Hepatitis B

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Hepatitis B is an infection acaused by the hepatitis B virus (HBV). The virus is transmitted by exposure to infectious blood or body fluids such as semen and vaginal fluids, while viral DNA has been detected in the saliva, tears, and urine of chronic carriers. Hepatitis B viruses cannot be spread by holding hands, sharing eating utensils or drinking glasses, kissing, hugging, coughing, sneezing, or breastfeeding. The acute illness can cause liver inflammation, jaundice and, rarely, death. Chronic hepatitis B may eventually cause cirrhosis and liver cancer, 30+ years after the original infection. The hepatitis B vaccine, given to newborns, is one of the most neurotoxic vaccines in use. Many neurological side effects and complications have been reported.

Package inserts for Hepatitis B vaccines

October 26, 2020 - Prenatal hepatitis B screening, and hepatitis B burden among children, in Ontario: a descriptive study "From 2012 to 2016, 93% of pregnant women were screened for HBV, with an HBsAg prevalence of 0.6%. Prevalence of HBsAg increased with age, peaking at older than 45 years at 3%. ... HBsAg testing was performed in 92.7% (Appendix 1, supplemental  of pregnancies in Ontario from 2012 to 2016. The prevalence of HBsAg positivity was 0.63% among the 651 745 tests performed.

September 20, 2019 – Skin immunization with third-generation hepatitis B surface antigen using microneedles “L-HBsAg is a third-generation hepatitis vaccine capable of inducing antibodies in non-responders and thus providing potentially therapeutic treatment. In this study, L-HBsAg was administered using microneedles (MN) without an adjuvant to induce intradermal (ID) immunization, and the efficacy of ID immunization was compared with that of intramuscular (IM) immunization that uses a conventional formulation with an adjuvant of aluminum hydroxide (L-HBsAg-AL-IM).”

October 8, 2018 – Transcriptome profiling in blood before and after hepatitis B vaccination shows significant differences in gene expression between responders and non-responders “In conclusion, our study has shown that immune-related gene expression differs between responders and nonresponders after Engerix-B vaccination with a peak response at day 3 in the responder group and a delayed and suppressed response at day 7 in the non-responder group. Our data also suggest that the immune status before vaccination may influence the response to vaccines. Additional studies, preferentially using a similar hypothesis-free approach, are required to confirm this observation. Finally, a more holistic and system biology-based approach will be necessary to provide a predictive framework of classifiers to distinguish responders from non-responders.”

August 2018 - Central Demyelinating Diseases after Vaccination Against Hepatitis B Virus: A Disproportionality Analysis within the VAERS Database “In VAERS, multiple sclerosis or similar demyelinating illnesses were up to five times more likely to be reported after a hepatitis B vaccination than after any other vaccination. Since DPA is mainly suited for hypothesis generation, further studies evaluating the nature of the link between MS and HB vaccination would be of considerable importance.”

April 25, 2018 - Hepatitis B vaccination coverage among adults aged ≥ 18 years traveling to a country of high or intermediate endemicity, United States, 2015 "Although travel to a country of high or intermediate hepatitis B endemicity was associated with higher likelihood of hepatitis B vaccination, hepatitis B vaccination coverage was low among adult travelers to these areas. Healthcare providers should ask their patients about travel plans and recommend and offer travel-related vaccinations to their patients or refer them to alternate sites for vaccination. Comment: Low vaccination acceptance is most likely tourists are not going to be having sex, sharing needles or toothbrushes with the natives. Hepatitis b is not spread through casual contact. 

April 12, 2018 - Antibody response to hepatitis B vaccine is independently associated with hepatitis B breakthrough infection among adults: Results from a three-year follow-up study in China "The study documents the association between hypo-response to HepB and hepatitis B breakthrough infection (HBBI) among adults. It also suggests more attention should be given to new HBV infection among young adults."

March 27, 2018 - Why France is making eight new vaccines mandatory "The consultation was a turning point that anchored the idea that legal coercion could be the solution to France’s crisis with vaccines and that the law should extend to all childhood vaccines. This conclusion ran counter the historical trend in French public health of emphasizing individual autonomy. In the case of vaccination, this approach has been reflected in the fact that since the end of the 1960s, all new vaccines were introduced without being made mandatory, and that two older mandatory vaccination laws, pertaining to smallpox and tuberculosis, were abrogated in 1984 and 2007, respectively. Since the hepatitis B vaccine scare, an intense reflection on the ways to improve vaccination policies has occupied the French public health milieu."

March 14, 2018 - Hepatitis B vaccination and the putative risk of central demyelinating diseases – A systematic review and meta-analysis "Exposure ascertainment used prospectively recorded data to minimize recall bias. However, records covering the three years preceding the first symptoms were available for only 163 of the 438 MS cases identified. ... Geier et al. came to the same conclusion in 2005 with their study conducted in the VAERS database, the risk of developing MS  (multiple sclerosis) after anti-hepatitis B vaccination being 5.2-fold higher than for tetanus vaccination."

February 16, 2018 - Maternal, and Birth Factors Associated with Hepatitis B Vaccination at Birth "Of 17,458 births, 14,006 (80.2%) infants received a HepB birth dose. Hospital use of preprinted newborn routine admission vaccination orders was associated with HepB birth dose receipt. Not using illicit drugs during pregnancy, maternal age <35 years, and weekday births were associated with HepB birth dose receipt. Hospitals using preprinted admission orders' had higher frequencies of HepB birth dose receipt. Additional study is needed to identify HepB birth dose receipt barriers among infants with maternal illicit drug use, maternal age ≥35 years, or deliveries during a weekend." COMMENT: Parents - be sure STANDING ORDERS are not in place and are stricken from your hospital birth plan if you want to refuse the hepatitis B vaccine for your newborn.

January 29, 2018 -Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a licensed hepatitis B vaccine in adults (full text) "Alum-adjuvanted vaccines approved for the prevention of hepatitis B infection are highly effective in children 'but less so in adults. Vaccinating adults at risk for hepatitis B 'remains a challenge. For example, in 2010, an estimated 77.2% of 14 million individuals with diabetes 59 years of age and younger (10.8 million individuals) had not been vaccinated. Little progress has been made; in 2015, an estimated 75.6% of such persons had not been vaccinated. Even when the alum-adjuvanted vaccines are administered, they have several limitations. Such limitations will make it difficult to achieve the recent call by the World Health Assembly and by the US National Academies of Sciences, Engineering, and Medicine for eliminating viral hepatitis as a public health problem by 2030."

January 2, 2018 - Assessing the safety of hepatitis B vaccination during pregnancy in the Vaccine Adverse Event Reporting System (VAERS), 1990–2016 "We found 192 reports involving pregnant women following hepatitis B vaccination of which 110 described AEs (57.3%); 12 'were classified as serious (6.3%); one newborn death was identified in a severely premature delivery, and there were no maternal deaths. Eighty-two (42.7%) reports did not describe any AEs. Among pregnancies for which gestational age was reported, most women were vaccinated during the first trimester, 86/115 (74.7%). Among reports describing an AE, the most common pregnancy-specific outcomes included 23 reports of spontaneous abortion (miscarriage), and 7 reports of preterm delivery, and elective termination in 5 reports."

September 2017 - Declining antibody levels after hepatitis B vaccination in Down syndrome (DS): A need for booster vaccination? "Only 48.1% of the Down Syndrome children aged 7-10 years and 31.9%  of the DS children aged >10 years had a protective anti-HBs titer (≥10 IU/L). The geometric mean anti-HBs titer was significantly lower in the DS children; this suggests booster vaccination for HBV may be needed. Comment: Or could it be that children with Down Syndrome have a ge'ne'tic tendency 'to be n'on-converters? Evaluating other serum titers would be valuable informaiton for NOT adding boosters to these children who are already genetically compromised. 

August 2, 2017 - Predictors of Infant Hepatitis B Immunization in Cameroon: Data to Inform Implementation of a Hepatitis B Birth Dose. " Among 4,594 mothers analyzed, 66.7% of infants completed the hepatitis B vaccine series; however, an average four-week delay in series initiation was noted with median dose timing at 10, 14 and 19 weeks of age. ... Increased awareness of HBV is needed among pregnant women and high-risk groups about vertical transmission, the importance of facility delivery and the effectiveness of prevention beginning with monovalent HBV vaccination 'at birth." Conflicts of Interest: JDO is supported by NIH/NICHD

August 2017 - Serologic Responses After Hepatitis B Vaccination in Preterm Infants Born to Hepatitis B Surface Antigen–Positive Mothers: Singapore Experience (full text) "The main limitation of our study is the small number of preterm infants. This is consistent with the incidence of prematurity (averaging 10%–15% of the birth cohort per year) combined with the low prevalence of HBsAg-positive mothers (1.8/100 deliveries).12 The local, maternal HBsAg-positive rates are likely to continue to decline with the universal hepatitis B vaccination program, and large cohorts of preterm low birth weight infants are unlikely to be available for future studies. Hence, large, collaborative multicenter studies will be necessary to determine whether vaccine efficacy differs with different dosing regimens for preterm infants both to HBeAg-positive and negative carrier mothers."

