Covid-19 vaccine: USFDA approval for Covaxin likely to take longer

Crucial data from the vaccine’s phase 3 trials are yet to be published

Bharat Biotech’s US partner Ocugen has been forced to take a longer route to receive approval for Covaxin’s use in the United States, following the recommendation of the Food and Drugs Administration (FDA), which has asked for more data from an additional clinical trial.

The biopharmaceutical company will scrap its plans to chase emergency use authorisation (EUA) for the Covid-19 vaccine in the US and pursue a biological license application (BLA) instead, which would take longer and require more data to be submitted to the drug regulatory body, the company said in a statement on Thursday.

“Although we were close to finalizing our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path,” Shankar Musunuri, CEO and co-founder of Ocugen said in a release.

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“While this will extend our timelines, we are committed to bringing Covaxin to the US. This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect (the) US population in the long term.”

Bharat Biotech has not yet made public the results of Covaxin’s phase 3 clinical trials even in India, pushing back their tentative publication from June to July on account of a large number of data points that need to be assessed. The results from this trial are key to the Covid-19 vaccine’s bid for emergency approval by the World Health Organisation (WHO) and export its vaccines worldwide.

Without such emergency approval from the WHO, the vaccine is unlikely to be recognized internationally and recipients could even be viewed as effectively unvaccinated while travelling to countries abroad.

(With agency inputs)