine cost and negative public perception."
December 17, 2013 - Acceptability and uptake of female adolescent HPV vaccination in Hong Kong: A survey of mothers and adolescents "Policymakers should devise tailored, targeted and efficient vaccination strategies to achieve universal coverage for an effectively organized HPV vaccination program."
December 16, 2013 - Overcoming barriers to HPV vaccination: Non-inferiority of antibody response to human papillomavirus 16/18 vaccine in adolescents vaccinated with a two-dose vs. a three-dose schedule at 21 months (full text)
Adverse Events
Study staff recorded safety profile assessments of local symptoms (pain and redness at the injection site) and general symptoms (fever, headache, fatigue, and gastrointestinal symptoms that included nausea, vomiting, diarrhea and/or abdominal pain, arthralgia, myalgia, urticaria and rash) at the next scheduled appointment after administration of each vaccine. Staff also inquired about and recorded any serious adverse events at each contact, and among withdrawals.
December 16, 2013 - Not the right time: why parents refuse to let their daughters have the human papillomavirus vaccination "The decision-making process was complex. These parents preferred to wait until their daughter was older and believed the information they received from the school health system was insufficient. The results indicate that a more flexible HPV vaccination schedule may improve vaccine uptake. This includes more transparent information about the virus and the vaccine and information about who to contact to get the daughter vaccinated at a later date."
December 11, 2013 - The Australian Experience With the Human Papillomavirus Vaccine "To achieve this outcome requires government endorsement and commitment; education of the community at large; realization of the safety, efficacy, and immunogenicity of the available prophylactic vaccines in reducing HPV-related infections and disease, especially neoplasia; and governments procuring vaccines at affordable prices through the various options now available (eg, support from the GAVI Alliance to eligible countries, tiered pricing, negotiation with pharmaceutical manufacturers). We have the tools to reach this goal, and it is time these tools were implemented."
December 3, 2013 - Parent and provider perspectives on immunization: Are providers overestimating parental concerns? "Providers underestimated parental attitudes toward vaccine importance (particularly influenza and HPV), and overestimated the proportion of parents who thought route of administration mattered (63%) and that number of injections per visit was the most important factor (76%) around parental vaccine decisions (P < 0.001 for parent–provider mismatch)."
December 1, 2013 - Literature review of HPV vaccine delivery strategies: Considerations for school- and non-school based immunization program "School-based programs achieved high HPV vaccination coverage rates in 9 to 13-year-old girls across the different studies and geographic locations, suggesting non-health facility-based programs are possible for HPV vaccine introduction. Grade-based, compared to age-based, eligibility criteria may be easier to implement in school settings. More studies are needed to explore the methods to standardize estimates for HPV vaccine coverage so that programs can be appropriately evaluated."
November 25, 2013 - French link between Gardasil and multiple sclerosis - Gardasil Vaccine: Charges Filed against Laboratoire Sanofi Pasteur MSD "On November 7th, 2013, members of the vaccine injury community held a briefing for congressional staffers to present many of the problems in the Vaccine Injury Compensation Program in preparation for hearings in the House Oversight and Government Reform Committee.
November 25, 2013 - Barriers to Human Papillomavirus Vaccination Among US Adolescents "Health care professionals may benefit from guidance on communicating HPV recommendations to patients and parents. Further efforts are also needed to reduce missed opportunities for HPV vaccination when adolescents interface with the health care system. Efforts to increase uptake should take into account the specific needs of subgroups within the population. Efforts that address system-level barriers to vaccination may help to increase overall HPV vaccine uptake."
November 14, 2013 - Motor palsies of cranial nerves (excluding VII) after vaccination: Reports to the US Vaccine Adverse Event Reporting System (full text) Cranial nerve palsies were reported after a wide variety of vaccines (Table 3). Most reports (43; 63%) listed a single vaccine. Among reports listing single vaccines, the most common vaccines were influenza vaccine, Gardasil, influenza H1N1, and zoster vaccine live. Among reports listing multiple vaccines, the most common vaccines included hepatitis A vaccine; measles, mumps, and rubella vaccine live; diphtheria and tetanus toxoids and acellular pertussis vaccine; Hemophilus influenzae type b vaccine; and pneumococcal conjugate vaccine 7-valent. There was no conspicuous clustering of live or inactivated vaccines with palsies of particular cranial nerves. Comment: In other words, almost every vaccine had a traceable side effect.
November 5, 2013 - Estimation of HPV prevalence in young women in Scotland; monitoring of future vaccine impact (full text) "Baseline pre-immunisation levels of the vaccine-specific types were high, with HPV 16 the more common than HPV 18. The aggregate occurrence of non-vaccine types, in particular, 'those deemed to be high-risk', is more prevalent than the vaccine-specific types and our results are comparable to those of other recent UK based studies."
November 3, 2013 - Human Papilloma Virus Vaccine Associated Uveitis. "A total of 24 case reports of uveitis associated with human papillomavirus vaccination were identified, all cases were female, and the median age was 17. Median time from HPV vaccination to reported ADR was 30 days (range 0-476 days).Discussion: According to World Health Organization criteria, the relationship between human papillomavirus vaccination and uveitis is "possible." Causality assessments are based on the time relationship of drug administration, uveitis development and re-challenge data. Conclusions: Clinicians should be aware of possible bilateral uveitis and papillitis following HPV vaccination."
October '25, 2013 - Health Disparities in Human Papillomavirus Vaccine Coverage: Trends Analysis From the National Immunization Survey–Teen, 2008–2011 "We evaluated HPV vaccine uptake patterns over 2008–2011 by race/ethnicity, poverty status, and the combination of race/ethnicity and poverty status, utilizing National Immunization Survey–Teen data. Minority and below-poverty adolescents consistently had higher series initiation than white and above-poverty adolescents."
September 26, 2013 - Vaccinating Women Previously Exposed to Human Papillomavirus: A Cost-Effectiveness Analysis of the Bivalent Vaccine (full text) "Competing interests: Geoff Garnett has acted as consultant for and/or received grants for other studies from Sanofi Pasteur MSD, Merck, and GSK. Hugo Turner and Iacopo Baussano have no competing interests. This does not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials."..."The incremental cost of extending the vaccine programme increased with the inclusion of older age groups (see Table 2). However it should be noted that the true incremental cost of extending the vaccine programme will be highly depended on the cost of the vaccine. The vaccination programme generated some cost savings to the health service (approximately £336 million for the current UK strategy) by reducing the number of treatments (for precancerous lesions and cervical cancers), but these savings were outweighed by the cost of the vaccination programme itself."
September 23, 2013 - A universal virus-like particle-based vaccine for human papillomavirus: Longevity of protection and role of endogenous and exogenous adjuvants "We also show that exogenous and endogenous adjuvants (LPS and encapsidated single-stranded RNA) have minor effects on antibody titers. Immunization with VLPs containing encapsidated ssRNA predominantly shifts the response to a Th1, rather than a Th2-like response. Importantly, immunization with L2-VLPs (without endogenous and exogenous adjuvants) in the presence of alum hydroxide elicited a robust antibody response."
September 16, 2013 - Postural tachycardia syndrome following human papillomavirus vaccination "Six patients who developed new-onset POTS 6 days to 2 months following human papillomavirus vaccination are reported. Three patients also had neuro-cardiogenic syncope, and three patients were diagnosed with possible small fiber neuropathy. Symptoms in all patients improved over 3 years with pharmacotherapy and non-pharmacological measures but residual symptoms persisted. Molecular mimicry with the formation of cross-reacting autoantibodies to the potential targets of the autonomic ganglia, neurons, cardiac proteins or vascular receptors is considered as possible pathogenesis of new-onset POTS after immunization. Conclusion: Correct diagnosis of POTS and awareness that POTS may occur after vaccination in young women is essential for prompt and effective management of this condition."
September 16, 2013 - Maternal Underestimation of Child's Sexual Experience: Suggested Implications for HPV Vaccine Uptake at Recommended Ages "Despite the official recommendation for routine HPV vaccination of boys and girls at age 11–12 years, parents and providers are more likely to vaccinate their children/patients at older ages. Preferences for vaccinating older adolescents may be related to beliefs about an adolescent's sexual experience or perceived parental resistance to vaccinating children who are assumed to be sexually inexperienced."
August 31, 2013 - HPV vaccination program in Japan "Although HPV vaccination has just been included in the routine vaccination schedule and publicly funded since April 2013, a new health directive advises prefectural governors not to actively recommend the vaccine, and to cease all vaccine promotion. However, health facilities are to continue to offer parents seeking the vaccine full support, and facilitate vaccine access. Such advice obviously creates enormous confusion for public health officials, doctors, and parents. A joint meeting of the Vaccine Adverse Reactions Review Committee (VARRC) has indicated that they might remove HPV vaccination from the schedule, despite evidence of its cost-effectiveness in Japan."
