The US Food and Drug administration has denied approval for emergency use of Covaxin, developed by Hyderabad-based Bharat Biotech, and has asked for additional data, biopharmaceutical Ocugen, the US partner of the Indian vaccine maker has said.
The FDA recommended Ocugen to "pursue a Biologics Licence Application (BLA) submission instead of an EUA application" and "requested additional information and data".
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.
"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," said Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen, in a statement on Thursday.
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 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.
Covaxin has so far emerged safe in clinical trials to date, said Bruce Forrest, Acting Chief Medical Officer and member of the vaccine scientific advisory board of Ocugen.
The "Ministry of Health and Family Welfare of Republic of India reported no potential thromboembolic events following the administration of over 6.7 million doses of Covaxin," Forrest added.
Bharat Biotech developed Covaxin in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
It is an inactivated vaccine that is manufactured using a vero cell manufacturing platform. Covaxin has showed strong results in all the studies conducted to date including a vaccine efficacy rate of 78 per cent overall efficacy and 100 per cent in severe Covid-19 disease, including hospitalisations, in second interim results of Bharat Biotech's Phase 3 clinical trial.
Covaxin studies show that it effectively neutralised the Brazil variant of SARS-CoV-2, B11282, the alpha variant, B117, which was first identified in the UK, as well as the delta variant, B1617, which was first identified in India.
More than 30 million doses have been supplied in India and other countries. Itis currently being administered under emergency use authorisations in 13 countries, and applications for emergency use authorisation are pending in more than 60 additional countries.