SEC approves Covaxin Phase 3 trials efficacy data

The Subject Expert Committee (SEC) has approved Bharat Biotech phase 3 trials efficacy data. According to the data submitted, Covaxin has shown 77.8 percent efficacy. The Phase 3 trials for the vaccine were conducted on 25,800 subjects as per reports.

The Hyderabad-based vaccine maker had submitted its phase 3 trial efficacy data results of COVAXIN vaccine to Drug Controller General of India (DCGI) over the weekend, Dr VK Paul, member (health) of Centre's topmost think tank NITI Aayog said on June 21.

Phase 1 trials of this indigenously developed vaccine showed enhanced immune response without any serious side effects in the participants enrolled for the phase 1 trials, according to the results published in The Lancet Infectious Disease journal.

Covaxin is an inactivated vaccine developed by chemically treating novel coronavirus samples to make them incapable of reproduction. This process leaves the viral proteins, including the spike protein of the coronavirus which it uses to enter the human cells, intact.

Bharat Biotech is also expected to attend a "pre-submission" meeting on July 23 with the World Health Organisation (WHO) for emergency use listing of its COVID-19 vaccine candidate, Scroll reported.

An approval from WHO would allow the vaccine maker to export its vaccines and facilitate easier international travel of Indian citizens who have been given the jab, the report said.