August 28, 2013 - Racial Disparities in Human Papillomavirus Vaccination: Does Access Matter? "Lower rates of HPV vaccination among African-American females do not appear to be explained by differential access to health care. More research is necessary to elucidate factors contributing to HPV vaccination in this population."
August 2013 - The ‘Trojan horse’ oncogenic strategy of HPVs in childhood "The presence of high-risk HPVs in the neonatal oral mucosa supports the transmission of HPVs from the mother to her newborn. This review presents current evidence that supports the perinatal transmission of high-risk HPVs and suggests that this may be the initial step of the oncogenic strategy of high-risk HPVs in humans. The hypothesis that children are a unique reservoir of silent high-risk HPVs, analogously to the Trojan horse, should be investigated further." Comment: Is this a Trojan horse to add the HPV vaccine to the pediatric vaccination schedule? It was the smallpox era that claimed the children were filthy niduses of disease.
July 31, 2013 - Human Papilloma Virus Vaccine and Primary Ovarian Failure: Another Facet of the Autoimmune/Inflammatory Syndrome Induced by Adjuvants "Serological evaluations showed low levels of estradiol and increased FSH and LH and in two cases, specific auto-antibodies were detected (anti-ovarian and anti-thyroid), suggesting that the HPV vaccine triggered an autoimmune response. Pelvic ultrasound did not reveal any abnormalities in any of the three cases. All three patients experienced a range of common non-specific post-vaccine symptoms including nausea, headache, sleep disturbances, arthralgia and a range of cognitive and psychiatric disturbances. According to these clinical features, a diagnosis of primary ovarian failure (POF) was determined which also fulfilled the required criteria for the ASIA syndrome."
July 11, 2013 - Transposon leads to contamination of clinical pDNA vaccine "We report unexpected contamination during clinical manufacture of a Human Papilomavirus (HPV) 16 E6 encoding plasmid DNA (pDNA) vaccine, with a transposon originating from the Escherichia coli DH5 host cell genome. During processing, the presence of this transposable element, insertion sequence 2 (IS2) in the plasmid vector was not noticed until quality control of the bulk pDNA vaccine when results of restriction digestion, sequencing, and CGE analysis were clearly indicative for the presence of a contaminant."
July 9, 2013 - The case for semi-mandatory HPV vaccination in China "China, have failed to adopt the vaccine largely because of its unprecedented high price ($360 for a three dose series in the United States). The price of vaccine will likely take years, if not decades, to drop. Similarly, expecting the Global Alliance for Vaccination and Immunization (GAVI) or other global charity organizations to exercise triaged assistance toward worldwide coverage and mandatory HPV vaccination is unrealistic, given the staggering level of funding needed and the lengthy political process involved.
July 9, 2013 - Antiviral therapy may trigger some genetic variants of cervical cancer "The study also concludes antiviral treatments or therapeutic vaccines could be dangerous in women whose lesions already show signs of HPV integration. This may help explain why some past studies using the antiviral drug interferon had inconclusive results regarding its value in treating cervical cancer. The researchers suggested that patients with existing HPV lesions may wish to discuss findings of this study with their physicians before starting such treatments."
July 9, 2013 - Social equity in Human Papillomavirus vaccination: a natural experiment in Calgary Canada (full text) "Vaccine cost is not a barrier to parents in the Alberta program, since the vaccine is provided by the Government of Alberta, and administration of the vaccine is conducted exclusively by Public Health Nurses in Alberta Health Services. However, vaccine cost has been raised as a concern about the program itself. Ironically, the “community” based delivery model in Calgary has proven to be substantially more expensive than the “in-school” model because of the additional staff time required for follow up calls to parents and for vaccine administration (Alberta Health Services: Costs of Human Papillomavirus Vaccination Services (unpublished observations) Alberta; 2012). This model also introduces costs to the parents related to transportation, time away from work and inconvenience."
July 4, 2013 - HPV vaccine acceptability among men: a systematic review and meta-analysis (full text) "HPV vaccine attitudes: acceptability was positively correlated with perceived HPV vaccine benefits (r=0.51, p<0.001), anticipatory regret (r=0.27, p<0.001), perceived HPV vaccine effectiveness (r=0.19, p<0.001); and negatively correlated with fear of needles (r=−0.11, p<0.05) and fear of side effects (r=−0.09, p<0.01)."
July 2013 - A National Study of HPV Vaccination of Adolescent Girls: Rates, Predictors, and Reasons for Non-Vaccination "The most common reasons for non-vaccination were concerns about vaccine safety, danger to daughter, and provider non-recommendation. Relatively poor HPV vaccine initiation and only modest 3-dose completion continue to be a major public health concern that requires continued efforts to address identified predictors and reasons for non-vaccination."
June 26, 2013 - Increasing girls' knowledge about human papillomavirus vaccination with a pre-test and a national leaflet: a quasi-experimental study (pdf)"Methods Participants Girls aged 11–14 years were recruited from three secondary public schools (state funded: one urban, two rural), whilst attending their first year there. One of the authors (PAWHS) approached schools in different regions by telephone and asked if they were willing to cooperate. The number of participants was based on feasibility; however, a post-hoc power analysis showed that the power was 0.992.
June 13, 2013 - Citizen intervention in a religious ban on in-school HPV vaccine administration in Calgary, Canada "The publicly funded Calgary Catholic School District Board voted against in-school HPV vaccine administration. In 2009, vaccine uptake was 70% in Calgary public schools and 18.9% in Calgary Catholic schools. To physician-citizens who requested in-school vaccination, the elected school trustees repeatedly responded that they were “directed” by the bishop. When trustees refused to hear from the city's chief oncologist, a citizen's group was created and held a June 2012 media event to help overturn the ban. The Board remained intransigent until the citizen's group threatened legal action, former senior administrators pressured the Board, Pediatrics reported that the HPV vaccine had no effect on sexual behavior, and the bishop told trustees that they could consult school councils.
June 2013 - Inequalities in the uptake of Human Papillomavirus Vaccination: a systematic review and meta-analysis (full text) "The highest uptake rates reported in this study were achieved through school-based vaccination programmes which have been shown to be acceptable and convenient to parents/carers"..."School-
June 12, 2013 - A pilot randomized study to assess immunogenicity, reactogenicity, safety and tolerability of two human papillomavirus vaccines administered intramuscularly and intradermally to females aged 18–26 years "This pilot randomized study assessed Cervarix® and Gardasil® administered either intramuscularly or intradermally, in different doses (full-dose or reduced to 20%) by different methods (needle and syringe or PharmaJet needle-free jet injection device). Following an initial reactogenicity study of 10 male subjects, sexually naïve women aged 18–26 years were randomized to the eight study groups to receive vaccine at 0, 2 and 6 months. 42 female subjects were enrolled and complete data were available for 40 subjects. Intradermal administration of either vaccine raised no safety concerns but was more reactogenic than intramuscular administration, although still tolerable."
May 18, 2013 - GAVI injects new life into HPV vaccine rollout "However, as GAVI scales up the use of the vaccine, the price is expected to come down further. Merck has already agreed to lower the price of its vaccine further if total volumes increase in the future. GSK should do the same. The challenge now is to make sure that countries have strong enough health systems for a national rollout. Merck must also stick to its promise, and its next reduction in vaccine price should be substantial." Comment: Never forget it's always all about the money.
May 9, 2013 - Epidemiologic Approaches to Evaluating the Potential for Human Papillomavirus Type Replacement Postvaccination "Although vaccination is expected to reduce the prevalence of these HPV types, there is concern about the effect this could have on the distribution of other oncogenic types. According to basic ecological principles, if competition exists between ≥2 different HPV types for niche occupation during natural infection, elimination of 1 type may lead to an increase in other type(s)."
May 1, 2013 -Immunogenicity of 2 Doses of HPV Vaccine in Younger Adolescents vs 3 Doses in Young Women "Sexually active women provided a vaginal swab at study entry for HPV detection and genotyping. Because this was a post-licensure study, data were only collected on serious adverse events occurring within 30 days of each vaccination. This information was collected at the next visit or if the participant called with concerns."
May 1, 2013 - HPV Vaccination Too Soon for 2 Doses? "Consequently, HPV vaccine uptakes and completion of the 3-dose series have been suboptimal in the United States and globally, with the exception of some countries that have used school-based, opt-out vaccination programs. The potential of a reduced-dose HPV vaccine schedule to address logistical barriers and decrease costs combined with the finding that girls have more robust immune responses to vaccination than women have led to discussions about the use of a 2-doses HPV vaccine schedule in girls.
April 30, 2013 - Factors associated with human papillomavirus vaccination among young adult women in the United States "Among women who were not interested in receiving HPV vaccine (n = 920), the main reasons reported included: not needing the vaccine (41.3%); concerns about safety of the vaccine (12.5%); not knowing enough about the vaccine (11.9%); not being sexually active (8.2%); a doctor not recommending the vaccine (7.6%); and already having HPV (2.7%). Among women with health insurance, 10 or more physician contacts within the past.