July 2017 - Effect of Combination Vaccines on Hepatitis B Vaccine Compliance in Children in the United States (full text) "A higher proportion of children receiving Hepatitis B single-antigen vaccine only were living above the poverty level, receiving vaccines from private providers and not enrolled in public health insurance. These characteristics are consistent with the profile of unvaccinated children and parents who intentionally refuse or delay their child’s vaccines." Comment: Well-educated parents are understanding why hepatitis B vaccination is not necessary for '''''their children. 

July 2017 - Hepatitis B vaccine non-response: A predictor of latent autoimmunity? "Taking into account that HBV vaccination is provided in the 1st year of life worldwide, I propose that all babies should be tested for anti-HBs response after completion of the vaccine series. And I suggest that children with undetectable anti-HBs titers after recommended immunization schedule, as well as the additional booster doses, should be followed up over time because they may be at risk of developing a number of autoimmune disorders." Comment: This is suggesting that NON-RESPONDERS are at higher risk of developing autoimmune disease. This is contrary to the usually '''''recommended strategy of re-vaccinating until a response is forced upon the immune system. Does this apply to adult non-responders too? 

June 2017 - Will Infant Hepatitis B Vaccination Protect Into Adulthood?: Extended Canadian Experience After a 2-, 4- and 6-month Immunization Schedule "Given such differences, one can reasonably argue that sufficient uncertainty exists about long-term protection after infant vaccination to warrant reconsideration of the infant priming regimen, favoring schedules with more doses or antigen, use of adjuvants or more delayed final doses, as with the current schedules in Belgium and Germany (doses at 2, 3, 4 and 11–15 months, in addition to a birth dose for high risk infants). While WHO does not currently recommend a booster dose for any age group, booster vaccination in adolescence might eventually prove useful' as a means to reinforce and extend protection in those immunized as infants. Whether a booster dose could extend the protection of adults immunized as infant's to better resemble that of adults immunized as adolescents 'remains an important unanswered question. The fact that substantial differences exist in measures of residual protection among teenagers after infant or adolescent HBV vaccination warrants close ongoing scrutiny of whether important differences will emerge in long-term protection, with or without booster vaccination."

May 19, 2017 - Effect of prophylactic or therapeutic administration of paracetamol on immune response to DTwP-HepB-Hib combination vaccine in Indian infants (full text) "The study found no evidence that paracetamol usage either as prophylactic or for treatment impact immunological responses to DTwP-HepB-Hib combination vaccine."

May 9, 2017 - Immune response to hepatitis B vaccination among people with inflammatory bowel diseases: A systematic review and meta-analysis

• We examine the response rate to HBV vaccination in patients with IBD.
• Only three of five inflammatory bowel disease patients show a serological response to HBV vaccination.
• Vaccination should be performed during remission, or before starting therapy.

April 29, 2017 - A randomized, controlled clinical trial to evaluate the immunogenicity of a PreS/S hepatitis B vaccine Sci-B-Vac™, as compared to Engerix B®, among vaccine naïve and vaccine non-responder dialysis patients "Dialysis patients have a suboptimal response to hepatitis B (HBV) vaccination. This study aimed to compare the immunogenicity of two vaccines: the third-generation Sci-B-Vac vs. the second-generation Engerix B. The cohort included two groups of dialysis patients: naïve and previously vaccinated non-responders. Primary endpoints were antibody titers ≥10 IU/L at 3 and 7-month post-vaccination. Secondary objectives were seroprotection rates in vaccine-naïve patients and in previously vaccinated non-responders."

April 25, 2017 - Minimal association of alleles of human leukocyte antigen class II gene and long-term antibody response to hepatitis B vaccine vaccinated during infancy "Totally 297 children 5–7 years after the completion of primary vaccination against hepatitis B in infancy, without booster immunization or natural resolved infection, were enrolled. Of them, 86 children with anti-HBs <10 mIU/ml were considered as long-term non- or hypo-responders, and 211 others with anti-HBs ≥10 mIU/ml were defined as long-term responders. Ten alleles in HLA-DR and -DQ subregions were detected by polymerase chain reaction with sequence-specific primers."

April 25, 2017 - Chronic hepatitis B: Immunological profile and current therapeutic vaccines in clinical trials

• Antiviral treatments do control HBV replication but do not eliminate virus-infected hepatocytes (liver cells).
• Virus-host interactions lead to different issues of chronic hepatitis B infection.
• Therapeutic vaccines should overcome the established tolerogenic environment.
• First generation of therapeutic vaccines, based on HBsAg, showed limited efficacy.
• Second generations of therapeutic vaccines are now being tested in clinical trials.
• Combining therapeutic vaccines with novel treatments should enhance their efficacy.

March 2017 - Immunogenicity of Augmented Compared With Standard Dose Hepatitis B Vaccine in Pediatric Patients on Dialysis: a Midwest Pediatric Nephrology Consortium Study "Patients receiving a multidose booster series had a response rate of 86% (44 out of 51), compared with 76% (91 out of 119) in patients receiving a single-dose booster (P=0.21). Twenty-seven patients received more than one single-dose booster or multidose series, and 26 out of 27 (96%) e'ventually gained immunity after receiving one to three additional single-dose boosters or multidose booster series. Conclusions; 'There was no clear gradient of increasing seroconversion rate with increasing vaccine dose in this cohort of pediatric patients on dialysis." COMMENT: All that matters is MAKING AN ANTIBODY. The consequences of repeated vaccination or the potential for long term illness is irrelevant. 

February 15, 2017 - Adolescent booster with hepatitis B virus vaccines decreases HBV infection in high-risk adults "Maternal HBsAg-positive status was an independent risk factor for vaccination-protected children to develop HBV breakthrough infection in adulthood. Adolescent boosters might be appropriate for high-risk individuals who were born to HBsAg-positive mothers when their serum anti-HBs < 10 mIU/ml. '''Comment: Studies are being done now to justify adding another HBV booster for adolescents"

February 2017 - Characterization of the disassembly and reassembly of the HBV glycoprotein surface antigen, a pliable nanoparticle vaccine platform "We reassembled isolated sAg protein into nanoparticles by detergent removal and reassembly resulted in a wider distribution of particle diameters. Knowledge of these driving forces of nanoparticle assembly and stability should facilitate construction of epitope-displaying nanoparticles that it can be used as immunogens in vaccines."

February 2017 - A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months (full text) "A hexavalent vaccine [diphtheria–tetanus toxoids–pertussis, hepatitis B vaccine, inactivated poliovirus vaccine and H. influenzae type b (DTPa3–HBV–IPV/Hib); Infanrix-hexa) used as the Control] has been licensed in Europe for over a decade (the only hexavalent vaccine available at the time of the study), a period during which improvement in immunization timeliness and stable effectiveness in disease prevention has been observed." . . . "The fully liquid investigational hexavalent vaccine [diphtheria–tetanus toxoids–acellular pertussis 5, hepatitis B, inactivated poliovirus vaccine and H. influenzae type b (DTaP5–HB–IPV–Hib)] reported here contains a 5-antigen pertussis component and has a different carrier protein conjugated to the Hib antigen. This report presents results from a pivotal European Union Phase III study (NCT01341639), assessing the safety, tolerability and immunogenicity of DTaP5–HB–IPV–Hib compared with Control, when administered at 2, 3, 4 and 12 months, concomitantly with Prevenar 13 (PCV13) (Pfizer, Philadelphia, PA), RotaTeq (RV5) and ProQuad (MMRV). Another study of DTaP5–HB–IPV–Hib and Control when administered in the 2-month, 4-month, and 11-month to 12-month schedule has also been completed and is described in a separate  manuscript

COMMENT: I believe this was perhaps one of the more despicable studies I have ever seen…using a FULL complement of vaccines and nearly the SAME VACCINE as the placebo/control. Nearly 100% of babies in both groups had side effects, which were only followed for a dismal 15 days (remember, if they develop seizures or SIDS on day 16 or after, it’s not due to the vaccine, according to the study design.) Prevnar 13 and ProQuad (MMRV) are two of the most neurotoxic vaccines on the market. Thirty children had serious adverse events (SAEs) within the first 30 days, but the types of side effects were not included in the discussion.

All that matters to these "investigators"  is that EACH vaccine antigen induces an antibody, the generalized marker of contamination. This “research” should be labeled medical assault. I wonder what was offered to coerce parents into sacrificing their children to the Pharma gods? I wonder what type of health problems children had six or 12 months later? 

January 26, 2017 - Will Infant Hepatitis B Vaccination Protect into Adulthood? Extended Canadian Experience After a 2, 4, 6 Month Immunization Schedule. "However, anamnestic responses were weaker in 15-16 year olds and lost in some. Booster responses in 10-11 year olds were vigorous in comparison. Extended evaluation of protection is warranted." Comment: Looks like there is more money to be made, another required booster before high school senior year.

January 23, 2017 -Identification of amino acids in antigen-binding site of class II HLA proteins independently associated with hepatitis B vaccine response
Highlights

  • Case-control association study of HBV vaccine response in 574 university students.
  • Conditional analyses identified responsible variants despite broad linkage disequilibrium in HLA.
  • Amino acid variants in HLA-DRβ1 and -DPβ1 were independently associated with response.
  • These variants located in antigen-binding pockets and regulated their physical properties.
  • HBsAg presentation through HLA pocket structures will involve heterogeneity in vaccine response.

