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 COVID-19 Vaccine Update: India's Drug Administration gives final approval to Covishield, Covaxin

 

Supervisory General of Drugs in India

New Delhi: The Drug Administration in India on Sunday finally approved the Oxford vaccine in India under the names Covishield and Covaxin for Bharat Biotech. This makes them the first vaccine approved.

This is because on Saturday a group of experts from the Central Indian Drug Authority recommended the General Controller for Medicines in India to approve the limited use of the local Covid-19 Covaxin vaccine developed by Bharat Biotech in an emergency, particularly in connection with infections. of the mutant strain.

 

Bharat Biotech's vaccine recommendation comes a day after the Thematic Committee of the Central Organization for Drug Control (SEC) approved the Oxford-AstraZeneca application for approval of the emergency use of the Indian Serum Institute for Covishield vaccine.

According to the official announcement, the SEC met on Friday and Saturday and made its recommendations regarding expedited approval applications from SII, Bharat Biotech International Ltd, and Cadila Healthcare Ltd. Phase III testing. from.

The panel of experts recommended that the Serum Institute in India, Pune, approve limited emergency use of vaccines under a number of regulatory provisions.

Limited use in an emergency

He recommended "giving Bharat Biotech a limited emergency permit in the public interest as a precaution that is abundant in clinical trials, especially in relation to infection with mutant strains," the Health Ministry said.

However, according to sources, the commission said the company would continue its ongoing Phase 3 clinical trials and provide data from those trials when and when they become available.

Recommendations are made for review and a final decision by drug regulators in India.

Covaxin is a topically engineered coronavirus vaccine developed by Bharat Biotech in partnership with the Indian Medical Research Council (ICMR).

While the commission approved the limited emergency use of the Oxford COVID-19 vaccine on Friday, the commission has enacted several legislative provisions, including that injections are indicated for active immunization in people 18 years and over to prevent disease and that SII should be the earliest. Make safety, efficacy, and immunogenicity data available for review from ongoing clinical trials in the country and around the world.

In addition, Pune-based companies must provide security data, including Post Immunization Adverse Events (AEFI) and Special Interest Adverse Events (AESI) data, with the appropriate analysis every 15 days for the first two months and every month thereafter. Completion of ongoing clinical trials in the country as recommended.