In what Hyderabad-based Bharat Biotech claims is the largest efficacy trial in India across 25 trial sites, the company claims its Covid-19 vaccine Covaxin is 65 per cent effective against the Delta variant.
In a pre-print paper that is yet to be peer-reviewed, the company claimed that the vaccine is also 63 per cent effective against asymptomatic Covid-19 and is 93 per cent effective against severe Covid-19 and 79 per cent effective against mild, moderate and severe Covid-19 disease.
It also claimed that the vaccine is well tolerated with minimal adverse events after immunisation.
Phase 3 clinical trials of the vaccine was an event-driven analysis of 130 symptomatic Covid-19 cases, reported at least two weeks after the second dose, conducted at 25 sites across India. The whole virion inactivated vaccine against SARS-CoV2, was developed in partnership with the Indian Council of Medical Research and the National Institute of Virology in Pune.
The Phase 3 trials were conducted between November 16, 2020, and January 7, 2021, with 25,798 participants who were randomised to BBV152 or placebo groups. The preprint data of COVAXIN efficacy has not been certified by peer-review, according to Medrxiv in which the data was published.
‘The successful safety and efficacy readouts of Covaxin establishes the ability of India and developing world countries to focus towards innovation and novel product development,” Bharat Biotech MD Dr Krishna Ella said.
Safety analysis has demonstrated adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side effects and less than 0.5 per cent of subjects feeling serious adverse events.
The vaccine maker claims to be the first to report promising efficacy against asymptomatic infections based on qPCR testing that will help in reducing transmission.
(The article is posted from Deccan Herald without any modification.)
