The Subject Expert Committee (SEC) of the Central Drug Standard Control Organisation on Friday has held that the data provided by Bharat Biotech for its coronavirus vaccine 'Covaxin' is not sufficient for grant of emergency use approval and has asked for more information, top sources said.
Earlier on Friday, the expert committee, which is tasked with vetting COVID-19 vaccine proposals, recommended emergency licensure for the Serum Institute of India-manufactured 'Covishield'. It became the first vaccine to secure recommendation for emergency use in India. The Pune-based Serum Institute has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing 'Covishield' while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for 'Covaxin'.
As for Bharat Biotech's Covaxin, official sources said that the SEC on COVID-19 of the Central Drugs asked the firm to expedite volunteer recruitment for the ongoing phase 3 clinical trial and recommended that it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for the vaccine. The SEC recommendations on Covishield and in regard to Covaxin were earlier forwarded to the Drugs Controller General of India (DCGI) for final approval.
The SEC, which earlier had sought additional safety, immunogenicity and efficacy data from the 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.
"After detailed deliberation, the committee recommended for grant of permission for restricted emergency use of the vaccine (Oxford COVID-19) subject to various regulatory provisions," a source said.
While granting the restricted 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 four to six weeks.
Further, 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.
Pune-based SII should also submit safety data including the data on adverse events 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, according to the recommendations.
The committee had convened a meeting to take a call on the emergency use authorisation sought by the Serum Institute, Bharat Biotech and America's Pfizer for their coronavirus vaccines candidates.
Pfizer was the first one to apply for the accelerated approval on December 4, followed by the Serum Institute and Bharat Biotech on December 6 and 7, respectively.
The meeting comes a day before dry run of the vaccine is slated to commence in all the states and Union Territories to equip the administration in management of vaccine supply, storage and logistics including cold chain management
The Central government plans to vaccinate nearly 30 crore people in the first phase of drive. It will be offered to one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.