April 11, 2013 - Promoting Human Papillomavirus (HPV) Vaccination Through African American Beauty Salons "Behavioral: Health Education Session - The educational messages during the education session will engage individual women, their peer group, their family members and community influencers in a way that is authentic and share-able. Involving women in give-and-take discussions with people they trust and respect—their hairdressers—will be essential to increasing the number of them who consider the HPV vaccine for themselves and for those they care about. The investigators plan to recruit eight (8) predominantly African American beauty salons in Philadelphia and train multiple stylists in each salon to act as in-salon educators and facilitators for client recruitment to sexual health education sessions. These education sessions will be run by trained health educators (also African American females) and take place during "down times" in each of the salons, on a rotating basis. There will be two types of sessions offered, one for mothers of females ages 9-18 and one for females ages 18-26." Sponsor: Merck HPV Beauty Salon Campaign "MEE will be implementing an 18-month, non-randomized pilot study to assess the feasibility and effectiveness of using Black beauty salons as settings for culturally-sensitive health education about the impact of HPV and cervical cancer, along with HPV vaccination. The pilot project, which will take place in Philadelphia, is underwritten by Merck, Inc., makers of the Gardasil vaccine."
April 4, 2013 - Political and News Media Factors Shaping Public Awareness of the HPV Vaccine "Younger people, women, and those with more education were significantly more likely to be aware of the vaccine. Even after controlling for these characteristics, we found that exposure to news media was associated with higher HPV vaccine awareness. Whereas liberals and conservatives were both more aware of the vaccine compared with moderates, the data are suggestive that liberals were more sensitive to news coverage."
April 2013 - Human papillomavirus vaccine and systemic lupus erythematosus "In the current study, a temporal association between immunization with HPV-vaccine and the appearance of a spectrum of SLE-like conditions is reported. Additionally, among the patients described, several common features were observed that may enable better identification of subjects at risk. Further studies are required to assess the safety of immunization with the HPV vaccine in patients with autoimmune-rheumatic diseases or in subjects at risk of autoimmunity as well as the potential beneficial effect of preventive immunosuppressants."
March 18, 2013 - Reasons for Not Vaccinating Adolescents: National Immunization Survey of Teens, 2008–2010 "Despite doctors increasingly recommending adolescent vaccines, parents increasingly intend not to vaccinate female teens with HPV. The concern about safety of HPV grew with each year. Addressing specific and growing parental concerns about HPV will require different considerations than those for the other vaccines."
March 1, 2013 - Gardasil VAERS Reports - Published by Judicial Watch, Inc. **important**
March 2013 - Development and Impact of Human Papillomavirus Vaccines "Numerous questions remain, including cost-effectiveness, vaccination of males, societal acceptance of HPV vaccination, and cervical dysplasia screening in the HPV-immunized population. Access to vaccination for underserved populations both in developed and resource-poor nations remains an issue. Multivalent vaccines that encompass additional oncogenic HPV strains are under development." Comment: The “Big Lie” is a propaganda technique. Adolf Hitler coined the expression in his 1925 book Mein Kampf. '''''Hitler claimed the “Big Lie” needed to be “so colossal" that no one would believe someone "could have the impudence [boldness] to distort the truth so infamously." His right-hand man, Goebbels, has been attributed with saying, “'''''If you repeat a lie long enough, it becomes truth.” '''''The vaccine industry famously uses this technique. Every abstract, every article, every speech, every textbook repeats the same lies about vaccines – they are safe, effective, harmless and the best discovery in all history – the masses and their physicians, come to believe it.
** Only four serotypes – 6 11, 16 and 18 – were selected from pooled data to become Gardasil. U.S. women have a low prevalence these vaccine serotypes In a 2007 study of 2,026 women age 14 to 59, only 3.4% tested posit'ive to these four strains. '''Reference: Dunne EF, et. al. “Impact of low prevalence of vaccine serotypes in North American women, on the use of human papillomavirus vaccine (HPV).” JAMA. 2007;297:813-9"
March 2013 - Cross protection against HPV might prevent type replacement "Findings from a 2012 study showed a 13·6% increase in the incidence of non-vaccine-related HPV types in adolescents and women (aged 13—26 years) given Gardasil within 3 years of vaccination (ie, the post-surveillance period) by comparison with adolescents given Gardasil in the pre-surveillance period when vaccination had just been approved before implementation."..."IV and JAG have no conflicts of interest. The institution at which DMH did vaccine studies during 1999—2008 received funding from Merck and GlaxoSmithKline."
February 27, 2013 - Increasing Human Papillomavirus Vaccine Acceptability by Tailoring Messages to Young Adult Women's Perceived Barriers "The most commonly selected barrier and primary reason for not getting vaccinated was concern about vaccine adverse effects (endorsed by 55%). Knowledge about HPV vaccination increased after exposure to the intervention but did not differ by experimental condition."
February 6, 2013 - Exploring individual HPV coinfections is essential to predict HPV-vaccination impact on genotype distribution: A model-based approach "Understanding better how concurrent infections with multiple types change the acquisition and time to clearance of type-specific infections is essential to be able to predict the impact of vaccination on genotype distribution. Longitudinal data collection in populations, particularly examining infection and coinfection acquisition and clearance, is needed to better predict HPV-vaccine impact.
February 1, 2013 - HPV vaccines and cancer prevention, science versus activism (pdf) "In this regard, Gerhardus and Razum have recently noted that the “…unwarranted confidence in the new [HPV] vaccines led to the impression that there was no need to actually evaluate their effectiveness”. Similarly, the notion that HPV vaccines have an impressive safety profile can only be supported by highly flawed design of safety trials and is contrary to accumulating evidence from vaccine safety surveillance databases and case reports which continue to link HPV vaccination to serious adverse outcomes (including death and permanent disabilities). For example, compared to all other vaccines in the U.S. vaccination schedule, Gardasil alone is associated with 61% of all serious adverse reactions (including 63.8% of all deaths and 81.2% cases of permanent disability) in females younger than 30 years of age.
February 2013 - Virus-like particles for the prevention of human papillomavirus-associated malignancies "HPV vaccines have not been demonstrated as effective to treat existing infections, and efforts to develop a therapeutic HPV vaccine continue. Furthermore, current HPV L1-VLP vaccines provide type-restricted protection, requiring highly multivalent formulations to broaden coverage to the dozen or more oncogenic HPV genotypes. This raises the complexity and cost of vaccine production. The lack of access to screening and high disease burden in developing countries has spurred efforts to develop second-generation HPV vaccines that are more affordable, induce wider protective coverage and offer therapeutic coverage against HPV-associated malignancies. In this article, the authors examine the progress and challenges of these efforts, with a focus on how they inform VLP vaccine design."
January 30, 2013 - A survey on human papillomavirus awareness and acceptance of vaccination among nursing students in a tertiary hospital in Ankara, Turkey "Majority of the nursing students knew the causal relationship between HPV and cervical cancer. Seventy-eight percent of the nursing students and 22.4% of the control group stated that they had heard of HPV vaccine. While the rate of the willingness to be vaccinated was 33.7% in the nursing student group, it was only 13.4% in the control group."
January 30, 2013 - Female human papillomavirus (HPV) vaccination: Global uptake and the impact of attitudes "In all countries, the success of vaccination programmes is dependent on the support of the public and healthcare professionals. Whilst public acceptance is dependent on multiple factors, it has repeatedly been shown that recommendation by a health professional, particularly clinicians, is key to vaccine uptake. Worryingly, it appears that a proportion of clinicians still have significant reservations about promoting vaccination, particularly for younger age groups. A commitment now, to fully educating both the public and clinicians, has the potential to make a dramatic future impact."
January 10, 2013 - What college women know, think, and do about human papillomavirus (HPV) and HPV vaccine "Both non-vaccinees and vaccinees had positive attitudes '''''about mandating HPV''''' vaccine. Knowledge and attitudes toward the vaccine were not directly linked to the outcome predictors – intention to obtain the vaccine and vaccine uptake. Attitude about receiving HPV vaccine, subjective norms '''('complying with the expectations of others), and perceived behavioral control were correlated with the outcome predictors'.''' Subjective norms consistently predicted intention to obtain HPV vaccine and vaccine uptake."
November 30, 2012 - Reframing Cervical Cancer Prevention. Expanding the Field Towards Prevention of Human Papillomavirus Infections and Related Diseases "The hepatitis B virus (HBV) vaccination programs offer a model for HPV introduction in which newborn and infant immunization achieves a rapid reduction in the prevalence of the HBV carrier rates in immunized cohorts of children, and of liver cirrhosis and liver cancer decades later. In contrast, screening for cervical pre-cancer is largely restricted to industrialized populations and upper social classes in developing countries.
