Covaxin 77.8% Effective Against COVID-19, Claims Phase 3 Data

Bharat Biotech shared the final Phase III results of Covaxin, its COVID-19 vaccine on Saturday, six months after it was approved for emergency use authorisation in the country. The Hyderabad-based vaccine manufacturer reported that the vaccine shows 77.8 per cent efficacy against the original SARS-CoV-2 virus as well as 65 per cent against the upcoming Delta variant.

Covaxin produced in India in collaboration with the Indian Council of Medical Research and National Institute of Virology was approved for emergency use in January 2021, even though its Phase III trials were ongoing. This decision was criticised by many experts as there was not enough evidence proving that the vaccine worked in neutralising the virus.

The statement released by Bharat Biotech claims that Covaxin was not only effective against the original strain but also all the other variants B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma).at varying efficacies. The vaccine produced neutralising antibodies against all the strains.

Also Read:Explained: Delta And Delta Plus COVID Variants And Its Impact

The Phase III trial results were based on 130 people who developed COVID-19 two weeks after receiving the second dose and showed 63 per cent efficacy against people who were asymptomatic and 93 per cent efficacy against severe COVID-19/.

The Phase III study enrolled 25,800 participants between 18-98 years of age, including 10 per cent over the age of 60.

The safety analysis for the vaccine established that only 12 per cent of subjects experienced commonly known side effects and less than 0.5 per cent of subjects complained about any serious adverse events. Through these results, Bharat Biotech inferred that Covaxin was better than other COVID-19 vaccines.

Bharat Biotech's final results come at a time when it needs approval in other countries such as US that require complete efficacy data for authorising emergency use. Even the WHO required the company to send Phase III results to apply for Emergency Use Listing from the WHO.

While Covaxin has received EUA from 16 countries, its purchase order was suspended in Brazil after reports of corruption in this deal were raised in the Brazilian parliament.

Also Read:Explained: Why Brazil Suspended $324 Mn Deal With Covaxin