January 3, 2017 - A Randomized Controlled Trial to Evaluate a Potential Hepatitis B Booster Vaccination Strategy Using Combined Hepatitis A and B Vaccine[ .] "The adverse events were not statistically different among groups(P=0.345). Conclusions. Combined hepatitis A and B vaccine could stimulate both high level of anti-HAV and anti-HBs antibodies and not increase adverse events, providing a new choice for hepatitis B booster. The trial was registered with the ClinicalTrial.gov number NCT02445703.

December 2016 - Eliminating hepatitis B virus as a global health threat "The authors then evaluated five strategies, including scaling-up infant vaccination coverage to 90%, birth-dose vaccination coverage to 80%, peripartum antivirals coverage for mothers with positive hepatitis B e antigen to 80%, increasing access to antivirals to 80%, and developing a cure for HBV infection. The first three interventions target new infections, whereas HBV treatments prevent disease progression, cirrhotic complications, and liver cancer."

August 9, 2016 - Dynavax gets November Adcomm review for hep B vaccine "In a note to investors this week, RBC Capital Markets analyst Simos Simeonidis pointed out that based on that study and two prior Phase III trials, “Heplisav-B is clearly efficacious.” But he said that the FDA’s decision to have a second Adcomm review suggests “lingering concerns about Heplisav-B’s safety profile.” COMMENT: The new oil-based adjuvant 'in Heplisav-B had never been tested in human trials and had a significantly 'increased risk''''' of myocardial infarctions (heart attack), but ACIP approved it anyway in 2018. 

August 9, 2016 - Neonatal hepatitis B vaccination impaired the behavior and neurogenesis of mice transiently in early adulthood "HBV induced impaired behavioral performances and hippocampal long-term potentiation at 8 weeks (w) of age without influence at 4 or 12 w. At 6 w, there was decreased neurogenesis, M1 microglial activation and a neurotoxic profile of neuroimmune molecule expression [increased tumor necrosis factor-α and reduced interferon (IFN)-γ, brain-derived neurotrophic factor and insulin-like growth factor-1] in the hippocampus of the HBV-vaccinated mice. In the serum, HBV induced significantly higher levels of interleukin (IL)-4, indicating a T helper (Th)-2 bias. Moreover, the serum IFN-γ/IL-4 ratio was positively correlated with the levels of neurotrophins and neurogenesis in the hippocampus at the individual level. These findings suggest that neonatal HBV vaccination of mice results in neurobehavioral impairments in early adulthood by inducing a proinflammatory and low neurotrophic milieu in the hippocampus, which follows the HBV-induced systemic Th2 bias."

July 19, 2016 - A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11–12 months "The Experimental Group (656 infants) received the investigational hexavalent vaccine (DTaP5-HepB-IPV-Hib) and the Control Group (659 infants) received Infanrix-hexa (DTaP3-HBV-IPV-Hib) at 2, 4 and 11–12 months of age.  Both groups were concomitantly given Prevnar 13 (PCV13) and Rotateq (RV5) or Rotarix (RV1) at 2, 4 months of age. 'AND then both groups were given Prevnar 13 at 11–12 months.  Subjects administered RV5 received a 3rd dose at 5 months of age.  Conclusion: New vaccine was as "safe and immunogenic" as the control. 

Comment: There is no control group and these infants were PUMMELED three times with multiple doses of all of these vaccines. Why? TO BE SURE THEY DEVELOP AN ANTIBODY TO EVERY ANTIGEN. 'Period. Not to determine if they are protected from TWENTY SIX infections (the number of antigens injected).  

Who followed these 1300 children for the next several years to evaluate their long term health? To see if they had developed autoimmune or neurological illness? To see if they had neurodevelopmental disorders? 'Answer: No one. 

April 2016 - Commentary: Assessing the impact of temporally associated adverse events on neonatal hepatitis B vaccination "A loss of confidence in vaccine safety, due to rumours or coincidental adverse events after vaccination, is a major and ongoing issue that has resulted in many documented instances of under-vaccination potentially putting large numbers of people at risk of vaccine-preventable disease and death, as well as requiring costly outbreak response activities. Stringent regulatory standards to ensure the safety and quality of vaccines are essential to maintain public confidence in vaccines. Swift investigation, response and communication with the public are also important to prevent a loss in public confidence following reports of adverse events following immunization (AEFI). Hepatitis B vaccination at birth is particularly prone to association with coincidental deaths because infant mortality is highest during the early neonatal period. Diverse methods have been used to investigate the impact of reported AEFIs, including modelling the impact on disease, in-depth qualitative studies and monitoring vaccination coverage....

  • Comment: There are many glaringly inaccurate statements in this abstract.
    • “Rumors or coincidental adverse events”
    • “Stringent regulatory standards to ensure safety”
    • “Swift investigations… to prevent loss in public confidence?” 
    • “Coincidental deaths due to high infant mortality among neonates”?

April 2016 - Loss of confidence in vaccines following media reports of infant deaths after hepatitis B vaccination in China"The HBV vaccine event resulted in the suspension of a safe vaccine, which was associated with a decline of parental confidence, and refusal of vaccination. Suspension of a vaccine can lead to loss of confidence that is difficult to recover. A timely and credible investigation, accompanied by proactive outreach to stakeholders and the media, may help mitigate the negative impact of future coincidental adverse events following immunization."

January 20, 2016 - Development of a more efficient hepatitis B virus vaccine by targeting hepatitis B virus preS to dendritic cells "Conventional hepatitis B virus (HBV) vaccines fail to induce protective antibody titers in 5–10% of immune-competent vaccinees. Therefore, there remains an urgent need to develop a safe and effective HBV vaccine. Methods: In this study, we developed an effective and economical method for producing the HBV vaccine by using the high binding capacity of biotin–streptavidin" Comment: Patent owner free to license for a fee is NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH

August 7, 2015 - Blockbuster expectations for hepatitis B therapeutic vaccine "A French biotech has raised $63.4 million in an initial public offering to take a Cuban-made vaccine for treating hepatitis B virus (HBV) infections into phase 3 trials."

July 9, 2015 - A longitudinal cohort study of the relationship between Thimerosal-containing hepatitis B vaccination and specific delays in development in the United States: Assessment of attributable risk and lifetime care costs. (full text) "The results of the present study confirm and extend previous epidemiological studies finding a significant relationship between exposure to Thimerosal-containing childhood vaccines and an increased risk of specific delays in development. It was observed, in the overall cohort and the cohorts separated by sex, that infants who received increased organic Hg (mercury) from thimerosal-containing hepatitis B vaccines (T-HBVs), in comparison with infants who received no organic Hg (mercury) from T-HBV within the first month of life, the first 2 months of life, and the first 6 months of life, were significantly more likely to subsequently be diagnosed with specific delays in development. Further, it was observed that there was a significant dose-dependent relationship between increasing doses of organic Hg from T-HBVs administered within the first 6 months of life and the eventual risk of a child being diagnosed with specific delays in development."

COMMENT: This is one of the most critically important studies ever published showing the effect of injected mercury on a developing infant's brain.

June 26, 2015 - Preparation by alkaline treatment and detailed characterization of empty hepatitis B virus core particles for vaccine and gene therapy applications "Viral-like proteins (VLPs) are some of the most powerful protein-engineering tools utilized to expose immunological epitopes and/or cell-targeting signals and for the packaging of genetic material and immune stimulatory sequences. Although hepatitis B core viral-like proteins and their numerous derivatives are produced using highly bacterial and yeast cultures, the current purification and packaging protocols are not sufficiently optimized and standardized." Comment: To learn more about what is planned in using VLPs in pregnant women, please see Novavax' Recombinant Protein Nanoparticle Vaccine Technology

May 18, 2015 -Review of Epidemiological Studies on Hib & Hepatitis B Vaccines and Autism (pdf) "Studies referenced by the CDC website as well as other potentially relevant studies were reviewed. The review concluded that there are zero studies meeting these criteria which resulted in a finding of ‘no association’. The review identified one independent study which found a 3x increased risk of autism associated with the HBV vaccine. In summary, there were no studies on the Hib Conjugate Vaccine and the only study which was performed found a link between the Hepatitis B vaccine and autism. The details of the review are included in the following tables."

May 11, 2015 - A retrospective study of the administration of vaccination for hepatitis B among newborn infants prior to hospital discharge at a midwestern tertiary care center "Of 5,663 mother-infant pairs, 5175 (91.4%) infants received Hep B within 7 days after delivery. The majority of those not vaccinated had a medical indication to delay vaccination. Single women were significantly more likely to have an infant not vaccinated, after adjustment for all other factors. Women of minority groups were significantly less likely to have an infant who lacked Hep B at hospital discharge than Caucasian women."

April 20, 2015 - Outcomes of Infants Born to Women Infected With Hepatitis B "RESULTS: Data from 17 951 mother-infant pairs were analyzed. Among 9252 (51.5%) infants for whom hepatitis B surface antigen testing results were available, 100 (1.1%) acquired perinatal HBV infection. Both hepatitis B (HepB) vaccine and hepatitis B immune globulin were administered within 12 hours of birth for 10 760 (94.9%) of 11 335 infants with information."

COMMENT: A module on Hepatitis B is part of the PREGNANCY COURSE,  available at www.VaccineU.com This course goes into detail about how seldom a baby born to a mother who is hepatitis B positive actually contracts a hepatitis B infection. 

