An expert panel of India’s drug regulator on Friday gave permission to pharmaceutical firm Bharat Biotech for administering a third dose of its coronavirus vaccine to a few volunteers during second phase of the clinical trials, PTI reported.

The Hyderabad-based firm told the Subject Expert Committee of the Drugs Controller General of India that a booster shot of Covaxin could be given six months after the second dose.

The expert panel accepted the recommendation on March 23 during its 148th meeting. “The firm presented amendments in the approved Phase II clinical trial protocol for administration of booster dose after 6 months after second dose,” the Subject Expert Committee said.

It added, “After detailed deliberation, the committee recommended that the firm should conduct the booster dose study only in 6 mcg [microgram] cohort and also should follow up the subjects at least for six months after the third dose.”

The panel also directed Bharat Biotech to present the details of the primary and secondary objectives and various assessments during the trial. “Accordingly, firm (Bharat Biotech) should submit the revised clinical trial protocol for evaluation,” the committee said.

Covaxin is one of the two vaccines being used in India’s immunisation programme. The other one is the AstraZeneca vaccine, which is locally produced by the Serum Institute of India.

Covaxin is a two-dose inactivated vaccine, which is given 28 days apart. The indigenous vaccine had shown 81% efficacy in phase-three trials in India, which involved 25,800 subjects.

A total 6,87,89,138 Covid-19 vaccines doses have been administered in India so far since the country began inoculating citizens in January. On Thursday, the country entered its third phase of the vaccination drive, under which all people above 45 years will be covered. At least 20 lakh signed up for the vaccination on the first day, reported News18.

Meanwhile, India on Friday recorded 81,466 new coronavirus cases, pushing the overall count in the country to 1,23,03,131, data from the health ministry showed. This was the biggest single-day jump in six months. The toll climbed to 1,63,396, after 469 new deaths were recorded in a day, the highest since December 6.