Polio IPV
Polio is a viral infection that has been associated with varying degrees of paralysis. On March 26, 1953, American medical researcher Dr. Jonas Salk announced on a national radio show that he had successfully developed a vaccine against poliomyelitis. For promising eventually to eradicate the disease, which is known as "infant paralysis" because it mainly affects children, Dr. Salk was celebrated as the great doctor-benefactor of his time. In 2012, polio is considered one of the global “filth diseases” and isolated outbreaks still occur in a handful of war-torn countries with inadequate sanitation.
Poliovirus Vaccine Inactivated IPOL® Package Insert
September 22, 2022 – Persistence of protective anti-poliovirus antibody levels in 4-year-old children previously primed with Picovax®, a trivalent, aluminium-adjuvanted reduced dose inactivated polio vaccine “No serious AEs were reported. A total of 150 (92%) subjects reported 678 AEs, of which 259 were systemic AEs (111 subjects) and 419 ISRs (146 subjects). The vast majority (90.2%) of the subjects experienced at least one mild AE; 33.1% had at least one moderate AE and 1.2% had at least one severe AE (Table 4). A total of 71.8% of the subjects reported at least one AE that was considered certainly or possibly related to vaccination by the investigator.”
August 31, 2022 - Polio’s Re-emergence Underscores Need to be Current on Vaccines "Then, in July, the polio virus, the first case in the U.S. in almost a decade, was detected in an unvaccinated individual in Rockland County, N.Y. A single confirmed case may not seem like cause for concern, but experts say potentially 200 people around that case may have been exposed or are now carrying the virus. And while it may not result in paralysis – or even death – polio can have lasting, life-altering effects."
August 3, 2022 - UPDATE: In July 2022, CDC was notified of a case of polio caused by vaccine-derived poliovirus type 2 (VDPV2) in an unvaccinated individual from Rockland County, New York "Public health experts are working to understand how and where the individual was infected and provide protective measures, such as vaccination services to the community to prevent the spread of polio to under- and unvaccinated individuals. ... A vaccine-derived poliovirus (VDPV) is a strain related to the weakened live poliovirus contained in oral polio vaccine (OPV). If allowed to circulate in under- or unimmunized populations.
July 9, 2021 - Oral Polio Vaccine to Protect Against COVID-19: Out of the Box Strategies? "While antibodies produced from vaccination help prevent disease, the immune training by live vaccines is thought to decrease the severity of disease and the amount of damage to organic tissue, including mucosal surfaces, by reducing viral shedding and invasive pathogens, allowing for nonspecific protection against other pathogens. This effect was demonstrated by Upfill-Brown et al. (2017), a randomized controlled trial that found that OPV use was associated with decreased prevalence of Shigella and E. coli diarrhea among male children and of Campylobacter jejuni diarrhea among children of both sexes in Bangladesh .
October 20, 2020 - A Health Economic Analysis for Oral Poliovirus Vaccine to Prevent COVID-19 in the United States "The costs of reintroducing a single OPV dose to 331 million Americans would exceed $4.4 billion. Giving a dose of bivalent OPV to the entire U.S. population would lead to an expected 40 identifiable cases of vaccine-associated paralytic polio, with young Americans at the highest risk. Reintroducing any OPV use in the U.S. poses a risk of restarting transmission of OPV-related viruses and could lead to new infections in immunocompromised individuals with B-cell related primary immunodeficiencies that could lead to later cases of paralysis. Due to the lack of a currently licensed OPV in the U.S., the decision to administer OPV to Americans for nonspecific immunological effects would require purchasing limited global OPV supplies that could impact polio eradication efforts. Health economic modeling suggests no role for reintroducing OPV into the U.S."
April 8, 2019 - Immunogenicity and Safety of a Sabin Strain–Based Inactivated Polio Vaccine: A Phase 3 Clinical Trial (full text) “Compared with OPV, the manufacture of conventional IPV requires a much higher standard for biosafety and other containment requirements, mainly because IPV uses virulent poliovirus strains as raw material. These strict requirements substantially limit the number of manufacturers producing IPV, especially in middle- and low-income countries. To end vaccine-associated and vaccine-derived polio in resource-limited areas, the WHO encourages the development new IPVs that use less virulent strains, such as the Sabin strain–based inactivated polio vaccine (sIPV), which carries a lower biosafety risk and demonstrates a long-term affordability and accessibility. The aim of this study was to report immunogenicity and safety findings from a phase 3 clinical trial of a new sIPV developed in China.”
January 29, 2019 - Lack of immune interference between inactivated polio vaccine and inactivated rotavirus vaccine co-administered by intramuscular injection in two animal species "Our results demonstrate that IRV when adjuvanted with alum and administered alone or in combination with IPV did not impair the immune responses to either rotavirus or poliovirus serotypes 1, 2 and 3. Similarly, IPV when formulated and administered alone or together with IRV induced comparable levels of neutralizing" Comment: visit the Conflicts of Interest page.
August 6, 2018 -Feasibility of jet injector use during inactivated poliovirus vaccine house-to-house vaccination campaigns "Parental refusal related to frequent polio vaccination campaigns was the biggest challenge. In addition, novelty of the device posed a challenge to teams as they needed to reassure parents about safety of the device. To take full advantage of the ability to take injectable vaccines door-to-door during vaccination campaigns using a needle-free jet injector device, tailored social mobilization efforts are needed ahead of campaigns."