April 8, 2015 - Media and public reactions toward vaccination during the ‘hepatitis B vaccine crisis’ in China "A total of 17 infant deaths were reported that were associated with Hepatitis B vaccination. Three major waves of high media and public attention were detected. The daily indicators reached their peaks in the second wave after the relevant vaccine was suspended by the authority (from December 20 to December 29, 2013) with 23,200 daily online news reports, 34,018 Sina Weibo posts and 17,832 Baidu search indices. There were significant correlations between the daily amount of online news, Weibo posts, and Baidu searches (p < .001). The contents analysis suggested 1343 out of 1608 (83.5%) original Weibo posts expressed negative sentiment with almost 90% in the second wave."..."Policy change such as suspension of the suspected vaccine might trigger an even greater reaction and more negative sentiment. The government should provide ways to address emerging public concerns after policy change to avoid misinformation and misunderstanding during such a vaccine crisis." Comment: Heaven forbid that anything negative is '''''said about a vaccine, even when 17 infants died. 

April 8, 2015 - Hepatitis B vaccination among adolescents 13–17 years, United States, 2006–2012 "Coverage among adolescents 13–17 years in 2012 ranged by state from 84.4% in West Virginia to 98.7% in Florida (median 93.3%). Characteristics independently associated with a higher likelihood of HepB vaccination included living more than 5 times above poverty level, living in Northeastern or Southern region of the United States, and having a mixed facility as their vaccination provider." Comment: West Virginia's Hep B vaccination rate is 84.4% even though an exemption is difficult to obtain in that state, and yet the rate is lower than Florida. 

March 2015 -Immunogenicity, Safety, and Antibody Persistence at 3, 5, and 10 Years Postvaccination in Adolescents Randomized to Booster Immunization with a Combined Tetanus, Diphtheria, 5-Component Acellular Pertussis, and Inactivated Poliomyelitis Vaccine Administered with a Hepatitis B Virus Vaccine Concurrently or 1 Month Apart (pdf) "The study was powered to evaluate immunogenicity, and so rare AEs or SAEs may not have been detected. Safety was assessed for '14 days' after each vaccination (except for SAEs, which were collected at any time through 30 days after the last vaccination) but this information was not collected throughout the 10-year follow-up. Only 62.8% of the participants could be assessed at the 10-year follow-up, and not all participants could be assessed at all time points. The determination of prior exposure to pertussis disease or pertussis vaccination was based on participant 'recall only and was not verified from medical records."

February 15, 2015 - Durability of Antibody Response Against Hepatitis B Virus in Healthcare Workers Vaccinated as Adults (full text) "Healthcare workers (HCWs) in the United States are mandated to receive hepatitis B vaccine and are at risk for hepatitis B through occupational exposure. Therefore, they would be an ideal population to assess the durability of antibody response and long-term (≥10 years) vaccine protection and to determine response to a booster dose in those who did not maintain the immune response to primary vaccination as adults."  Comment: They HOPE that the antibody level lasts 10 years? Healthcare workers can exercise their right to refuse hepatitis B vaccination using an OSHA Declination Form. 

February 11, 2015 - Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease and type 2 diabetes mellitus "Many patients with chronic kidney disease (CKD) are hyporesponsive to currently licensed alum-adjuvanted hepatitis B vaccines, including Engerix-B® (HBsAg-Eng)." COMMENT Patients with chronic kidney disease and on dialysis are a primary target for hepatitis B vaccination. This study reveals this population of patients is a frequent non-responder. 

February 2015 - Hepatitis B Vaccination Rate among Medical Students at the University of Port Harcourt Teaching Hospital (Upth) "One hundred and sixteen (36.7%) had received 2 doses, while 44 (13.9%) had received one dose. There was a statistical significant relationship among marital status (p = 0.01), clinical level (p = 0.02) and hepatitis B vaccine uptake. Conclusion: The hepatitis B vaccination rate among medical students at the University of Port Harcourt Teaching Hospital is low. National and institutional legislation for adult vaccination against Hepatitis B should be promulgated for those at higher risk."

December 30, 2014 - Efficacy of Neonatal HBV Vaccination on Liver Cancer and Other Liver Diseases over 30-Year Follow-up of the Qidong Hepatitis B Intervention Study: A Cluster Randomized Controlled Trial (full text) "We sincerely thank all participants and their families in the QHBIS and all staff who were involved in the initial intervention study and subsequent follow-up studies; we greatly appreciate 'Merck' for vaccine donation through WHO, the support from the Ministry of Health, China, and the support and statistical consultation in the original intervention study from WHO and from University of Oxford, England. Comment: So donations from Merck are going through WHO? Merck is profiting from their own vaccine with the results of this study'''.

December 11, 2014 - Universal infant immunization and occult hepatitis B virus infection in children and adolescents: a population-based study "Breakthrough infections in immunized subjects seem to associate with more occurrence of OBI than natural infections in un-vaccinated subjects. In post-vaccination era, anti-HBc seropositivity is a useful marker for OBI screening in HBsAg-negative subjects, and a very low level viral replication and HBsAg expression is the major mechanism underlying OBI.

December 5, 2014 - Repeated vaccinations do not improve specific immune defenses against Hepatitis B in non-responder health care workers "We found that the great majority of the non-responders had a functional immune system and a preserved ability to respond to other conventional antigens. Our most important findings are that the frequency of HBsAg-specific memory B cells is comparable in non-responders and controls and that booster immunization 'does NOT 'lead either to antibody production or memory B cell increase in non-responders''."

November-December 2014 - Hepatitis B Vaccination and Associated Oral Manifestations: A Non-Systematic Review of Literature and Case Reports "As some complications after hepatitis B vaccinations are manifested intraorally, it is necessary for dentists to know about these adverse reactions. According to our knowledge, this is the first attempt ever made to review the complications appearing orally after hepatitis B vaccination. Dentists need to keep in mind the possibility of hepatitis B vaccination as a possible etiology if a patient presents with LP, systemic lupus erythematosus, idiopathic thrombocytopenic purpura and neuromuscular disorders. A randomized control clinical trial with a large sample size should be undertaken in the future to substantiate the findings in these case reports."

November 27, 2014 - Chronic fatigue syndrome and fibromyalgia following immunization with the hepatitis B vaccine: another angle of the ‘autoimmune (auto-inflammatory) syndrome induced by adjuvants’ (ASIA) "This study suggests that in some cases CFS and FM can be temporally related to immunization, as part of ASIA syndrome. The appearance of adverse event during immunization, the presence of autoimmune susceptibility and higher titers of autoantibodies all can be suggested as risk factors. ASIA criteria were fulfilled in all patients eluding the plausible link between ASIA and CFS/FM."

November 25, 2014 - Enhancing of hepatitis B virus vaccine and its gene (patent) "Immune response to hepatitis B vaccine varies significantly across different individuals. In many people receiving the standard 6-month 3-dose vaccination regimen, not enough antibody was produced to offer protection. The proteins described in this invention can significantly augment the immune response to hepatitis B vaccine. Accordingly, these proteins can be used to develop hepatitis B vaccine adjuvant or directly in combination with the hepatitis B vaccines that are currently available. Simultaneous use of a certain Amount of SBP with hepatitis B vaccine can increase the immunogenicity of the vaccine, and increase the titer of neutralizing antibodies."

November 2014 - Evolution of multiple sclerosis in France since the beginning of hepatitis B vaccination "Statistical data from these latter sources seem to show a significant correlation between the number of hepatitis B vaccinations performed and the declaration of multiple sclerosis occurring between 1 and 2 years later."

October 2014 - Thimerosal-Containing Hepatitis B Vaccination and the Risk for Diagnosed Specifi c Delays in Development in the United States: A Case-Control Study in the Vaccine Safety Datalink (full text) "The present study provides compelling new epidemiological evidence supporting a significant relationship between increasing organic-Hg exposure from Thimerosal-containing childhood vaccines and the risk of a diagnosis for specific developmental delays in BOTH males and females. Many recent studies support the biologically plausible role of organic-Hg exposure from Thimerosal-containing vaccines in the pathogenesis of specific delays in development."

July 17, 2014 - The Safety and Immunogenicity of Two Hepatitis B Vaccine Formulations (Thiomersal-Free and Thiomersal-Containing) in Healthy Vietnamese Infants: A Phase III, Prospective, Single-Blinded, Randomized, Controlled Trial. "Conclusions: The thiomersal-free formulation of Hepavax-Gene(R) was non-inferior to the thiomersal-containing formulation of Hepavax-Gene(R) in terms of immunogenicity. There was evidence that the 'thiomersal-free' vaccine was associated with 'fewer local adverse events."

July 16, 2014 - Immunization with hepatitis B vaccine accelerates SLE-like disease in a murine model. "Mice immunized with hepatitis B vaccines (EnergixB) and/or aluminum hydroxide had decreased red blood cell counts  (p < 0.001), memory deficits (p < 0.01), and increased activated microglia in different areas of the brain compared with mice immunized with phosphate buffered saline. Anxiety-like behavior was more pronounced among mice immunized with alum."

