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No US emergency nod coming, Covaxin to seek full approval | India News – Times of India


HYDERABAD: Bharat Biotech’s US companion, Ocugen, has dropped plans to apply for emergency-use authorisation (EUA) for Covaxin within the US and can as a substitute pursue the biologics licence utility (BLA) route, which is a full approval, based mostly on the US drug regulator’s advice. The transfer will delay the rollout of India’s indigenously developed Covaxin within the US market.
Pointing out the explanations for BLA, Bharat Biotech stated: “With good herd immunity and a major share of the inhabitants vaccinated, the pandemic is decreasing within the US. On the sidelines of this, the USFDA had earlier communicated that no new EUA could be accepted.”
Bharat Biotech, Ocugen will want to maintain smaller US trial
Admitting that the BLA course of would prolong timelines for making Covaxin out there within the US, Bharat Biotech stated: “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, in the meantime, issued a press release 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 stated it’s in discussions with the FDA to perceive the extra data required to help a BLA submission and anticipates that information from a further scientific trial will likely be required.
This implies that Bharat Biotech and Ocugen can have to conduct a smaller scientific trial within the US, on the strains of the Phase 3 research it’s conducting on 4,500 volunteers in Brazil the place it just lately acquired approval for Covaxin imports.
A Bharat Biotech spokesperson stated: “Yes, we are conducting a clinical trial in the US.” Bharat Biotech is but to submit its Phase 3 efficacy information. It has solely offered an interim efficacy determine of 78% based mostly on the second interim evaluation.
Dr Bruce Forrest, a member of the vaccine scientific advisory board of Ocugen, stated that within 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.”



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