December 1, 2017 - Fractional-Dose Inactivated Poliovirus Vaccine Campaign — Sindh Province, Pakistan, 2016 (full text) "Following the declaration of eradication of wild poliovirus (WPV) type 2 in September 2015, trivalent oral poliovirus vaccine (tOPV) was withdrawn globally to reduce the risk for type 2 vaccine-derived poliovirus (VDPV2) transmission; all countries implemented a synchronized switch to bivalent OPV (type 1 and 3) in April 2016 (1,2). Any isolation of VDPV2 after the switch is to be treated as a potential public health emergency and might indicate the need for supplementary immunization activities (3,4). On August 9, 2016, VDPV2 was isolated from a sewage sample taken from an environmental surveillance site in Hyderabad, Sindh province, Pakistan. Possible vaccination activities in response to VDPV2 isolation include the use of injectable inactivated polio vaccine (IPV), which poses no risk for vaccine-derived poliovirus transmission. Fractional-dose, intradermal IPV (fIPV), one fifth of the standard intramuscular dose, has been developed to more efficiently manage limited IPV supplies. fIPV has been shown in some studies to be noninferior to full-dose IPV and was used successfully in response to a similar detection of a single VDPV2 isolate from sewage in India."
September 25, 2017 - Long-term evaluation of mucosal and systemic immunity and protection conferred by different polio booster vaccines (full text) "Plant boosters with VP1 and FDA approved adjuvants (in other vaccines) maintains the same level of titers from 29 to 400 days and confers the same level of neutralizing antibodies against all three serotypes throughout the duration of this study. Lyophilized plant cells expressing VP1 can be stored without losing efficacy, eliminating cold chain. Long-term (>2 years) studies in dogs showed lack of toxicity of CTB fusion proteins. Although vaccine studies in this investigation used lyophilized tobacco cells expressing VP1 in chloroplasts, high level expression has been achieved in lettuce chloroplasts and large biomass production is in progress. Virus-free, cold-chain free vaccine is therefore ready for further clinical development."
September 1, 2017 - The Immunogenicity of Fractional Intradermal Doses of the Inactivated Poliovirus Vaccine Is Associated With the Size of the Intradermal Fluid Bleb (full text) "The switch was to have been accompanied by the introduction of a routine dose of the (trivalent) inactivated poliovirus vaccine (IPV) in all countries using OPV only to mitigate against the risk of future type 2 disease in the event of a 'vaccine-derived poliovirus' type 2."... "This study demonstrates, to our knowledge for the first time, a significant positive correlation between the size of the ID fluid bleb generated at the time of ID fIPV administration and the subsequent immune response."
- Potential conflicts of interest. A. S. B. is an employee of the Bill & Melinda Gates Foundation, which provided grant funding for the trial.
- R. C. has received grants from the Bill & Melinda Gates Foundation during the conduct of this trial.
- B. K. has previously received grant funding from GSK and Pfizer to conduct vaccine research although not for vaccines in any way related to those used in this trial.
- M. R. was Chief Science Officer for PharmaJet during the performance of this study, and is now CEO/President of Thrivant Health, Inc.
July 2017 - Immunogenicity and safety of three aluminium hydroxide adjuvanted vaccines with reduced doses of inactivated polio vaccine (IPV-Al) compared with standard IPV in young infants in the Dominican Republic: a phase 2, non-inferiority, observer-blinded, randomised, and controlled dose investigation trial (full text) "Three serious adverse events, all assessed as being unrelated to the vaccinations, occurred in the trial: two events of bronchiolitis and one event of amoebic dysentery. 19 adverse events were reported in the trial including the abovementioned three serious adverse events." ... "Three serious adverse events, all assessed as being unrelated to the vaccinations, occurred in the trial: two events of bronchiolitis and one event of amoebic dysentery. 19 adverse events were reported in the trial including the above mentioned three serious adverse events. Three mild injection site reactions (≤25 mm) and 16 systemic adverse events, all with group frequencies less than 2%.
June 16, 2017 - Inactivated polio vaccines from three different manufacturers have equivalent safety and immunogenicity when given as 1 or 2 additional doses after bivalent OPV: Results from a randomized controlled trial in Latin America (full text) 'Most SAEs (69 of 73, 95%) were Infections and Infestations (MEDRA code 10021881). Of 134 IMEs reported in 100 subjects, 107 (80%) were General Disorders and Administration Site Conditions (MEDRA code 10018065). No severe solicited or unsolicited AEs were reported."
May 9, 2017 - Intranasal and sublingual delivery of inactivated polio vaccine "Intranasal vaccination showed to be more efficient in eliciting both systemic and mucosal immune responses compared with the sublingual route. However, besides possible redirection to olfactory bulbs (Bell’s palsy), the risk of wheezing in young children exists. The sublingual route could be an easy and safe polio immunization approach. Nevertheless, for the induction of evident immunity upon sIPV vaccination under the tongue, strong mucosal adjuvants might be required. Therefore, further research on polio vaccination via the sublingual route should include the search for a safe and effective adjuvant and the development of novel oral dosage forms that improve antigen uptake by the oral mucosa."
