New Delhi: The U.S. Food and Drug Administration has rejected the approval of Covaxin, developed by Bharat Biotech, which is based in Hyderabad, to use emergencies, said biomedical Ocugen, the US partner of the Indian vaccine manufacturer.
The FDA has recommended that Ocugen “pursue a BLA (Biologics License Application) instead of an EUA application” and “request additional information and data”.
The company anticipates that data from an additional clinical trial will be required to support the submission.
“Although we still wanted to process the EUA application for submission, we received a recommendation from the FDA to follow a BLA path. Although it 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 the potential to address the SARS-CoV-2 variant, including the delta variant, and given the unknown about what is needed to To protect the long-term U.S. population, “Ocugen chairman Shankar Musunuri, chief executive officer and co-founder, said in a statement on Thursday.
Ocugen recently announced that it has acquired exclusive rights to commercialize Covaxin in Canada and has entered into discussions with Health Canada for regulatory approval.
The company will pursue prompt authorization for Covaxin under the interim order regarding the import, sale and advertising of drugs for use in connection with Covid-19 in Canada, ”reads the statement.
Covaxin has so far emerged safely in clinical trials, said Bruce Forrest, acting medical officer and member of the vaccination advisory board against Ocugen.
The “Ministry of Health and Family Welfare of the Republic of India has not reported any potential thromboembolic events following the administration of more than 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-sel manufacturing platform. Covaxin has shown strong results in all the studies conducted so far, including a vaccine efficacy rate of 78 percent overall efficacy and 100 percent in severe Covid-19 disease, including hospitalizations, in the second interim results of the Bharat Biotech Phase 3 Clinical Study.
Covaxin studies show that it neutralized the Brazilian variant of SARS-CoV-2, B11282, the alpha variant, B117, first identified in the United Kingdom, as well as the delta variant, B1617, which was the first once identified in India.
More than 30 million doses have been provided in India and other countries. It is currently being administered in 13 countries under emergency use permits, and applications for emergency use authorization are pending in more than 60 additional countries.
Source: Telangana Today