July 2014 - Cost-Effectiveness of Ensuring Hepatitis B Protection for Previously Vaccinated Healthcare Personnel "To examine the cost-effectiveness of pre- and postexposure approaches for ensuring hepatitis B protection among previously vaccinated healthcare personnel (HCP). Design. A decision-analytic model was developed for alternative strategies of ensuring hepatitis B protection under assumptions of 68% and 95% long-term protection after a primary vaccination series." Comment: Health Care Workers may be getting a fourth Hep B vaccine

April 9, 2014 - Use of contingency management incentives to improve completion of hepatitis B vaccination in people undergoing treatment for heroin dependence: a cluster randomised trial "Modest financial incentives delivered in routine clinical practice significantly improve adherence to, and completion of, HBV vaccination programmes in patients receiving opioid substitution therapy. Achievement of this improvement in routine clinical practice should now prompt actual implementation. Drug treatment providers should employ contingency management to promote adherence to vaccination programmes. The effectiveness of routine use of contingency management to achieve long-term behavior change remains unknown.

March 2014 - Supercritical fluid extraction provides an enhancement to the immune response for orally-delivered hepatitis B surface antigen "Orally-delivered subunit vaccines produced in maize may help to alleviate the disease burden by providing a low-cost, heat-stable alternative to the parenteral vaccine. Oral subunit vaccination has been an elusive goal due to the large amounts of antigen required to induce an immunologic response when administered through the digestive tract. Here we show that high levels of HBsAg were obtained in maize grain, the grain was formed into edible wafers, and wafers were fed to mice at a concentration of approximately 300 μg/g. When these wafers were made with supercritical fluid extraction (SFE)-treated maize material, robust IgG and IgA responses in sera were observed that were comparable to the injected commercial vaccine (Recombivax)." Comment: The entire concept of 'edible vaccine' has been under development for quite some time, especially with Hepatitis B vaccines. This is a new approach: use maize. How will they monitor the dose? What if someone in 3rd world countries eats 50 wafers because they are hungry? What does a vaccine reaction or overdose look like? They are using any type of mechanism to make money…and to ensure we are all inoculated.

February 17, 2014 - A rare case of Raynaud’s vasculitis secondary to Hepatitis B vaccination: The induced auto-immune attack syndrome (pdf) "It can be concluded that antiviral immunization such as Hepatitis B vaccination can rarely induce vasculitis. Physicians should be aware of rare instances of small and medium vessel vasculitis. Patients should be informed of this rare potential side effect of Hepatitis B vaccination prior to administration and physicians made aware of vaccination-induced Raynaud’s vasculitis in the differential diagnosis of a patient presenting with vasculitic symptoms."

February 2014 - Isolated abducens nerve palsy following neonatal hepatitis B vaccination "We report a case of sudden-onset abducens nerve palsy in an otherwise healthy 8-day-old boy following neonatal hepatitis B vaccination. A complete workup, including magnetic resonance imaging of the brain and orbits revealed no abnormalities. The patient recovered fully, with no recurrence of the abducens nerve palsy despite receiving the full course of the hepatitis B vaccine as well as other recommended immunizations through 18 months of age. We review the literature regarding vaccination-induced abducens nerve palsy and discuss the possible mechanisms of injury." COMMENT: Autoimmune inflammatory reaction, paralyzing a cranial nerve, was no reason to stop vaccinating. This paralysis is sometimes permanent, leading to in-turning eye and double vision.

January-February 2014 HLA-DPB1 and anti-HBs titer kinetics in hepatitis B booster recipients who completed primary hepatitis B vaccination during infancy (full text) "Gender difference was another factor found to affect the responsiveness of booster in this study. We found that female subjects had significantly stronger booster responses compared with male subjects. In the immune system, a gender gap has long been observed clinically. In humans, female subjects usually expressed higher level of antibodies and antibody-stimulating Th2 cytokines. They also had higher chances to develop autoimmune diseases because of a more responsive immune system. Our finding was consistent with previous studies, including a recent large-scale HBV vaccination cohort study.

January 28, 2014 - Supercritical fluid extraction provides an enhancement to the immune response for orally-delivered hepatitis B surface antigen "Orally-delivered subunit vaccines produced in maize (corn) may help to alleviate the disease burden by providing a low-cost, heat-stable alternative to the parenteral (injected) vaccine. Oral subunit vaccination has been an elusive goal due to the large amounts of antigen required to induce an immunologic response when administered through the digestive tract. Here we show that high levels of HBsAg were obtained in maize grain, the grain was formed into edible wafers, and wafers were fed to mice at a concentration of approximately 300 μg/g."

January 14, 2014 - Systems analysis of sex differences reveals an immunosuppressive role for testosterone in the response to influenza vaccination (full text) "In this study, we have used a systems approach to the analysis of sex differences in the immune system in humans. These data reinforce and extend previous reports, and point toward a mechanistic hypothesis that may drive the sex disparities observed in responses to vaccination. Differences in vaccine responsiveness in males versus females have been reported for most commercially available vaccines including  yellow fever, influenza, measles, mumps, rubella, and hepatitis, among others. As in these studies, we find stronger responses to influenza vaccination and significantly increased serum levels of proinflammatory molecules in females compared with males, specifically LEPTIN (25), IL-RA and CRP.

January 8, 2014 - Systematic review of human papillomavirus vaccine coadministration "Our review included 9 studies, 4 of quadrivalent HPV vaccine and 5 of bivalent HPV vaccine; coadministered vaccines included: meningococcal conjugate, hepatitis A, hepatitis B, combined hepatitis A and B, tetanus, diphtheria, acellular pertussis (Tdap), and inactivated poliovirus vaccines. Studies varied in methods of data collection and measurement of immunogenicity and safety. Noninferiority of immune response and an acceptable safety profile were demonstrated when HPV vaccine was coadministered with other vaccines."  COMMENT: Give all the vaccines together and as long as each antigen stimulates an antibody response, the vaccine was "effective" and the combination given together is acceptible. 

January 7, 2014 - Purification of HBV antigens for use in vaccines Assignee: GlaxoSmithKline Biologicals, S.A. (Rixensart, BE) "Many vaccines which are currently available require a preservative to prevent deterioration. A frequently used preservative is thiomersal which is a mercury-containing compound. Some concerns have been raised about the use of mercury in vaccines, although commentators have stressed that the potential hazards of thiomersal-containing vaccines should not be overstated (Offit; P. A. JAMA Vol. 283; No:16). Nevertheless. it would be advantageous to find new and potentially safer methods of preparation of vaccines to replace the use of thiomersal in the manufacturing process. There is thus a need to develop vaccines which are thiomersal-free, in particular, hepatitis B vaccines."

December 30, 2013 - Reports to the Vaccine Adverse Event Reporting System after hepatitis A and hepatitis AB vaccines in pregnant women "VAERS received 139 reports of adverse events (AEs) s in pregnant women; 7 (5.0%) were serious; No maternal or infant deaths were identified. Sixty-five (46.8%) did not describe an AE. For those women whose gestational age was available, most were vaccinated during the first trimester, 50/60 (83.3%) for Hep A and 18/21 (85.7%) for Hep AB. The most common pregnancy-specific outcomes following Hep A or Hep AB vaccinations were 15 spontaneous abortion reports (10.8%), elective termination in 10 (7.2%), and 7 'pre-term delivery reports (5.0%) . The most common non-pregnancy specific outcome was urinary tract infection and nausea vomiting with 3 (2.2%) reports each. One case of amelia of the lower extremities was reported in an infant following maternal Hep A immunization."

December 19, 2013 - Findings from a hepatitis B birth dose assessment in health facilities in the Philippines: Opportunities to engage the private sector (full text) "Median timely HepB-birth does coverage was 90% among government clinics, 87%  among government hospitals, and 50%  among private hospitals. The '''''private hospitals were least likely to receive supervision and to report vaccination data to the national Expanded Programme on Immunization"..."'''''Multiple avenues exist to engage the private sector in hepatitis B prevention including through '''''existing laws''''', newborn health initiatives, '''''hospital accreditation processes''''', and raising awareness of the '''''government's free vaccine program."

November 2013 - Hepatitis B vaccination with or without hepatitis B immunoglobulin at birth to babies born of HBsAg-positive mothers prevents overt HBV transmission but may not prevent occult HBV infection in babies: a randomized controlled trial "The current practice of administration of vaccine with HBIG at birth to babies born of HBsAg-positive mothers '''''is not effective''''' in preventing occult HBV infection in babies, which may be up to 40%. Because the most important risk factors for mother-to-baby transmission of HBV infection are the replicative status and high HBV DNA level in mothers; it will be worthwhile investigating the role of antivirals and HBIG administration during pregnancy to prevent mother-to-child transmission of HBV infection." COMMENT: We offer a module on HEPATITIS B in the PREGNANCY COURSE at VaccineU.com - we go into great detail explaining WHY babies born to hepatitis B infected mothers are at high risk ONLY under certain circumstances. 

September 4, 2013 - Change of Hepatitis B Large Surface Antigen Variants after 13 Years Universal Vaccination Program in China "The prevalence of LHBs mutants were compared between the 1992 and 2005 surveys in children and adult groups. The prevalence of ‘α’ determinant mutants in the children increased from 6.5% in 1992 to 14.8% in 2005, where G145R mutant occurred most frequently."

