A dose of Bharat Biotech’s COVID-19 vaccine candidate Covaxin. Photo REUTERS/Adnan Abidi/File
New Delhi: Vaccine major Bharat Biotech on Wednesday said its COVID-19 vaccine candidate, Covaxin, has demonstrated an interim vaccine efficacy of 81% in phase 3 clinical trials.
The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research (ICMR), the Hyderabad-based company said in a statement.
“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,” Bharat Biotech chairman and managing director Krishna Ella said.
Covaxin demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants, he added.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with ICMR.
Covaxin and Oxford-AstraZeneca’s Covishield are the two vaccine candidates that are being administered in the country. Covishield has an efficacy rate of 70% after the second dose.
According to NDTV, the company said that interim analysis also showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.
“The clinical trial will continue through to final analysis at 130 confirmed cases in order to gather further data and to evaluate the efficacy of COVAXIN in additional secondary study endpoints,” the company added.
The company said that 36 of the 43 participants who tested positive received a placebo, compared with seven cases in people who were given the Bharat Biotech vaccine candidate. This points to an efficacy rate of 80.6%.
According to Livemint, the data was released by the Hyderabad-based company comes days after the Central Drugs Standard Control Organisation’s Subject Expert Committee had asked the firm to submit efficacy and safety data.
“Firm should submit Efficacy and Safety data of the ongoing Phase III clinical trial in adults along with the age subgroup analysis,” it said.
Covaxin was approved before data of its phase 3 clinical trials was approved, invoking a sharp reaction from some scientists and health experts. They said that while it might emerge that Covaxin is safe and efficient, they criticised the government’s rush to approve the candidate before this data was available.