An FDA advisory panel this week recommended agency approval for two respiratory syncytial virus (RSV) vaccines for older adults, in today's bite-sized hospital and health industry news from Maryland and Mississippi.
- Maryland: Earlier this week, FDA's Vaccines and Related Biological Products Advisory Committee recommended agency approval for two RSV vaccines for adults over 60. On Tuesday, the panel voted 7-4 to recommend Pfizer's candidate, ruling that the company's data demonstrated that the vaccine was safe and effective against the virus for older adults. Then, the panel on Wednesday voted 12-0 on effectiveness and 10-2 on safety for GlaxoSmithKline's vaccine candidate. While FDA reviewers previously highlighted a rare risk for Guillain-Barré syndrome with the two vaccine candidates, the agency often follows the panel's recommendations. If FDA approves the candidates, they will be the first publicly available vaccines that protect against RSV. (Perrone, Associated Press, 2/28; Jewett, New York Times, 3/1; Rodriguez, USA Today, 3/1; Hein, MedPage Today, 3/1; Ravipati, Axios, 3/1)
- Maryland: FDA on Friday announced plans to enhance its oversight of tobacco and nicotine products, including e-cigarettes. In particular, FDA Commissioner Robert Califf shared that the agency intends to improve communication and transparency on product reviews as well as increase use of the tobacco advisory committee and intra-agency meetings regarding enforcement. Califf restated a call for Congress to reach a user fee agreement with the e-cigarette industry to help fund the agency's workload. "To achieve these goals, we need to have the appropriate resources to hire and retain staff with the skills needed to effectively meet our public health mandate around tobacco," Califf said. (Clason, Roll Call, 2/24)
- Mississippi: Gov. Tate Reeves (R) on Tuesday signed a bill banning gender-affirming care for transgender youth, making Mississippi the third state to enact such a law. The law comes after similar bans were enacted in Utah and South Dakota. Under the legislation, the state prohibits the provision of "gender transition procedures," which include puberty blockers and gender reassignment surgeries, to any individual under 18. If healthcare workers violate the law, they will have their licenses revoked. In addition, the law bans people from "knowingly" engaging in conduct that "aids or abets" in providing gender-affirming care to minors. It also prohibits the allocation of public funds – both state and federal – to any organization or individual that provides gender-affirming care to minors. Meanwhile, several medical groups, including the American Medical Association (AMA), have cautioned that bans on gender-affirming care could have negative mental health impacts for trans youth, who face an increased risk of suicide. The Department of Justice has also said that blocking access to treatments could violate "federal constitutional and statutory provisions that protect transgender youth against discrimination." (Chen, Axios, 2/28)