September 2013 - Results of a phase III clinical trial with an HBsAg-HBIG immunogenic complex therapeutic vaccine for chronic hepatitis B patients: Experiences and findings "Overstimulation with YIC did not increase but decreased its efficacy due to immune fatigue in hosts. An appropriate immunization protocol should be explored and is crucial for therapeutic vaccination. Multiple injections of alum alone could have stimulated potent inflammatory and innate immune responses contributing to its therapeutic efficacy, and needs further investigation."

August 29, 2013' - Rapid loss of vaccine-acquired hepatitis B surface antibody after three doses of hepatitis B vaccination in HIV-infected persons "In multivariate analysis, time between the third dose and the first post-vaccine serology testing at 180–359 days (OR = 0.077, p = 0.049) and at ≥360 days (OR = 0.065, p = 0.019) were associated with poor vaccine responses. A significant decrease in seropositivity appeared as early as 180 days after the third vaccine dose, suggesting a rapid loss of vaccine-acquired hepatitis B surface antibody in HIV-infected persons."

April 26, 2013 - In the United States Court of Federal Claims Office of Special Masters Damages; decision based on proffer hepatitis B vaccine; chronic fatigue syndrome (pdf) "A lump sum payment of $1,076,412.15 representing compensation for life care expenses expected to be incurred during the first year after judgment ($40,357.92), lost future earnings ($838,566.45), pain and suffering ($194,580.48), and past unreimbursable expenses ($2,907.30), in the form of a check payable to petitioner." Comment: This is a VAERS settlement for Hepatitis B vaccine injury.

July 29, 2013 - High non-responsiveness of males and the elderly to standard hepatitis B vaccination among a large cohort of healthy employees "From the age of 29 on in men and 43 on in women, more than 5% of subjects did not respond to hepatitis b vaccines. Compared with women, men had a higher risk of non-response and exhibited a steeper decline in antibody titres produced with increasing age."

July 19 2013 - Tick-Borne Encephalitis and Hepatitis B Nonresponders Feature Different Immunologic Mechanisms in Response to Tick-Borne Encephalitis and Influenza Vaccination with Involvement of Regulatory T and B Cells and IL-10 "HLA-DR subtypes associated with hepatitis B nonresponsiveness were overrepresented in this group, and high IL-10 levels were linked to these subtypes. Whereas TBE and hepatitis B nonresponders had increased IL-10–producing FOXP3+ T regulatory cells upon vaccination, only in hepatitis B nonresponders, showing elevated prevaccination IL-10 levels, a prominent population of B regulatory cells was detected. We conclude that immunological pathways of nonresponsiveness follow different patterns depending both on vaccine Ag and genetic predisposition of the vaccine.

April 10, 2013 - The new nano-complex, Hep-c, improves the immunogenicity of the hepatitis B vaccine "The new nano-complex, Hep-c, improves the immunogenicity of the hepatitis B vaccine "Our findings show that Hep-c can not only preserve the alum capacity to effectively stimulate production of the antibodies but also cover its inefficiency in inducing Th1 response and prompting cellular immunity. Thus, by boosting the performance of the hepatitis B vaccine, it seemed that this nano-adjuvant has the suitable potential to be used in the commercial HBS vaccine formulation." COMMENT: Nanotechnology is going to be a horrific antigen. 

April 8, 2013 - A novel hepatitis B vaccine containing Advax™, a polysaccharide adjuvant derived from delta inulin, induces robust humoral and cellular immunity with minimal reactogenicity in preclinical testing "Unlike alum, the adjuvant effect of Advax™ was seen even when injected 24 h before the HBs antigen. Advax adjuvant similarly enhanced humoral and cellular immune responses in guinea pigs to a third generation preS-HBs antigen. Advax adjuvant when combined with Hepatitis B antigens could provide enhanced protection over current generation HBV vaccines for immunization of low responder populations."

March 22, 2013 - Observational Study of Vaccine Efficacy 24 Years after the Start of Hepatitis B Vaccination in Two Gambian Villages: No Need for a Booster Dose (full text) "Adolescents and young adults vaccinated in infancy are at increased risk of hepatitis B infection, but not chronic infection. Married women were not at increased risk. There is no compelling evidence for the use of a booster dose of HBV vaccine in The Gambia."

February 4, 2013 - Hepatitis B vaccination at three months of age: A successful strategy? "The students vaccinated at three months of age had a higher rate of non-protective antibodies (47.2%) comparing to those vaccinated after the first year of life (17.0%, P < 0.0001) with a significantly lower antibody level (P < 0.001)."

January 2013 - Chronic hepatitis B infection in adolescents who received primary infantile vaccination "Having maternal HBeAg positivity is the most important determinant for HBsAg positivity in adolescents who received postnatal passive-active HB vaccination 15 years before. A significant proportion of complete vaccinees may have lost their immunological memories against HBsAg. (HEPATOLOGY 2013)" Comment: This study was done in Taiwan, where hepatitis b is a common infection. In the U.S., the hepatitis B vaccine is given to all children at birth, regardless of the infection status of the mother. By giving hepatitis B vaccines at birth, the ability to detect an antibody at age 2years is only 2-9%. All antibodies are absent by 15 years of age. Most notably about this article is that the risk of infection in children under 10 years of age – even in a high-risk country such as Taiwan – is less than 15%. Interestingly, only infants of mothers who are active carriers of hepatitis (HBeAg) are given at birth. Why do we give this vaccine to women without an active hepatitis B infection and push it so heavily in a low-risk country, such as the U.S.?

August 24, 2012 - Association of polymorphisms of cytokine and TLR-2 genes with long-term immunity to hepatitis B in children vaccinated early in life "Hepatitis B vaccine is effective in preventing hepatitis B virus (HBV) infection. However, 5–10% of vaccinees fail to produce sufficient antibody against hepatitis B surface antigen (anti-HBs)."

August 1, 2012 - Sleep and Antibody Response to Hepatitis B Vaccination "Clinical protection status (anti-hepatitis B surface antigen immunoglobulin G ≥ 10 mIU/ml) was assessed 6 mo after the final immunization. Regression analyses revealed that shorter actigraphy-based sleep duration was associated with a lower secondary antibody response independent of age, sex, body mass index, and response to the initial immunization."

March 3, 2012 - JCVI response on hepatitis B vaccination "The prevalence and incidence of hepatitis B infection in the UK is more similar to that of Scandinavia (where universal vaccination is not given) than to the parts of Europe to which Horton refers. Additionally, most (>90%) of chronic infection in the UK is a result of transmission outside the country."..."Horton implies that the decision to use a health intervention should not be based on economic criteria such as cost per quality-adjusted life-year gained—but, given a finite financial resource, what he proposes as an alternative is unclear."

February 2012 - Autoimmunity following hepatitis B vaccine as part of the spectrum of 'Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants' (ASIA): analysis of 93 cases. "We have retrospectively analyzed the medical records of 114 patients, from different centers in the USA, diagnosed with immune-mediated diseases following immunization with hepatitis-B vaccine (HBVv). All patients in this cohort sought legal consultation. Of these, 93/114 patients diagnosed with disease before applying for legal consultation were included in the study."

January 17, 2012 - Hepatitis B vaccine induces apoptotic death in Hepa1-6 cells. "We conclude that exposure of 'Hepa1-6 cells to a low dose of adjuvanted hepatitis B vaccine leads to loss of mitochondrial integrity, apoptosis induction, and cell death, apoptosis effect was observed also in C2C12 mouse myoblast cell line after treated with low dose of vaccine (0.3, 0.1, 0.05 μg/ml). In addition In vivo apoptotic effect of hepatitis B vaccine was observed in mouse liver."

January 2012 - Maternal Characteristics and Hospital Policies as Risk Factors for Nonreceipt of Hepatitis B Vaccine in the Newborn Nursery "Results: A total of 64,425 infants were identified in the birth cohort, of whom 61.6% received a birth dose of HBV. Higher maternal education and income were associated with nonreceipt of HBV (master's degree vs. eighth grade or less:"

September 21, 2011 - Hexavac withdrawal The following correspondence was rejected in 2005 by the British Medical Journal. Having regard to the persistent stubborness of regulatory bodies not to see evidence of toxicity before new drugs are registered, it is still of relevance..."The withdrawal of the vaccine Hexavac® by the European Medicine Agency (EMEA), in September 2005, caused surprisingly few reactions. EMEA’s reason for withdrawal (lack of efficacy) is questionable: early, post-marketing period is usually not devoted to efficacy re-assessments, whereas the last public statement on Hexavac (Dec 2003) was related with a safety problem (sudden infant death syndrome [SIDS]).

August 2011- IOM Adverse Effects of Vaccines Evidence and Causality "Evidence Convincingly Supports a Causal Relationship: The MMR vaccine is linked to a disease called measles inclusion body encephalitis, which in very rare cases can affect people whose immune systems are compromised and usually occurs within a year of acute measles infection or vaccination. The MMR vaccine also is linked to febrile seizures, which are a type of seizure that occurs in infants and young children in association with fever. Febrile seizures are generally benign and hold no long-term consequences. Six types of vaccines—MMR, varicella zoster, influenza, hepatitis B, meningococcal, and tetanus-containing vaccines—are linked to anaphylaxis. The committee also found convincing evidence of a causal relationship between injection of the vaccine, independent of the antigen involved, and two types of adverse events, including syncope, or fainting, and deltoid bursitis, or frozen shoulder, characterized by shoulder pain and loss of motion."

