The approvals come as Robert F. Kennedy Jr.—who has been critical of vaccines—takes leadership of the Department of Health and Human Services.
Days after vaccine skeptic Robert F. Kennedy Jr. was confirmed as secretary of the U.S. Department of Health and Human Services, the FDA issued a pair of vaccine approvals—one for GSK’s meningococcal shot and another for Bavarian Nordic’s chikungunya jab.
GSK’s Penmenvy can now be used to immunize patients aged 10 through 25 years, eliciting protection against the five major Neisseria meningitidis serogroups—A, B, C, W and Y—and helping to prevent invasive meningococcal disease (IMD). According to the pharma, Penmenvy “could simplify meningococcal vaccination delivery and help protect more US adolescents” against invasive meningococcal disease (IMD).
GSK is “excited” about Penmenvy’s approval, CSO Tony Wood said. The vaccine will “help improve meningococcal vaccination coverage in the United States, especially for IMD caused by serogroup B,” the leading cause of the disease in teens and young adults, he said.
Penmenvy’s approval is supported by data from two Phase III studies, which together enrolled more than 4,800 participants. Results showed that the vaccine elicited a similar immune response compared with one dose of the group A, C, Y and W vaccine Menveo and two doses of the group B shot Bexsero, as per an April 2024 announcement from GSK. Both Menveo and Bexsero are also manufactured by GSK.
Currently, the Centers for Disease Control and Prevention recommends that adolescents aged 11 and 12 years get a shot that covers the A, C, W and Y serogroups, followed by a booster once they turn 16. At this age—and through 18 years—adolescents should also get immunized with a group B vaccine, though the agency recommends “a shared clinical decision-making process” for this.
Pfizer currently dominates the meningococcal space with its pentavalent Penbraya, which won FDA approval in October 2023. The CDC’s Advisory Committee on Immunization Practices will meet next week, Feb. 26, to discuss GSK’s Penmenvy.
The FDA on Friday also greenlit Bavarian Nordic’s Vikmunya, the first virus-like particle single-dose vaccine in the U.S., designed to protect patients aged 12 and above against chikungunya. The approval is based on Phase III data from more than 3,500 people, of whom 97.8% had neutralizing antibodies at 21 days after immunization. Vikmunya was also well-tolerated in the study, with side effects that were mild or moderate.
The shot will become commercially available in the U.S. in the first half of this year, according to Bavarian Nordic.
These approvals come amid the possibility of an HHS that could be hostile to vaccines. Recently confirmed Secretary Kennedy has a long history of being anti-vaccine, being a founder of the nonprofit Children’s Health Defense, which continues to associate vaccines with unsupported complications, such as asthma and autism.
Kennedy has downplayed concerns about his anti-vaccine sentiments, saying in a Senate hearing that “all of my kids are vaccinated, and I believe vaccines have a critical role in healthcare.”
Lawmakers were largely unconvinced, however. In his confirmatory hearing before the entire Senate, Kennedy won by a slim 52-48 margin, along party lines. Senator Mitch McConnell (R-Ky), who broke with his party and stood against Kennedy, cited his vaccine skepticism and documented record of peddling “dangerous conspiracy theories and eroding trust in public health institutions,” according to Forbes.
