Covaxin, the indigenous Covid-19 vaccine, developed by Bharat Biotech in collaboration with the Indian Council for Medical Research and the National Institute of Virology, became the second vaccine in India to take a further step towards final approval for emergency use. . The Central Drug Control Organization (CDSCO) subject matter expert committee recommended Covaxin for emergency restricted use on Saturday. On Friday, Covishield of the Serum Institute of India received the recommendation. Both will now have to await final approval from the Comptroller General of Drugs of India (DCGI).
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The development comes on a day when a nationwide vaccination exercise was conducted under the supervision of the Union Ministry of Health. Union Minister Prakash Javadekar said on Saturday that India is perhaps the only country with several near-ready candidate vaccines.
Bharat Biotech had applied for the emergency use authorization for the first time on 7 December. The expert panel at the time asked the company to submit its safety and efficacy data from the ongoing phase 3 clinical trial for further consideration.
On Friday, as the expert panel discussed the details of Covishield (Oxford / Astrazeneca vaccine) and Covaxin (Bharat Biotech), it asked Bharat Biotech to expedite the recruitment of volunteers for the third phase of the ongoing trial. A day later the recommendation came.
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Both candidate vaccines have been recommended for restricted emergency use that comes with some passengers. For the Oxford vaccine, the panel has imposed certain regulatory provisions, including that the injection is indicated for active immunization in persons 18 years of age or older to prevent disease and that it must be administered intramuscularly in two doses with an interval of four to six weeks. .
The Bharat Biotech vaccine candidate is an inactivated vaccine that is developed by inactivating (killing) the live microorganisms that cause disease. This destroys the pathogen’s ability to replicate, but keeps it intact so that the immune system can still recognize it and produce an immune response. There are many inactivated vaccines against hepatitis A, influenza, polio and rabies, which offer “excellent protection”, said Bharat Biotech.
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