July 2011 - Chronic fatigue after hepatitis B vaccination. "Although and regrettably, much of this documentation is embargoed as secret by Court order according to French law (as there is no Freedom of Information Act in France), in a number of instances it permitted indirect cross-checking with public data."

Volume 73, Issue 24, 2010 - Hepatitis B Vaccination of Male Neonates and Autism Diagnosis, NHIS 1997–2002 "Boys vaccinated as neonates with Hepatitis B had threefold greater odds for autism diagnosis compared to boys never vaccinated or vaccinated after the first month of life. Non-white boys had greatest risk."

July 2010 - The response to hepatitis B vaccine: does it differ in celiac disease? " There is a relationship between nonresponsiveness to hepatitis B virus (HBV) vaccine and certain human leukocyte antigen (HLA) genotypes. In healthy population, 4–10% vaccine recipients fail to produce protective levels of antibodies to the HBV vaccine after standard immunization depending upon age and the presence of various underlying diseases. Celiac disease (CD) is an HLA-associated immunological disease. It has been suggested that certain HLA haplotypes which are linked to CD are associated with nonresponse to HBV vaccine as well."..."The response to HBV vaccine in celiac children who were compliant to GFD is not different from a healthy population

June 1, 2008 - Gluten Intake Interferes With the Humoral Immune Response to Recombinant Hepatitis B Vaccine in Patients With Celiac Disease

March 3, 2008 - IgE-mediated large local reaction from recombinant hepatitis B vaccine "The cutaneous adverse effects of rHBV comprise local and generalized reactions. Local cutaneous events predominantly consist of transient inflammatory reactions resulting from nonspecific lymphoid or granulomatous reactions. Allergic reactions to the vaccine strain, adjuvants, conservatives or other excipients are less frequently involved in local cutaneous adverse reactions and remain anecdotal. Brightman et al. (4) described a comparable case clinic and presumed the reaction to result from an IgE-mediated S. cerevisiae allergy. We present a patient in whom the regional and temporal relationship between injection and symptoms is highly indicative of an rHBV-related adverse event. This presumption is endorsed by the positive basophil activation test (BAT) and IgE-blotting results for the vaccine and the absence of sensitization from alternative causes.

March 2008 - Newly identified prion linked to the chromatin-remodeling factor Swi1 in Saccharomyces cerevisiae

July-August 2007 - Extensive Keloid Formation and Progression after Each Vaccination (pdf) "A 45-year-old Latino-American female with type III skin developed extensive keloidal scars on bilateral upper arms (deltoid area) after multiple vaccinations given during childhood. "..."Keloid formation has occurred after vaccination with bacilli Calmette-Guerin (BCG), small pox and hepatitis B vaccinations. We report the case of a female patient who developed extensive keloidal scars on her bilateral upper arms beginning in childhood after routine vaccinations with smallpox, BCG, diphtheria-tetanus-pertussis (DTP) and measles. These keloids progressed when the patient received additional vaccines to include hepatitis A, meningococcal (tetravalent, serogroups A, C, Y, and W-135), yellow fever, and boosters of tetanus-diphtheria (Td) and measles-mumps-rubella (MMR)."

January 30, 2007 - Severe necrotizing pancreatitis following combined hepatitis A and B vaccination (full text) Necrotizing pancreatitis is a severe form of pancreatitis and is associated with substantial morbidity and mortality. We report a case of necrotizing pancreatitis that developed following combined hepatitis A and B vaccination. No other causes of pancreatitis could be determined. Although confirming the diagnosis is challenging, 3 main factors suggest a possible link to the vaccine: the chronology of the events, the patient's human leukocyte antigen genotype and the incongruent immune response to the vaccine components. This report serves to alert physicians to the possible development of necrotizing pancreatitis after vaccination.

June 5, 2006 - Hepatitis B Virus Infection: Epidemiology and Vaccination (full text) "The earliest recognition of the public health importance of hepatitis B virus (HBV) infection is thought to have occurred when it appeared as an adverse event associated with a vaccination campaign. In 1883 in Bremen, Germany, 15 percent of 1,289 shipyard workers inoculated with a smallpox vaccine made from human lymph fell ill with jaundice during the weeks following vaccination. The etiology of “serum hepatitis,” as it was known for many years, was not identified until the 1960s, and only following the subsequent development of laboratory markers for infection was its significance as a major cause of morbidity and mortality worldwide fully appreciated.

November 2005 - Anti-phospholipid antibodies following vaccination with recombinant hepatitis B vaccine "We conclude that HBV can induce aPL, although rarely. In genetically susceptible individuals or together with some other triggers such combination might confer the risk of developing a continuous autoimmune response in an individual."

November 2005 - Fatal Syncope-Related Fall After Immunization "The death was ruled as accidental, and the medical examiner concluded that a vasovagal reaction had led to this injury. This death was first reported in the lay press, and then the events were reported to the Vaccine Adverse Event Reporting System (VAERS)."

September-October 2005 - Gianotti-Crosti syndrome in an infant following immunization. "Gianotti-Crosti syndrome (GCS), first described by F. Gianotti in 1955, was originally reported to be associated with hepatitis B virus infection in children"..."Here we report the occurrence of GCS in an infant five days after the fourth immunization against poliomyelitis, DTPa, Hib, hepatitis B and Streptococcus pneumoniae."

September 2005- A Study of Molecular Mimicry and Immunological Cross-reactivity between Hepatitis B Surface Antigen and Myelin Mimics (pdf) "In view of the observed SHBsAg/MOG cross-reactivity, the vaccine’s possible role as a trigger for the induction and/or maintenance of viral/self cross-reactivity through molecular mimicry must be further investigated."

July 2005 - Multiple sclerosis and hepatitis B vaccination: Adding the credibility of molecular biology to an unusual level of clinical and epidemiological evidence "A number of convergent facts, however, suggests that the manufacturing process could introduce HBV polymerase as a contaminant, and then trigger an auto-immune process against myelin in some vaccinated subjects."

June 2005- A case-control study of serious autoimmune adverse events following hepatitis B immunization.

May 23, 2005 - Multiple sclerosis and hepatitis B vaccination: could minute contamination of the vaccine by partial hepatitis B virus polymerase play a role through molecular mimicry? " We hypothesise that some of the apparent adverse reactions to the vaccine could be due to a process called of molecular mimicry, the HBV polymerase, which could be a contaminant in the recombinant or plasma-derived vaccines, could act as autoantigens and induce autoimmune demyelinating diseases such as multiple sclerosis."

February 9, 2005 - Adjuvant debuts in new hep B vaccine The European approval of a new high-potency vaccine for hepatitis B virus (HBV) marks the debut on the marketplace of a new adjuvant ingredient that can significantly improve the effectiveness of immunizations, reports Phil Taylor.

February 2005 - Autoimmune hazards of hepatitis B vaccine. (pdf) "According to Hippocratic tradition, the safety level of preventive medicine must be very high, as it is aimed at protecting people against diseases that they may not contract. In HBV documented hazards, two main categories emerge: (1) central demyelinating disorders, most probably related to a mechanism of molecular mimicry; (2) disorders reproducing the non-hepatic manifestation of natural hepatitis B, which leads to question the rationality of injecting viral antigens added with adjuvants in order to protect against an infection where the causative agent is not always cytotoxic by itself, but may act via the formation of antigen antibodies complexes. The aim of the present paper was to stimulate research on the unusual toxicity of HBV vaccine and to induce international pressure on health authorities in order to obtain the release of the whole of cumulated clinical and epidemiological evidence in the normal circulation of scientific information and peer-reviewed research.

September 2004 - A latex-containing hepatitis-B vaccine administered in a severely latex allergic paediatric patient after specific sublingual immunotherapy: a case report

September 2004 - Two case reports of cutaneous adverse reactions following hepatitis B vaccine: lichen planus and granuloma annulare.

August 2004 - Lichen planus induced by hepatitis B vaccination: a new case and review of the literature.

January 2004 - Hepatitis B immunisation induces higher antibody and memory Th2 responses in new-borns than in adults

January 2004 - Hepatitis B surface antigenaemia following vaccination with a combined vaccine against hepatitis A and B. "We report a case of transient hepatitis B surface antigenaemia (HBsAg) following vaccination with a combined vaccine against hepatitis A and B in healthy adults. This phenomenon has been observed following administration of recombinant hepatitis B (monovalent) vaccine, mainly in newborns or dialysis patients."

December 2003 - Kawasaki disease in an infant following immunisation with hepatitis B vaccine

October 2003 - Hepatitis B vaccine nonresponse and celiac disease. "We postulate that celiac disease patients may have a significant predisposition to hepatitis B vaccine nonresponse. Both celiac disease and hepatitis B vaccine nonresponse is genetically mediated. Celiac disease patients may have a failure of induction of humoral immune response needed for development of long term immunity; the mechanism for this is unclear."

August 2003 - Wells' syndrome following thiomersal-containing vaccinations "A 3½-year-old boy presented on three occasions with painful, itchy, oedematous plaques on his limbs. On two occasions he had received hepatitis B vaccination 11–13 days previously, and on the third occasion received triple antigen (DTP) vaccination 10 days earlier."

