Covishield: Oxford-AstraZeneca COVID-19 vaccine gets recommendation for emergency use, DCGI to take final call

New Delhi, Jan 01: The subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) expert panel on Friday recommended approval of Oxford COVID-19 vaccine Covishield for emergency use in India, subject to certain regulatory provisions, official sources said.

The Pune-based Serum Institute of India (SII), the world''s largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield.

The SEC, which earlier had sought additional safety, immunogenicity and efficacy data from SII and Bharat Biotech, deliberated on their applications seeking emergency use authorisation (EUA) for their shots on Wednesday, and met again on Friday to review the matter.

While granting emergency use approval for the Oxford COVID-19 vaccine, the panel imposed certain regulatory provisions, including that the shot is indicated for active immunisation in individuals of 18 years or more to prevent the disease and that it should be administered intramuscularly in two doses at an interval of 4 to 6 weeks.

Further, the SII should submit safety, efficacy and immunogenicity data from the ongoing clinical trials in the country and across the globe for review at the earliest.

Also, the Pune-based firm should submit the safety data including the data on adverse event following immunisation (AEFI) and adverse event of special interest (AESI) with due analysis every 15 days for the first two months and monthly thereafter till the completion of the ongoing clinical trial in the country. 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.

"In terms of safety, Covishield was well tolerated with respect to solicited adverse events...majority of solicited reactions were mild in severity and resolved without any sequelae.

"Therefore, Covishield is safe and can be used effectively for prevention of COVID-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield," the EUA application signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at Serum Institute of India (SII), had stated.

SII had applied to the Drugs Controller General of India (DCGI) for EUA for Oxford COVID-19 vaccine on December 6, while the Hyderabad-based Bharat Biotech had sought the nod for its indigenously developed Covaxin on December 7.

Pfizer had applied for regulatory approval for its vaccine on December 4.