Parliament must be provided with correct study on Pentavalent

The deaths of healthy children taken for routine immunisation are not acceptable.

On 18 March, The Sunday Guardian published a report suggesting that Pentavalent vaccine was killing children instead of protecting them. In response to a question on the subject, Union Minister for Health and Family Welfare Ashwini Kumar Choubey told the Lok Sabha that the Pentavalent vaccine was safe.

The minister has told Parliament of a study conducted by International Clinical Epidemiology Network (INCLEN) and the government where 30,688 infants who received Pentavalent vaccine at 6 weeks, 10 weeks and 14 weeks of age showed “there is no increase in death and hospitalisation rates reported in the first week after vaccination, as compared to fourth week after vaccination”.

The Sunday Guardian had earlier described a study of 45 million infants who received DPT vaccination and 25 million received Pentavalent vaccine. There were 4.8 deaths per million vaccinated with DPT and 9.6 deaths per million vaccinated with Pentavalent vaccine. There were 4.7 additional deaths per million vaccinated with Pentavalent vaccine instead of DPT and this doubling of deaths was found to be statistically very significant. Extrapolating the data, the authors estimated that vaccination of 26 million children each year in India would result in 122 additional deaths within 72 hours, due to the switch from DPT to Pentavalent vaccine.

It would appear that the misleading INCLEN study was given to Parliament. If Pentavalent vaccine was causing five deaths per million vaccinated as reported in The Sunday Guardian, in a sample of 30,688 there would be 0.17 deaths. The study sample was so minuscule that it would not pick up even one death. 

The deaths of healthy, innocent children taken for routine immunisation cannot be acceptable in any society. Parliament needs to be told how this misleading study was presented to it.

Over 25 million babies have received the Pentavalent vaccine. To make amends, the minister needs to provide Parliament data on death rates reported in the first week after vaccination, as compared to fourth week after vaccination in this entire cohort of 25 million babies or at least a random cohort of at least five million babies who received the vaccine. If indeed this shows up excess deaths, the vaccine needs to be withdrawn immediately. As this pertains to the lives of children, it brooks no further delay.

Jacob Puliyel, who can be contacted at puliyel@gmail.com, is a member of the National Technical Advisory Group on Immunization of the Government of India. The opinions expressed are personal