November 6, 2012 - “Who will take the blame?”: Understanding the reasons why Romanian mothers decline HPV vaccination for their daughters "Results show as main reasons for not vaccinating their daughters perceiving the vaccine as risky, the belief that the vaccine represents an experiment that uses their daughters as guinea pigs, the belief that the vaccine embodies a conspiracy theory that aims to reduce the world's population and general mistrust in the ineffective health system. Mothers stated they would need clear, factual information about the HPV vaccine and its link to cervical cancer in order to motivate them to accept it for their daughters."
November 2012 - An Opportunity for Cancer Prevention During Preadolescence and Adolescence: Stopping Human Papillomavirus (HPV)-Related Cancer Through HPV Vaccination "We conducted a descriptive study of the correlates of refusal and acceptance of human papillomavirus (HPV) vaccination by rural parents of preadolescent and adolescent children."
October 19, 2012 - Monitoring HPV Vaccine Impact: Early Results and Ongoing Challenges (full text) "Because the major benefit of HPV vaccination—prevention of cervical and other less common HPV-associated cancers—will not be evident for decades, a spectrum of intermediate outcomes are being monitored to assess the early impact of HPV vaccines. Although considered to be the simplest and earliest indicator of vaccine impact, a reduction in HPV vaccine type prevalence may not be sufficient to guide vaccine policy and practices."
October 8, 2012 - Human Papillomavirus Genotypes in High-Grade Cervical Lesions in the United States "Age and racial/ethnic differences in HPV type distribution may have implications for vaccine impact, and must be considered in monitoring trends."
October 2012 - Premature ovarian failure 3 years after menarche in a 16-year-old girl following human papillomavirus vaccination "The diagnostic tasks were to determine the reason for her secondary amenorrhoea and then to investigate for possible causes of the premature ovarian failure identified. Although the cause is unknown in 90% of cases, the remaining chief identifiable causes of this condition were excluded. Premature ovarian failure was then notified as a possible adverse event following this vaccination."
September 14, 2012 - Estimates of the annual direct medical costs of the prevention and treatment of disease associated with human papillomavirus in the United States "The overall annual direct medical cost burden of preventing and treating HPV-associated disease was estimated to be $8.0 billion (2010 U.S. dollars)."
September 7, 2012 - Do correlates of HPV vaccine initiation differ between adolescent boys and girls? "Only 14% of sons had received one or more doses of HPV vaccine compared to 44% of daughters (p < 0.01)."..."Among sons, initiation of HPV vaccine was lower for those living in high income households (odds ratio [OR] = 0.22, 95% CI, 0.09–0.53) and higher for those whose race was neither white nor black (OR = 3.26, 95% CI, 1.06–10.04)."
August 7, 2012 - Reevaluation of epidemiological data demonstrates that it is consistent with cross-immunity among human papillomavirus types "This paper demonstrates that cross-immunity between HPV types is consistent with epidemiological data, contrary to previous interpretations. 'Cross-immunity may cause significant type replacement following vaccination, and therefore should be considered in future vaccine studies and epidemiological models."
August 7, 2012 - Title: Composition comprising an adenoviral expression vector comprising a CD40L fusion protein for generating immune responses (patent) "Further provided are methods of generating an immune response against cancer expressing a tumor antigen in an individual by administering an effective amount of the invention vector. Still further provided are methods of generating immunity to infection by human papilloma virus (HPV) by administering an effective amount of the invention vector which encodes the E6 or E7 protein of HPV. The immunity generated is long term."
August 3, 2012 - Knowledge about human papillomavirus (HPV), and health beliefs and intention to recommend HPV vaccination for girls and boys among Korean health teachers "Although a school-based HPV vaccine program has yet to be introduced in Korea, health teachers should possess general knowledge about HPV and HPV vaccination, and differences in attitudes and intentions related to HPV vaccination between girls and boys should be reduced."
July 27, 2012 - Prevalence of type-specific human papillomavirus infection among women in France: Implications for screening, vaccination, and a future generation of multivalent HPV vaccines "HPV 16 was the type most strongly associated with a diagnosis of cervical intraepithelial neoplasia grade 3 or higher (CIN3+) (odds ratio = 11.64 vs. HPV 16 absent, P < 0.001). A high proportion of high-grade cervical lesions (60.6% of genotyping assay-positive CIN2+) were associated with HPV types 31, 33, 45, 52, or 58. These data indicate that almost all young women could benefit from HPV prophylactic vaccination, but confirm the need for continued cervical screening and highlight the potential benefit of future vaccines targeting a wider range of HPV types."
June 18, 2012 - Vaccine-Relevant HPV Infections and Future Acquisition of High-Risk HPV Types in Men "These prospective data on combinations of HPV infections over time do not suggest the potential for post-vaccination HPV type replacement. Future surveillance studies are needed to definitely determine if elimination of HPV types by vaccination will alter the HPV type distribution in the population."
June 6, 2012 - Low HPV Vaccine Coverage Among Female Community College Students. "All who had initiated the vaccine had a doctor's recommendation. To increase uptake among 18-26-year-old women, research should explore provider interventions to increase vaccine recommendation, and also identify individuals and groups who may have negative beliefs about vaccine safety and efficacy to provide support in vaccine decision-making."
May 28, 2012 - Sorting through search results: A content analysis of HPV vaccine information online "Health professionals designing online communication with the intent of increasing HPV vaccine uptake should take care to include information about the risks of HPV, including susceptibility and severity''. Additionally, websites should include information about the benefits of the vaccine (i.e., effective against HPV), low side effects as a barrier that can be overcome, and ways in which to receive the vaccine to raise individual self-efficacy." Comment: What about posting the risks of Gardasil, the long term side effects of polysorbate 80, and the effectiveness of pap-smears for reducing the incidence of cervical cancer?
May 28, 2012 - Do the media provide transparent health information? A cross-cultural comparison of public information about the HPV vaccine "We conclude that the media lack balanced reporting on the dimensions completeness, transparency, and correctness. We propose standards for more balanced reporting on websites and in newspapers."
May 21, 2012 - An update on human papillomavirus vaccine [GARDASIL uptake among 11–17 year old girls in the United States: National Health Interview Survey, 2010] "Among parents of unvaccinated girls, 60% were not interested in vaccinating their daughters and mentioned three main reasons: “does not need vaccine” (25.5%), “worried about safety” (19.3%) and “does not know enough about vaccine”(16.6%). Of those who were interested, 53.7% would pay $360–$500 for the vaccination, while 41.7% preferred to receive it at a much lower cost or for free.
May 2012 - Pharmaceutical companies' role in state vaccination policymaking: the case of human papillomavirus vaccination. "Although policymakers acknowledge the utility of manufacturers' involvement in vaccination policymaking, industry lobbying that is overly aggressive, not fully transparent, or not divorced from financial contributions to lawmakers risks undermining the prospects for legislation to foster uptake of new vaccines."
April 27, 2012 - Completion of the human papillomavirus vaccine series among insured females between 2006 and 2009 "Among insured females in the United States, the percentage of females who complete the' HPV vaccine series is dropping over time, especially among younger females, who are specifically targeted to receive the vaccine. Physicians need to stress the importance of completing all 3 vaccinations to their patients."
April 2, 2012 - An update on human papillomavirus vaccine uptake among 11-17 year old girls in the United States: National Health Interview Survey, 2010. "Among parents of unvaccinated girls, 60% were not interested in vaccinating their daughters and mentioned three main reasons: "does not need the vaccine" (25.5%), "worried about safety" (19.3%) and "does not know enough about vaccine" (16.6%)."
April 2, 2012 - Factors associated with HPV vaccine uptake in teenage girls: A systematic review "School-based vaccination programs have a high vaccine uptake. More studies are required to determine actual vaccine course completion and factors related to high uptake and completion, and information from a broader range of developed and developing settings is needed." Comment: The use of peer pressure in schools increases vaccination rates.]
April 2, 2012 - Potential overestimation of HPV vaccine impact due to unmasking of non-vaccine types: Quantification using a multi-type mathematical model There could be an increase of 3–10% in long-term cervical cancer incidence due to non-vaccine HPV types following vaccination." Comment: And they don't think this i's 'significant?
Jan-Feb 2012 - Ill-informed consent? A content analysis of physical risk disclosure in school-based HPV vaccine programs. "We conducted an online search for program related HPV vaccine risk/benefit documents for all 13 Canadian jurisdictions between July 2008 and May 2009 including follow-up by e-mail and telephone requests for relevant documents from the respective Ministries or Departments of Health. The physical risks listed in the documents were compared across jurisdictions and against documents prepared by the vaccine manufacturer (Merck Frosst Canada), the National Advisory Committee on Immunization (NACI), the Society of Obstetricians and Gynecologists of Canada (SOGC), and a 2007 article in Maclean's Magazine. No jurisdiction provided the same list of vaccine-related physical risks as any other jurisdiction. Major discrepancies were identified."
