Additional clinical trial data needed for US approval of Covaxin: Bharat Biotech

Bharat Biotech didn't clarify the nature of the clinical trial - whether it is a local bridging trial or a Phase -3 trial sought by the USFDA. The vaccine maker said Covaxin has received emergency use authorisation’s from 14 countries with more than 50 countries in the process.

Viswanath Pilla

June 11, 2021 / 13:07 IST

The NASDAQ-listed Ocugen has rights to commercialise Covaxin in the US.

Bharat Biotech on June 11 said that data from an additional clinical trial will be required now to support the marketing application submission for Covaxin in the US.

The company didn't clarify the nature of the clinical trial - whether it is a local bridging trial or a Phase -3 trial sought by USFDA.

The company said USFDA didn't reject its partner Ocugen emergency use authorisation (EUA) but recommended changing the application to a full Biologics License Applications (BLA) approval under changed circumstances.

"The USFDA had earlier communicated that no new EUA’s will be approved for covid vaccines," Bharat Biotech said in a statement.

"All applications have to follow the biological license application process, which is the standard process for vaccines," the company said.

COVID-19 Vaccine

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A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

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Additional clinical trial data needed for US approval of Covaxin: Bharat Biotech

Bharat Biotech didn't clarify the nature of the clinical trial - whether it is a local bridging trial or a Phase -3 trial sought by the USFDA. The vaccine maker said Covaxin has received emergency use authorisation’s from 14 countries with more than 50 countries in the process.

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Additional clinical trial data needed for US approval of Covaxin: Bharat Biotech

Bharat Biotech didn't clarify the nature of the clinical trial - whether it is a local bridging trial or a Phase -3 trial sought by the USFDA. The vaccine maker said Covaxin has received emergency use authorisation’s from 14 countries with more than 50 countries in the process.

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