A time-bound and transparent investigation of all deaths and serious adverse events that have occurred following vaccination is required, say a group of public health professionals, in their letter to Union Health Minister Harsh Vardhan.

“AEFIs (adverse events following immunisation) are to be investigated through well-defined procedures for vaccine pharmacovigilance and the reports made available in the public domain for trust-building and transparency,” the letter, signed by 29-odd public health representatives, said.

The development comes even as multiple global health regulators investigate adverse events including reports of blood clots being reported in their countries. This week saw the UK regulator and the European Medicines Agency investigate blood clot reports in recipients of the AstraZeneca-OxfordUniversity vaccine. Over the last three days, two regulators and the World Health Organisation weighed in on the benefits of the vaccine, but all of them flagged concerns on the rare blood clots that could be linked to the vaccine and needed to be investigated further. In fact, of the 10-plus countries that suspended the use of the AZ vaccine, Norway, Sweden and Denmark have not revoked their suspension and are studying the details. A report is expected next week. Finland has joined this list and suspended the AZ vaccine, following blood clot reports.

India though has not seen a similar public discussion on the issue nor have details on adverse events been shared in public domain, point out the experts.

Details awaited from Govt

“We are for vaccination and not anti-vaxxers. And we are concerned over the hesitancy there is among people to take the vaccine,” said Amar Jesani, Editor - Indian Journal of Medical Ethics (IJME), who signed the letter. The government needs to give details on the adverse events and the response of the system in caring for these individuals who have had reactions, however limited the number may be, he said.

“We understand that at least 65 deaths have occurred following vaccination since the campaign started on January 16. However, the National AEFI Committee’s investigation findings of only two of these deaths have been made public. Till now, no case of serious AEFI, including death, has been attributed to the vaccine,” the letter said. This is the group’s second letter on the issue in about three months.

Advocate Veena Johari, who also signed the letter, points out that transparency on the details of the investigation into the deaths and adverse events will help build trust among people about the vaccines. The letter urged the Centre to make details public on the different vaccines rolled out and the adverse events that were reported, its causality assessment report, investigations, clinical diagnosis of the death and whether guidelines were followed to investigate adverse events reported in a cluster, among others.

Based on these investigations, vaccination procedures need to be modified to prevent the adverse events from occurring again, said the letter signed by Sandhya Srinivasan, Consulting Editor, IJME; Anand Grover, Senior Advocate and former UN Special Rapporteur on the Right to Health; Dr KV Babu, Dr Mira Shiva, Dr T Jacob John, Dr SP Kalantri and Dr Yogesh Jain, among others.