India approves AstraZeneca Covid vaccine

Sunday, 03 Jan, 2021

The vaccine developed by Bharat Biotech is based on an inactivated form of the coronavirus.

The Indian government has approved the coronavirus vaccine developed by Oxford University/AstraZeneca for emergency use.

However, Public Health Minister Anutin Charnvirakul said on Thursday that he had secured the supply of at least 2 million doses of Covid vaccine from producers "between February and April".

As India gears up to launch the world's largest immunisation drive, Union Health Minister Harsh Vardhan on Saturday said that one crore healthcare workers and two crore frontline workers would be given free vaccine in the first phase of the inoculation drive.

It is the first vaccine to get approval in India.

The Subject Expert Committee (SEC) on COVID-19 of the CDSCO, which had earlier sought additional safety and immunogenicity data from SII, deliberated on its application seeking emergency use authorisation (EUA) for the shots on Wednesday and met again on Friday to review the matter. The company, however, is yet to disclose the results or study design of Phase 3 trials.

As per reports, two full doses of the vaccine must be administered to an individual in a gap of 4-6 weeks. The data generated so far demonstrates a strong immune response (both antibody as well as T cell) and in-vitro viral neutralisation.

Stating that India has been given two COVID-19 vaccines by January 2, chairman, Liver Transplant Unit, Medanta Hospital Arvind Soin said, "The DCGI has gone to great lengths to ensure these are safe vaccines and the emergency use comes with explicitly stated conditions".

SII had presented bridge trial data (on safety and immunogenicity or whether the vaccine induces the desired immune response against Sars-CoV-2 virus) from 1600 Indian volunteers apart from data from global trials from the United Kingdom and Brazil. The firm tested the vaccine on 22,000 volunteers whereas it has to recruit 26,000 volunteers and submit the data to the government. Serum Institute of India (SII) will manufacture the vaccine.

The AstraZeneca shot has distinct advantages over other vaccines that have been approved by governments around the world.

After detailed deliberations, the SEC has also recommended for grant of permission to Cadila Healthcare Ltd in Ahmedabad for conduct of phase-3 clinical trial protocol for its vaccine candidate.

A representative of India's Central Drugs Standard Control Organisation (CDSCO), whose experts are meeting for the second time this week, declined to comment.