• Maryland: FDA has approved Moderna's new mRNA flu vaccine mFlusiva, making it the first flu vaccine to use the technology. In February, Vinay Prasad, who formerly led FDA's biologics division, rejected Moderna's application for its mRNA flu vaccine over concerns about controls used in clinical trials. However, FDA later reversed its decision and said it would review the vaccine application by Aug. 5. In June, FDA's Vaccines and Related Biological Products Advisory Committee unanimously voted to recommend mFlusiva for people ages 50 to 64, as well as those ages 65 and older. On Wednesday, FDA issued a standard approval for use of the vaccine in adults ages 50 to 64 and accelerated approval for adults ages 65 and older. For the latter group, Moderna has agreed to conduct a Phase 4 (post-licensure) trial to gather more effectiveness data. In clinical trials, mFlusiva was shown to be around 27% more effective than a standard flu shot. Moderna also said it only takes two to three months to go from choosing a flu strain to rolling out the vaccine compared to roughly six months for traditional flu vaccines. "This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation," Moderna said in a statement. "We are grateful to the clinical trial participants, investigators, regulators and Moderna teams whose contributions made this milestone possible." (Lovelace Jr., NBC News, 8/5; CBS News, 8/6; Branswell, STAT, 8/5)
• New Jersey: Johnson & Johnson (J&J) has agreed to pay $5.5 billion to settle long-running lawsuits related to claims that its talc products caused ovarian cancer. The new settlement would cover around 76,000 claims with no limit on payouts. According to J&J, it plans to issue the first round of payments, which will amount to no more than $3 billion, next year. Additional payments will be made in 2028. Although J&J has agreed to the deal, it will only be finalized when it is accepted by 95% of the ovarian cancer claimants in either state or federal court. "While we are confident the Company would have ultimately prevailed with further litigation, as it has in the vast majority of cases tried to date, this resolution allows the Company to put this matter behind it and remain focused on its mission to develop medicines and devices that save lives," said Erik Haas, J&J's worldwide VP of litigation. Currently, J&J does not have any talc-based products, having switched to using cornstarch six years ago. (Associated Press/MedPage Today, 7/28; Fields, The Hill, 7/28)
• Virginia: The Virginia Department of Health recently reported the state's first locally acquired case of dengue. Dengue is a mosquito-borne viral illness that is common in tropical and subtropical areas. In recent years, cases have been increasing worldwide, including record outbreaks in the Americas. Although most dengue infections are mild or asymptomatic, some cases can be severe, leading to internal bleeding, organ failure, and death. According to state health officials, the affected patient had not traveled outside Virginia but was likely infected by a mosquito that previously bit an infected traveler, transmitting the virus. Most cases of dengue occur in travelers who were infected abroad, and the risk of dengue in Virginia remains low. "There is no evidence of continued transmission and no additional reports of locally acquired dengue cases at this time," state health officials said. (Sun, Washington Post, 8/4)

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