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FDA set to publish reviews of data relating to COVID-19 vaccine EUAs

Agency set to publish data as part of 'transparency' efforts

The US Food and Drug Administration (FDA) has announced that it will publicly post reviews of data relating to emergency use authorisations (EUA) of COVID-19 vaccines.

In a statement, FDA commissioner Stephen Hahn revealed the transparency plans, adding that the agency’s drug and biological products center will publish its reviews ‘to the extent appropriate and permitted by law’.

“Let me be clear on a crucial point – the issuance of an EUA is based on data and science. For an EUA to be authorised, FDA’s career scientists conduct a rigorous evaluation of currently available scientific evidence about a medical product,” said Hahn

“We work with sponsors so that additional data about the product’s safety and effectiveness continues to be collected and reviewed,” he added.

In October, the FDA released new guidelines detailing how it will grant EUAs for COVID-19 vaccines, which included a new advisory stipulating that data from phase 3 studies should include a median follow-up duration of at least two months.

Following this guidance, Bloomberg reported that the FDA will also not require pre-approval inspections for vaccine developers seeking EUAs.

Jerry Weir, director of viral products at the FDA’s vaccines office, revealed that companies who submit their COVID-19 vaccine for an EUA will not have to undergo these inspections during an FDA advisory committee meeting.

Weir did add that all companies that submit a potential COVID-19 vaccine for an EUA will be required to provide complete details of their manufacturing processes and demonstrate how they have established a quality control unit.

A number of potential vaccines are involved in late-stage clinical testing, and Pfizer/BioNTech and Moderna have both reported initial efficacy data on their vaccine candidates this month.

Pfizer/BioNTech’s COVID-19 vaccine candidate, BNT162b2, demonstrated an efficacy rate of above 90% in preliminary results from a phase 3 study that was published last week.

On Monday, Moderna also revealed the first results for its vaccine, mRNA-1273, reporting that the vaccine candidate achieved an efficacy rate of 94.5% in its phase 3 study.

The respective vaccine developers did add, however, that this efficacy rate could change over the course of ongoing evaluations.

Article by
Lucy Parsons

18th November 2020

From: Regulatory



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