Ocugen Inc, the US partner of Bharat Biotech, will now need to submit additional information and data for a full approval.

Stocks of covaxin arriving at an Indian airportRepresentational image
news COVID-19 Vaccine Friday, June 11, 2021 - 12:42

In a setback for Covaxin, the Indian-made vaccine against COVID-19, the US Food and Drug Administration (FDA) has rejected its Emergency Use Authorisation (EUA) application. Ocugen Inc, the US partner of Bharat Biotech which made Covaxin along with government body Indian Council of Medical Research (ICMR) will now have to apply for approval through a much more elaborate process. Ocugen in a statement on Thursday announced that as recommended by the FDA, it will pursue submission of a Biologics Licence Application (BLA) for Covaxin. BLA, is a "full approval" mechanism by the FDA for drugs and vaccines. "The company will no longer pursue an Emergency Use Authorisation (EUA) for Covaxin. The FDA provided feedback to Ocugen regarding the ‘Master File’. The FDA had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data," Ocugen said.

The development may delay the launch of Covaxin in the US, Ocugen said. Ocugen is in discussions with the FDA to understand the additional information required to support a BLA submission. The company anticipates that data from an additional clinical trial will be required to support the submission. "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," Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer and co-founder of Ocugen said.

"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," he added. In this context Bharat Biotech released a statement. It said, "With good herd immunity and significant percentage of the population vaccinated, the pandemic is reducing in the United States. The US FDA had earlier communicated that no new EUA’s will be approved for covid vaccines." 

"All applications have to follow the biological license application process, which is the standard process for vaccines.  Data from an additional clinical trial will be required to support the marketing application submission for Covaxin," it added.

The company said said Covaxin has received EUAs from 14 countries with more than 50 countries in process.  "No vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA. When approved, it will be a great leap forward for vaccines Innovation and manufacturing from India," the company further said.

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 the vaccine under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 in Canada.

Meanwhile in India, Bharat Biotech is yet to make its phase three trials data public. Even the WHO too in May had said that more information is required from Bharat Biotech.

Read: Bharat Biotech needs to give more info for Covaxin emergency use listing: WHO

(PTI inputs)

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