Stumbling block

Saturday, 12 June 2021 | Pioneer

USFDA rejects Covaxin’s application for emergency use approval, putting it under pressure

Covaxin, the anti-COVID vaccine made by Bharat Biotech and already administered to 2.9 crore Indians, including Prime Minister Narendra Modi, has failed to get emergency use approval (EUA) in the US. The country’s Food and Drug Administration (FDA) has cited lack of required data as the reason. It has since closed the doors for re-application for EUA, asking Ocugen, Bharat Biotech’s American partner for Covaxin’s supply in the US, to take the full-fledged approval route in the future. The FDA has recently issued a new guideline that it will no longer grant EUA to new applications. The FDA has asked Ocugen to conduct a new, local trial of Covaxin on the basis of which it will re-evaluate the vaccine. If Covaxin gets approval based on a local trial, it will become eligible for full approval. The development puts Bharat Biotech under tremendous pressure to seek international approval. It has invited criticism at home for not making public details of the phase three clinical trial. It had received EUA in India without any phase three trial data, owing to which it faced vaccine hesitancy. Covaxin is India’s milestone indigenous vaccine developed by Bharat Biotech in association with Indian Council of Medical Research. It is a whole-virus inactivated vaccine. The company has placed requests for approval also with the World Health Organisation (WHO) and is said to have submitted at least 90 per cent of the required documents.

For international recognition of a vaccine, it has to receive approval either from WHO, European Union or foreign health regulators like the FDA. The fate of the WHO application in face of rejection by FDA is yet to be known. Bharat Biotech’s case floundered at the beginning itself when the health regulator of Brazil refused to issue a “good manufacturing practices” certificate to the Indian company’s facilities and said it would not allow Covaxin’s import into Brazil and the case was resolved only after Bharat Biotech agreed to strict conditions for its import. Brazil, however, reduced the number of doses from the original 20 million to just four million. Eleven countries have given regulatory approval for Covaxin so far. They are Iran, the Philippines, Mauritius, Mexico, Nepal, Guyana, Zimbabwe and Paraguay, besides India. But approvals from the international bigwigs matter most. The FDA rejection puts millions of Indians who took the dose in a spot. The company and the Government have the immediate task to remove doubts from the minds of people about Covaxin’s efficacy. Indian virologists are saying that from emerging data it looks like inactivated vaccines give less protection, but that does not mean Covaxin will not protect because it has a different adjuvant. The Government should immediately go in for independent vaccine effectiveness studies to rule out all misgivings. It should ask Bharat Biotech the reason for non-release of the trial data. The vagueness surrounding Covaxin has the potential to undermine public confidence further, particularly after the FDA fiasco.

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