FDA asks Bharat Bio’s US partner Ocugen to apply for full authorisation
Hyderabad-based Bharat Biotech will conduct clinical trials of Covaxin in the US after it hit a roadblock to secure emergency use authorisation for its Covid-19 vaccine from the US drug regulator.
The company’s US partner, Ocugen, said on Thursday it would follow the biologics licence application (BLA) route to seek full licensure of Covaxin in the US.
Bharat Biotech said Ocugen had received a recommendation from the FDA to pursue BLA path for Covaxin, which is full approval. “All applications have to follow the BLA process, which is the standard process for vaccines. Therefore, for BLA, the data from an additional clinical trial will be required to support the marketing application submission for Covaxin. This process will extend our timelines,” the vaccine maker said.
A company source told Business Standard that Bharat Biotech planned to conduct these additional clinical trials in the US. The company did not divulge details on whether these would be bridging studies comprising smaller groups of volunteers or large-scale studies.
V K Paul, member, health, NITI Aayog, said at a press briefing on Friday: “We respect their (USFDA’s) decision and we expect that our manufacturer will be able to comply with whatever is required to be done. Their decision has no bearing on our programme. Our regulator has approved it. We have so much data on safety.”
He said every country has its regulatory system and while scientific frameworks are the same, nuancing is based on context.
“Nuancing can be different, especially in countries where science is strong, for us manufacturing is strong…We have also asked for trials till now for vaccines for children.”
Bharat Biotech said with good herd immunity and a significant percentage of the population vaccinated, the pandemic is reducing in the US. “The USFDA had earlier communicated that no new emergency use authorisation (EUA) would be approved for new Covid-19 vaccines,” Bharat Biotech said.
According to reports, AstraZeneca is too weighing options to apply for full approval in the US for its Covid-19 vaccine, a process that takes longer.
Timelines, however, are not clear. A senior official at a vaccine firm said there was no precedence of an India-developed vaccine getting full authorisation in the US. “Typically, the timelines would be long. It can take months or even a year. However, we cannot say if processes will be expedited during the pandemic,” the official explained.
Covaxin has received EUAs from 14 countries with more than 50 countries in the process. It is now in the process of seeking emergency use listing (EUL) from the World Health Organization.
Paul said the data analysis of phase 3 clinical trials of Covaxin will be made public in the next seven to eight days. “It is beyond the data that was shared with the DCGI,” he added.
Bharat Biotech claimed that no vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA.
Ocugen in a statement on Thursday announced that as recommended by the USFDA, it will pursue submission of a BLA for Covaxin. Biologics Licence Application, or BLA, is a “full approval” mechanism by the FDA for drugs and vaccines. “The company will no longer pursue a EUA for Covaxin. The FDA provided feedback to Ocugen regarding the Master File. The company had previously submitted and recommended that Ocugen pursue a BLA submission instead of a EUA application for its vaccine candidate and requested additional information and data,” Ocugen had said.
“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, CEO and co-founder of Ocugen, had said in a statement.
Ocugen is partnering Bharat Biotech to co-develop, supply, and commercialise Covaxin in Canada. It will retain 45 per cent of the profits from sales of Covaxin in the US and Canada.
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