Home > News > Covid-19: Interim clinical efficacy of Covaxin is 81%, says Bharat Biotech | India News

Covid-19: Interim clinical efficacy of Covaxin is 81%, says Bharat Biotech | India News


HYDERABAD: India’s first indigenous Covid-19 vaccine Covaxin has demonstrated an 81% efficacy in preventing Covid-19 after the second dose, as per the interim results of Phase III trials made public by its developer Bharat Biotech.
The company said the first interim analysis is based on 43 cases of Covid-19, of which 36 cases were observed in the group of volunteers that received the placebo as against 7 cases observed in volunteers who got the two doses of Covaxin, resulting in an efficacy of 80.6%.
Bharat Biotech expects to share further details of the trial results as additional data becomes available, with an additional interim analysis planned for 87 cases and the final analysis planned for 130 cases out of all the 25,800 volunteers who took the two shots of the vaccine.
The volunteers participating in the Phase III efficacy study, touted as the largest to be held in India so far, are aged between 18-98 years and include 2,433 participants over the age of 60 and 4,500 volunteers with comorbidities.
“The primary endpoint of Phase III clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) Covid-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline,” the company said.
The company also said that the inclusion of the Algel-IMDG adjuvant in the vaccine enhances T-cell immune responses to Covid-19, leading to long-term protection.
Covaxin not only demonstrates high clinical efficacy trend against Covid-19 but also significant immunogenicity against the rapidly emerging variants,” Bharat Biotech chairman and managing director Dr Krishna Ella said.
“Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today’s results from our Phase III clinical trials, we have now reported data on our Covid-19 vaccine from Phase I, II, and III trials involving around 27,000 participants,” Dr Ella said.
The company claimed that Covaxin is based on an established manufacturing platform and has a better safety profile as compared to other vaccine platforms.
Covaxin, codenamed BBV152, is a whole virion inactivated SARS-CoV-2 vaccine produced in vero cells platform.
Covaxin is one of the two vaccines that has been approved for vaccination drive in the country. The other vaccine being used is Covishield, developed by Oxford University and AstraZeneca.
PM Modi had started the Phase 2 vaccination drive by taking the first dose of Covaxin.

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