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No emergency use, US FDA asks Bharat Biotech to obtain full approval

Ocugen, Bharat Biotech’s Covaxin partner in the US, “will no longer pursue an Emergency Use Authorization” of the vaccine in that country, the American clinical stage biopharmaceutical company told Nasdaq on Thursday.

Written by Prabha Raghavan | New Delhi |
June 12, 2021 4:56:01 am
Covaxin, Covaxin vaccine, Cowin, Delhi government, Covaxin stock in Delhi, Covaxin second dose in Delhi, Covaxin availability, Delhi news, india news, indian express"The unvaccinated population is still vulnerable and needs to follow Covid-appropriate behaviour," he added.

BHARAT BIOTECH’S efforts to receive fast-tracked emergency approvals for Covaxin in the US have faced a setback, with the American drug regulator recommending that the vaccine be put through the process for a full authorisation instead.

However, the decision to not consider Covaxin for Emergency Use Authorisation (EUA) in the US is unlikely to have any bearing on the WHO’s ongoing review of the Indian Covid vaccine for Emergency Use Listing (EUL), according to experts. It will also have “no bearing” on India’s own vaccination programme.

Ocugen, Bharat Biotech’s Covaxin partner in the US, “will no longer pursue an Emergency Use Authorization” of the vaccine in that country, the American clinical stage biopharmaceutical company told Nasdaq on Thursday.

The US Food and Drug Administration (FDA), in its feedback regarding Ocugen’s “master file” for Covaxin, had recommended that the company pursue a Biologics Licence Application (BLA) “instead of an EUA application”.

The FDA had requested “additional information and data” regarding the vaccine. Ocugen anticipates that data from an additional clinical trial will be required to support its submission for a BLA.

A BLA would take longer for Ocugen to receive compared with its initial expectations of an EUA, the application for which the company had been “close” to finalising for submission. “While this will extend our timelines, we are committed to bringing Covaxin to the US,” said Ocugen board chairman, co-founder and CEO Dr Shankar Musunuri.

“The application for Covaxin’s approval will now be added to a standard queue and it can take up to a year for it to receive a BLA. The documentation requirements are greater than that of an EUA application and the review process is lengthier, taking about six months or more,” said Massachusetts-based vaccine expert Dr Davinder Gill.

Bharat Biotech attributed the US regulator’s decision to “good” herd immunity and the fact that a “significant” percentage of the population in that country has been vaccinated. “On the sidelines of this, the US FDA had earlier communicated that no new emergency use authorization (EUA) would be approved for new Covid-19 vaccines,” it stated.

On May 25, the FDA had reissued its guidance on EUA for Covid vaccines, which includes a new section on how the agency intends to prioritise review of requests. This guidance alerts manufacturers that it may decline to review and process EUA requests “in cases where it is not feasible for FDA to verify the conduct of clinical trials, trial data integrity or manufacturing facility standards,” the agency said.

“When FDA assesses investigational Covid-19 vaccines for use under EUA, FDA’s review includes: stringent evaluation of product quality, including a determination that the facilities producing the product meet appropriate standards; evaluation of the conduct of clinical trials; and assessment of trial data integrity,” stated the FDA’s guidance document.

The document added that it may need to “further prioritize” among the EUA requests it receives for Covid vaccine candidates, given the need to address urgent public health priorities.

“For the remainder of the current pandemic, FDA may decline to review and process further EUA requests other than those for vaccines whose developers have engaged in an ongoing manner with the Agency during the development of their manufacturing process and clinical trials program as described in this guidance…,” stated the document.

Bharat Biotech’s application for an EUL at the WHO, however, is different from that for an EUA at the FDA. The American regulator’s decision, which has not raised any red flags about the data submitted for an EUA, is not expected to impact the Hyderabad vaccine maker’s expected timeline to receive an EUL between July and September 2021.

“The WHO process is independent of the FDA,” said vaccine expert Dr Gagandeep Kang, Professor at The Wellcome Trust Research Laboratory at Christian Medical College-Vellore’s Division of Gastrointestinal Sciences.

According to the WHO website, only vaccines that have completed proper phase 2b and phase 3 trials, and have been approved by the reference National Regulatory Authority (NRA), can submit applications for an EUL.

Bharat Biotech had first received restricted emergency permission from the Central Drugs Standard Control Organization (CDSCO) following clinical trials in India. This includes a large-scale phase 3 trial on over 25,000 participants.

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