January 19, 2012 - The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise "A human papillomavirus vaccine, Gardasil, and two rotavirus vaccines, RotaTeq and Rotarix, have been chosen for surveillance in the current cycle because their evaluations would benefit most from PRISM's large cohort size."
January 18, 2012 - Mandatory Vaccinations are Being Forced on Workers and Children "However, the author's recommendation that “if voluntary vaccination proves unsuccessful, states should seriously consider compulsory vaccination laws without generous exemptions” appears premature. As Gostin noted, clinical trial evidence has not demonstrated that HPV vaccines can actually prevent invasive cervical cancer, let alone cervical cancer deaths. Because HPV vaccines were specifically developed to protect against cervical cancer, we conclude that in the absence of long-term data, their true benefits remain speculative."
January 16, 2012 - Systemic lupus erythematosus following HPV immunization or infection?
January 2012 - The HPV Vaccine and Parental Consent "Dr. Carson continues to describe the vaccine’s efficacy, prevalence, and known side effects. Alex decides she would like to receive the vaccine. Dr. Carson asks Alex’s mother to re-enter the room and begins to discuss the recommendation for the HPV vaccine. Alex’s mother objects. “The HPV vaccine is mandated here in Virginia for 11-year-old girls. I would have chosen to opt out of the mandate because I don’t want my daughter to act irresponsibly or suffer unknown side effects.”..."For example, in Virginia, where Dr. Carson practices and Alex lives, minors can consent to the kinds of medical services listed above in parentheses. At the same time, Virginia parents have a right to obtain their child’s health records unless the disclosure of those records would be reasonably likely to cause substantial harm to the minor or another person. As a result, in some circumstances parental permission and knowledge might be avoided initially, but the minor patient’s privacy and confidentiality may not be entirely protected."
December 22, 2011 - Human papillomavirus (HPV) vaccine policy and evidence-based medicine: Are they at odds? "Cumulatively, the list of serious ADRs related to HPV vaccination in the US, UK, Australia, Netherlands, France, and Ireland includes deaths, convulsions, syncope, paraesthesia, paralysis, Guillain – Barr é syndrome (GBS), transverse myelitis, facial palsy, chronic fatigue syndrome, anaphylaxis, autoimmune disorders, deep vein thrombosis, pulmonary embolisms, and pancreatitis."
December 21, 2011 - Gardasil Boys Come Marching In 4 New Gardasil Deaths Reported to VAERS – 2 out of 4 are Boys
November 15, 2011 - Human papillomavirus genotype distribution in Madrid and correlation with cytological data (pdf) "Although a vaccine against HPV16 and 18 could theoretically prevent approximately 50% of HSILs, genotypes not covered by the vaccine are frequent in our population. Knowledge of the epidemiological distribution is necessary to predict the effect of vaccines on the incidence of infection and evaluate cross-protection from current vaccines against infection with other types."
November 7, 2011 - Follow-up Analysis of Adolescents Partially Vaccinated Against Human Papillomavirus
November 3, 2011 - Missed clinical opportunities: Provider recommendations for HPV vaccination for 11–12-year-old girls are limited
November 1, 2011 - Human Papillomavirus Vaccination Series Initiation and Completion, 2008 –2009 "Parental education regarding disease risks and benefits of HPV vaccination before exposure is needed to promote vaccine uptake."
October 19, 2011 - Decision For or Against HPV Vaccination - A Qualitative Study with Adolescent Girls
October 14, 2011 - Progress Toward Implementation of Human Papillomavirus Vaccination --- the Americas, 2006--2010
October 14, 2011 - Acceptability and response to a postal survey using self-taken samples for HPV vaccine impact monitoring
October 10, 2011 - Multiple Human Papillomavirus Infection: Don’t Forget the Genetic Background "The efficacy of cross-protection in terms of the levels of neutralizing antibodies generated to nonvaccine types, and the duration of their protection, remains to be determined. Common conserved epitopes, shared among HPV types that belong to the same clade, may serve as a good rationale for DNA-based vaccines preventing the spread of the close-linked serotypes."
October 6, 2011 - Mandatory HPV Vaccination and Political Debate (full text) "There is no evidence that HPV vaccines increase sexual activity among adolescents, but this aspect of mandatory vaccination is a political hot button. State mandates override parental consent, fueling long-standing anti-vaccination movements. Moreover, HPV vaccination is different than most diseases warranting compulsion because the virus is not airborne and does not pose immediate risks of transmission through casual contact among adolescents, such as in schools."
October 6, 2011 - Vaccine counseling: A content analysis of patient-physician discussions regarding human papillomavirus vaccine "Additional quantitative analyses of patient-physician discussions about vaccine may generate further recommendations regarding optimal communication strategies for HPV vaccine counseling."
October 6, 2011 - Attitudes to HPV vaccination among mothers in the British Jewish community: Reasons for accepting or declining the vaccine "Although mothers thought HPV vaccination was a good idea in general, many did not perceive it as necessary for their daughter, citing Jewish religious laws governing family purity and abstinence until marriage as reasons for daughter's low susceptibility. These beliefs combined with concerns about the novelty of the vaccination were the main reasons given for declining the vaccine."
September 28, 2011 - Why don’t we know how much vaccines cost? "Unicef’s brave decision to publish the price of the drugs and vaccines it buys has changed the conversation on global health. Why don’t governments, purchasing drugs and vaccines on our behalf, show equal courage?"
September 19, 2011 - Adolescents' awareness of HPV infections and attitudes towards HPV vaccination 3 years following the introduction of the HPV vaccine in Hungary.
September 15, 2011 - Human papillomavirus vaccine: What are women most concerned about? "The top three factors that most women felt very important were vaccine effectiveness (45.4%), effect duration (44.0%) and long-term side-effects (43.7%). Education level significantly affected the degree of concerns in these areas (OR = 1.15, P < 0.001, 1.14,P < 0.001 and 1.09, P = 0.006, respectively) while income was significantly inversely associated with the importance of cost (OR = 0.92,P < 0.001) and effectiveness (OR = 0.95, P = 0.047)."
September 9, 2011 - Proof-of-Principle Evaluation of the Efficacy of Fewer Than Three Doses of a Bivalent HPV16/18 Vaccine
September 7, 2011 - SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil To FDA: Requests Public Safety Investigation
September 7, 2011 - Racial/Ethnic and Poverty Disparities in Human Papillomavirus Vaccination Completion
September 2, 2011 - SANE Vax to FDA: Recombinant HPV DNA found in multiple samples of Gardasil
September 2011 - The case for vaccinating boys against human papillomavirus. Public health genomics 12(5-6): 362-7, 2009. A proposed ethical framework for vaccine mandates: competing values and the case of HPV. Kennedy Institute of Ethics journal 18(2): 111-24, Jun 2008. and Arthur L. Caplan Description of Bioethics Expertise
September 2011 - Randomized Trial of the Immunogenicity and Safety of the Hepatitis B Vaccine Given in an Accelerated Schedule Coadministered with the Human Papillomavirus Type 16/18 AS04-Adjuvanted Cervical Cancer Vaccine (pdf) "Because the hepatitis B vaccine was introduced into infant immunization programs only relatively recently in many countries or has not yet been introduced, many young women receiving the HPV vaccine in a catch-up program may also require the hepatitis B vaccine. If young women receiving both vaccines are in a high-risk group for acquiring hepatitis B (e.g., travelers, drug users, or sex workers), they are likely to receive the vaccine in an accelerated schedule."
September 2011 - Exploring the Presentation of News Information About the HPV Vaccine: A Content Analysis of a Representative Sample of U.S. Newspaper Articles.
August 30, 2011 - HPV vaccine decision making in pediatric primary care: a semi-structured interview study (pdf) - "Programs to improve HPV vaccine delivery in primary care should focus on promoting effective parent-clinician communication. Research is needed to evaluate strategies to help clinicians engage reluctant parents and passive teens in discussion and measure the impact of distinct clinician decision making approaches on HPV vaccine delivery."
August 18, 2011 - Another Look at the Human Papillomavirus Vaccine Experience in Canada "We discuss the example of the policy process surrounding the adoption of the human papillomavirus (HPV) vaccine in Canada to consider whether public good arguments continue to dominate immunization policymaking. Specifically, we show how a range of stakeholders framed HPV vaccination as a personal rather than a public matter, despite the absence of controversy over mandatory immunization as was the case in the United States. Our findings suggest an erosion of the persuasiveness of public good arguments around collective immunization programs in the policy discourse. (Am J Public Health. Published online ahead of print August 18, 2011:e1-e8."
August 2011 - The human papillomavirus (HPV) vaccine and cervical cancer: uptake and next steps. "The epidemiology of HPV, the mechanisms of action, protocols for vaccine immunization, rates of uptake, and barriers to vaccination at the policy, provider, and patient levels are reviewed. Various intervention techniques are described, and policy-level programs, such as legislation supporting mandates, subsidized public education, and cost-reduction initiatives, are also explored."
