An expert panel on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Friday recommended grant of permission for restricted emergency use of Oxford COVID-19 vaccine Covishield in India, subject to certain regulatory provisions, official sources said.
As for Bharat Biotech, the Subject Expert Committee (SEC) on COVID-19 of the CDSCO asked the firm to expedite volunteer recruitment for the ongoing clinical trial and said it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for its vaccine Covaxin, they stated.
The SEC, which earlier had sought additional safety, immunogenicity and efficacy data from Serum Institute of India (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 SII, the world’s largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield.
While considering Bharat Biotech’s application, the SEC noted that the ongoing clinical trial is a large one with 25,800 subjects of which 22,000 have been enrolled, including subjects with comorbid conditions, which has demonstrated safety till date but efficacy is yet to be demonstrated.
“After detailed deliberation, the committee recommended that the firm should try to expedite the recruitment and may perform interim efficacy analysis for further consideration of restricted emergency use approval,” an official source said.
Pfizer’s application was not deliberated, sources said.
The United Kingdom’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.
“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 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.