Highlights:
• B cell stimulation is crucial for an effective post-vaccination antibody response.
• We assessed memory B cell responses to pneumococcal booster vaccination in preschool children.
• There were large differences between the B cell responses to individual serotypes.
• Priming and boosting with the same vaccine did not increase memory B cell responses.
•There was a unique immunological response to serotype 3.
June 16, 2017 - Inactivated polio vaccines from three different manufacturers have equivalent safety and immunogenicity when given as 1 or 2 additional doses after bivalent OPV: Results from a randomized controlled trial in Latin America (full text) 'Most SAEs (69 of 73, 95%) were Infections and Infestations (MEDRA code 10021881). Of 134 IMEs reported in 100 subjects, 107 (80%) were General Disorders and Administration Site Conditions (MEDRA code 10018065). No severe solicited or unsolicited AEs were reported."
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 (GlaxoSmithKline Inc., Mississauga, Ontario, Canada); 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) (Merck & Co., Inc., Kenilworth, NJ) and ProQuad (MMRV) (Merck & Co., Inc., Kenilworth, NJ). 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.
- Funding for this research was provided by Merck & Co., Inc., Sanofi Pasteur, Inc. and Sanofi Pasteur MSD. Although the funding companies formally reviewed a penultimate draft, the opinions expressed are those of the authors and may not necessarily reflect those of the sponsors. All coauthors approved the final version of the manuscript.
- T.V., T.B., A.F.V. and K.P. were investigators for the sponsor supported by research grants.
- M.F.P., S.A.F., J.X., G.F.L., J.E.S. and A.W.L. are employees of Merck & Co., Inc. and may hold company stock and/or stock options.
- F.B., S.T. and E.Z. are employees of Sanofi Pasteur MSD
COMMENT: I believe this was perhaps one of the most 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.
Arghhh!! 'All that matters to these poisoners who have been deemed to be “investigators” is that EACH vaccine antigen induces an antibody, the generalized marker of contamination. This “research” should be labeled medical assault, maybe assault with a potentially deadly weapon. I wonder what was offered to coerce parents into sacrificing their children to the Pharma gods? I wonder how many of these '''''children remained “healthy” after at the endpoint of this trial?
January 19, 2017 - Genetically Thermo-Stabilised, Immunogenic Poliovirus Empty Capsids; a Strategy for Non-replicating Vaccines (full text) "All vaccines in current use depend on growth of virus and most of the non-replicating (inactivated) vaccines involve wild type viruses known to cause poliomyelitis. The attenuated vaccine strains involved in the eradication programme have been used to develop new inactivated vaccines as production is thought safer. However it is known that the Sabin vaccine strains are genetically unstable and can revert to a virulent transmissible form."
January 13, 2017 - CDC MMWR Guidance for Assessment of Poliovirus Vaccination Status and Vaccination of Children Who Have Received Poliovirus Vaccine Outside the United States "This report summarizes current Advisory Committee on Immunization Practices (ACIP) recommendations for poliovirus vaccination and provides CDC guidance, in the context of the switch from tOPV to bOPV, regarding assessment of vaccination status and vaccination of children who might have received poliovirus vaccine outside the United States, to ensure that children living in the United States (including immigrants and refugees) are protected against all three poliovirus types."
January 11, 2017 - Concomitant administration of a fully liquid, ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal serogroup C conjugate vaccine in infants "Secondary immunogenicity and safety analyses showed that co-administration of DTaP-IPV-HB-PRP-T and MenC vaccines did not impact the immune response to the antigens of each of the two vaccines. All vaccines were well tolerated and the safety profile of DTaP-IPV-HB-PRP-T vaccine was similar in both groups. ClinicalTrials.gov
- Sponsor: Sanofi Pasteur MSD Collaborator: Sanofi Pasteur, a Sanofi Company Information provided by (Responsible Party): Sanofi Pasteur MSD
December 7, 2016 - Simultaneous vaccination with MMR and DTaP-IPV-Hib and rate of hospital admissions with any infections: A nationwide register based cohort study "By 2 years of age, 4965 children had simultaneous MMR and DTaP-IPV-Hib as their most recent vaccination. Compared with MMR alone, simultaneous administration was associated with a higher rate of lower respiratory tract infections (adjusted incidence rate ratio (IRR), 1.27; 95% confidence interval (CI), 1.13–1.42). There was no effect on other infections. Overall, simultaneous administration was associated with a 7% (95% CI, 0–15%) increase in infectious disease admissions."
September 22, 2016 - Acceptance of multiple injectable vaccines in a single immunization visit in The Gambia pre and post introduction of inactivated polio vaccine "Prior to IPV introduction, 9.9% of healthcare providers and 35.7% of infant caregivers expressed concern about a child receiving more than 2 injections in a single visit. Nevertheless, 98.8% and 90.9% of infants received all required vaccinations for the visit before and after IPV introduction, respectively. Comment: Third world countries knew for years the US was no longer using oral polio vaccine due to polio virus from the vaccine strain.
