Bharat Biotech's Covaxin reported phase 3 clinical trial efficacy of 81%

Bharat Biotech's Covaxin reported phase 3 clinical trial efficacy of 81%

Bharat Biotech CMD Krishna Ella termed it as an important milestone in vaccine discovery, for science and our fight against Coronavirus

Bharat Biotech, manufacturer of Covaxin has demonstrated clinical efficacy of 81 per cent in phase 3 clinical trials. Covaxin (BBV152) contains a whole virion inactivated SARS-CoV-2 vaccine, which is produced in Vero cells. The company's CMD, Krishna Ella noted that the vaccine demonstrated high clinical efficacy and significant immunogenicity against rapidly emerging variants. The vaccine was developed in collaboration with the Indian Council of Medical Research.

Mr Ella further said, "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 released its statement on 3 March 2021 stating that 25,800 participants were enrolled. The age group was between 18 to 98 years including 2433 over the age of 60 and 4500 with comorbidities. The vaccine, taken 28 days apart, can be transported in ready-to-use liquid formulation and is refrigerator stable at 2-8°C. Being ready-to-use formulation, this aids in distribution at a different part in the vaccine supply chains.

The point estimate of 81 per cent efficacy is based on 43 Covid-19 cases where 36 occurring in the placebo group and the other seven in the Covaxin group. This analysis also includes a review of the safety database where severe serious and medically attended adverse events occurred at low levels which were balanced between the vaccine and placebo groups.

Observing the said efficacy, the company said that the participants received the vaccine or placebo in 1:1 ratio. This vaccine demonstrated the efficacy of preventing Covid-19 in those without prior infection after the second dose. The company will continue to collect further data of 130 confirmed cases to evaluate the vaccine's efficacy in additional secondary study endpoints. The company will share details of the additional interim analysis for 87 cases and the final analysis of 130 cases.

The drug Covaxin was given emergency use authorization by the Drug Controller General of India. This authorization was given to the vaccine in the clinical trial mode. This vaccine is being used as a part of the National Immunisation Program in India. Moreover, a recent study of the National Institue of Virology has indicated that the vaccine can neutralize UK variant strains. Bharat Biotech has also signed a binding letter of intent with Ocugen, for developing a vaccine in the US market.