July 6, 2020
COVID-19 focused drug and vaccine firms need to keep a close eye on the US FDA according to lawyers who predict manufacturing and trial rules will continue to change.
The US Food and Drug Administration (FDA) issued its latest guidance for firms developing vaccines against SARS-CoV-2 – the virus that causes COVID-19 – last week.
The document sets out what trial data vaccine firms will need to supply. It also makes clear developers will have to seek approval the traditional way because “there are currently no accepted surrogate endpoints that are reasonably likely to predict clinical benefit of a COVID-19 vaccine.”
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The guidance also touches on production, explaining while cGMP compliance is vital “COVID-19 vaccine development may be accelerated based on knowledge gained from similar products manufactured with the same well-characterized platform technology, to the extent legally and scientifically permissible.”
The agency adds “Similarly, with appropriate justification, some aspects of manufacture and control may be based on the vaccine platform, and in some instances, reduce the need for product specific data.”
Manufacturing data is also critical for developers seeking Emergency Use Authorisation according to the FDA which said, “for a vaccine for which there is adequate manufacturing information, issuance of an EUA may be appropriate once studies have demonstrated the safety and effectiveness of the vaccine but before the manufacturer has submitted and/or FDA has completed its formal review of the biologics license application.”
The new guidelines are the latest in a series issued by the FDA during the coronavirus pandemic. And they are unlikely to be the last according to analysis by law firm Morgan Lewis.
In a blog post last week Kathleen Sanzo and Jacqueline Berman advised developers to track FDA’s COVID-19 related actions, “as additional guidance and modifications to existing guidances are likely to be issued as reopening plans are implemented.”
For manufacturers they highlighted agency requirements relating to employ health and monitoring as key.
“FDA recommends that manufacturers “vigilantly monitor” drug manufacturing employees that have been exposed to confirmed or suspected COVID-19. Employees that test positive or have COVID-19 symptoms must be excluded from drug manufacturing areas.
They added that “Such employees should not return to manufacturing areas until they meet the Centers for Disease Control’s criteria for discontinuation of home isolation.”
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