Expert panel recommends nod for Bharat Biotech’s Covaxin amid new virus strain

A government panel on Saturday recommended for authorisation Bharat Biotech International’s covid-19 vaccine Covaxin after a meeting that stretched over three days, the health ministry said in a statement.

The subject expert committee (SEC) of Central Drugs Standards Control Organisation (CDSCO) on Saturday made recommendations for “grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains, to M/s Bharat Biotech International Ltd, Hyderabad,” the health ministry said.

The SEC’s decision is likely to soon be followed by a final authorisation by the Drugs Controller General of India (DCGI) V.G. Somani, who heads the CDSCO. Typically, the DCGI clears a proposal for approval or emergency licence when it is recommended by the SEC.

Certain experts, like former Indian Council of Medical Research scientist Raman R Gangakhedkar as well as NITI Aayog member-health V.K. Paul, have said that they believe Covaxin may be able to provide immunity even against the new strain as it is a wholly inactivated virus—that is an entire dead virus.

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.

The health ministry confirmed on Saturday that the SEC recommended for emergency licensure to Pune-based Serum Institute of India’s vaccine, subject to multiple regulatory conditionalities.

On Saturday, the SEC also recommended that Zydus Cadila be granted permission to conduct Phase-III clinical trial. The company is developing a DNA-based vaccine but has so far not released its data from pre-clinical trials as well as the first two phases.

While Serum Institute had submitted data from its phase 2 and 3 bridging study as well as that from AstraZeneca, it was not clear what data Bharat Biotech had submitted.

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’s phase 1 and 2 data involving a total of 680 participants showed Covaxin induced immunity against covid-19 through antibodies as well as T-cells and was found to be safe with no serious adverse events related to the vaccine, as per pre-prints of the results which have not yet been peer-reviewed.

Covishield is Serum Institute’s version of the adenovirus-vector vaccine originally co-developed by AstraZeneca and the University of Oxford, while Bharat Biotech’s Covaxin is India’s first indigenously-developed vaccine—a traditional platform that contains killed virus along with a substance called adjuvant that boost the immune response.

An official involved in the process, on condition of anonymity, said that Bharat Biotech had submitted interim data from phase 3 efficacy trial and that the decision was “based on science”. However, the official did not divulge how many participants’ data was available and what was the interim efficacy of the vaccine.

Bharat Biotech’s application was part of a rolling review process with the regulator, which means that data was available with the DCGI and the panel members as it was processed by the trial sites and the company. The company is conducting a phase 3 trial, where it has enrolled more than half the 26,000 participants it plans to have. However, considering that the firm had started enrolling participants only in mid-November, and the vaccine’s effect is observed 42 days after the trial begins, it is unclear how many participants’ efficacy data they had.

Bharat Biotech’s Covaxin is also significant for India considering that it is being indigenously developed and manufactured, which potentially ensures a greater supply. The company, however, has faced criticism over the lack of data when it sought approval.

Bharat Biotech and Serum Institute had submitted their proposals to the DCGI for an emergency licensure early December, but the SEC had in its 9 December meeting asked the two companies to return with more data, with the maker of Covaxin asked to come back with its efficacy data.