Deaths recorded after the pentavalent vaccine compared with deaths recorded after the diphtheria-tetanus-pertussis vaccine: a preliminary (exploratory) analysis

Deaths recorded after the pentavalent vaccine compared with deaths recorded after the diphtheria-tetanus-pertussis vaccine: a preliminary (exploratory) analysis
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Medical Journal of Dr. DY Patil Vidyapeeth
Jacob Puliyel, Jaspreet Kaur, Ashish Puliyel, Visnubhatla Sreenivas
2018

Abstract

Introduction: Immunization is one of the most effective public health tools available to prevent death and disease. Serious adverse reactions after immunization (AEFI) are rare. However, simultaneous deaths from SIDS (Sudden Infant Death Syndrome) also occur temporally associated with vaccination. In 2010, the Government of India (GoI) introduced a new Standard Operating Procedure (SOP) for recording adverse reactions after immunization (AEFI). There had been in the newspapers missed news of deaths immediately after the administration of the pentavalent vaccine (PV) which was introduced by the Indian government in December 2011. This study was conducted to examine whether a signal could emerge from passively collected data with the new SOP. epidemiological.

Materials and methods: we used the data provided by the Indian Government on the number of children who had received 3 doses of DPT (tetanus pertussis difetrite), on the number of those who had received PV (pentavalent) and the number of deaths among the vaccinated within 72 hours.

Risultati: after PV was introduced in the states, 45 million children received the DPT vaccine and 25 million the pentavalent vaccine. There were 217 deaths within 72 hours of DPT vaccination and 237 following PV. There were 4.8 deaths per 1 million DPT vaccinated (95% confidence interval [CI]: 4.2-5.5) and 9.6 deaths (95% CI: 8.4-10.8) per million PV vaccinated (cross 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 DPT (P <0.0001)

Thread: deaths following the DPT vaccine would include the natural rate of deaths in that incubation period, plus any deaths caused by DPT. For the purpose of this study, we hypothesized that all deaths associated with DPT are simultaneous SIDS deaths. Taking this as the base rate of SIDS, we observe an increase in the death rate after PV. This study demonstrated an increase in news of sudden unexplained deaths within 72 hours of PV administration compared to the DPT vaccine. If improvements in the AEFI surveillance system or other factors contributed to this increase, this cannot be ascertained by this study.

Conclusions: These findings are not to justify variations in the current vaccination calendar, but the differential death rate between DPT and PV certainly calls for further rigorous population surveys.


Conclusions

This study demonstrated a probable increase in unexplained deaths within 72 hours of administration of the pentavalent vaccine compared with the trivalent diphtheria-tetanus-pertussis. It was not possible in this study to verify whether this increase was due to an improvement in the surveillance systems of serious events following immunization or other factors not studied or recognized here. These results do not allow to modify the current vaccination calendar, but the difference in mortality rates between the pentavalent and the trivalent requires further and rigorous population-based surveys.


Translation by Paolo Molino and Chiara Remedia, CLiVa Tuscany