No US emergency nod coming, Covaxin to seek full approval

HYDERABAD: Bharat Biotech’s US partner, Ocugen, has dropped plans to apply for emergency-use authorisation (EUA) for Covaxin in the US and will instead pursue the biologics licence application (BLA) route, which is a full approval, based on the US drug regulator’s recommendation. The move will delay the rollout of India’s indigenously developed Covaxin in the US market.
Pointing out the reasons for BLA, Bharat Biotech said: "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 EUA would be approved."
Bharat Biotech, Ocugen will need to hold smaller US trial
Admitting that the BLA process would extend timelines for making Covaxin available in the US, Bharat Biotech said: “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.”
Ocugen chairman, CEO and co-founder Dr Shankar Musunuri, meanwhile, issued a statement saying, “Although we were close to finalising our EUA application for submission, we received a recommendation from the FDA to pursue the BLA path. While this will extend our timelines, we are committed to bringing Covaxin to the US.”
Ocugen said it is in discussions with the FDA to understand the additional information required to support a BLA submission and anticipates that data from an additional clinical trial will be required.
This means that Bharat Biotech and Ocugen will have to conduct a smaller clinical trial in the US, on the lines of the Phase 3 study it is conducting on 4,500 volunteers in Brazil where it recently received approval for Covaxin imports.
A Bharat Biotech spokesperson said: “Yes, we are conducting a clinical trial in the US.” Bharat Biotech is yet to submit its Phase 3 efficacy data. It has only provided an interim efficacy figure of 78% based on the second interim analysis.
Dr Bruce Forrest, a member of the vaccine scientific advisory board of Ocugen, said that in the “clinical trials to date, the emerging safety profile of Covaxin is supportive of it being generally well tolerated with a good safety profile, India’s health ministry reporting no potential thromboembolic events following the administration of over 6.7 million doses of Covaxin in that country.”