US firm eyes trials for Bharat Biotech’s Covaxin but delay in EUL a concern
- Bharat Biotech itself seems stuck in a regulatory loop, with WHO on Tuesday missing another deadline for the grant of emergency use listing
Even as World Health Organization (WHO) will decide on the grant of emergency use listing for Bharat Biotech’s Covaxin on November 3, US biopharmaceutical company, Ocugen, has announced the filing of an Investigational New Drug (IND) application with USFDA to begin US trials of Bharat Biotech’s Covaxin.
Ocugen has the rights to commercialize Bharat Biotech’s inactivated whole virion anti-Covid-19 vaccine in the United States and Canada. “…submitted an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN™ outside the United States,” Ocugen said in a statement on Wednesday
The Phase 3 trial proposed to be done in the US will be more like a bridging study.
“We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population,” said Shankar Musunuri, chairman of the board, chief executive officer, and co-founder of Ocugen.
Bharat Biotech itself seems stuck in a regulatory loop, with WHO on Tuesday missing another deadline for the grant of emergency use listing. Independent technical experts of the UN health body analysing the data instead sought more clarification from the vaccine maker.
Earlier, a decision on Covaxin EUL was expected on October 5, after WHO representatives sought additional information on September 27.
“Let me say that Bharat has been submitting data regularly and very quickly, but they submitted the last batch of data on the 18th of October,” said Dr Mariangela Simao, assistant director general, access to medicines and health products, WHO, on Thursday. She was responding to a question on the delay.
It is not yet clear, what data has been submitted to the WHO for grant of EUL, as neither the company nor the UN health body has made it public. Interestingly, the company has been claiming that Covaxin data has been ready for perusal since June, this year.
Bharat Biotech did not respond to queries on the latest delay.
WHO’s emergency use licences typically assess safety and efficacy, risk management plans, cold chain requirements, and sometimes extend to physical inspection of manufacturing sites. For instance, in the case of Sinopharm’s vaccine, which, like Bharat Biotech’s, is an inactivated one, WHO conducted onsite inspections of the manufacturing facility.
Bharat Biotech is yet to publish the results of its Phase 3 trials in any of the peer-reviewed journals, and the clinical efficacy results against Covid-19 infection have made their way into the public domain through a pre-print study that was posted on medRxiv in July, this year, or press notes declaring 93.4% efficacy against severe disease, 77.8% efficacy against symptomatic disease, and 63.6% efficacy against asymptomatic disease.
“Let me just clarify and without wanting to mention any specific manufacturer but saying that we have assessed an Indian manufacturer earlier in the year and it took 30 days… So, this is not about moving quicker with one or another vaccine…,” added Simao.
Dr Bruce Aylward, senior advisor to WHO director general, said, “We’re committed at the organisation from the very top under the Director General to move these processes as rapidly as possible. But let’s be very clear, the timeline for EULing a vaccine depends 99% on manufacturers, the speed, the completeness with which they can get data to the independent groups that assesses for WHO. We just want to be very, very clear on that point.”
The grant of emergency use authorisation to Covaxin by India’s drugs regulator on January 3, 2021, also was severely criticised as the company was yet to make public even interim efficacy results at the time. A government official directly involved in the process said “the vaccine data is robust”. He added: “These are procedural measures that need to be duly followed. Experts seek clarification on some points, which the company provides. Not too much should be read into it.”
But WHO’s delay in granting an EUL to Covaxin has raised questions in some quarters, especially because the body has not delayed approvals to many of the other vaccines that are part of the vaccine drives of countries.
“Look at vaccines such as Pfizer, Moderna, and one of the Chinese vaccines, they were cleared pretty fast. Bharat Biotech needs to present its case properly. And if there are data discrepancies, then what was the Indian regulator doing? Why haven’t the Indian experts asked similar questions? On what basis was the emergency use authorisation given?” asked a senior public health expert, requesting anonymity.
But most experts believe that it is just a matter of time now before the approval is granted. “The technical expert group has to look at the data from various angles... therefore, you do need additional data at times. Whatever is causing the delay seems to be a minor issue,” said Dr Narinder Kumar Mehra, senior immunologist, and former dean, All India Institute of Medical Sciences, Delhi.
With inputs from pti