August 31, 2016 - Incompatibility of lyophilized inactivated polio vaccine with liquid pentavalent whole-cell-pertussis-
July 29, 2016 - Safety of DTaP-IPV/Hib vaccine administered routinely to infants and toddlers (full text) "Poisoning by other medications and drugs - There were a total of 11 cases combined after the 3rd and 4th doses. Of these, one that was after the 4th dose of DTaP-IPV/Hib was determined by the study investigator (Klein) possibly to be related to receipt of DTaP-IPV/Hib. It consisted of an approximate 3×4cm flat area of erythema near the injection site that was diagnosed as “Vaccines adverse reaction”. "..."The largest two categories of non-fever events were “Nausea with vomiting” and “Vomiting alone” of which there were 16 total cases. The range of days was from the day 1 to day 18. The mean days for medical attention were 11 and 6, respectively, or 8.6 when the two categories are combined. Additionally, one sub-category was allergic reactions of which there were four cases, two of which were determined by the investigator to be related to receipt of DTaP-IPV/Hib (both being cases of urticaria beginning on the day of vaccination).
July 19, 2016 - A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11–12 months "A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11–12 months "The DTaP5-HB-IPV-Hib Group received the investigational hexavalent vaccine (DTaP5-HB-IPV-Hib) and the Control Group received Infanrix-hexa (DTPa3-HBV-IPV/Hib) at 2, 4 and 11–12 months of age. Both groups received concomitantly Prevnar 13 (PCV13) and Rotateq (RV5) or Rotarix (RV1) at 2, 4 months of age and PCV13 at 11–12 months. Subjects administered RV5 received a 3rd dose at 5 months of age." Comment: This is not a true control group.
May 19, 2016 - Humoral and intestinal immunity induced by new schedules of bivalent oral poliovirus vaccine and one or two doses of inactivated poliovirus vaccine in Latin American infants: an open-label randomised controlled trial "IPV induced small but significant decreases in a composite serotype 2 viral shedding index after mOPV2 challenge. 21 serious adverse events were reported in 20 patients during the study, including two that were judged to be possibly related to the vaccines. Most of the serious adverse events (18 [86%] of 21) and 24 (80%) of the 30 important medical events reported were infections and infestations."
April 2016 - Is introduction of IPV “Good news for billions of children”? "In 2008, following the demonstration of methodological flaws in studies concluding that there was no sign of a negative effect of DTP, the Global Advisory Committee on Vaccine Safety stated that it would monitor the evidence of non-specific effects of vaccines. It remains to be assessed whether IPV has non-specific effects and especially whether IPV could be detrimental for child health. IPV has been used as a comparator vaccine in randomised trials; girls randomly assigned to IPV had 52% (95% 2–128) higher mortality than did boys who were randomly assigned to the vaccine.
April 2016 - Is introduction of IPV “Good news for billions of children”? – Author's reply – Author's reply "OPV cessation will prevent hundreds of estimated cases of vaccine-associated paralytic poliomyelitis every year. Developed countries like the USA switched from the oral to the IPV for routine immunisation decades ago to prevent the morbidity and in some cases mortality caused by vaccine-associated paralytic poliomyelitis.
March 15, 2016 - Proposed Revised Vaccine Information Materials for Polio and Varicella Vaccines "The vaccines initially covered under the National Vaccine Injury Compensation Program were diphtheria, tetanus, pertussis, measles, mumps, rubella and poliomyelitis vaccines. Since April 15, 1992, any health care provider in the United States who intends to administer one of these covered vaccines is required to provide copies of the relevant vaccine information materials prior to administration of any of these vaccines. Since then, the following vaccines have been added to the National Vaccine Injury Compensation Program, requiring use of vaccine information materials for them as well: hepatitis B, Haemophilus influenzae type b (Hib), varicella (chickenpox), pneumococcal conjugate, rotavirus, hepatitis A, meningococcal, human papillomavirus (HPV), and seasonal influenza vaccines. Instructions for use of the vaccine information materials are found on the CDC Web site at: http://www.cdc.gov/
March 12, 2016 - Changing oral vaccine to inactivated polio vaccine might increase mortality "On average, about 75 cases of vaccine-associated paralytic poliomyelitis are reported each year worldwide, and WHO has suggested that OPV be gradually replaced by inactivated polio vaccine (IPV) to reduce the number of such cases. Results from a randomised trial in 2015 suggest that OPV might have beneficial non-specific effects that reduce all-cause mortality by 17%, possibly to a greater extent in boys than in girls, whereas previous evidence suggests that IPV increases all-cause mortality by 10%.5 Consequently, the proposed change from OPV to IPV might lead to increased all-cause mortality through loss of the beneficial non-specific effects of the live vaccine, and adverse non-specific effects of the inactivated vaccine. Replacement of OPV with IPV could translate to approximately 4000 deaths for each case of vaccine-associated paralytic poliomyelitis prevented, and might cause more than 300 000 additional deaths each year.
- KLF reports funds to attend and present at the Optimmunize meetings in Copenhagen hosted by Peter Aaby and Christine Stabell Benn, authors on publications describing non-specific effects of oral polio vaccine.
- OL's laboratory at Boston Children's Hospital has and anticipates patent applications for in-vitro platforms to assess vaccine immunogenicity and for novel vaccine adjuvants. All other authors declare no competing interests.
