Bharat Biotech to submit revised Phase 3 clinical trial protocol to DCGI by next week

Covaxin is India’s first vaccine candidate against Covid-19

Bharat Biotech is likely to resubmit the proposal for the Phase 3 clinical trial to the drugs controller general of India (DCGI) for its anti-coronavirus disease (Covid-19) vaccine candidate, Covaxin, early next week.

While it received the drugs controller’s nod for the Phase 3 trial in India late Thursday, the country’s apex drugs regulator has asked the company to revise certain details of the protocol it had submitted on October 2.

“DCGI has asked us to change a few details in the protocol. These are minor procedural changes. We are currently in the process of making the necessary changes, and will hopefully re-submit the proposal to CDSCO [Central Drugs Standard Control Organisation] in the next few days,” Sai Prasad, executive director, Bharat Biotech International Ltd., told HT.

Prasad is a part of the product development team at Bharat Biotech.

The virus was isolated in an ICMR lab, which had shared one of the 11 virus strains that it managed to culture in February this year with Bharat Biotech.

According to scientists, coronavirus is difficult to isolate; however, scientists at NIV managed to isolate and culture 11 strains—the basic requirement to develop a vaccine or work on any research related to a virus.

The strain was successfully transferred from NIV to Bharat Biotech International Ltd. (BBIL) in Hyderabad. Both have partnered to develop India’s first anti-Covid-19 vaccine.

The indigenous, inactivated vaccine candidate was developed and manufactured at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility located in Genome Valley, Hyderabad, India.

The company received the Central drugs controller’s approval for Phase 1 and Phase 2 human clinical trials on June 29, after it submitted the results generated from preclinical studies, demonstrating safety and immune responses.

Human clinical trials for Covaxin began across India in July 2020. As per the current plan, the Phase 3 trial, to determine vaccine efficacy, will begin early to mid-November this year.

The company plans to enrol at least 26,000 participants for the Phase 3 trial at 25 to 30 hospitals across 13-14 states.

For the Phase 1 clinical trial, it had recruited 375 subjects, and as part of the Phase 2 trial, it gave the vaccine candidate to 400 participants.

Bharat Biotech has completed the Phase 1 trial, and submitted the results, which showed no major safety concern, to DCGI. For Phase 2, the safety test is complete, and the immunogenicity test (to know body’s immune response to the vaccine) is currently underway.

Bharat Biotech had earlier announced that it was working on a unique intranasal vaccine for Covid-19, for which animal trials have already been completed, with good results.

“No vaccine is going to be 100% effective but then for respiratory diseases it is anyway not possible to have 100% efficacy. There seem to be a few promising vaccine candidates but eventually the Phase 3 trial results will determine which one works well,” said Dr GC Khilnani, former head of the pulmonology and sleep medicine department at the All India Institute of Medical Sciences (AIIMS), Delhi.