July 1, 2011 - A Competitive Serological Assay Shows Naturally Acquired Immunity to Human Papillomavirus Infections in the Guanacaste Natural History Study "Conclusions. Both assays showed an association between positive results and significant protection from subsequent infections for HPV16 and HPV18 combined. cLIA seroprevalence was lower than VLP ELISA, suggesting that the assay detects a subset of antibodies following natural infection that are specifically linked to immunity against subsequent HPV infection.
Summer 2011 - Prejudicial Distribution of the HPV Vaccine "The voices that permeate are those of heavily-funded marketing campaigns, physicians in their white coats, ministers in their pulpits, and the government. Government control attempts to move beyond manipulation to coercion – forcing girls to be vaccinated or forgo school attendance. Likewise, religious control invokes the power of God – for believers, the ultimate authority."
June 4, 2011 - HPV-Related Oral Cancer Incidence Spikes Sharply "Dr. Gillison worked for 3 years with Merck & Co., the maker of the HPV vaccine Gardasil, and commented that Merck will not likely pursue this indication. Merck was interested in studying the vaccine in prevention of oral cancers but saw the endeavor as too much of an uphill battle in part because oral cancers are not readily accessible visibly or through biopsy. Merck instead successfully opted to seek approval for the prevention of anal cancers, an indication that was approved in December 2010 for male and females 9-26 years old."
April 2011 - Demyelinating disease and vaccination of the human papillomavirus "Conclusions:: Have been described seizures, autoimmune disorders such as Guillain-Barre syndrome, transverse myelitis, or motor neuron disease, probably adverse effects following immunization by the HPV vaccine. So we suggest that vaccine may trigger an immunological mechanism leading to demyelinating events, perhaps in predisposed young."
March-April 2011 - Human papillomavirus vaccination rates and state mandates for tetanus-containing vaccines - "Mean HPV vaccine series initiation levels were significantly lower in states without Td/Tdap vaccine mandates than in those with mandates."
March 22, 2011 - Gardasil-induced erythema nodosum. Erythema nodosum is a panniculitis occurring more frequently in young women. We report a 16-year-old woman who presented with e'rythema nodosum that occurred following Gardasil administration (vaccine against HPV types 6, 11, 16 and 18) and that is proposed to young female. This adverse effect is not a contraindication to the HPV vaccination because its benefit against the oncogene risk of Papillomavirus is documented. Comment: Wonder how they can make these statement of facts with no proof they are true? (documented benefits.)
February 1, 2011 - Increasing uptake of Gardasil among American adolescents: Comparisons with the history of Hepatitis B vaccination. "The distribution of HPV vaccine does not conform to the geographic incidence rate of cervical cancer. Contrary to contemporary belief, school immunization mandates for Hepatitis B vaccines were not the impetus for their acceptance. Familial beliefs about HPV vaccines appear to be the most significant challenge to Gardasil uptake rate."
February 1, 2011 - Maternal characteristics that predict a preference for mandatory adolescent HPV vaccination. Adolescent human papillomavirus (HPV) vaccination uptake, as a means of cervical cancer prevention, remains suboptimal with significant racial disparity. A survey study of mothers already engaging in their own cancer screening, at a predominantly black urban site and a predominantly white suburban site, finds that a majority of mothers surveyed support hypothetical mandates for adolescent HPV vaccination three years after the introduction of these vaccines. Enactment of state laws may represent an efficient means to improve HPV vaccination in adolescent daughters of these mothers. Nevertheless, in a sizable minority, maternal perceptions of the HPV vaccine may hinder adherence to these vaccination laws. In these women, tailored interventions directed at these perceptions may be required.
January 3, 2011 - Syncope and seizures following human papillomavirus vaccination: a retrospective case series. " Victoria, Canada: 97/1653 SAEFVIC reports met the study criteria: afebrile seizures (3), syncopal seizures (31) and syncope alone (63). Median age at vaccination was 15 years (range, 8-26 years). Injuries were reported in seven cases, including one vertebral fracture. A SAEFVIC clinic review was undertaken in 41% (40/97) and 22 patients received further 4vHPV vaccine doses administered supine, with no recurrences. The reporting rate after 4vHPV vaccine for syncope and syncopal seizures was 7.8/100, 000 and 2.6/100, 000 doses distributed, respectively. CONCLUSION: Syncope and syncopal seizures occurred after 4vHPV vaccination in Victoria at rates similar to those seen internationally.
Jan 2011 - Potential cross-reactivity between HPV16 L1 protein and sudden death-associated antigens "In particular, nine out of the 34 viral pentamers are present in a human protein, titin, alterations of which have been linked to cardiac failure and sudden cardiac death. The present data may help evaluate the potential cross-reactivity risks in anti-tumor vaccination protocols based on HPV16 L1 protein.
January 1, 2011 - Human Papilloma Virus (HPV), Cancer, and HPV Vaccines -- Frequently Asked Questions (pdf) "Most genital warts are caused by 2 HPV types, HPV 6 and HPV 11. These rarely develop into cancer and are called "low-risk" viruses. However, other sexually transmitted HPVs have been linked with genital or anal cancers in both men and women."
January 2011 - Guillain-Barré syndrome after Gardasil vaccination: data from Vaccine Adverse Event Reporting System 2006-2009. Using data from Vaccine Adverse Event Reporting System, we identified 69 reports of Guillain–Barré Syndrome (GBS) after Gardasil vaccination that occurred in the United States between 2006 and 2009. The onset of symptoms was within 6 weeks after vaccination in 70% of the patients in whom the date of vaccination was known.
January 2011 - Gardasil Vaccination: Evaluating The Risks Versus Benefits Lucija Tomljenovic, PhD, (pdf) "The efficacy of Gardasil in preventing cervical cancer has not been demonstrated and the marketing campaign has been misleading. The efficacy of Gardasil remains unsubstantiated since the vaccine hasn’t been adequately tested on the primary age group to which it is currently given."
October 27, 2010 - HPV vaccine: an overview of the immune response, clinical protection, and new approaches for the future. (full text) Current prophylactic vaccines have the primary end-points to protect against HPV-16 and 18, the genotypes more associated to cervical cancer worldwide. Nevertheless, data from many countries demonstrate the presence, at significant levels, of HPVs that are not included in the currently available vaccine preparations, indicating that these vaccines could be less effective in a particular area of the world. The development of vaccines covering a larger number of HPVs presents the most complex challenge for the future. Therefore, long term immunization and cross-protection of HPV vaccines will be discussed in light of new approaches for the future.
October 9, 2010 -Virus-like particles in vaccine development. Virus-like particles (VLPs) are multiprotein structures that mimic the organization and conformation of authentic native viruses but lack the viral genome, potentially yielding safer and cheaper vaccine candidates.
October 2010 - HPV vaccination's second act: promotion, competition, and compulsion. "Policymakers, vaccine manufacturers, and the public health community must now respond to the presence of competing vaccines that are similar but distinct, particularly with respect to genital wart prevention and the benefits of vaccinating males. This work arises in the shadow of the contentious introduction of the HPV vaccine Gardasil (Merck & Co, Inc, Whitehouse Station, NJ) in 2006, particularly the opposition to efforts in many states to require the vaccine for school attendance. I review the current status of HPV vaccine policy in the United States and examine issues of public health ethics and policy central to ongoing and future HPV vaccination programs."
September 2010 - Low rates of free human papillomavirus vaccine uptake among young women. Only 59 women (28.2%) who were offered this free service completed the series. Just over half (50.7%) received the first dose. Of those, 78.3% returned to receive the second and 55.7% returned for the third. Young women who felt their mothers might not want them to be vaccinated were much less likely to complete the series compared with those who felt their mothers would 'definitely' want them to be vaccinated (P = 0.0002). Also, young women who indicated that they would take the time to return to the clinic for doses two and three were far more likely to complete the series (P = 0.0004).
September 2010 - HPV/cervical cancer vaccination: parental preferences on age, place and information needs. "A 25% response rate was achieved (769/3123). Receipt of the HPV vaccine in a clinic setting was preferred by 40% of parents; 25% preferred vaccination at school. Fifty percent preferred vaccination to occur at age 13 or older; 28% thought ages 10, 11 or 12 appropriate. One in three parents wanted more information and 65% said they would seek information from their family doctor before deciding on the vaccine for their daughter(s)."
August 19, 2010 - HPV Vaccination Mandates — Lawmaking amid Political and Scientific Controversy (full text) Ethical and legal principles dictate that public health laws should use the least restrictive means possible to advance health goals.15 The policymaking dynamics that were illuminated by our study reflect the centrality of this view in politics as well. Robust public health evidence supports the effectiveness of vaccination mandates in achieving high rates of vaccination coverage. However, proposals for coercive measures may trigger backlash — perhaps for reasons largely unrelated to the merits of the particular proposal. This danger underscores the need for careful, individualized assessment of the risks and benefits of each new expansion of the state's reach into citizens' health decisions.
