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COVID-19 vaccines: Public health experts urge government to release details of adverse event data – Moneycontrol

Representative image: Reuters

Representative image: Reuters

A group of experts has expressed concern over the Central government not sharing data on serious Adverse Events Following Immunisation (AEFI) with Covid-19 vaccines, and sought details of all AEFIs as of March 16, as well as the status of investigations into those events.

AEFIs have to be investigated through well-defined procedures for vaccine pharmacovigilance and the reports have to be made available in the public domain to build trust and ensure transparency.  This is especially important for new vaccines such as the Covid vaccines currently being rolled out across the country under emergency-use authorisation.

In a letter, the 29 experts from the fields of public health, ethics, medicine, law, and journalism, who support the immunisation programme, have sought details from the government regarding findings of all completed serious AEFI investigations. In particular, they have sought details of cause of death, by clinical diagnosis; autopsy findings where possible to confirm or revise the clinical diagnosis; causality assessments and the reasoning behind those assessments.

The experts also wanted to know the processes undertaken by various AEFI committees, including whether the WHO guidelines for investigation of AEFIs occurring as a cluster have been strictly followed.

The public health experts noted that the government had stopped sharing any details on AEFIs after February 26, 2021.

The letter was addressed to Health Minister Dr Harsh Vardhan; Drug Controller General of India VG Somani; Niti Aayog Member VK Paul; Department of Biotechnology Secretary Renu Swarup; and NK Arora, Member, National Task Force on Covid-19 and National AEFI Committee.

Moneycontrol has seen a copy of the letter.

In January, the experts had written to the government expressing concern over the lack of information on investigations into deaths following Covid-19 vaccinations in India.

“In our letter dated January 31, 2021, we asked for details of all investigations into deaths and other serious AEFIs, as well as the minutes of AEFI monitoring committees, and details of all AEFI committee members and other experts overseeing the vaccine rollout. We have not received any response,” the letter said.

The letter alleged that critical updates to the fact sheets recommended by the CDSCO’s Subject Expert Committee have not been issued, even though they are meant to provide additional guidance and clarify the use of the vaccines in certain persons, such as those with allergies, those who are immunocompromised or using immunosuppressants, or those using blood thinners/anti-coagulants.

The letter also said that there are gaps in AEFI investigations at the local level affecting the quality of evidence submitted to State and National AEFI Committees, which depend on these findings to make causality assessments.

The letter said that at least 65 deaths have occurred following vaccination for Covid-19 since the campaign began on January 16. However, the National AEFI Committee’s reports on only two of those deaths have been made public.

“Media reports indicate that many deaths post vaccination with Covishield, AstraZeneca’s vaccine, which is being manufactured in India by the Serum Institute of India, occurred due to cardiac arrest, cerebral venous thrombosis and stroke,” the letter said.

Denmark, Iceland, Norway, Italy, France, Bulgaria, Germany, Luxembourg, Estonia, Lithuania, Latvia and Ireland have paused immunisation with the AstraZeneca vaccine pending investigation of a small number of post-vaccination deaths from intravascular clotting or thromboembolic events, while Austria has suspended the use of certain batches.

The European Medicines Agency and WHO said that the benefits of the AstraZeneca coronavirus vaccine outweighed the risks amid concerns that the shots caused blood clots in some people.

The health experts include Amar Jesani, Editor, Indian Journal of Medical Ethics; Anand Grover, Senior Advocate, Director, Lawyers’ Collective; Dr Babu KV, Public Health Activist, Kannur; Brinelle D’Souza, Co-convenor, Jan Swasthya Abhiyan and faculty member, School of Social Work, Tata Institute of Social Sciences, Mumbai;  Laxmi Murthy, Journalist, Bengaluru; S Srinivasan, LOCOST, Vadodara; Dr SP Kalantri, Physician, Sewagram; Dr Siddhartha Das, Theoretical Physicist, Purnea, Bihar; Dr T Jacob John, Retired Professor and Head, Department of Clinical Virology, Christian Medical College; Malini Aisola, Public Health Professional.

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