FDA won't require manufacturing inspections for emergency COVID-19 vaccine use

As the leading COVID-19 vaccines move closer to potential emergency use, the research and regulatory processes have been intensely scrutinized. But there’s one area that hasn’t seen as much attention so far—manufacturing facility inspections.

COVID-19 vaccine developers seeking FDA emergency use authorizations won’t have to undergo pre-approval site inspections, agency official Jerry Weir said at the FDA’s open meeting last week, according to Bloomberg. The FDA conducts thousands of facility inspections per year, and some find flaws that drug or vaccine companies must remedy before launching new products. 

While the FDA mandates site inspections before a full approval, they’re not required for an emergency use authorization, Bloomberg reports. 

Moderna, one of the leading vaccine developers, has never had a facility inspected by the FDA, according to the news service. The mRNA biotech was founded in 2010 and has no approved products on the market. 

If COVID-19 vaccines score authorization for emergency use, they're expected to be administered to millions of people. 

Instead of pre-EUA inspections, the agency will require companies to submit detailed information about manufacturing processes, Weir said during the meeting. And it’ll require the companies to set up internal quality control groups. 

For its manufacturing scale-up, Moderna partnered with Lonza to help boost its capacity by bringing the contract manufacturer's New Hampshire site into the fold. The FDA has inspected that site several times, Bloomberg reports. Pfizer is the other leading mRNA player and has had its sites inspected before.

But in this case, pre-EUA inspections are warranted given that both Moderna and Pfizer are using new technology, NIH official and FDA vaccine advisory committee member Luigi Notarangelo said at the meeting. He said it would “provide some additional trust into the process.”

Fierce Pharma has reached out to Moderna and Pfizer for comment about their plans to ensure quality. Behind those companies, Johnson & Johnson and AstraZeneca are also advancing phase 3 programs in large, late-stage trials.

https://www.fiercepharma.com/pharma/fda-won-t-require-site-inspections-for-covid-vaccine-emergency-authorizations-bloomberg