February 25, 2016 - Alternative administration routes and delivery technologies for polio vaccines "The target product profile of these vaccines includes not only dose sparing but also high stability, which is important for stockpiling, and easy application important for (emergency) vaccination campaigns."
December 31, 2015 - New Strains Intended for the Production of Inactivated Polio Vaccine at Low-Containment After Eradication "New polio vaccines will be needed to safeguard global eradication: Sabin strains are known to evolve to fill the niche left by wild-strains so their long-term use is incompatible with eradication; most current inactivated vaccine is made from wild polioviruses so that production presents a significant biosecurity risk."
November 17, 2015 - Bone erosion and subacromial bursitis caused by diphtheria–tetanus–
October 13, 2015 - Synthetic virus seeds for improved vaccine safety: Genetic reconstruction of poliovirus seeds for a PER.C6® cell based inactivated poliovirus vaccine "The synthetic strains were phenotypically identical to wild-type polioviruses as shown by equivalent infectious titers in culture supernatant and antigenic content, even when infection cultures are scaled up to 10–25 L bioreactors. Moreover, the synthetic seeds were genetically stable upon extended passaging on the PER.C6® cell culture platform. Use of synthetic seeds produced on the serum-free PER.C6® cell platform ensures a perfectly documented seed history and maximum control over starting materials. It provides an opportunity to maximize vaccine safety which increases the prospect of a vaccine end product that is free from adventitious agents."
September 23, 2015 - Immunogenicity of a New Vaccination Schedule for the Final Phase of Polio Elimination "Removal of Sabin poliovirus strains is essential in the endgame of global polio eradication. Concern remains whether immunity induced by a single IPV dose will prevent the emergence of circulating vaccine-derived type-2 poliovirus after removal of Sabin type-2 virus. By documenting superior immunogenicity of the alternative schedule, this study provides the scientific support for implementing it. Editorialists note that duration of immunity after one or two doses of IPV is unknown and should be assessed.
August 27, 2015 - Twenty-Eight Years of Poliovirus Replication in an Immunodeficient Individual: Impact on the Global Polio Eradication Initiative (full text) "This is by far the longest reported poliovirus excretion and represents the most comprehensive collection of iVDPV sequential isolates available. Provided antibody titres and immunisation coverage are maintained it is likely that the population will be protected against paralytic disease, but it is also possible that this virus could circulate in populations only using IPV as described in Israel for wild poliovirus, thus representing a possible source of polio re-emergence, particularly as these iVDPV strains are antigenically atypical and drifted from both Sabin 2 and MEF-1 vaccine strains. This is particularly relevant at present as there are imminent plans to remove type 2 poliovirus from OPV. Moreover the use of IPV based on the Sabin strains is being encouraged by WHO for reasons of environmental safety and the data presented here suggest that it is less effective.
August 16, 2015 - Preparation for global introduction of inactivated poliovirus vaccine: safety evidence from the US Vaccine Adverse Event Reporting System, 2000–12 "We classified death reports according to previously published body-system categories (respiratory, cardiovascular, neurological, gastrointestinal, other infectious, and other non-infectious) and reviewed death reports to identify the cause of death. We classified sudden infant death syndrome as a separate cause of death considering previous concerns about sudden infant syndrome after vaccines." Comment: This is what they do --- manipulate the data any way they want so they can make the statement "safe and effective." They balloon the numerator to 250M to make the nearly 42,000 adverse events seem inconsequential and toss out the 783 deaths as unimportant. They do not even mention (at least not in this summary) that less than 10% of all adverse events are reported. And now, they are starting to remove the older VAERS reports, saying they are "not important." I wonder how many of the deaths were classified as SIDS - oh! are they finally admitting the SIDS can (and is) caused by vaccines? Those in the vaccine industry are greedy murderers - and should be charged with same.
June 12, 2015 - Poliovirus immunity in newly resettled adult refugees in Idaho, United States of America "This study demonstrated a WPV immunity rate of <60% in a recently resettled adult refugee population in the United States, reinforcing the need to ensure poliovirus immunity in all newly arrived adult refugees, either by expanding pre-departure immunization or by screening for immunity at resettlement and vaccinating when indicated."
June 2015 - A novel outbreak enterovirus D68 strain associated with acute flaccid myelitis cases in the USA (2012–14): a retrospective cohort study"Phylogenetic analysis revealed that all enterovirus D68 sequences associated with acute flaccid myelitis grouped into a clade B1 strain that emerged in 2010.Of six coding polymorphisms in the clade B1 enterovirus D68 polyprotein, five were present in neuropathogenic poliovirus or enterovirus D70, or both.One child with acute flaccid myelitis and a sibling with only upper respiratory illness were both infected by identical enterovirus D68 strains."
May 21, 2015 - Immunogenicity and reactogenicity of a decennial booster dose of a combined reduced-antigen-content diphtheria–tetanus–acellular pertussis and inactivated poliovirus booster vaccine (dTpa–IPV) in healthy adults (full text)"Pain was the most frequent solicited local adverse event (AE; ≥62.7% subjects) and fatigue the most frequent solicited general AE (≥18.5%). No serious AEs were reported during the study."..."This study was sponsored and funded by GlaxoSmithKline Biologicals SA. GlaxoSmithKline Biologicals SA was involved in all stages of the study conduct and analysis; and also took charge of all costs associated with developing and publishing the manuscript."
