CDSCO panel recommends granting approval for restricted emergency use of Bharat Biotech’s indigenous COVID vaccine Covaxin in India | Subject Expert Committee Recommends Conditional Approval To Kovaxin After Kovshield

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On the second day of the new year, there has been another good news about the Corona vaccine. The Subject Expert Committee on Corona on Saturday recommended conditional approval of Bharat Biotech’s Kovaxin for emergency use. A similar approval was also recommended 24 hours earlier to CoviShield of Serum Institute. Now the case of both vaccines is with the Drug Controller General of India. On any given day, both vaccines will get final approval and vaccination can start in the country.

The results of Kovaxin’s Phase-2 clinical trials were revealed on 23 December. The trials were conducted on 380 healthy children and adults. Two formulations of 3 µg and 6 µg were decided. Two groups were formed. He was given two doses with a difference of four weeks. In phase-2 trials, covaxin produced high level antibodies. Even after 3 months of the second vaccination, the number of antibodies in all volunteers appeared to be increasing.

Endibody claims to last 6 to 12 months
Based on the results of the trial, the company claims that due to covaxin, the antibodies made in the body last for 6 to 12 months. Antibody is the protein present in the body which neutralizes the attack of viruses, bacteria, fungi and parasites. This vaccine is currently undergoing Phase-3 trials in the country.

Largest phase three trial in the country
Bharat Biotech has conducted a phase three trial of Kovaxin, the indigenous vaccine of Corona, at 23,000 volunteers. Trials started in many cities across the country from November have targeted to test the vaccine at 26,000 volunteers. This is the first and largest phase three trial of any Corona vaccine in India. Earlier, no vaccine in the country has been phase-trialed on such a large scale.

So far, three companies have sought approval, two have been approved
So far, three pharma companies in India have sought approval for emergency use of the corona vaccine. Of these, Kovyshield and Kovaxin have received conditional approval. CoveShield or AZD1222 is made by Oxford University in association with the British pharma company AstraZeneca. Adar Poonawala’s Serum Institute of India (SII) is conducting trials in its India. On 1 January, the Subject Expert Committee recommended its approval.

Covaxin is indigenous. It is made by Hyderabad-based company Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). It has also been approved. Bharat Biotech applied for it on 7 December. On 2 January, it was recommended by the committee to approve it. The third vaccine to be approved was the American company Pfizer. Pfizer’s vaccine has been approved by WHO for emergency use around the world.

Emergency use approved in these countries