Gujarat Exclusive > National-World > DCGI seeks more data from Serum Institute, Bharat Biotech for approving their COVID vaccines

DCGI seeks more data from Serum Institute, Bharat Biotech for approving their COVID vaccines


The government regulator dealing with the emergency use authorisation (EUA) application of COVID-19 vaccine manufacturers has clarified that the Serum Institute of India and Bharat Biotech will have to submit more data for securing EUA in India.

The Subject Experts Committee (SEC) on EUA is of the view that it is better to wait for the UK to grant EUA to vaccine jointly developed by AstraZeneca and the University of Oxford. While the SEC does not have the authority to approve a vaccine, its views are important as it gives recommendations to the Drugs Controller General of India (DCGI).

Two COVID-19 vaccines still undergoing clinical trial

In India, the Serum Institute of India is manufacturing Covishield, the COVID-19 vaccine developed by Oxford University and drug manufacturer AstraZeneca. Meanwhile, Bharat Biotech is developing an indigenous COVID-19 vaccine named Covaxin.

Though both these vaccines are currently under Phase 3 clinical trials in India, Serum Institute and Bharat Biotech had applied for emergency use approval from DCGI.

Pfizer also seeking EUA

Apart from these, Pfizer has also applied for emergency use permission and its application is under consideration.

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Last week, the UK became the first country in the world to grant emergency use approval to Pfizer’s COVID-19 vaccine and its mass vaccination has already started in the country.

British regulator asks people with allergies to avoid Pfizer shot

The UK’s medicine regulator has advised that people with a history of significant allergic reactions do not get Pfizer-BioNtech’s COVID-19 vaccine after two people reported adverse effects on the first day of rollout.

Britain began mass vaccinating its population on Tuesday in a global drive that poses one of the biggest logistical challenges in peacetime history, starting with the elderly and frontline workers

National Health Service medical director Stephen Powis said the advice had been changed after two NHS workers reported anaphylactoid reactions associated with receiving the vaccine.


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