Hyderabad, June 12: With the United States Food and Drug Administration (US FDA) recommending Ocugen Inc, the US partner of Bharat Biotech, to go for Biologics License Application (BLA) instead of Emergency Use Authorisation (EUA), the launch of the first indigenous Indian Covid-19 vaccine (Covaxin) in the US market may be delayed.
As additional information and data is to be submitted with BLA, the launch of Bharat Biotech’s Covaxin is likely to take more time.
“Our US partner, Ocugen has received a recommendation from the Food and Drug Administration (FDA) to pursue Biologics License Applications (BLA) path for Covaxin, which is full approval. All applications have to follow the BLA process, which is the standard process for vaccines. Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for Covaxin. This process will extend our timelines,” Bharat Biotech said in a statement on Friday.
According to Hyderabad-based company, with good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the US. “On the sidelines of this, the USFDA had earlier communicated that no new emergency use authorisation (EUA) would be approved for new Covid-19 vaccines.”
No vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA, it said. “When approved, it will be a great leap forward for vaccines innovation and manufacturing from India,” it added.
Covaxin has received already EUAs from 14 countries with more than 50 countries in the process.
In February, Ocugen and Bharat Biotech had entered into a definitive agreement to co-develop, supply, and commercialise Covacin for the US market.
Ocugen will have US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval (including EUA) and commercialisation for the US market, a joint statement had said.
Bharat Biotech had said that it would supply initial doses to be used in the US upon Ocugen’s receipt of an EUA. In addition, Bharat Biotech will support the technology transfer for manufacturing in the US. In consideration for the exclusive license to the US market, Ocugen will share the profits from the sale of Covaxin in the US market with Bharat Biotech, with Ocugen retaining 45 per cent of the profits.
Early this month, Ocugen also received exclusive co-development, manufacturing, and commercialisation rights to Covaxin in Canada.