Covaxin 77.8% effective against Covid-19 in Lancet study
Covaxin, the indigenous Covid-19 vaccine developed by Bharat Biotech and the Indian Council of Medical research has 77.8% efficacy against symptomatic infections, 93.4% against severe infections, and 65.2% against infection by the highly infectious Delta variant of the SARS-CoV-2 virus which causes the coronavirus disease, according to an analysis of the vaccine’s Phase 3 trials published on Friday in The Lancet.
The data is the same as that published in a pre-print study four months ago.
“The Lancet peer review confirms the efficacy analysis that demonstrates Covaxin to be effective against Covid-19. Covaxin is the only Covid-19 vaccine to have demonstrated efficacy data from Phase 3 clinical trials against the Delta variant at 65.2%,” said Bharat Biotech in a statement on Friday.
The efficacy analysis was done after the evaluation of 130 confirmed Covid-19 cases, with 24 observed in the vaccine group as against 106 in the placebo group, the article said.
Bharat Biotech developed the anti-Covid jab in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology in Pune. WHO, on November 3, issued a Emergency Use Listing for Covaxin, which has been part of India’s vaccine programme since January. Of the 1.1 billion vaccine doses administered till Friday evening in India, over 125 million, or 11% are of Covaxin.
The company received strains of Sars-CoV-2 isolated by the Indian government’s apex virology laboratory in March 2020.
“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,” Krishna Ella, chairman and managing director of Bharat Biotech, said in a statement.
“The data from our product development and clinical trials has been published in 10 peer-reviewed journals, making Covaxin one of the most highly published Covid-19 vaccines in the world. This accomplishment reflects the undeterred commitment by my team members at Bharat Biotech, our public partners, ICMR, the National Institute of Virology and the trust imposed by our trial participants who made this happen,” Ella said.
The long gap between the publication of Covaxin’s Phase 3 results in a release and in a peer-reviewed journal and the delay in WHO granting an EUL to the vaccine had become talking points. Pfizer, whose vaccine was approved for emergency use by the US drug regulator in December 2020, published its Phase 3 results in a peer-reviewed journal in the same month.
Oxford/AstraZeneca’s vaccine was approved for use by the UK regulator in December 2020. Covaxin was approved by India’s drug regulator before interim results of its Phase 3 trials were available, and the company finally published these in a release in June 2021.
Balram Bhargava, director general of the ICMR, said, “Following successful isolation of the Sars-CoV-2 virus at the ICMR-National Institute of Virology in Pune, ICMR and Bharat Biotech embarked upon one of the most successful public-private partnerships to develop the virus isolate into an effective Covid-19 vaccine. “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...” he added. According to the company, its emergency-use authorisation application is in process in at least 50 countries.