Chennai: Bharat Biotech’s vaccine, whose emergency use approval before finishing final stage testing had triggered a row, has shown an 81 per cent efficacy in preventing symptomatic Covid-19 in an interim analysis of the advanced clinical trial, the company said, boosting prospects of its usage.
Covaxin, which was shunned by some health workers due to lack of final trial data, showed efficacy better than the company’s previous guidance of around 60 per cent.
In a statement, Bharat Biotech chairman Krishna Ella said Covaxin has ‘demonstrated high clinical efficacy’ as also shown ‘significant immunogenicity’ against rapidly emerging variants.
In a separate video address, he added that ‘many people criticised us’.
The results come as a shot in the arm for India’s immunisation drive against coronavirus.
The drug regulator in January had allowed Covaxin as well as the vaccine made by AstraZeneca’s local partner, the Serum Institute of India Ltd.
But the lack of final trial data inhibited the use of Covaxin, which made up for only about 11 per cent of the more than one crore vaccines administered till last week.
The findings cement Bharat Biotech’s claims of India’s first successful home-made Covid-19 vaccine being safe while also brightening prospects for sales overseas.
Bharat Biotech said the efficacy data was based on tests on 25,800 subjects, the largest ever conducted in India.
The Phase three study enrolled participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with co-morbidities, it added.
“Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today’s results from our Phase three clinical trials, we have now reported data on our Covid-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants”, Ella said.