An expert panel on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Friday recommended to grant 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.
DCGI to give final approval
The application will be sent to Drugs Controller General of India (DCGI) VG Somani for final approval. The approval will pave the way for the vaccine's rollout in India, which also has the highest number of infections in the world, after the US. The rollout will begin from January 6, according to ministry sources.
UK already approved emergency use authorisation of Oxford vaccine
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.
After SII's application, the SEC started reviewing the EUA application by Bharat Biotech for its COVID-19 vaccine Covaxin but is yet to take a final decision on the matter, sources said.
"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.
(With inputs from PTI)