HYDERABAD: In a move that will delay rollout of indigenous Covid-19 vaccine Covaxin in the US market, Bharat Biotech’s US partner Ocugen has dropped plans of applying for an emergency use authorisation (EUA).
It will instead pursue the biologics license application (BLA) route, which is a full approval, based on the US drug regulator’s recommendation.
“Although we were close to finalizing 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,” Dr Shankar Musunuri, CEO & co-founder of Ocugen said in a statement.
Read Also‘US Covaxin move won’t hit our vax drive’NEW DELHI: The US Food and Drug Administration’s refusal of emergency use authorisation (EUA) to Bharat Biotech’s Covaxin has no bearing on India’s Covid-19 vaccination programme, Niti Aayog member (health) Dr V K Paul said, adding that the Indian regulator has evaluated and is satisfied with theOcugen said it is in discussions with FDA to understand the additional information required to support a BLA submission and anticipates that data from an additional clinical trial will be required to support the submission.
This could mean that Bharat Biotech and Ocugen may 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.
Read AlsoCovaxin-Covishield study triggers spatA war of words broke out on Twitter after Bharat Biotech’s SARS-CoV-2 project lead Raches Ella questioned the findings of a recent comparative study of the immune responses evoked by Covishield and Covaxin in healthcare workers.A Bharat Biotech spokesperson confirmed, “Yes, we are conducting a clinical trial in the US.” However, the spokesperson did not provide any further details on the size of the trials or the timelines.
“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 an EUA application for its vaccine candidate and requested additional information and data,” Ocugen said in a regulatory filing.
Bharat Biotech is yet to submit its phase-3 efficacy data and has only provided an interim efficacy figure of 78% based on the second interim analysis.
Pointing out the reasons for going for BLA, Bharat Biotech said: “With a good herd immunity and 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 for new Covid-19 vaccines.” Read AlsoBrazil health regulator finally gives green signal to Covaxin importsIn a move that paves the way for exports of indigenously developed Covid-19 vaccine Covaxin to Brazil, its health regulator Anvisa (Agência Nacional de Vigilância Sanitária) has finally given the green signal for exceptional import of Bharat Biotech’s vaccine.Admitting that 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.” Read AlsoExperts question Covaxin’s high private market price as R&D was govt subsidisedExperts have questioned the rationale of high prices of Covaxin since it is based on an established technology, is domestically-produced, and it’s R&D has been part-subsidised by the Centre.
Other vaccines like polio and hepatitis B using a similar technology platform, are affordable due to largeDr Bruce Forrest, acting chief medical officer and 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.” Ocugen had earlier indicated that it was planning to file for EUA in the US in the first half (H1) of 2021 and was hopeful of rolling out the vaccine in the US in H2 of 2021 with a target of supplying 100 million doses per annum starting 2021 and plans to set up local manufacturing there.
Watch US FDA rejects emergency use authorisation for Covaxin