A day after DCGI's expert panel recommended that the Oxford-AstraZeneca and Bharat Biotech vaccines against COVID-19 be allowed for emergency use in the country, the drug regulator DCGI will brief the media at 11 am on Sunday at the National Media Centre regarding the vaccine.
On Saturday, the Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation (CDSCO) made recommendations to the Drugs Controller General of India to grant permission for restricted emergency use of the Serum Institute of India (SII) and Bharat Biotech's vaccines. As per an official release, the SEC met on Friday and Saturday and made its recommendations in respect of the accelerated approval process request of the SII, Bharat Biotech International Ltd as well as about phase-III trials of Cadila Healthcare Ltd.
#COVID19Update— Ministry of Health (@MoHFW_INDIA) January 2, 2021
Subject Expert Committee (SEC) of @CDSCO_INDIA_INF makes recommendations in respect of accelerated Approval Process request of @SerumInstIndia, @BharatBiotech & Phase-III Trials of M/s Cadila Healthcare Ltd.https://t.co/hwNyTYqSJM pic.twitter.com/9uLOrjV7cQ
The Subject Expert Committee recommended a grant of permission for restricted emergency use of the vaccine, subject to multiple regulatory conditionalities, to Serum Institute of India, Pune. It also recommended the grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains, to Bharat Biotech International Ltd Hyderabad. The recommendations were made for the consideration and final decision of the Drugs Controller General of India.
Covaxin is an indigenously developed Coronavirus vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR). Meanwhile, Bharat Biotech on Saturday said it is moving towards achieving the target of having 26,000 volunteers across the country for Phase-3 trials of its Covid-19 vaccine. The company has already roped in 23,000 volunteers for the trials, it said.
Bharat Biotech, Serum Institute and Pfizer had applied with the Drug Controller General of India (DCGI) for emergency use authorisation for their respective vaccines.
According to PTI, while granting the restricted emergency use approval for the Oxford COVID-19 vaccine on Friday, the expert panel had 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 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.
The Serum Institute of India, the world's largest vaccine manufacturer, has tied up with AstraZeneca to manufacture Covishield. Pfizer had applied for regulatory approval for its vaccine on December 4 has not yet turned for deliberation.
Union Health Minister Harsh Vardhan appealed to people on Saturday not to be misguided by "rumours" regarding the safety and efficacy of the Coronavirus vaccine, and said, "We will not compromise on any protocol before approving a vaccine." He also said that in the first phase of COVID-19 vaccination, free vaccine shall be provided across the nation to most prioritised beneficiaries that include one crore healthcare and two crore frontline workers.
(With agency inputs)