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COVID-19 vaccine developers won't face pre-approval FDA inspections for EUAs

Companies typically face inspections before gaining approval from the FDA

The US Food and Drug Administration (FDA) will not require pre-approval inspections for vaccine developers seeking emergency use authorisations (EUA), Bloomberg reports.

Typically, companies who seek approval for a drug or a vaccine are required to undergo inspections prior to authorisation from the FDA.

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 such inspections during an FDA advisory committee meeting.

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

Moderna, one of the companies at the forefront of the race to find and submit a COVID-19 vaccine for approval, has never undergone an inspection by the FDA, according to Bloomberg.

However, Moderna has partnered with Lonza to bolster its capacity for manufacturing scale-up of its mRNA-based vaccine candidate, with the contract manufacturer’s site having been inspected by the FDA several times, Bloomberg reports.

Eli Lilly, which is developing antibody drug treatments for potential use against COVID-19, was issued an Official Action Indicated (OAI) notice last year after an inspection at its Branchburg, New Jersey site in the US.

Reuters reported that the FDA inspectors had discovered ‘serious quality control issues’ at the plant, finding that data had been deleted from previous manufacturing processes.

The Branchburg site is among several worldwide Lilly plants currently producing bamlanivimab, one of the company’s COVID-19 neutralising antibodies.

Last week, Lilly said it has hired an independent consultant to review systems at the site, adding that it has been working closely with the FDA to remedy the issues.

The company maintained that it had not received a warning letter or other enforcement letter from the agency related to the quality control issues.

“We are confident in the quality systems for our global manufacturing processes. Our commitment to the safety of our medicines has not – and will not – change during our efforts to provide treatments to fight this global pandemic,” Lilly added in a statement.

Article by
Lucy Parsons

28th October 2020

From: Regulatory



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