Bharat Biotech Says Covaxin Shows 81% Efficacy In Phase 3 Interim Results
The vaccine was approved for emergency use authorization in India even though its clinical trials were underway
Covaxin - Bharat Biotech's indigenously produced vaccine - has shown an efficacy of 81% against COVID-19 in its interim results of the drug's phase three trials, the company said.
The vaccine produced in collaboration with the Indian Council of Medical Research was criticised as soon as it received approval in India. The vaccine was approved for emergency use authorization while its clinical trials were still underway.
Using an inactivated SARS-CoV-2 strain isolated by the National Institute of Virology, Bharat Biotech has produced this vaccine.
From the 25,800 participants who had never been infected by SARS-CoV-2, the vaccine manufacturer released its interim efficacy results after 43 participants were infected by the virus. While 36 of the participants belonged to the control group, 7 of them had received the vaccine. Efficacy was determined after these participants developed symptoms of COVID-19, 14 days after receiving the second dose of the vaccine. The control and vaccine groups were divided on a 1:1 ratio suggesting that from the 25,800 participants, half received the vaccine while the other half received the placebo. (PLEASE EXPLAIN A PLACEBO)
Participants were between the age group of 18-98 in the Phase 3 trials of which 2,433 were over the age of 60 and 4,500 had some or the other co-morbidities. This is one of the only COVID-19 vaccines that includes people older than the age of 75.
According to Bharat Biotech, this is only the first interim analysis for the vaccine. A second interim analysis will be conducted once 87 people are confirmed to be infected by the virus through PCR tests. The final analysis will take 130 PCR-confirmed cases into consideration.
Even though still in the clinical trial stages, it was widely publicised that Prime Minister Narendra Modi was administered Covaxin at the All India Institute of Medical Sciences in Delhi. Bharat Biotech has also repeatedly shared that close to 40 countries have requested for Covaxin to be a part of their vaccination drives.
The vaccine is stable at 2 to 8°C, thus it can be refrigerated and can be shipped in a ready-to-use liquid formulation. It has a 28-day open vial policy as a unique product characteristic.
"Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today's results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants. COVAXIN® demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants," said Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech.
Scientists at NIV studied the action of this vaccine against the UK variant of COVID-19 and found the vaccine to be effective against this strain that is seen to be more contagious than the original strain of SARS-CoV-2
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