Covaxin: Bharat Biotech submits interim phase 3 results to drugs regulator
Vaccine major Bharat Biotech submitted the initial results of the phase 3 trials of Covaxin, its anti-Coronavirus disease (Covid-19) vaccine that has shown nearly 81% efficacy against the viral disease, to the national drugs regulator.
The company reportedly has asked for a review of the clinical trial mode condition that was put in place by the Drugs Controller General of India (DCGI) VG Somani before he granted the vaccine emergency-use authorisation.
“The company submitted the interim phase 3 trials report three-four days ago, and in the next subject expert committee meeting, the matter will be heard,” confirmed a senior official in the central drugs standard control organisation (CDSCO), requesting not to be named.
The subject expert committee of CDSCO is likely to meet on Thursday.
The company was granted restricted emergency-use approval on January 3 under clinical trial mode for want of phase 3 efficacy data.
Under clinical trial mode, the company has to follow all measures that are usually followed when an individual is given a vaccine shot during a clinical trial such as taking informed consent, close active follow-up of the recipient for a stipulated time etc.
Covaxin is a two-dose vaccine administered to an individual 28 days apart.
The company announced its interim phase 3 results on March 3.
Bharat Biotech’s Covaxin is one of the two vaccines approved for restricted use in India currently. The other one is Oxford-AstraZeneca vaccine that is being locally manufactured by Serum Institue of India as Covishield.
Meanwhile, The Lancet Infectious Diseases on Tuesday published the interim phase 2 trial results of Covaxin that show a two-fold increase in antibody titres than phase 1.
Also, side effects were observed only in 10-12% participants, which, according to the company, is six times less than other Covid-19 vaccines in use under emergency-use authorisation.