Bharat Biotech reports positive Covaxin phase 3 results with 77.8% efficacy
Covaxin phase 3 results : Bharat Biotech, an Indian biotech company, said that Covaxin, its whole virion inactivated vaccine against SARS-CoV2, has demonstrated efficacy of 77.8% against symptomatic Covid-19 in phase 3 clinical trials.
Efficacy analysis of the Bharat Biotech vaccine showed that it was 93.4% effective against severe symptomatic Covid-19.
Against asymptomatic Covid-19, the efficacy data showed 63.6% protection.
Bharat Biotech said that while none of the licensed SARS-CoV-2 vaccines have reported efficacy against asymptomatic Covid-19 in a randomized controlled trial, based on qPCR testing, Covaxin could show promising efficacy against the same, which will help in reducing transmission of the disease.
Bharat Biotech management comments on Covaxin phase 3 results
Dr. Krishna Ella – Chairman and Managing Director, Bharat Biotech, commenting on Covaxin phase 3 results, said: “The successful safety and efficacy readouts of COVAXIN as a result of conducting the largest ever COVID Vaccines trials in India establishes the ability of India and developing world countries to focus towards innovation and novel product development.
“We are proud to state that Innovation from India will now be available to protect global populations.”
Covaxin, which was developed in partnership with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) Pune, has been widely used in India under emergency use authorization well ahead of the release of its phase 3 results.
According to Bharat Biotech, Covaxin’s phase 3 clinical trials were an event driven analysis of 130 symptomatic cases, reported at least two weeks following the second dose. The late-stage trials were held at 25 sites in India.
The Bharat Biotech Covid vaccine was assessed through neutralizing antibody responses against various variants such as B.1.617.2 (Delta), B.1.617.1 (Kappa), P2-B.1.1.28 (Gamma), B.1.1.7 (Alpha), and B.1.351 (Beta),
COVAXIN is formulated with the Algel+IMDG adjuvant. IMDG is a TLR7/8 agonist which induces memory T cell responses in addition to strong neutralizing antibodies.
Bharat Biotech said that the activation of cell mediated immune responses is particularly valuable in a multi epitope vaccine like Covaxin, where immune protection can be obtained from S, RBD and N proteins alike.
IMDG was developed under partnership between Virovax and National Institute of Allergy and Infectious Diseases (NIAID), a subsidiary of National Institutes of Health USA.