- Conflict of interest statement SK, KH and MK are employees of GSK
- and KH and MK declare having GSK stocks.
- NR was previously employed by GSK group of Companies.
- TFS has received honoraria from GSK as consultant, lecturer, member of advisory boards and for conducting clinical trials on behalf of his institution.
May 05, 2015 - Vaccination and risk for developing inflammatory bowel disease: a meta-analysis of case-control and cohort studies "Subgroup analysis for Crohn’s disease (CD) and ulcerative colitis (UC) found an association between poliomyelitis vaccine and risk for developing CD (RR=2.28; 1,12-4,63) or UC (RR=3.48 ; 1,2-9,71). The RR of developing IBD after H1N1 vaccination was 1.13 (0.97-1.32). Conclusions: Results of this meta-analysis show no evidence supporting an association between childhood immunization or H1N1 vaccination in adult and risk of developing IBD. Association between poliomyelitis vaccine and risk for CD or UC should be analyzed with caution because of study heterogeneity.
April 21, 2015 - Alternative delivery of a thermostable inactivated polio vaccine(full text) "Conflict of interests: Gijsbert van de Wijdeven (GW) is founder of Bioneedle Technology Group (BTG) and the Bioneedle technology is proprietary to BTG. GW provided the empty Bioneedles. Intravacc did the study design, preparation of the final formulations, product characterization, immunogenicity studies and data processing. There were no restrictions on the use of generated data."
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."
- This study was funded by Sanofi Pasteur, which also contributed to the study design, data collection, analysis and interpretation, review and editing of the manuscript (by Robert Lersch), and the decision to publish.
- J. Embree and B. Law have no conflicts of interest to declare. T. Voloshen and A. Tomovici are employees of Sanofi Pasteur
February 2015 - Introduction of Inactivated Polio Vaccine and Specific Determinants of Vaccine Hesitancy "Overall, Complacency (2.29) and Convenience (2.11) domains were more pro-vaccine hesitant, than Confidence (1.83) domain. However, none was significantly associated with likelihood of a parent’s hesitancy towards IPV vaccination. But certain individual questions: competence of vaccinators (p = 0.04), confidence that their child will not to be infected with poliomyelitis even when not vaccinated (p = 0.03) and, willingness to vaccinate with IPV when OPV is still in use (p = 0.01) were significantly associated with vaccine hesitancy."
November 12, 2014 - Intradermal Inactivated Poliovirus Vaccine: A Preclinical Dose-Finding Study "NanoPass MicronJet600 microneedles. Intradermal delivery of partial vaccine doses induced antibodies at titers comparable to those after immunization with full human dose delivered intramuscularly. The results suggest that intradermal delivery of IPV may lead to dose-sparing effect and reduction of the vaccination cost."
October 16, 2014 - Achieving and Maintaining Polio Eradication — New Strategies (full text) "In that event, the only realistic approach to control of the outbreak would be widespread immunization of the at-risk population with OPV or a combination of IPV and OPV. But either option requires creating a risk of downstream cVDPV, threatening final eradication. To better prepare for this possible threat, the Bill and Melinda Gates Foundation is supporting the development and clinical evaluation of new genetically stable OPV strains with reduced ability to genetically revert to cVDPVs. Note: cVDPV is circulating vaccine-derived poliovirus
October 2014 - Effect of Formaldehyde Inactivation on Poliovirus "Inactivated polio vaccines, which have been used in many countries for more than 50 years, are produced by treating live poliovirus (PV) with formaldehyde. However, the molecular mechanisms underlying virus inactivation are not well understood."..."We show that inactivation with formaldehyde has an effect on early steps of viral replication as it reduces the ability of PV to bind to hPVR, decreases the sensitivity of PV to convert to 135S particles, and abolishes the infectivity of its viral RNA."
May 19, 2014 - Immunogenicity and safety of one dose of diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine (Repevax®) followed by two doses of diphtheria, tetanus and poliomyelitis vaccine (Revaxis®) in adults aged ≥40 years not receiving a diphtheria- and tetanus-containing vaccination in the last 20 years "Overall, 336 participants were included (mean age: 60.2 years). Post-dose 3 seroprotection rates were: diphtheria, 94.6% (CI 91.5–96.8); tetanus and poliomyelitis, 100% (CI: 98.8–100). Percentage of participants with an antibody titre ≥5 EU/mL against pertussis antigens was ≥95.8% for all five pertussis components." Comment: Add adults to the mix of combination vaccines. Sure will help pharma profits."
January 7, 2014 - Dynamic profiles of neutralizing antibody responses elicited in rhesus monkeys immunized with a combined tetravalent DTaP-Sabin IPV candidate vaccine "In this study, the immunogenicity of a combined tetravalent DTaP-sIPV candidate vaccine was investigated in primates by evaluating the neutralizing antibody responses it induced."..."This implies that protective immunogenic effects are conferred by this combined tetravalent formulation."
