Covaxin Phase 3 trial data in July; 100% effective against hospitalisations; Phase 4 next

Hyderabad-based vaccine manufacturer Bharat Biotech, which is carrying out its phase 3 trial, will publish the data in July, and following that the company will be applying for the full licensure for Covaxin. Speaking about Covaxin's efficacy, Bharat Biotech said that the efficacy data of the vaccine have been reported at overall efficacy of 78 per cent and efficacy against hospitalisations at 100 per cent.

Bharat Biotech on Covaxin's efficacy

"While virus inactivated vaccines have demonstrated one of the best safety records globally," it added. Vaccine's efficacy refers to the ability of a vaccine to bring about the intended beneficial effects on vaccinated individuals. 

Bharat Biotech said, "It is critical to understand, and further emphasise the Phase-3 data will first be submitted to Central Drugs Standard Control Organisation (CDSCO), followed by peer-reviewed journals, with a timeline of 3 months for publication, and as communicated earlier Covaxin phase 3 results full trial data will be made public during July. Once data from the final analysis of phase III studies are available, Bharat Biotech will apply for full licensure for Covaxin."

In a recent preliminary pre- peer-reviewed study about vaccine efficacy report, Bharat Biotech had clarified that it has undergone and will continue to undergo the most intensive safety and efficacy monitoring in Indian vaccines history.

"A recent comparative report on an evaluation of immunogenicity responses to spike protein after the first and second dose of Indian manufactured vaccines study had lots of flaws. The journal that stated the comparative report said more antibodies produced by Covishield than Covaxin. This is not a peer-reviewed publication, nor do it a statistically and scientifically designed study. The study design and conduct reflect an ad hoc analysis, rather than a predetermined hypothesis," the company said.

Giving out further details, Bharat Biotech informed that the COVID vaccine Covaxin will even undergo phase-4 trials to check the real-world effectiveness of the vaccines. "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 authorization," it added. 

(Image: PTI, Pixabay)