New Delhi: The Subject Expert Committee (SEC) on Saturday recommended granting permission to Bharat Biotech’s Coronavirus vaccine ( Covaxin) for “restricted emergency use” in the country. The development came after the government-appointed panel, earlier in the day, took up Bharat Biotech’s emergency-use request into consideration for the second time.Also Read - Will Develop Booster Shot For New Covid Variant 'Omicron', Says Moderna
The panel has submitted its findings to the national regulator- Drugs Controller General of India, which will now take a final call on the matter. The Bharat Biotech’s Coronavirus shots can be rolled out for vaccination in the country soon if all goes well and the vaccine manages to get the final approval. Also Read - WTO Delays Key Meeting Amid COVID Variant Concerns
“Subject Expert Committee (SEC) of Central Drugs Standards Control Organisation (CDSCO) recommends to DCGI for grant of permission for restricted emergency use of vaccine, subject to multiple regulatory conditionalities, to Serum Institute of India, Pune,” the government of India said in a statement. Also Read - World Races to Contain New COVID Threat; Will Flight Restrictions Help as New Virus Variant Emerges?
“CDSCO recommends for granting permission for restricted use in emergency situation in public interest as abundant precaution,in clinical trial mode,specially in context of mutant strain infection,to Bharat Biotech&for conduct of PhaseIII Clinical Trial Protocol to Cadila.”
The committee of experts assessing Coronavirus vaccines had called Hyderabad-based Bharat Biotech for a meeting in the afternoon today, a day after the firm was asked to present more data to get a nod, a top source said on Saturday.
On Friday, the Subject Expert Committee of the Central Drug Standard Control Organisation (CDSCO) had held that the data provided by Bharat Biotech for its Coronavirus vaccine is not sufficient for grant of emergency use approval and asked for more information.
The expert committee, tasked with vetting Covid-19 vaccine proposals, had convened a meeting to take a call on emergency use authorisation sought by the Serum Institute of India and Bharat Biotech for their respective vaccine candidates.
Notably, the panel recommended emergency licensure for the Serum Institute of India-manufactured ‘Covishield’. It become the first vaccine to secure recommendation for emergency use in India. The nod of the DCGI is, however, awaited on the recommendation.
The central government plans to vaccinate nearly 30 crore people in the first phase of drive in the next six to eight months. 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.