Vir Das, Konkona Sen Sharma raise concern after US FDA denies emergency use approval for Covaxin

The US Food and Drug Administration has denied approval for emergency use of Covaxin, developed by Hyderabad-based Bharat Biotech, and has asked for additional data, biopharmaceutical Ocugen, the US partner of the Indian vaccine maker has said.

A day after the US Food and Drug Administration (FDA) denied approval for emergency use of Covaxin, actors Vir Das and Konkona Sen Sharma have tweeted their concern, as they took the first shot of Covaxin a few weeks ago.

Vir Das tweeted, "Took the first available vaccine which was #covaxin by @BharatBiotech @SuchitraElla and now it appears both their FDA approval and WHO approval will take a lot longer than anticipated. Their data is still due. Many like me travel for work. We would like an explanation, please. [sic]"

Took the first available vaccine which was #covaxin by @BharatBiotech @SuchitraElla and now it appears both their FDA approval and WHO approval will take a lot longer than anticipated. Their data is still due. Many like me who travel for work. We would like an explanation please.

— Vir Das (@thevirdas) June 11, 2021

He further tweeted, "If you have taken #covaxin I recommend tagging these handles @BharatBiotech @SuchitraElla every single day until there is a clear explanation of where they stand and what their realistic timelines are. We were told this was safe, and put this in our bodies in good faith."

Here's what Konkona Sen Sharma tweeted:

This is the vaccine I took. Can’t wait to find out more 🤦🏽‍♀️ https://t.co/Bv2z26QnDY

— Konkona Sensharma (@konkonas) June 12, 2021

The US Food and Drug Administration has denied approval for emergency use of Covaxin, developed by Hyderabad-based Bharat Biotech, and has asked for additional data, biopharmaceutical Ocugen, the US partner of the Indian vaccine maker has said. The FDA recommended Ocugen to "pursue a Biologics Licence Application ( BLA ) submission instead of an EUA application" and "requested additional information and data". The company anticipates that data from an additional clinical trial will be required to support the submission.

Also Read: US FDA denies emergency use approval for Covaxin

"Although we were close to finalising our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. 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 US population in the long term," said Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen, in a statement on Thursday.

Ocugen recently announced that it secured exclusive rights to commercialise Covaxin in Canada and has initiated discussions with Health Canada for regulatory approval. "The Company will pursue expedited authorisation for Covaxin under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to Covid-19 in Canada," the statement said.

Also Read: Covaxin's Phase 3 trials results likely next month: Bharat Biotech

With inputs from IANS.

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