The World Health Organisation’s approval for Covaxin gets further delayed as the world health body on Monday sought more information from the vaccine’s Hyderabad-based manufacturer Bharat Biotech, which is seeking the WHO clearance for the home-grown Covid-19 shot since July.
"We are aware that many people are waiting for WHO’s recommendation for Covaxin to be included in the Covid-19 Emergency Use Listing, but we cannot cut corners - before recommending a product for emergency use, we must evaluate it thoroughly to make sure it is safe and effective," the WHO said in a statement.
Without the WHO approval, neither the two-dose vaccine can find an international market nor people who received Covaxin shots are recognised by majority of the nations as “vaccinated” for international travel.
The WHO said that Bharat Biotech - the manufacturer of Covaxin – was submitting data on a rolling basis for the experts to review and “one additional piece of information” had been sought from the company on Monday.
Asked for a response, the company remained silent. But after a previous WHO meeting, the firm on September 28 stated, “As a responsible manufacturer with past approvals for our other vaccines, we do not find it appropriate to speculate or comment on the regulatory approval process and its timelines. We are diligently working with the WHO to obtain the EUL at the earliest.”
The UN body on Monday said, “The time-frame for the WHO Emergency Use Listing procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low and middle income countries.”
The world health body follows two different routes in recognising the drugs and vaccines depending on the standards of national regulatory bodies.
For products approved by a stringent regulatory body like the US Food and Drug Administration or the regulatory agencies of Canada, the UK and European Union, the WHO approval is quick because they follow an “abridged assessment” on the basis of the procedures followed by such agencies.
But for nations like India, a panel of experts commissioned by the WHO go through the raw data rather than going by the national regulator’s (CDSCO) certification as the Indian regulator is not seen as one among those who are stringent.
India has so far administered more than 98.5 crore Covid-19 vaccine doses, of which 11.29 crore are Covaxin shots.
The WHO has granted the EUL so far to the vaccines manufactured by Pfizer-BNT, Moderna, AstraZeneca besides the jabs made by two Chinese companies.
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