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.
The company said the USFDA may have changed its position on EUA, with good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in that country.
Ocugen, Bharat Biotech’s partner for Covaxin in the US has said it will no longer seek EUA for its COVID -19 vaccine and will file for full approval of the jab after USFDA asked for additional information and data.
According to Bharat Biotech, Covaxin has received EUA’s 14 countries with more than 50 countries in the 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 vaccine innovation and manufacturing from India,” Bharat Biotech said.