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Covid-19: Covaxin Interim Clinical Efficacy is 81%, Says Bharat Biotech | India News

HYDERABAD: India’s first indigenous Covid-19 vaccine, Covaxin, has been shown to be 81% effective in preventing Covid-19 after the second dose, based on interim results of phase III trials released 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 seen in the group of volunteers who received the placebo versus 7 cases seen in volunteers who received the two doses of Covaxin, which which resulted in an efficiency of 80.6%.
Bharat Biotech hopes to share more details of the trial results as additional data become available, with an additional interim analysis planned for 87 cases and the final analysis planned for 130 cases out of the 25,800 volunteers who took the two injections of the vaccine.
Volunteers participating in the Phase III efficacy study, considered the largest ever conducted in India, are between the ages of 18 and 98 and include 2,433 participants over the age of 60 and 4,500 volunteers with comorbidities.
“The primary endpoint of the phase III clinical trial is based on the first occurrence of symptomatic Covid-19 (mild, moderate, or severe) confirmed by PCR starting at least 14 days after vaccination of the second serologically negative study ( to SARS-CoV -2) adult participants at the start of the study, ”the company said.
The company also said that the inclusion of the adjuvant Algel-IMDG in the vaccine enhances the immune response of T cells to Covid-19, leading to long-term protection.
Covaxin not only demonstrates a trend of high clinical efficacy against Covid-19, but also significant immunogenicity against rapidly emerging variants, ”said Bharat Biotech President and Managing Director Dr. Krishna Ella.
“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, ”said Dr. Ella.
The company claimed that Covaxin is built on an established manufacturing platform and has a better safety profile compared to other vaccine platforms.
Covaxin, codenamed BBV152, is a whole virion inactivated SARS-CoV-2 vaccine produced on the vero cell platform.
Covaxin is one of the two vaccines that has been approved for the vaccination campaign in the country. The other vaccine used is Covishield, developed by the University of Oxford and AstraZeneca.
PM Modi had started the Phase 2 vaccination campaign by taking the first dose of Covaxin.

Times of India