The US Food and Drug Administration (FDA) continues to provide advice and resources for professionals in the life-science industry, ranging from how to safely continue clinical trials, to advice on vaccine development, and updates on drug development. Following are highlights from this week’s COVID-19 activity.
COVID-19 vaccine development
The agency released a guidance entitled Development and Licensure of Vaccines to Prevent COVID-19. The document contains a range of suggestions for industry professionals, rather than binding recommendations.
“We have not lost sight of our responsibility to the American people to maintain our regulatory independence and ensure our decisions related to all medical products, including COVID-19 vaccines, are based on science and the available data,” said FDA commissioner Stephen Hahn. “This is a commitment that the American public can have confidence in and one that I will continue to uphold.”
In the guidance document, the FDA suggests the primary efficacy endpoint estimate should reach 50% or more. Additionally, the lower boundary should be less than 30% but higher than 0%, to be acceptable as a secondary efficacy endpoint.
The guidance also recommends companies plan pharmacovigilance activity prior to approval, and that they prepare to submit reports of adverse effects at more frequent intervals than might be expected for other vaccines.
Additionally, the FDA recommends drugmakers make every effort to ensure they include diverse patient populations in any clinical trials testing potential vaccines. For more information on the guidance, read the update in BioPharma-Reporter.
Companies purporting to offer products that prevent, treat or cure COVID-19 keep getting letters from the FDA for fraudulence. To date, the agency has not yet approved any such products to treat the virus. Here are the latest companies to receive warnings:
- Curativa Bay Corp. was cited for offering Hypochlorous Skin Spray, a topical hypochlorous acid-containing product for sale in the US.
- The FDA and Federal Trade Commission (FTC) jointly issued a warning letter to Hong Kong-based SuperHealthGuard and Loyal Great International Ltd. for selling unapproved products online to US customers.