March 15, 2003 - Cytokine Polymorphisms Play a Role in Susceptibility to Ultraviolet B-Induced Modulation of Immune Responses after Hepatitis B Vaccination (full text) "Cytokine polymorphisms play a role in susceptibility to ultraviolet B-induced modulation of immune responses after hepatitis B vaccination."

March 2003 - The antibody response to HBs antigen is regulated by coordinated Th1 and Th2 cytokine production in healthy neonates (full text) "In summary, we have demonstrated that both Th1 and Th2 responses are defective in human nonresponder neonates to recombinant HBsAg vaccine. This could be due to defect in either the HBsAg-specific T-cell repertoire or antigen presentation. Both issues are currently being investigated in our laboratory."

March 2003 - A review of hepatitis B vaccination. "The authors strongly urge that additional research be conducted into the molecular basis of adverse events following hepatitis B vaccine administration, so that further recommendations may be made on how to improve their safety profiles."

January 2003 - Hepatitis B vaccine -- do we need boosters? "The accumulated data from studies assessed in this Review indicate that protection is dependent on immune memory, rather than declining anti-HBs responses and add additional weight to the European Consensus recommendations that following a complete course of vaccination, booster doses are unnecessary in immunocompetent persons. If implemented, this recommendation will have considerable cost benefits world-wide."

December 29, 2002 - Childhood bullous pemphigoid following hepatitis B immunization. "This case suggests that the hepatitis B surface antigen can function as the triggering factor for BP by inducing a nonspecific immune reactivation which unmasks subclinical BP or by stimulating a specific antibody production that may cross-react with BP antigens."

December 2002 - Humoral response to recombinant hepatitis B virus vaccine at birth: role of HLA and beyond. "Tolerance to HBV peptides may have clinical implications, possibly being a marker for babies with a genetic risk of immunopathologies. In fact, many of the poor responders carried from two to four HLA-DQ alpha beta heterodimers predisposing to insulin-dependent diabetes mellitus and celiac disease."

November-December 2002 - Hepatitis B vaccination and adult associated gastrointestinal reactions: a follow-up analysis. "Hepatitis B vaccination was statistically associated by chi 2 analysis with gastrointestinal reactions including: hepatitis, gastrointestinal disease and liver function test abnormalities in comparison to our vaccine control groups. The reaction rate observed is outweighed by the benefits of the vaccine."

November-December 2002 - A one year followup of chronic arthritis following rubella and hepatitis B vaccination based upon analysis of the Vaccine Adverse Events Reporting System (VAERS) database. Chronic arthritis adverse reactions following adult rubella vaccination were primarily reported in females at about 45 years-old, and at a mean onset time of 10-11 days following vaccination. Chronic arthritis adverse reactions following adult hepatitis B vaccination were also primarily reported in females, with a mean onset time of 16 days following vaccination. The incidence rates of chronic arthritis following adult rubella and adult hepatitis B vaccinations were statistically significantly increased. The attributable risk of chronic arthritis following adult rubella vaccine ranged from 32 to 53 and from 5.1 to 9.0 following adult hepatitis B vaccine in comparison to the adult vaccine control groups. CONCLUSION: '''This study revealed that adult rubella and adult hepatitis B vaccines were statistically associated with chronic arthritis which persisted for at least one year. The etiology for these adverse reactions may involve autoimmune mechanisms.

March 2002 - Hepatitis B vaccination safety. "Patients and physicians need to be fully informed of the potential adverse reactions associated with hepatitis B vaccination so that together they can make an informed consent decision about the risk versus the benefit."

February 16, 2002 - Serious outbreak in a patient with recurrent acute disseminated encephalitis vaccine against hepatitis B: For or against vaccination? (translation)

May 2001 - Large artery vasculitis following recombinant hepatitis B vaccination: 2 cases. "Although small vessel vasculitis following hepatitis B vaccination has been reported a number of times, large vessel vasculitis associated with hepatitis B vaccination has been reported only once."

July 2000 - Severe pancytopenia triggered by recombinant hepatitis B vaccine. "We describe the case of a t'eenager who developed fever, arthritis, cutaneous vasculitis and severe pancytopenia 3 weeks after the third vaccination boost with a recombinant hepatitis B vaccine."

March 2000 - The first episode of central nervous system demyelinization and hepatitis B virus vaccination "Recently, in France, in the context of an Expanded Program on Immunization, several cases of CNS demyelination have been observed following injection of recombinant hepatitis B (HB) vaccine, leading to great concern."

December 1999 - Unilateral papilloedema after hepatitis B vaccination in a migraine patient. A case report including forensic aspects. "To report on a unilateral optic nerve reaction appearing 9-10 hours after vaccination against hepatitis B."

November 1999 - Unexplained fever in neonates may be associated with hepatitis B vaccine (pdf)"The increase in the number of cases of unexplained neonatal fever seems to be associated with the introduction of routine hepatitis B vaccination on the first day of life. The possibility that an excess number of neonates will undergo unnecessary procedures and treatment to diagnose unexplained fever justifies planning a controlled study to determine whether these preliminary findings point to a significant problem.

August 1999 - A hepatitis B virus variant found in the sera of immunised children induces a conformational change in the HBsAg "a" determinant. "The implications of this work are that serodiagnosis of HBV infections may be unreliable in populations where there is a possibility of variant HBV infections emerging in the face of increasing herd immunity to HBV as a result of vaccination, particularly using monoclonal antibody-based diagnostic tests."

July 1999 - Encephalitis after hepatitis B vaccination: recurrent disseminated encephalitis or MS? "Eight patients with confirmed CNS inflammation occurring less than 10 weeks after hepatitis B vaccination are described. They received follow-up clinically and on MRI for a mean period of 18 months."

May 18, 1999 - Hepatitis B Vaccine: Helping or Hurting Public Health? Hearing before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources "Judy Converse testified; Before discharge, he was immunized with Recombivax HB against hepatitis B. Neither I nor my husband recall receiving informed consents for this vaccine, nor do we recall seeing him get the shot, but it is in his immunization record. No signed informed consent specific to this hepatitis B vaccine was present in the copy of Ben's medical record which we recently requested. His fourth night in this world was his first at home. And about 5 hours after arriving home, he had his first seizure. Frantic calls to maternity and pediatric staff fell on deaf ears. The extent of the medical advice we received was to put him on our clothes dryer and turn it on."

September 1998 - The development of rheumatoid arthritis after recombinant hepatitis B vaccination. "These polymorphic residues in the binding site of the MHC class II molecules of the affected patients appear capable of binding some peptide sequences of the recombinant vaccine peptides they received and may be responsible for hepatitis B vaccine triggering development of RA in these cases."

February 1998 - Major adverse reactions to yeast-derived hepatitis B vaccines—a review "Our review of the literature revealed reports of serious adverse reactions which included immediate reactions (anaphylaxis and urticaria) as well as delayed reactions, including skin, rheumatic, vasculitic (including Systemic Lupus Erythematosus [SLE] and glomerulonephritis), hematologic, ophthalmologic and neurologic reactions. These cases were summarized and a pathogenetic mechanism is offered.

1998 - Immune thrombocytopenic purpura after recombinant hepatitis B vaccine: retrospective study of seven cases. "We retrospectively report 7 cases of thrombocytopenia occurring within 3 months (7 weeks on the average) of 1 or following injections of recombinant hepatitis B vaccine."

October 1997 - A case report of fluctuant sensorineural hearing loss after hepatitis B vaccination.

March 1997 - Patients who develop inflammatory polyarthritis (IP) after immunization are clinically indistinguishable from other patients with IP. (pdf) "Given that IP following immunization appears to be no diferent from other forms of IP\ we postulated that the immunization may have been acting as a trigger for the development of disease."

February 1997 - Occlusion of the central retinal vein after vaccination against viral hepatitis B with recombinant vaccines. "4 cases "Four patients under 50 years of age developed occlusion of the central vein of the retina after vaccination with recombinant hepatitis B vaccine. None of the classical causes of occlusion of the central vein of the retina could be evidenced."

1995 - Arthritis after hepatitis B vaccination. Report of three cases.

June 1994 - Acute cerebellar ataxia after immunisation with recombinant hepatitis B vaccine.

December 1993 - The course of hepatitis B in 9 children who became positive for viral surface antigen HBsAg in spite of vaccination. "Most of the infants who, in spite of passive-active hepatitis B immunisation, became HBsAg positive developed a chronic hepatitis B infection without clinical or biochemical dysfunctions. On the basis of these findings and considering possible therapy, guidelines are given for the follow up of children with chronic hepatitis B."

February 1992 - The immune response to hepatitis B vaccine in humans: inheritance patterns in families (full text) "Our results suggested that [HLA- B8,SC01,DR3] lacks an immune response gene for HBsAg, and that response is inherited in a dominant fashion."

December 1991 - Some Concern Over Instituting Hepatitis B Vaccine Into Babies' Routine Vaccination Schedules "By dividing 5,000 into $250 million to $300 million, a more cost-effective intervention strategy emerges. However, the reasons for not giving the vaccine remain. “If we give all babies vaccine, are we going to have a whole bunch of susceptible people who are 10 or 15 years old? Are we going to repeat the measles scenario?” Teele asked."

October 1990 - Inoculation failure following hepatitis B vaccination. The effect of additional vaccinations.

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