The deaths of nine health workers following administration of the Covid-19 vaccine in the 12 days since the start of the immunisation programme on January 16 is cause for concern. The government must immediately disclose all details of the investigations into these serious Adverse Events Following Immunisation and any action taken.

The deaths were reported from Uttar Pradesh, Karnataka, Andhra Pradesh, Rajasthan, Telengana, Gurugram and Odisha. The six men and three women who died were between 27 and 56 years old. The deaths took place between 24 hours and five days of taking the vaccines and all have been ascribed to cardiovascular problems or “brain stroke”. The vaccine taken in each case was Covishield.

In each case, the government has stated that the death was not due to the vaccine but has not revealed who made that determination and the details of the investigation.

Massive clinical trial

Covid-19 vaccines in India have been approved for restricted use in an emergency, on the basis of limited data indicating that the potential benefits of the vaccine are greater than the risks. They have been administered to more than 20 lakh health workers across India in less than two weeks, and are set to cover three crore health workers in the first phase of the Covid-19 vaccine campaign.

As a senior clinical pharmacologist noted, this massive rollout is in effect a very large clinical trial and requires a strong surveillance mechanism. This cluster of serious Adverse Events Following Immunisation – nine AEFI associated with same vaccine, during the same campaign, and with the same cause of death – would not have been identified in clinical trials of a few tens of thousands of people, and of just a few months. This cluster of AEFI in the Covishield vaccine must be thoroughly and urgently investigated, and the findings made known.