Bharat Biotech on Wednesday said it will release the complete results of phase-III clinical trials of its COVID-19 vaccine Covaxin in July.
The Hyderabad-based company said it will apply for full licence for Covaxin, which was granted emergency use authorisation by the country's drug regulator in January, after the release of phase-III data.
"It is critical to understand, and further emphasise the phase-III data will first be submitted to Central Drugs Standard Control Organisation (CDSCO), followed by peer-reviewed journals, with a timeline of three months for publication, and as communicated earlier, Covaxin phase-III results full trial data will be made public during July," the company told news agency ANI.
The phase-III trial data is also required for getting emergency use listing (EUL) from the World Health Organisation (WHO). A guidance document on the WHO website showed that Bharat Biotech submitted an expression of interest for EUL on April 19. Last month, the company told the government it had submitted 90 per cent documents to WHO for EUL for Covaxin.
In March, the vaccine maker said Covaxin demonstrated 81 per cent interim efficacy in preventing COVID-19 in those without prior infection after the second dose.
The vaccine has an overall efficacy of 78 per cent and efficacy against hospitalisation is 100 per cent, the news agency quoted the company as saying.
The company also rejected a recent comparative report on the evaluation of immunogenicity responses to spike protein after the first and second dose of Covishield, manufactured by the Serum Institute of India, and Covaxin. The report said more antibodies were produced by Covishield than Covaxin.
Bharat Biotech said it was not a peer-reviewed publication and the study was not designed scientifically. "The study design and conduct reflect an ad hoc analysis, rather than a predetermined hypothesis," ANI quoted the company as saying.
The company also said it will carry out phase-IV trials of Covaxin to check on the real-world effectiveness of the vaccine, and to ensure it meets every rigorous scientific standard for safety, effectiveness and manufacturing quality needed to support emergency use authorisation.
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