October 26, 2013 - Polio eradication: where are we now? "The plan has four simultaneous objectives: detection and interruption of wild poliovirus, strengthening of routine immunisation and withdrawal of the oral polio vaccine (OPV), containment of all virus samples and certification of interruption of transmission, and legacy planning to benefit other health and development initiatives. Notably, the '''most ambitious vaccine introduction plan in history has been initiated, which aims to introduce inactivated polio vaccines (IPV) by the end of 2015 in 124 countries to replace OPV and eliminate the rare risk of vaccine-derived cases of polio'''. In June of this year, the GAVI board agreed to provide financial support and play a lead role in introduction of IPV."
October 7, 2013 - The Potential Impact of Routine Immunization with Inactivated Poliovirus Vaccine on Wild-type or Vaccine-derived Poliovirus Outbreaks in a Posteradication Setting "The “endgame” for worldwide poliomyelitis eradication will entail eventual cessation of the use of oral poliovirus vaccine (OPV) in all countries to prevent the reintroduction of vaccine-derived polioviruses—exposing some populations to an unprecedented, albeit low, risk of poliovirus outbreaks. Inactivated poliovirus vaccine (IPV) is likely to play a large part in post-OPV management of poliovirus risks by reducing the consequences of any reintroduction of poliovirus."
'September 28, 2013 - Poliomyelitis: threats to eradication "We cannot afford to ignore these threats. A mass vaccination with OPV in Israel is a potential solution but does not eliminate future risks. I'PV-only countries need to consider the implications of this incident and perhaps modify their immunisation policies, and implement enhanced environmental sampling and regulations for international travellers to have OPV vaccination."
August 12, 2013 - Intradermal fractional booster dose of inactivated poliomyelitis vaccine with a jet injector in healthy adults "For global eradication of poliomyelitis, inactivated poliovirus vaccine (IPV) needs to become available in all countries. Using fractional-doses (reduced-doses) may impact affordability and optimize the utilization of the production capacity. Intradermal administration has the potential to lower the dose without reducing immunogenicity. A needle-free jet injector may be a reliable way to administer vaccines intradermally. The primary objective of this randomized controlled trial was to compare the immunogenicity and tolerability of fractional-dose intradermal IPV (Netherlands Vaccine Institute, NVI) booster vaccination administered with a jet injector (PharmaJet) to full-dose and fractional-dose intramuscular vaccination with a needle and syringe."
May 17, 2013 - Oral and inactivated poliovirus vaccines in the newborn: A review "The percentage of newborns who seroconverted at 8 weeks range from 6–42% for poliovirus type 1, 2–63% for type 2, and 1–35% for type 3. For mOPV type 1, seroconversion ranged from 10 to 76%; mOPV type 3, the range was 12–58%; and for the one study reporting bOPV, it was 20% for type 1 and 7% for type 3."
February 18, 2013 - Antigen sparing with adjuvanted inactivated polio vaccine based on Sabin strains "Six adjuvants with Sabin inactivated poliovirus vaccine were evaluated in rats. ► The increase of neutralizing antibodies was 3-, 15-, 24-fold for types 1, 2 and 3. ► After boost the increase was another 7-, 20-, 27-fold. ► It is feasible to increase the potency of polio vaccine by adjuvants."
January 31, 2013 - Priming after a Fractional Dose of Inactivated Poliovirus Vaccine "This evaluation shows that vaccinating infants with a single fractional dose of IPV can induce priming and seroconversion in more than 90% of im'''munized infants. (Funded by the World Health Organization and the Pan American Health Organization; Australian New Zealand Clinical Trials Registry number, ACTRN12610001046099.)"
November 15, 2012 - Hypersensitivity reactions to the Sabin vaccine in children with cow's milk allergy "All of the patients had a history of milk allergy, and no history or current evidence of egg hypersensitivity was found. Levels of cow's milk- and Sabin vaccine-specific IgE were increased, and the result of a skin prick test with cow's milk proteins or the Sabin vaccine was positive in each patient. In addition, an ELISA using specific rabbit antiserum detected α-lactalbumin in the Sabin vaccine. When α-lactalbumin was employed as a soluble inhibitor in a competitive ELISA, binding to vaccine-coated plates by cow's milk- or α-lactalbumin-specific rabbit antiserum or by patient serum containing IgE was inhibited."
November 19, 2012 - Adjuvants and inactivated polio vaccine: A systematic review "One strategy to make IPV more affordable is to reduce the dose by adding adjuvants, compounds that augment the immune response to the vaccine. No adjuvants are currently utilized in stand-alone IPV; however, several have been explored over the past six decades."
November 2012 - Development of the Polio Vaccine: A Historical Perspective of Tuskegee University’s Role in Mass Production and Distribution of HeLa Cells "In 1936, a polio epidemic swept through the Southern region of the United States, severely crippling children, both Black and White. This outbreak further exposed the challenges that Black polio patients faced when seeking or receiving medical care. The discriminatory practices of the time, especially in the South, left most Black patients with the disease perpetually searching for suitable treatment facilities."
April - June 2012 - Polio programme: let us declare victory and move on (pdf) "The polio eradication programme epitomises 'nearly everything that is wrong with donor funded ‘disease specific’ vertical projects, at the cost of investments in community-oriented primary health care (horizontal programmes).'"
