Covaxin, the coronavirus vaccine from Hyderabad-based Bharat Biotech, has been recommended for “restricted use in emergency situation in public interest” by a government-appointed panel, which submitted its findings to the Drugs Controller General of India on Saturday evening.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation (CDSCO) has made recommendations with respect to the ‘Accelerated Approval Process’ request of Serum Institute of India and Bharat Biotech International Ltd as well as about Phase-III Trials of Cadila Healthcare Ltd,” an official statement said.
According to sources, the committee, however, stated that the firm shall continue the ongoing phase 3 clinical trial and submit data emerging from the trial as and when available.
The committee noted that the vaccine is an inactivated whole virion, coronavirus vaccine, having potential to target mutated coronavirus strains, a source said. The data generated so far demonstrates a strong immune response (both antibody as well as T cell) and in-vitro viral neutralisation.
Recommendation for Covaxin comes a day after the panel had recommended emergency licensure for Serum Institute of India’s Covishield, but subject to certain conditions.
Hyderabad-based Bharat Biotech had started its phase 3 efficacy study of 26,000 participants only in mid-November and, considering that the second dose is given 28 days later and the immune response only two weeks after that, there is no clarity on availability of its interim efficacy data.
The company is now carrying out third and the largest phase of the clinical evaluation of the indigenous vaccine. During the trial, the efficacy of the vaccine would be compared to an unvaccinated group of people who are also part of the trial.
Out of 26,000 volunteers that it plans to recruit for the trial, 13,000 plus have been enrolled for the study.