The Drugs Controller General of India (DCGI) on Sunday gave licensing permission to Bharat Biotech to manufacture Covaxin, news agency ANI reported. Bharat Biotech has been asked to submit updated safety, efficacy and immunogenicity data from the ongoing Phase I, II and Ill clinical trials till the completion of trials, it further said.
The DCGI gave final approval to two Covid-19 vaccines on Sunday, paving the way for a huge inoculation program to stem the pandemic in the second worst-hit country.
Lauding the development, All India Institute Of Medical Science (AIIMS) director Randeep Guleria said, “It is a great day for the country and a good way to start the new year.” He also said that indigenously developed Covaxin - one of the two vaccines approved - can be used as backup.
The DCGI gave approval for the emergency use of two Covid-19 vaccines, one developed by AstraZeneca and Oxford University and the other by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).
The nod marks the first vaccine approvals for India, which after the United States, has recorded the most infections of the coronavirus disease.
The DCGI granted the approval on the basis of recommendations of a Covid-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). “After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situations,” DCGI Dr V G Somani told the media on Sunday.
Both of the vaccines are two-dose regimen and need 2-8 degrees Celsius storing temperature which make them more cost-effective in comparison to the other vaccine being developed by the US-based pharma giant Pfizer with its German partner BioNTech.
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