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US FDA rejects emergency use application for Bharat Biotech’s Covaxin, asks Ocugen to launch additional trial for full approval

“The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a BLA submission instead of a EUA application for its vaccine candidate and requested additional information and data," said a statement from Ocugen.

Ocugen, a US-based biotech firm has declared that it will pursue full approval for Bharat Biotech’s Covaxin based on the recommendation from the US Food and Drug Administration(FDA). The decision was taken after the US FDA asked the company to launch an additional trial so that the company can file for a Biologics Licence Application (BLA), which is a full approval.

On June 10, the US FDA had rejected Bharat Biotech’s application for Emergency Use Approval (EUA).

Ocugen had signed an agreement with Bharat Biotech to manufacture, supply and distribute ‘Made in India’ Covaxin, an advanced stage whole-virion inactivated COVID-19 vaccine, for the United States market. It is seen as one of the major steps in getting the WHO and the United States’ approval for the use of Covaxin as a credible vaccine candidate. Covaxin is currently being used in India in the vaccination program but is yet to get an approval from WHO.

“The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a BLA submission instead of a EUA application for its vaccine candidate and requested additional information and data,” said a statement from Ocugen to NYSE.

Under BLA submission, the FDA review process needs longer-term follow-up data for acceptance and approval. The company said it is in talks with the FDA to understand the scope of documents required to expedite the BLA submission process and seek approval for the vaccine. The company anticipates that data from an additional clinical trial will be required to support the submission, it added.

Shankar Musunuri, the chief executive of Ocugen said his organisation was committed to bringing Bharat Biotech’s Covaxin to the United States.

“Though we were on the verge of filing for a EUA approval, 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 United States. 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,” Musunuri said.

Recently, Ocugen had announced that it had bagged the exclusive rights to commercialise Covaxin in Canada and initiated discussions with Health Canada for regulatory approval. The company will hasten 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.

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OpIndia Staff
OpIndia Staffhttps://www.opindia.com
Staff reporter at OpIndia

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