Govt sees Covaxin efficacy as validation of its scientific process

1 month ago 25
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NEW DELHI: The phase 3 results of Covaxin released on Wednesday showing 81% efficacy is seen by the government as a major validation of the scientific process and regulatory decision making while granting emergency use authorisation that helped in achieving a timely rollout of the nationwide vaccination programme on January 16.
Bharat Biotech’s Covaxin is India’s first locally developed vaccine against Covid-19. The two-dose vaccine has been developed in collaboration with the ICMR and is based on whole inactivated virus. This means the vaccine exposes the body to the virus but not its virulence. This not only makes the vaccine a safer option but also increases its chances to be effective against mutations, experts say.
In fact, this was one of the reasons for the regulator to grant an early approval for restricted emergency use in “clinical mode trial” because authorities felt that a whole virus based vaccine like Covaxin is more likely to act against mutant strains. Also while efficacy data was not available, tests in primates showed it cleared infection in both lower and upper lungs, sources said.
Bharat Biotech said the first interim analysis of phase 3 data of Covaxin based on 43 cases, of which 36 cases of Covid-19 were observed in the placebo group versus seven cases observed in the vaccine group, resulted in a point estimate of vaccine efficacy of 80.6%.
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.
Despite the initial scepticism regarding Covaxin, the government and ICMR stood firm with the regulatory decision and took measures to address concerns and hesitancy.

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