July 2010 - Whom Do We Protect? Experts at Odds Over HPV VaccineRecommendation. Reducing the rate of human papillomavirus (HPV) infections is a laudable goal. After all, HPV is the leading cause of cervical cancer and can cause genital warts and several other extremely rare types of cancer. But experts don't agree on the best way to prevent the spread of HPV. The controversy centers on the recent approval of Gardasil - one of two available vaccines for preventing HPV infections - for use in boys and young men.
June 8, 2010 - Who Should Get the HPV Vaccine? Usage Expands Amid Debate "Full-page advertisements inviting parents to immunize their preadolescent boys against human papillomavirus (HPV) have kindled the debate over who should receive the world's first cancer vaccine. In the ads for Merck's Gardasil vaccine ( Parade magazine, April 25, 2010), two cherubic faces—one of a mischievous-looking boy in need of a haircut, the other of a tomboyish girl with braces on her teeth—straddle a headline proclaiming, “Your child could be ONE LESS person affected by HPV disease.”
June 2010 - Safety, tolerability, and immunogenicity of Gardasil given concomitantly with Menactra and Adacel. Concomitant administration was generally well-tolerated. No participants withdrew because of an AE. One serious AE of transient muscular weakness of <24 hours' duration after the third Gardasil injection was reported in group B and was deemed possibly vaccine-related by the investigator.
March 29, 2010 - HPV Vaccination's Second Act: Promotion, Competition, and Compulsion "I review the current status of HPV vaccine policy in the United States and examine issues of public health ethics and policy central to ongoing and future HPV vaccination programs."
May 26, 2010 - Will Merck's Gardasil HPV Vaccine be its Next Vioxx? "Medalerts.org reports that a young woman vaccinated with Gardasil is ten times more likely to file a VAERS report compared to influenza vaccination. HPV vaccines now account for 20 percent of all vaccine side effects aside from the H1N1 swine flu vaccine. America's daughters are twice as likely to have an emergency room visit. They are four times more likely to have a death sentence, five times more likely to receive a report of "did not recover," and seven times more likely to be pronounced "disabled."
May 2010 - A Population-Based Evaluation of a Publicly Funded, School-Based HPV Vaccine Program in British Columbia, Canada: Parental Factors Associated with HPV Vaccine Receipt (full text) "Policymakers need to consider that even with the removal of financial and health care barriers, parents, who are key decision makers in the uptake of this vaccine, are still hesitant to have their daughters receive the HPV vaccine, and strategies to ensure optimal HPV vaccine uptake need to be employed."
May 2010 - Gardasil® – The New HPV Vaccine: The Right Product, the Right Time? A Commentary (full text) - In the United States, as of the end of 2008, there were 12,424 reports of adverse events following immunization (AEFIs). Seven hundred and seventy-two reports (6.2% of all reports) described serious AEFIs, including 32 reports of death. Disproportional reporting of syncope and venous thromboembolic events were noted with data mining methods (Slade et al. 2009). These findings must be interpreted against the limitations (possible underreporting) of a passive reporting system. Both CIC and NACI have accepted the vaccine as safe, and neither recommended a post-marketing surveillance campaign. In the absence of long-term data about the vaccine's safety, that acceptance seems premature.
March 30, 2010 - FDA Freedom of Information Distribution VAERS Line List Report (pdf) Adverse Events Reports from Judicial Watch - more than 3,569 VAERS reports on Gardasil - May 2009 to March 2010.
February 2010 - Parent's Willingness to Get Vaccines in Schools "Purpose: To determine middle school parents' willingness to have their children vaccinated with specific vaccines at school during school hours."'
December 7, 2009 - Should boys receive the human papillomavirus vaccine? No "HPV vaccines and associated immunisation programmes are hugely expensive, and including boys will double the cost for a small unjustifiable return."
December 2009 - Gardasil needs a new consent form - Recently evaluated the 12,424 reports submitted to the VAERS between 1 June 2006 and 31 December 2008 concerning the risks of Gardasil administration. Reported serious adverse events included venous thromboembolism, Guillain–Barré syndrome, autoimmune disorders, pancreatitis, anaphylaxis, transverse myelitis, motor neuron disease and death. Venous thromboembolism was statistically associated with Gardasil injection.
October 28, 2009 - Report of Motor Neuron Disease After HPV Vaccine "Pathological features support the temporal association of the clinical presentation and vaccination and provides supporting evidence that immune-mediated reactions to the nervous system are potential risks after Gardasil vaccination," Catherine Lomen-Hoerth, MD, director of the Amyotrophic Lateral Sclerosis Center at the University of California–San Francisco, told the meeting."
August 18, 2009 - CDC Report Stirs Controversy For Merck's Gardasil Vaccine "A government report released Tuesday raises new questions about the safety of the cervical cancer vaccine Gardasil. The vaccine has been linked to 32 unconfirmed deaths and shows higher incidences of fainting and blood clots than other vaccines."
August 10, 2009 - RE: HPV Vaccination Mandate for Immigrant Women and Girls"The undersigned, over 140 immigrants’ rights, women’s rights, public health, medical, and reproductive justice organizations write to urge the CDC to act quickly and finalize the proposed criteria for identifying the Advisory Committee on Immunization Practices (ACIP) recommended vaccines as immunization requirements for immigrants."
July 1, 2009 - Dangers of HPV Vaccine Production in Plants, Microbes, and Viruses "Widespread releases of hazardous transgenes and vaccines have the potential to create viruses more deadly than the ones the vaccines protect against"
June 18, 2009 - FDA Information Pertaining to Labeling Revision for Gardasil Warnings and Precautions section alerts healthcare providers that tonic-clonic (jerking) movements and seizure-like activity can occur with fainting. Syncope and its associated signs and symptoms generally last only a short time (seconds to minutes) and resolve when the patient is placed in a position, such as lying down, to restore adequate blood flow to the brain.
June 24, 2009 - Knowledge and Early Adoption of the HPV Vaccine Among Girls and Young Women: Results of a National Survey "Few girls and young women believe that the HPV vaccine is protective beyond the true impact of the vaccine. Despite moderate uptake, many females at risk of acquiring HPV have not yet received the vaccine. These findings suggest the important role of both healthcare providers and parents in HPV vaccine adoption."
May-June 2009 - Vaccines for human papillomavirus infection: A critical analysis (pdf) This article takes a critical look at the pros and cons of human papillomavirus (HPV) vaccines. There is enough evidence to suggest that the prophylactic vaccines are efficacious in preventing various benign and malignant conditions (including cervical cancers) caused by HPV. Even though the vaccine is costly, hypothetical analysis has shown that HPV vaccination will be cost effective in the long run. Therapeutic HPV vaccines used to treat established disease are still undergoing evaluation in clinical studies, and results seem to be encouraging. Although several countries have started mandatory vaccination programs with the prophylactic HPV vaccines, conservatives have voiced concerns regarding the moral impact of such vaccination programs.
May 5, 2009 - Quantifying the possible cross-reactivity risk of an HPV16 vaccine (pdf) "Any antigen-based vaccine needs to be carefully and thoroughly designed and critically screened for potential side effects by comparing sequence similarity at the molecular level."
February 10, 2009 - High-risk and multiple human papillomavirus (HPV) infections in cancer-free Jamaican women (full text) "HPV genotype distribution in this group of Jamaican women differ from the patterns found in Europe, North America and some parts of Asia. It may be necessary therefore to consider the development of other vaccines which target genotypes found in our and similar populations."
February 2009 - Human Papillomavirus Vaccine Safety in Pediatric Patients: An Evaluation of the Vaccine Adverse Event Reporting System Recent news reports have linked the human papillomavirus (HPV) vaccine to serious adverse events (AEs) in children and adolescents. We used the Vaccine Adverse Event Reporting System (VAERS) database to extract postmarketing AEs reported in patients who received the vaccine. Since approval of the HPV vaccine in the US, 3,174 AEs occurring in children and adolescents (aged 6-17 y) have been reported to the VAERS. Of these, 191 (6%) were deemed to be serious. Although these AEs are of significant concern, more research is required before they can be directly correlated with the vaccine.
February 2009 - An Analysis by the National Vaccine Information Center of Gardasil & Menactra Adverse Event Reports to the Vaccine Adverse Events Reporting System (VAERS) (NVIC pdf) What follows is a comparison of some of the more serious Gardasil and Menactra adverse event reports submitted to VAERS.
January 26, 2009 - Opsoclonus myoclonus after human papillomavirus vaccine in a pediatric patient (pdf) "The patient was a fully vaccinated and developmentally appropriate 11-year-old female with seasonal allergies and mild asthma. Her initial symptoms consisted of a sudden onset of increased ‘‘moodiness’’ causing uncharacteristic anger and depression. These symptoms presented approximately 15 days after receiving her first human papillomavirus (HPV) (Gardisil) vaccination on 11/26/2007."