April 19, 2012 - Systematic Review of Mucosal Immunity Induced by Oral and Inactivated Poliovirus Vaccines against Virus Shedding following Oral Poliovirus Challenge (full text) "Despite over 50 years of vaccination with Salk's IPV, questions remain about the ability of this vaccine to prevent poliovirus circulation in remaining polio-endemic countries. In addition, basic immunology research is required to better understand the mucosal immune response to both I'''PV and OPV, and in particular the adaptive cellular and innate components. "Comment: Since the injectable polio vaccine (IPV) isn’t working, and the oral polio vaccine has been the primary cause of remaining polio outbreaks, new mucosal vaccines are being investigated.
February 22, 2012 - Risk of Febrile Seizures and Epilepsy After Vaccination With Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliovirus, and Haemophilus Influenzae Type b "DTaP-IPV-Hib vaccination was associated with an increased risk of febrile seizures on the day of the first 2 vaccinations given at 3 and 5 months, although the absolute risk was small. Vaccination with DTaP-IPV-Hib was not associated with an increased risk of epilepsy."
February 2012 - Safety and Immunogenicity of 2 Mixed Primary Infant Immunization Schedules of Pentavalent Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliomyelitis, and Haemophilus influenzae Type b Vaccines at 2, 4, and 6 Months of Age: A Randomized Controlled Trial “Mixed 2-, 4-, 6-month pentavalent infant vaccine schedules had different immunogenicity and reactogenicity, with a PPI schedule being more reactogenic, and less immunogenic for PRP and fimbriae 2 and 3 antigens at 7 months.”
April 2010 - Association of autism with polyomavirus infection in postmortem brains "Also polyviral infections tend to occur more frequently in the brains of autistic patients compared to controls (40% versus 7.7%, respectively; P = .08). Follow-up studies exploring vertical viral '''transmission as a possible pathogenetic mechanism in autistic disorder should focus on, but not be limited to, the role of polyomaviruses."
July 7, 2006 - The test-tube synthesis of a chemical called poliovirus: The simple synthesis of a virus has far-reaching societal implications (full text) "Once poliovirus, the chemical, has entered the cell, however, it has a plan for survival. Its proliferation is then subject to evolutionary laws: heredity, genetic variation, selection towards fitness, evolution into different species and so forth—that is, poliovirus obeys the same rules that apply to living entities. One could even argue that poliovirus undergoes sexual reproduction in the infected cell, as it readily recombines with sibling progeny or with other related viruses (P. Jiang, J.A.J. Faase, H. Toyoda, A.E. Gorbalenya and E. Wimmer, unpublished data) to exchange genetic information (Wimmer et al, 1993)."
June 19, 2006 - Frequency of apnea, bradycardia, and desaturations following first diphtheria-tetanus-pertussis-inactivated polio-Haemophilus influenzae type B immunization in hospitalized preterm infants (pdf) "There is an increase in adverse cardiorespiratory events following the first dose of DTP-IPV-Hib in preterm infants."
December 2005 - Th2-Associated Local Reactions to the Acellular Diphtheria-Tetanus-Pertussis Vaccine in 4- to 6-Year-Old Children “if the '''DTaP booster is accompanied by concomitant IPV boosting at the same site, ensuing Th2-associated local reactions and the accompanying boosting of TT-specific IgE are significantly reduced, while IgG boosting improves. This suggests the possibility that reactivation of Th1-polarized poliovirus-specific memory cells by IPV may provide “bystander” feedback inhibition of the Th2 component of DTaP-specific memory, both locally and in the draining lymph node. This possibility merits more-detailed investigation employing larger study groups, including subjects primed during infancy with IPV, which is now used in many countries in preference to oral poliovirus vaccine.”
August 2004 - Polio vaccines, Simian Virus 40, and human cancer: the epidemiologic evidence for a causal association. (full text)
September 2002 - Live oral poliovirus vaccines and simian cytomegalovirus. (pdf) "Although SCMV has never been shown to be infectious for humans,' the virus does replicate efficiently in human cells in vitro. Moreover, the experience with SV40 contamination of early poliovirus and adenovirus vaccines underscores the value of ensuring the freedom of vaccines from any viable adventitious agents. Although OPV is no longer produced in the United States, it seems likely that OPV will be used in other countries for some time. T'he present study illustrates the complexity of testing for and guaranteeing the absence of adventitious agents in vaccines."
April 1998 - Serological evidence of SV40 infections in HIV-infected and HIV-negative adults. "Although cross-reactive antibodies might theoretically contribute to the observed reactivities, these results suggest that SV40 neutralizing antibodies are present in certain individuals and raise the possibility that SV40 continues to infect humans long after vaccines were freed from conta'''mination."
August 3, 1995 - Effect of Inactivated Poliovirus Vaccine on the Antibody Response to Bordetella pertussis Antigens When Combined with Diphtheria-Pertussis-Tetanus Vaccine (full text) - "T'he interaction of antigens in combination vaccines is receiving increasing attention as recommendations for infant immunization change with the availability of new''' vaccines. This randomized study supports the conclusions of a previous nonrandomized study that found a diminished antibody response to B. pertussis antigens when poliovirus vaccine was administered with DTP."