Oxford-AstraZeneca Covid Vaccine Becomes First To Get Approval In India
The Oxford-AstraZeneca vaccine, Covishield, has been developed in collaboration with Serum Institute of India. Twitter Outlook Web Bureau 2021-01-01T16:38:52+05:30 Oxford-AstraZeneca Covid Vaccine Becomes First To Get Approval In India outlookindia.com 2021-01-01T21:30:22+05:30
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The Central Drugs Standard Control Organisation(CDSCO) expert panel recommended the grant of permission for restricted emergency use of Oxford Covid-19 vaccine Covishield in India. The vaccine was further sent for approval to the regulator Drugs Controller General of India (DCGI). The Oxford-AstraZeneca vaccine, Covishield, has been developed in collaboration with Serum Institue of India (SII).
Updated Jan 01, 2021 | 18:32 IST
The DCGI will take the final decision on emergency approval of Covishield based on the expert panel s recommendations. Representational Image | Photo Credit: PTI
Key Highlights
The Pune-based Serum Institute of India (SII) has tied up with AstraZeneca to manufacture Covishield in India
The SII is the largest vaccine manufacturer in the world
New Delhi: An expert panel of the Central Drugs Standard Control Organisation (CDSCO) on Friday recommended granting the emergency use authorisation for Covishield , a COVID-19 vaccine developed by Oxford University and Swedish drugmaker AstraZeneca.
Importantly, the Drugs Controller General of India (DCGI) will now take the final decision on emergency approval of the vaccine based on the expert panel s recommendations.
New Delhi, January 1
An expert panel on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) is set to recommend granting emergency use authorisation for the Oxford COVID-19 vaccine Covishield, being manufactured by Serum Institute of India, sources said on Friday.
The Pune-based Serum Institute of India (SII), the world’s largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday had approved the COVID-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use.
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.
NEW DELHI, Jan 1: An expert panel of India’s drug regulator today recommended emergency use approval for Oxford-AstraZeneca vaccine Covishield, being manufactured by the Serum Institute of India, paving the way for the roll-out of the first COVID-19 shot in the country in the next few days.
As for Bharat Biotech’s vaccine, official sources said, the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) asked the firm to expedite volunteer recruitment for the ongoing clinical trial and recommended it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for Covaxin.