January 9, 2009 - Gardasil again denied approval for women 27-45 "U.S. health regulators have again withheld approval for the use Gardasil cervical cancer vaccine by women aged 27 to 45, asking for longer-term clinical data, the drugmaker said on Friday."
November 2008 - HPV vaccine: a cornerstone of female health a possible cause of ADEM? "Referring to a recent publication on the efficacy and safety of a vaccine against infection with human papillomavirus (HPV) type 16 and 18, we report on a patient who developed acute disseminated encephalomyelitis (ADEM) following this vaccination, a 15-year old previously healthy girl presented to our hospital with new-onset headache, nausea, fever, vertigo and diplopia. She had no history of other recent vaccination or infection."
October 27, 2008 - Merck Targets Gardasil Advertising to Older Women Harvard University researchers said in this August 2008 study that the $400 vaccine isn't cost-effective in the older age group, a finding that supported the American Cancer Society's recommendations. Merck disagrees and says its vaccine can provide a benefit in that age group. Gardasil sales, which reached $1.5 billion in 2007, are slowing because of questions from proposed users on cost, safety and effectiveness, said Seamus Fernandez, a Leerink Swann & Co. analyst in Boston.
August 20, 2008 - Researchers Question If HPV Vaccine Is Worth the Risk "There is also the issue of side effects. FDA records reveal that, since Gardasil's approval, nearly 9,000 girls had "bad health events" after receiving their shots. These included 78 reported outbreaks of genital warts, 18 deaths and six cases of Guillain Barre Syndrome, which can result in paralysis. It is unknown whether there are unseen side effects, like decreasing the body's ability to fight off other strains of the HPV virus."
June 30, 2008 - Examining the FDA’s HPV Vaccine Records (pdf) Detailing the Approval Process, Side-Effects, Safety Concerns and Marketing Practices of a Large-Scale Public Health Experiment - JUDICIAL WATCH DOCUMENT. In May 2007, Judicial Watch submitted a request to the FDA under the Freedom of Information Act for all records concerning Merck’s new anti-HPV vaccine, Gardasil. After Judicial Watch filed a lawsuit in October 2007 to compel record production, the FDA finally released four sets of documents, the last in June 2008. These records detail the development and expedited approval of Gardasil. The documents include patent and licensing memoranda, test reports for the vaccine, and the final briefing document on Gardasil submitted to the FDA in April 2006, one month before the vaccine was approved. The FDA also produced 8,864 VAERS reports. Judicial Watch uncovered a transcript of Merck’s May 18, 2006, meeting with the Vaccines and Related Biological Products Advisory Committee (VRBPAC), at which the vaccine received a unanimous vote of approval.
June 1, 2008 - A Proposed Ethical Framework for Vaccine Mandates: Competing Values and the Case of HPV (pdf) "This work was developed in conjunction with the Center for Vaccines Ethics and Policy, a program of the Center for Bioethics at the University of Pennsylvania, The Wistar Institute Vaccine Center, and the Vaccine Education Center of Children’s Hospital of Philadelphia"
Spring 2008 - What Right Does the State Have to Compel Vaccination? Human Papilloma Virus and Its Implications (pdf) "Many bio-ethicists believe that personal autonomy is an inherent and paramount right, and that a state oversteps its authority when it mandates vaccination of all citizens without granting exceptions based on personal autonomy. As already noted, however, courts have specifically declared that personal autonomy is not infinite, and have rejected as a general principle the notion that individual autonomy is paramount."
September 6, 2007 - Prevalence of Human Papillomavirus in the Oral Cavity/Oropharynx in a Large Population of Children and Adolescents (full text) (free registration) "The overall prevalence of HPV in the oral cavity/oropharynx was 1.9%, and 13 HPV types were detected. Among the HPV positive (HPV+) children, the median age was 14 years, 70% were female, and 24% had been delivered by cesarean section similar to the HPV-negative group. None of the demographic characteristics or diseases was significantly associated with HPV status for all age groups combined (data not shown). HPV+ rates by age group are shown in Figure 1. The highest HPV prevalence rates by age group were in infants <1 year and in adolescents 16 to 20 years, producing a bimodal distribution of HPV in the oral cavity/oropharynx. The lowest rate was 0.8% in those 1 to 4 years gradually increasing with age."
August 20, 2007 - Estimating the number needed to vaccinate to prevent diseases and death related to human papillomavirus infection (full text) "The numbers needed to vaccinate to prevent outcomes related to HPV infection in a cohort of 12-year-old girls are shown in Table 1.
August 1, 2007 - Human papillomavirus, vaccines and women’s health: questions and cautions (full text) "Relatively few girls (about 1200 aged 9–15 years) were enrolled in the clinical trials of Gardasil, the youngest of whom were followed for only 18 months. Based on the assumption that they will not yet have been exposed to HPV viruses, girls in this age group represent the priority target population for mass vaccination. Clearly, this is a thin information base on which to construct a policy of mass vaccination for all girls aged 9–13, as per the National Advisory Committee on Immunization’s recommendations."
June 26, 2007 - Human Papillomavirus Vaccination: Expected Impacts and Unresolved Issues "Earlier studies evaluating safety (and immunogenicity) in a variety of populations all indicate that the vaccine is well tolerated and without significant, serious adverse events. However, the short duration of follow-up and a relatively small number of subjects observed in these studies limits conclusions made about the potential for rare adverse events or for vaccine-related outcomes occurring several years after vaccination. This has recently been highlighted by reports of 13 cases of Guillan-Barré syndrome (GBS) after HPV vaccination through the Vaccine Adverse Events Reporting System."
May 10, 2007 - Mandating HPV Vaccination — Private Rights, Public Good (full text) "The Supreme Court, when first adjudicating compelled vaccination, recognized that the “police power” granted to states under the Constitution's 10th Amendment permits all jurisdictions to legislate to “protect the public health and the public safety.” Thus, the Court said, Massachusetts was acting within its appropriate authority when requiring persons to submit to vaccination against smallpox and when imposing sanctions for noncompliance. Seventeen years later, the Court affirmed a Texas mandate that required documentation of the receipt of certain vaccinations before children could enter school."
May 10, 2007 - HPV Vaccination — More Answers, More Questions (full text) "In contrast to a
plateau in the incidence of disease related to HPV types 16 and 18 among vaccinated women, the overall disease incidence regardless of HPV type continued to increase, raising the possibility that other oncogenic HPV types eventually filled the biologic niche left behind after the elimination of HPV types 16 and 18. An interim analysis of vaccine trial data submitted to the FDA showed a disproportionate, but not statistically significant, number of cases of grade 2 or 3 cervical intraepithelial neoplasia related to nonvaccine HPV types among vaccinated women."
April 18, 2007 - Gardasil - the Cervical Cancer Vaccine? "If HPV alone caused cervical cancer than the number of cases in the U.S. would be the same as the number of women with HPV infections. Since only a relatively small percentage of HPV infected women get cervical cancer this raises the question whether a vaccine against HPV is the right target at all? In fact, according to the text Cancer: Principles & Practice of Oncology, "In most studies, HPV status was not a strong independent prognosticator of outcome in cervical cancer patients; however there appears to be a trend for HPV-negative tumors to do worse …those tumors containing HPV DNA tend to be of an early stage and low grade." This suggests that if the goal is to reduce deaths from cervical cancer the target should not be HPV at all because the tumors without HPV actually "do worse."
March 13, 2007 - HPV Vaccine Researcher Blasts Mandatory Marketing "Giving it to 11-year-olds is a great big public health experiment," said Diane M. Harper, who is a scientist, physician, professor and the director of the Gynecologic Cancer Prevention Research Group at the Norris Cotton Cancer Center at Dartmouth Medical School in New Hampshire. "It is silly to mandate vaccination of 11- to 12-year-old girls. There also is not enough evidence gathered on side effects to know that safety is not an issue."
December 7, 2006 - The Ethics and Politics of Compulsory HPV Vaccination (full text) "A critical question is whether achieving a higher level of coverage justifies the infringement on parental autonomy that compulsory vaccination inevitably entails. Different ethical frameworks that accord varying weights to communitarian and individualistic values will lead to contrasting answers to this question."
November 18, 2007 - What is wrong with the HPV vaccine mandate in Illinois? "Total adverse events from Gardasil are more than 15 times more prevalent than events following influenza vaccination, and loss of consciousness, more than 239 times more common among Gardasil recipients. According to a pre-licensure data presented to the FDA, spontaneous abortions occurred in nearly 25% of women who became pregnant following vaccination. Although this was a similar rate in the aluminum-containing placebo group, the rate far exceeds the typical background rates of 10% implying that both vaccine and adjuvant may be abortifacients."