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FDA Presses Industry to Better Diversify Covid-19 Testing Pool

June 30, 2020, 4:33 PM

Covid-19 vaccine tests should include racial and ethnic minorities, pregnant women, and patients with underlying health conditions, the FDA said, echoing calls from patient advocates to broaden the pool of participants.

The Food and Drug Administration released guidance Tuesday that laid out the criteria for companies like Moderna Inc., Sanofi, and Johnson & Johnson to put their Covid-19 vaccines on the market. The guidance, while not binding, is the FDA’s strongest statement to date about what it expects before it will authorize a vaccine. Industry relies heavily on these guidance documents when developing medical products.

Some Democrats have worried that the Trump administration’s push to get a vaccine by the end of the year through Operation Warp Speed would mar the scientific rigor of the agency. The vaccine candidate developed by the National Institutes of Health and Moderna will likely go into phase III clinical trials in the next several weeks.

“I’m as eager as anyone for a vaccine. But this isn’t just about doing something fast. It’s about doing something right,” Sen. Patty Murray (D-Wash.), the top Democrat on the Senate health committee, said during a hearing Tuesday.

FDA Commissioner Stephen Hahn said the guidance provides clarity about what data the agency expects from vaccine developers “so we can demonstrate to the world, to the national, to the American people that we are following our rigorous standards with respect to safety and efficacy.”

Clinical trials often have stringent criteria for who can enroll in these studies to eliminate any other variables that could affect the outcome. But groups such as Friends of Cancer Research and the American Society of Hematology have pushed for broadening criteria so it better reflects the people who will take that drug.

The FDA made clear in its guidance that it wants vaccine developers to test the drug on thousands of patients that reflect a diverse population of study groups.

“This inclusion helps to ensure that vaccines are safe and effective for everyone in the indicated populations,” it said. “FDA strongly encourages the enrollment of populations most affected by COVID-19, specifically racial and ethnic minorities.”

The agency also said studies should include elderly individuals and those with other medical conditions, as well as pregnant women and women of childbearing age. The FDA also called for a plan for assessing the vaccine in children.

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com

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