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SAFETY OF PENTAVALENT VACCINE

Ramesh Shankar
Wednesday, April 4, 2018, 08:00 Hrs  [IST]

A recent study by two prominent doctors brought out some disturbing facts about pentavalent vaccine which was included into India's immunization programme by the Union Health Ministry in December 2011. The study has found that administration of PV has led to double the number of deaths of children compared to Diphtheria-Pertussis-Tetanus vaccine. PV is a combination of DPT vaccine and two more vaccines against Haemophilus influenza Type-B (Hib) and Hepatitis B. PV was introduced into the immunization programme to replace DPT vaccine in a staged manner with a view to adding protection against Hib and Hepatitis-B without increasing the number of injections given to infants. Ever since, there have been stray reports of deaths soon after the administration of PV. This study was conducted to find any adverse event following immunisation which is any untoward medical occurrence which follows immunisation and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease. The study, published in the peer-reviewed Wolters Kluwer Health’s Journal, a publication of Dr DY Patil University, Mumbai, states that there were 237 deaths within 72 hours of administering the PV, twice the death rate among infants who received DPT vaccine. Dr Jacob Puliyel, head of paediatrics at St Stephen’s Hospital, and Dr V Sreenivas, professor of biostatistics at All India Institute of Medical Sciences, both in New Delhi are the authors of this study.  

What is more concerning is the sudden spike in deaths following immunisation in 2017 to 1139 from 176 in 2016 and 111 in 2015. The Union Health Ministry has now ordered a study on the sudden spike in deaths. According to government records, there were 10,612 deaths following vaccination (both PV and DPT) in the last 10 years. The authors undertook the study to find out if these deaths were merely coincidental or vaccine-induced. The study showed that approximately 45 million infants received DTP vaccination, and approximately 25 million were administered three doses of PV.  As per the study results, there were 4.8 deaths per million vaccinated with DTP and 9.6 deaths per million vaccinated with PV. There were 4.7 additional deaths within 72 hours, per million vaccinated with PV instead of DPT. There were wide differences between states in the AEFI death rates reported. States reporting higher rates of death with DPT were also the ones reporting more deaths with PV. The authors are of the view that these findings of differential death rates between DPT and PV do call for further rigorous prospective population-based investigations. In most developed countries including USA, this combination vaccine is not used as a Cochrane review of combined DTP-Hepatitis B-Hib vaccine found less immunological response to the combined vaccine than when they were administered separately and there were more local reactions to the combined vaccine. The Vaccine Adverse Event Reporting System (VAERS) data in the USA suggests there have not been any serious adverse events with these vaccines given separately.  For developing countries too, the same benefit against lethal diseases can be achieved if the vaccines DTP, Hib, and Hepatitis B are given separately as it is done in the US. No doubt, immunization is one of the most effective public health tools available to prevent death and disease. Now that the subject experts have come out with some startling revelations, it is the duty of the government to consider a rigorous review of deaths following vaccination with PV. The reports of sporadic unexplained deaths following immunisation with PV is a matter of concern as thousands of infant lives are at stake.

 

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pradeep awasthi Apr 10, 2018 10:24 AM
The observational findings of two investigators,on use of pentavalent vaccine,which is used for last three years,in an Indian immunisation programme for pediatric patients who suffers from H.influenza,Hib and Hepatitis-B,has given a wake up call to union health ministry to review on adverse effects associated with this vaccine.

Though on perameter of safety both the vaccines,sucha as Diptheria and pentavalent,there is a serious question mark,which has propelled union health ministry to have retrospective outlook on both the vaccines.But still pentavalent vaccinea has higher death rates which is sequentially reported and that two robust patient datas.Therefore need of hour is to further scrutinize and asses,a large patient data that confirms very leas deaths per year,who are on vaccination of Pentavalent vaccine.
Amitav Banerjee Apr 4, 2018 10:54 PM
Please note that the Journal is published from Pune and not Mumbai as mentioned in your Editorial.

Dr Amitav Banerjee
Editor in Chief
Medical Journal of Dr DY Patil Vidyapeeth (Deemed to be University, Pune)
 
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