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The World Health Organization’s (WHO’s) approval for emergency use listing (EUL) for Bharat Biotech International Ltd’s covid-19 vaccine is moving according to procedure and the Indian government’s haste in pushing through the process is only adding to speculation about the alleged delay, people aware of the negotiations with WHO said.

If Bharat Biotech’s Covaxin gets the approval, those inoculated with the vaccine can travel to countries that permit entry of fully vaccinated people. The company can also export it to countries that use vaccines approved by WHO.

“WHO has a process and it has technical reports specific to each class of vaccines and the requirement from companies. The prequalification team (in this case, for EUL) also gives clear guidance on what is expected from companies. Then there are clinical data requirements. Unless companies submit these data together to the scientific advisory group of experts, they cannot decide whether to grant EUL or not," said a scientist who has advised companies on how to submit their applications for WHO vaccine prequalification. This person did not wish to be named. Bharat Biotech is seeking approval for its inactivated vaccine.

The two inactivated vaccines that are currently approved by WHO are Sinovac and CanSino. One of the requirements for approval of these vaccines is to show that the viruses have been sufficiently inactivated, said the official cited above. “If that data is insufficient, the approval doesn’t go through," the person said.

Brazilian regulator ANVISA refused to approve the Bharat Biotech vaccine because of inadequate documentation.

Earlier this week, WHO, in a series of tweets, said it is waiting for “one piece of information" from Bharat Biotech to decide whether to grant the EUL or not.

Vaccine companies that Mint spoke to said WHO gives clear guidance on proceeding with documentation. In the case of Bharat Biotech, it is not that the company is not used to the process. In the past, it has got prequalification for its other vaccines such as those for typhoid and rotavirus. However, those vaccines were of a different platform than Covaxin.

Bharat Biotech did not respond to a query about the documentation WHO is seeking from the company. WHO also did not respond to an email query asking the organization about the “missing piece of information".

Though the Indian regulators approved Covaxin in January when the company started its phase 2 trials, WHO needs data from phase 3. The phase 3 data from Bharat Biotech was announced only in July and it takes WHO’s technical committee anywhere between three and five months to decide on EUL.

For example, Moderna’s vaccine received EUL five months after the company submitted its phase 3 data. In the case of Johnson & Johnson, it took three months from the end of phase 3 studies.

Another senior official from a vaccine company told Mint that the government’s lax regulatory standard has made companies get away with several shortcomings that would not be accepted anywhere else.

“However, now, as we compete on a global scale, we realize how difficult global processes are," the official at an Indian drugmaker said.

WHO is expected to decide on Covaxin by the end of this month.

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