Drug maker Bharat Biotech will seek a full licence for Covaxin once the results of its phase 3 trial are published in July. The vaccine is also scheduled for further testing "for real-world effectiveness", the company said today.
Referring to Covaxin's efficacy, or "its ability to bring about intended beneficial effects on individuals administered", the Hyderabad-based firm reiterated that it showed 78 per cent effectiveness overall and 100 per cent against hospitalisation, ANI reported today.
"It is critical to understand the phase 3 data will first be submitted to CDSCO," ANI reported Bharat Biotech as saying, referring to the Central Drugs Standard Control Organisation. This will be followed by peer-reviewed journals with a timeline of approximately three months for publication. "As communicated earlier, Covaxin phase 3 results full trial data will be made public during July."
The company dubbed "flawed" a recent comparative report based on a preliminary study which said that Covishield, the Covi vaccine produced by Serum Institute of India, generated more antibodies than Covaxin.
"It's neither a peer-reviewed publication nor a statistically and scientifically designed study. The study design and conduct reflect an ad hoc analysis...further, the study was not...approved by CDSCO," Bharat Biotech said.
Raches Ella, head of business development and advocacy at Bharat Biotech, had questioned why such "non-peer-reviewed work" was put out.
@Teensthack@singhak_endo surprised that media/researchers are concluding based on non-peer-reviewed work. Limitation 1: Spike-based IgG's are not appropriate when evaluating Covaxin, which induces broad antibody responses to Spike, N, and M. Recommend live virus neutralization. https://t.co/kdCbfjwFbv— Dr. Raches Ella (@RachesElla) June 7, 2021
Covaxin was cleared for use "in public interest" for India's nationwide vaccination drive amid controversy over its late-stage trial data not being available.
"Bharat Biotech is also doing phase 4 trials to check on the real-world effectiveness of the vaccines, and to ensure its vaccine met every rigorous scientific standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorisation," ANI reported it as saying.