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.

A research scientist works inside a laboratory of India's Serum Institute, which is manufacturing Covid-19 vaccines. Credit: Euan Rocha/Reuters

AEFI investigation

The government’s operational guidelines for Covid-19 vaccines describe the protocol for reporting and investigation of severe (such as anaphylactic shock) and serious AEFI (such as long-term disability, hospitalisation or death). The guidelines emphasise the importance of identifying cluster AEFI for urgent investigation.

These guidelines require immediate reporting of serious and severe AEFI; a chain of investigation to ensure centralised analysis of AEFI, and the use of an online database for rapid response to patterns in AEFIs, or potential safety signals warranting urgent investigation.

Reporting: The guidelines require that severe and serious AEFI are treated as a medical emergency and reported immediately to the District Immunisation Officer, along with all available details including medical reports and in the case of death, the findings of the postmortem examination or verbal autopsy.

Chain of investigation: The guidelines prescribe a chain of investigations from the district to the state and national levels. The national AEFI committee examines investigation findings from local and state committees all over the country to assess whether the AEFI was caused by the vaccine itself, by a quality defect, its administration, or vaccine anxiety, or if the events were coincidental.

Online database: The guidelines also require all serious and severe AEFI to be entered in the Co-WIN database as soon as they are reported. The Co-WIN application allows for a constant review of data from across the country for any patterns in the AEFIs, and for potential signals or undocumented links between the vaccine and a health event.

These processes are meant to ensure prompt and thorough investigation of all severe and serious AEFI, as well as note any patterns in their occurrence. to identify potential safety concerns with the vaccine, its quality, or its administration, in order to take prompt remedial action.

Flaws in protocol

While the guidelines require that severe and serious AEFI investigation be timebound, they do not specify the timeline.

Though cluster AEFIs are of particular concern in the rollout of a new vaccine, the operational guidelines for Covid-19 vaccines do not give details of how a cluster AEFI investigation should be conducted. This is a major lacuna in the rollout of a new vaccine with limited safety data.

Finally, though the guidelines state that severe and serious AEFI must be investigated on an urgent basis, there is no requirement to make the findings public.

A ground staff member walks past a container at the Indira Gandhi International Airport, New Delhi, December 22. Credit: Reuters/Anushree Fadnavis

Urgent need for investigation and transparency

The health workers who died had taken the vaccine with the confidence that it would protect them from a serious disease. They are owed some respect, and at least a prompt, thorough and transparent investigation of their deaths, and action based on that investigation.

1. The status of investigation of the nine deaths (as well as any others that have not been reported in the media), the details of all findings and the action taken, must be made public immediately.

2. The names, affiliations and qualifications of all AEFI investigation committee members should be placed in the public domain.

3. By what criteria were these deaths ruled to be unrelated to the vaccine? The procedure for investigation of cluster AEFIs is not stated in the operational guidelines.

4. Has the investigation been disrupted by problems in the data entry and analysis in the Co-WIN app? The Co-WIN app is reported to be malfunctioning, affecting data entry and automated notifications.

5. Why is the rollout not paused until investigation of the nine deaths following immunisation is completed? Clinical trials of Cvoid-19 vaccines have been paused at least thrice following reports of Serious Adverse Effects, and resumed only after some days once investigation ruled out a relation between the vaccine and the SAE.

6. Will any no-fault compensation be paid to the families of the healthcare workers who died? The Covid-19 vaccines have received emergency use approval with limited data. The rollout is in effect a clinical trial though those who received Covishield were not asked for informed consent.

7. Are there any more reports of deaths in the rollout? Information on all severe and serious AEFI in the Covid-19 vaccine rollout – the numbers, date of vaccination, details of the AEFI, place, investigation status and results – should be in the public domain.

Sandhya Srinivasan is consulting editor, Indian Journal of Medical Ethics.
Amar Jesani is editor, Indian Journal of Medical Ethics.
Veena Johari is an attorney, Courtyard Attorneys.