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Thursday, Apr 3 2025

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Missed Deadline: Novavax's Covid Shot Still Awaiting FDA's Full Approval

The Food and Drug Administration had already indicated that it approved the vaccine, but new agency leaders are now requesting more data. Meanwhile, FDA staffers who oversaw expert panel meetings on vaccines have been dismissed. Other news is on measles and shingles.

Federal drug regulators have missed the deadline for making a key decision regarding a Covid-19 vaccine from Novavax, days after the Food and Drug Administration鈥檚 vaccine chief was pushed out. The agency was set to give full approval to Novavax鈥檚 shot, but senior leaders at the agency are now sitting on the decision and have said the Novavax application needed more data and was unlikely to be approved soon, people familiar with the matter said.聽 (Whyte, 4/2)

The Food and Drug Administration laid off staffers who run an expert panel that advises the agency on vaccines, according to people familiar with the situation. The responsibilities of the four employees included monitoring conflicts of interest and overseeing meetings, according to the people who asked not to be named because the moves aren鈥檛 public. (Cohrs Zhang, 4/2)

The U.S. Food and Drug Administration said on Tuesday it had named Scott Steele as acting director of its Center for Biologics Evaluation and Research (CBER), following the exit of top vaccine scientist Peter Marks. An FDA insider for the past five years, Steele has advised on medical policy and served as senior adviser at CBER. He was an adviser on science and technology at the White House during George W. Bush's administration. (4/1)

On measles vaccination 鈥

Colorado鈥檚 vaccination rate for measles is one percentage point lower than needed to reach herd immunity, according to the state epidemiologist with the health department. 鈥淲hat we call the community immunity or herd immunity threshold for measles is about 95 percent. So statewide we are falling short of that. So that does mean that Colorado is potentially at risk for outbreaks,鈥 said the state epidemiologist, Rachel Herlihy. (Borden and Daley, 4/1)

Health officials in Colorado are addressing the one measles case in the state in hopes of preventing an outbreak. The Colorado Department of Public Health and Environment led the meeting on Tuesday, emphasizing the importance of early treatment and vaccination to prevent further spread. ... The state's vaccination rate stands at 88% for kindergarteners and 94% for older children, but areas with lower rates pose a risk. (Arenas, 4/2)

Steep federal funding cuts have forced public health officials in one of Texas鈥 most populous counties 鈥 Dallas 鈥 to cancel dozens of vaccination clinics and lay off 21 workers on the front lines of combatting the state鈥檚 growing measles outbreak. 鈥淚 just had to tell our commissioners this morning that we鈥檝e had to cancel over 50 different clinics in our community,鈥 said Dr. Philip Huang, director and health authority for the Dallas County Health and Human Services Department. Many of the clinics had been planned for schools in areas with low vaccination rates, he said. (Edwards, 4/1)

On the shingles vaccine 鈥

Getting vaccinated against shingles can reduce the risk of dementia, according to a new study led by Stanford researchers. The study, published in Nature on Wednesday, found that older adults who received the shingles vaccine were 20% less likely to develop dementia in the subsequent seven years than those who did not receive the vaccine. (Ho, 4/2)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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