On 19 January, VK Paul, a member of the NITI Aayog, told journalists at a press conference that the COVID-19 vaccines being administered in India were completely safe. In the three days since the start of India’s mass-vaccination drive on 16 January, two healthcare workers had died after suffering serious Adverse Events Following Immunisation. By the third week of February, the health ministry reported 41 AEFI deaths.
In his 19 January statement urging people to take the vaccines, Paul—who is also the chairman of the National Expert Committee on Vaccine Administration for Covid-19, or NEGVAC—offered assurances about the AEFI-surveillance system. “Look at the AEFI-surveillance system that has been perfected in our country,” he said. “It hasn’t come in the last six weeks. It has been built at least since the past two-and-a-half decades. This is a very functional program based on best practices of the world and operates under WHO oversight.” However, the treatment of the deaths after COVID-19 vaccinations in the first month of their rollout has indicated an unnecessary rush in AEFI investigations, coupled with a lack of transparency. Civil-society groups focussed on public health have written to the government urging it to recognise the deaths as a cluster of serious AEFIs and to make investigation reports public.
According to the National Health Mission’s guidelines for AEFI surveillance and management, an AEFI “is any untoward medical occurrence which follows immunisation and which does not necessarily have a causal relationship with the usage of the vaccine.” While minor AEFIs are merely recorded in an online portal or registry—the CoWIN app for the COVID-19 vaccination drive—more serious or severe AEFIs need to be reported to the district’s immunisation officer and AEFI committee. AEFI committees at the district, state and national level, evaluate AEFI reports, identify AEFI clusters and patterns, determine causes of AEFIs and make recommendations for managing post-vaccination illnesses.
The first AEFI death in the COVID-19 vaccination drive occurred in the evening of 17 January. Mahipal Singh died in Moradabad a day after he got the Covishield vaccine. The Caravan accessed his post-mortem report, which noted that Singh had pus pockets in his lungs and his heart had enlarged to weigh 500 grams from the normal weight of 200 grams. The report ruled the cause of death as a “heart attack/ septicemic shock.” Dr Milind Chandra Garg, the chief medical officer in Moradabad, told me that the district AEFI board had met twice before arriving at the decision that Singh’s death was not caused by the vaccine. “We had a meeting once on 17th night right after his death and on 18th after the post mortem report.” Garg refused to share details of the discussions held in the meetings.