Covid-19 vaccines: Investigate adverse events and make reports public, say public health professionals

PT Jyothi Datta Mumbai | Updated on March 17, 2021

EMA report on AstraZeneca-Oxford vaccine and blood clot reports expected tomorrow

Even as the European Medicines Agency (EMA) reviews the AstraZeneca-Oxford University vaccine after more than 10 countries temporarily suspended its use, a group of public health professionals have called for an investigation of deaths and serious adverse events in India as well.

“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 public health representatives said in a letter to Health Minister Dr Harsh Vardhan and others involved with the vaccines programme.

“We understand that at least 65 deaths have occurred following vaccination for Covid-19 since the vaccination 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.

The call for transparency becomes that much more important when new vaccines such as that for Covid-19 are being rolled out to millions of recipients. In the past few days, several European countries, including Germany, Italy, France, Austria and Ireland, have suspended the use of the AZ vaccine following reports of blood clots in the recipients. The EMA is scheduled to give its directive on the issue on Thursday.

Echoing EMA’s early observations, the WHO had indicated that there may not be a link between the vaccine and the blood clot incidents. However, it, too, is reviewing the scientific data.

‘Building trust’

Advocate Veena Johari, one of the 29 people who signed the letter, told BusinessLine that transparency on the details of the investigation into the deaths and adverse events 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 needed to be modified to prevent the adverse events from occurring again, said the letter signed by Sandhya Srinivasan, Consulting Editor, Indian Journal of Medical Ethics (IJME); Amar Jesani, 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.

Published on March 17, 2021

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