Bharat Biotech’s Covaxin has shown an interim vaccine efficacy of 81% in Phase 3 clinical trial, the Hyderabad-based company said. “Covaxin demonstrates (not only) high clinical efficacy trend against Covid-19 but also significant immunogenicity against the rapidly emerging variants,” Krishna Ella, chairman of Bharat Biotech, said in a statement.
With this, the company said it has reported data on its Covid-19 vaccine from phase 1, 2, and 3 trials involving around 27,000 participants.
Covaxin was approved for restricted use in an emergency situation by the Drug Controller General of India in January without efficacy data as the company had not finished recruiting participants for Phase 3 trials then. Some experts had raised concern over approving the vaccine without efficacy data, and initially there were reports that many beneficiaries were reluctant to sign the consent form for the vaccine.
The company said the first interim analysis is based on 43 participants who were infected with the SARS Cov2. Of these, 36 cases of Covid-19 were observed in the placebo group (or those who did not receive the vaccine) versus seven cases observed among those who received Covaxin, resulting in a point estimate of vaccine efficacy of 80.6%.
Bharat Biotech has to reach 130 cases to fully release its data on efficacy. The company has enrolled 25,800 participants between 18-98 years of age for Phase 3 study, including 2,433 over the age of 60 and 4,500 with comorbidities. The interim analysis showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups, the company said.
“The bench-to-bedside journey of completely indigenous Covid-19 vaccine in less than eight months’ time showcases the immense strength of Aatmanirbhar Bharat (self-reliant India) to fight the odds and stand tall in the global public health community,” said Balram Bhargava, director general of premier biomedical research institute ICMR.