"We Don't Monitor Deaths, We Monitor Adverse Events," Says Government on Deaths After Vaccination

Of the 134 cases that India reported, the cause of death among 96% of children was listed as being “unclassifiable” or “coincidental due to something other than vaccine.”

A medical worker administers polio drops to an infant at a hospital during the pulse polio immunization programme in Agartala, capital city of India's northeastern state of Tripura, January 18, 2015. Credit: Reuters/Jayanta Dey

A medical worker administers polio drops to an infant at a hospital during the pulse polio immunization programme in Agartala, capital city of India’s northeastern state of Tripura, January 18, 2015. Credit: Reuters/Jayanta Dey

New Delhi: Responding to concerns raised in the Indian Journal of Medical Ethics regarding the deaths of children following vaccinations, the government said they don’t monitor deaths, but monitor all adverse events following immunisation (AEFI). “Adverse events include deaths, clustering and hospitalisation, and we monitor all of these, not just deaths specifically,” said Dr Pradeep Haldar, deputy commissioner for immunisation at the health ministry.

This was in response to a letter published in the Indian Journal of Medical Ethics (IJME), where two doctors drew attention to the cases of AEFI reported between 2012 and 2016 – out of the 134 cases that India reported, 78 babies survived hospitalisation while 58 died. The causes of deaths among 96% of children following vaccination were listed by India as being “unclassifiable” or “coincidental due to something other than vaccine”. The doctors found that not even one of these cases was classified as a vaccine-product related reaction.

“If a child is admitted to a hospital with intractable convulsions after vaccination, if it survives, the reaction could be classified as vaccine-product-related, but if it dies, it will be classified as a “coincidental death – underlying or emerging condition, or condition caused by something other than vaccine” (C) or “unclassifiable” (D),” the authors, Jacob Puliyel, a pediatrician and member of the National Technical Advisory Group on Immunisation, and Anant Phadke, an executive member of the All India Drug Action Network, wrote.

The larger issue that the authors raise is a global one – they say there is a problem with the WHO’s philosophy on post-vaccination since the WHO changed its classification of AEFI. They have asked the WHO to revise their classification as well. From the authors’ analysis, the WHO’s new classification and definitions imply that no death can result from vaccination, and if any death occurs, it is “coincidental” and not due to the vaccine.

“We are following the WHO’s guidelines precisely. When we immunise normal children, that’s where the tolerance to side effects will be almost zero. So obviously if there are any effects of that immunisation, parents will be worried saying that the child was normal to begin with. This adverse reaction doesn’t mean there’s a problem with the vaccine or that we stop immunisation. People will not know the technical details. We have to build public confidence,” said Haldar.

On the authors’ analysis of the WHO’s classification as being designed to absolve vaccines from being related to deaths, Haldar says the authors think wrongly that “all adverse effects are related to vaccines. And when they are not, they are saying that the classification itself is wrong.”

The WHO changed the way causal links in deaths were made to vaccines. Following a case in Sri Lanka, where five children died after the pentavalent vaccine Quinvaxim in 2008, WHO investigators wrote that they deleted the categories of “probable” and “possible” in their study of the cases and concluded that the AEFI were “unlikely” to be related to the vaccine. After this incident, the WHO formally revised its AEFI classification. The authors in IJME acknowledge that a casual link between the AEFI and vaccination is often hard to prove, but in the interest of precaution and scientific inquiry, they say it is best to say that the association of deaths with a vaccine is “probable” or “possible” although it is difficult to be “certain.”

As a vaccine producer, deaths related to vaccines could raise alarms 

India is a major supplier of vaccines globally and currently supplies to various UN agencies as well, including UNICEF, WHO and the Pan American Health Organization. Vaccine production received a boost in February this year when India received the maximum possible marks in a WHO assessment of India’s vaccine regulatory system.

Vaccine related deaths in India are thus an embarrassment as the country is keen to retain its place as the global leader in vaccine production. WHO’s Prequalification Programme of India’s National Regulatory Authority ensures that access to vaccines meet standards of quality, safety and efficacy as well as programme needs.

The WHO’s granting of maximum marks to India in this area was done on a benchmarking tool they use. For this, they assessed the Central Drugs Standard Control Organisation, State Drug Regulatory Authorities, the Pharmaco-vigilance Programme of India and AEFI structures at the Central and state levels.

In the WHO’s new algorithm, deaths are classified as vaccine related if they caused a “statistically significant increase in deaths” in the phase three trials. If this happens, then the vaccine itself would not be licensed.

Immunisation as a matter of pride and controversy in India

This analyisis of deaths following vaccinations comes soon after Union health minister J.P. Nadda said, “No child should die in the country from vaccine-preventable diseases. We stand committed to reducing child deaths.” The doctors are raising the issue of children possibly dying from the vaccines themselves. The minister made these comments while launching the Pneumococcal Conjugate Vaccine in his home state of Himachal Pradesh in May this year.

India’s Universal Immunisation Programme (UIP) runs at a massive scale. It offers protection from 12 diseases and over 2.6 crore beneficiaries have been immunised so far, with a 6.7% annual increase in immunisation cover.

“While these vaccines in the private sector were accessible to only those who could afford them, by making them available under the UIP, the government is ensuring equitable access to those who need them the most, the underprivileged and underserved,” Nadda said in May.

While this has been a matter of pride, India’s immunisation programme has also been dogged by controversy. Phase three of India’s UIP has just been approved by the government for roll out. It was to be run by the Public Health Foundation of India (PHFI) along with the government of India, but following a setback regarding PHFI’s foreign funding accounts, the entire programme has been handed over to a foreign agency, Jon Snow International.

Puliyel along with others, had earlier raised questions regarding the conflict of interest of the UIP, given the funding of the programme by the Bill and Melinda Gates Foundation (BMGF). The government tried to take some steps to address this issue earlier this year. However, even with PHFI out of the programme, the UIP still continues to be funded by the BMGF.