Krishna Ella, chairman and managing director of Bharat Biotech, said the peer review in The Lancet, an authoritative voice in global medicine, validated their commitment to data transparency and meeting the stringent peer review standards of leading medical journals.After the World Health Organisation’s emergency use listing to Covaxin, vaccine maker Bharat Biotech received a booster shot from The Lancet. A peer review by The Lancet has confirmed the efficacy of the vaccine against Covid-19 to be at 77.8%.
The peer reviewed and published analysis in The Lancet was based on safety and efficacy analysis data from Phase III clinical trials of Covaxin. It said Covaxin was 77.8% effective against symptomatic Covid-19 and has a 65.2% efficacy against the Delta variant of the virus. The vaccine demonstrated 93.4% efficacy against severe symptomatic Covid-19.
Krishna Ella, chairman and managing director of Bharat Biotech, said the peer review in The Lancet, an authoritative voice in global medicine, validated their commitment to data transparency and meeting the stringent peer review standards of leading medical journals.
“The data from our product development and clinical trials have been published in 10 peer-reviewed journals, making Covaxin one of the most highly published Covid-19 vaccines in the world,” Ella said.
Dr Balram Bhargava, director general, Indian Council of Medical Research (ICMR), said, following the successful isolation of SARS-CoV-2 virus at ICMR-NIV, 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.
“The bench-to-bedside journey of Covaxin in less than 10 months showcases the immense strength of Atmanirbhar Bharat along with the Indian academia and industry in fighting against the odds and carving a niche in the global community,” Bhargava said.
Covaxin was developed under a partnership with ICMR and the National Institute of Virology (NIV), with Bharat Biotech receiving the SARS-COV-2 strains through this collaboration. Bharat Biotech also had an ongoing collaboration with ViroVax through the Indo-US Vaccine Action Program to develop and evaluate IMDG (Alhydroxiquim-II), a novel TLR7/8 agonist molecule, which is formulated as part of the adjuvant in Covaxin.
The company has manufactured and supplied 150 million doses of Covaxin, and said it will achieve an annualised capacity of one billion doses by 2021-end.
Since the WHO listing, the company has received emergency use authorisation in several countries, with applications in process in more than 50 countries. Bharat Biotech has partnered with Ocugen to obtain approvals for Covaxin in the United States and Canada.
The Covaxin efficacy data demonstrated a 63.6% protection against asymptomatic Covid-19, 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta and 70.8% protection against all variants of the SARS-CoV-2 virus. The Phase-3 trial efficacy and safety study involved 25,800 volunteers across 25 sites in India and is the largest clinical trial conducted for a Covid-19 vaccine in the country. The Data Safety Monitoring Board has not reported any safety concerns related to the vaccine.
Covaxin is currently being evaluated in controlled clinical trials in children between the ages of two and 18, with results expected in Q4 of 2021.
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