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After Covishield, India’s Covaxin Gets Expert Panel Approval for Emergency Use | India News


NEW DELHI: The Indian Pharmaceutical Authority’s subject matter expert committee on Saturday recommended the emergency restricted use of Covaxin from Bharat Biotech. The recommendation comes a day after the panel recommended emergency use authorization for Covishield from the Serum Institute of India (SII).
The Central Medicines Control Organization (CDSCO) Subject Matter Expert Committee (SEC) on Covid-19 deliberated again on Saturday on the Hyderabad-based pharmaceutical company emergency use authorization (USA) request after which presented additional data, facts and analysis after Friday’s review meeting, PTI reported citing a source.
Both Covaxin and Covishield are awaiting final marketing approval from the Comptroller General of Medicines of India (DCGI).
Covaxin will be the first locally developed vaccine to receive emergency approval in India.
It was developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR).
Covishield, on the other hand, is developed by AstraZeneca and the University of Oxford and is being manufactured locally by the Serum Institute.
IBS, the world’s largest vaccine producer, has already stocked around 50 million doses of the AstraZeneca / Oxford injection.
On Friday, the SEC had approved Covishield with certain conditions.
The panel said that each vaccine recipient will receive a vaccine fact sheet prior to vaccination.
The manufacturer can also be asked to report adverse events every 15 days.
The Indian regulator also received an emergency use request for the Covid-19 vaccine from Pfizer Inc with Germany’s BioNTech, the first opportunity to secure regulatory approval in the West.
Meanwhile, a nationwide trial was held on Saturday to assess field readiness for the vaccination process.
The exercise was conducted in all state capitals at at least three session sites.
Earlier today, the Union Health Minister Harsh Vardhan said that Covid-19 vaccines will be provided at no cost to all Indians.
(With inputs from agencies)

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