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FDA Declines Emergency-Use Approval for Covaxin for Paediatric Use

FDA Declines Emergency-Use Approval for Covaxin for Paediatric Use

An illustrative photo of a person in a face mask holding up a vial labelled ‘Covaxin’. Photo: PTI

Bengaluru: The US Food and Drug Administration (FDA) has declined to issue an emergency-use authorisation (EUA) for Covaxin, the COVID-19 vaccine co-developed by Hyderabad-based Bharat Biotech, for recipients aged 2-18 years.

The decision was publicised in a statement by Ocugen, Inc., which is Bharat Biotech’s partner in the US. Ocugen and Bharat Biotech entered into an agreement in 2020 for the former to “develop” and “supply” Covaxin for the US market.

This decision follows a similar one in June last year, in which FDA officials rejected an EUA for Covaxin for adults. Instead, they asked Ocugen to conduct a local trial in the US first.

As The Wire Science wrote at the time:

Earlier, in March 2021, the FDA had said that it would no longer consider further vaccine applications for approval in the US. However, the Ocugen statement expressed confidence that this rule wouldn’t apply to Covaxin because Ocugen has been in discussions with the FDA since last year.

The Ocugen statement ends saying, “Ocugen intends to continue working with FDA to evaluate the regulatory pathway for the pediatric use of Covaxin.”

The company’s shares fell more than 23% following the FDA’s announcement.

The full statement is available to read here, and below.

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