69 research outputs found
Bending the truth ostensibly for public good: The case of the pneumococcal conjugate vaccine
No full textDeaths reported after pentavalent vaccine compared with death reported after diphtheria-tetanus-pertussis vaccine: An exploratory analysis
No full textIntroduction: Immunization is one of the most effective public health tools available to prevent death and disease. Serious adverse events following immunization (AEFI) are rare. However, coincidental sudden-infant-death-syndrome (SIDS) deaths do occur temporally associated with vaccination. In 2010, the Government of India (GoI) introduced a new standard operating procedure (SOP) to report AEFI. There have been stray newspaper reports of deaths soon after the administration of the pentavalent vaccine (PV) which was introduced by the GoI in December 2011. This study was conducted to examine if there is an epidemiological signal from the data collected passively under the new SOP. Materials and Methods: We used data provided by the GoI on the number children who received three doses of diphtheria-tetanus-pertussis vaccine (DTP), the number receiving PV and the number of deaths in the vaccinated within 72 h. Results: After PV was introduced in the states, 45 million infants received DTP vaccination and 25 million received PV. There were 217 deaths within 72 h after DTP was administered and 237 following PV. There were 4.8 deaths per million vaccinated with DTP (95% confidence interval [CI]: 4.2–5.5) and 9.6 deaths (95% CI: 8.4–10.8) per million vaccinated with PV (odds ratio 1.98 (95% CI 1.65-2.38) There were 4.7 additional deaths (95% CI: 3.5–5.9), per million, vaccinated with PV instead of DTP (P < 0.0001). Discussion: Deaths following DTP vaccination would include the natural rate of deaths within that window period, plus deaths if any, caused by DTP. For purposes of this study, we assumed that all the deaths associated with DTP are coincidental SIDS deaths. Taking that as the base rate of SIDS, we look for any increase in the death rate after PV. This study demonstrated an increase in reports of sudden unexplained deaths within 72 h of administering PV compared to DTP vaccine. Whether improvements in AEFI surveillance system or other factors contributed to this increase cannot be ascertained from this study. Conclusion: These findings do not warrant deviation from current vaccination schedule, but the differential death rates between DTP and PV do call for further rigorous prospective population-based investigations
Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency
No full textRevised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique
No full textThe World Health Organisation (WHO) has recently revised how adverse events after immunization (AEFI) are classified. Only reactions that have previously been acknowledged in epidemiological studies to be caused by the vaccine, are classified as a vaccine-product–related-reaction. Deaths observed during post-marketing surveillance are not considered as “consistent with causal association with vaccine”, if there was no statistically significant increase in deaths recorded during the small Phase 3 trials that preceded it. Of course, vaccines that caused deaths in the control-trials stage would not be licensed. After licensure, deaths and all new serious adverse reactions are labelled as ‘coincidental deaths’ or ‘unclassifiable’, and the association with vaccine is not acknowledged. The resulting paradox is evident. The definition of causal association has also been changed. It is now used only if there is “no other factor intervening in the processes.” Therefore, if a child with an underlying congenital heart disease (other factor), develops fever and cardiac decompensation after vaccination, the cardiac failure would not be considered causally related to the vaccine. The Global Advisory Committee on Vaccine Safety has documented many deaths in children with pre-existing heart disease after they were administered the Pentavalent vaccine. The WHO now advises precautions when vaccinating such children and this has reduced the risk of death. Using the new definition of causal association, this relationship would not be acknowledged and lives would be put at risk. In view of the above, it is necessary that the AEFI manual be revaluated and revised urgently. AEFI reporting is said to be for vaccine safety. Child safety (safety of children) rather than vaccine safety (safety for vaccines) needs to be the emphasis.</ns4:p
Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique
No full textThe World Health Organisation (WHO) has recently revised how adverse events after immunization (AEFI) are classified. Only reactions that have previously been acknowledged in epidemiological studies to be caused by the vaccine are classified as a vaccine-product–related-reaction. Deaths observed during post-marketing surveillance are not considered as ‘consistent with causal association with vaccine’, if there was no statistically significant increase in deaths recorded during the small Phase 3 trials that preceded it. Of course, vaccines noted to have caused a significant increase in deaths in the control-trials stage would probably not be licensed. After licensure, deaths and all new serious adverse reactions are labelled as ‘coincidental deaths/events’ or ‘unclassifiable’, and the association with vaccine is not acknowledged. The resulting paradox is evident. The definition of causal association has also been changed. It is now used only if there is ‘no other factor intervening in the processes’. Therefore, if a child with an underlying congenital heart disease (other factor), develops fever and cardiac decompensation after vaccination, the cardiac failure would not be considered causally related to the vaccine. The Global Advisory Committee on Vaccine Safety has documented many deaths in children with pre-existing heart disease after they were administered the pentavalent vaccine. The WHO now advises precautions when vaccinating such children. This has reduced the risk of death. Using the new definition of causal association, this relationship would not be acknowledged and lives would be put at risk. In view of the above, it is necessary that the AEFI manual be revaluated and revised urgently. AEFI reporting is said to be for vaccine safety. Child safety (safety of children) rather than vaccine safety (safety for vaccines) needs to be the emphasis.</ns4:p
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