A statement by the manufacturer Bharat Biotech International said: “the Lancet peer review confirms the efficacy analysis that demonstrates Covaxin to be effective against Covid-19.”
It added: “Covaxin is the only Covid-19 vaccine to have demonstrated efficacy data from Phase 3 clinical trials against the Delta variant at 65.2 per cent.”
The medical journal said that “no severe vaccine-related deaths or adverse events were recorded during a randomised trial involving 24,419 participants aged 18 to 97 years between November 2020 and May 2021 in India.”
Bharat Biotech developed the Covid-19 vaccine in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology in Pune.
Krishna Ella, the chairman and managing director of the company, told Indian media: “The peer review of Covaxin’s Phase 3 clinical trial data in The Lancet, an authoritative voice in global medicine, validates our commitment to data transparency and meeting the stringent peer review standards of world-leading medical journals.”
The Lancet peer-review confirms the efficacy analysis of Bharat Biotech's Covaxin - As per phase-three clinical trials data, Covaxin demonstrates 77.8% efficacy against symptomatic COVID19 pic.twitter.com/6tnUneq3e6
— ANI (@ANI) November 12, 2021
Dr Ella had earlier lashed out at all those questioning Covaxin and its efficacy and alleged that “negative publicity” was responsible for Covaxin getting the Emergency Use Listing (EUL) by the World Health Organisation.
When he was asked about the reason for negative publicity, Dr Ella responded: “When Prime Minister [Narendra Modi] took the vaccine, immediately they said it’s a BJP vaccine, it’s a Modi vaccine. All sorts of synonyms. We are scientists, we don’t understand the politics.”
Earlier this month, the WHO had said that its technical advisory group had ruled that the benefits of Covaxin significantly outweighed the risks and that it met WHO standards for protection against Covid-19.
Published today in Lancet, peer-reviewed results for COVAXIN. Excellent overall efficacy of 78% against CoVID.
Importantly, against the delta variant Covaxin efficacy is 65.2%, while that of Covishield is 59.8%.
Heartiest congratulations, @SuchitraElla. https://t.co/yilG5hDDIi pic.twitter.com/DIlkGoEZKg
— Anand Ranganathan (@ARanganathan72) November 12, 2021
Balram Bhargava, the director-general of the ICMR was quoted by Hindustan Times newspaper as saying: “I am delighted to see that the Phase 3 efficacy data has also been published in The Lancet, one of the most reputed journals worldwide. It speaks highly about the strong position of Covaxin among other global front-runners [with respect to] Covid-19 vaccines.”
According to Bharat Biotech, Covaxin’s emergency-use authorisation application is in process in at least 50 countries.
“With more than 150 million doses manufactured and supplied, and with an excellent safety and efficacy profile, Covaxin is a major contributor to the global fight against the Covid-19 pandemic,” it said.
Bharat Biotech added: “Covaxin is currently being evaluated in controlled clinical trials among children aged 2-18, with results available during Q4 this year. Bharat Biotech is poised to achieve its goal of an annualised capacity of 1 billion doses of Covaxin by the end of 2021.”
Today, as Bharat biotech celebrates the WHO approval of COVAXIN®, we stumbled upon a video of a little girl dressed up as COVAXIN®. We all were delighted to have watched this along with our whole team in today's meeting. Thank you Vidhathri, for being a mascot for COVAXIN®
— BharatBiotech (@BharatBiotech) November 5, 2021
Meanwhile, Bahrain on Friday become the latest country to approve Covaxin for emergency use of the jab, the Indian embassy announced.
In India, 25.8 per cent of the population is fully vaccinated, as per the latest available data.