Top FDA Approvals and Updates from February 2025 in Infectious Disease
Approved vaccines for chikungunya, meningococcal disease, updates on HIV prevention, key regulatory decisions, and more.
FDA Approves Bavarian Nordic’s Chikungunya Vaccine or Those 12 and Older
The FDA has approved Bavarian Nordic’s Vimkunya vaccine, the first virus-like particle (VLP) single-dose vaccine for chikungunya, for individuals aged 12 and older. Approval was based on positive phase 3 trial results, where up to 97.8% of participants developed neutralizing antibodies within 21 days. The vaccine, expected to launch in the US by mid-2025 and in Europe after final approval, offers protection against the mosquito-borne illness, which can cause severe joint pain. Vimkunya is the second chikungunya vaccine approved in the US and provides a broader coverage option for younger and older adults.1
FDA Approves GSK’s Penmenvy Vaccine Targeting Meningococcal Serogroups A, B, C, W, and Y
The FDA has approved GSK’s Penmenvy (MenABCWY) vaccine for individuals aged 10-25, offering protection against five major meningococcal serogroups (A, B, C, W, and Y). This pentavalent vaccine combines elements of GSK’s Bexsero and Menveo and met all 11 primary endpoints in a Phase 3 trial involving 3,650 participants. The vaccine demonstrated strong immune responses against diverse MenB strains and was well tolerated. Administered as two intramuscular doses six months apart, Penmenvy provides expanded protection for adolescents and young adults, particularly those in high-risk environments such as dormitories.2
FDA Approves Aztreonam and Avibactam for Complicated Intra-Abdominal Infections
The FDA has approved Emblaveo, a fixed-dose intravenous combination of aztreonam and avibactam, for treating complicated intra-abdominal infections (cIAI) in adults with limited or no alternative treatment options. Used alongside metronidazole, it targets resistant Gram-negative bacteria, including MBL-producing multidrug-resistant pathogens. The approval was supported by the phase 3 REVISIT trial, which assessed its efficacy, safety, and tolerability in hospitalized patients with cIAI. Emblaveo was granted QIDP and Fast Track Designations to expedite its development and review. Expected for commercial availability in Q3 2025, this therapy addresses the growing threat of antimicrobial resistance.3
bioMérieux Receives FDA Clearance for its BioFire FilmArray Gastrointestinal Panel Mid
The FDA has cleared bioMérieux’s BioFire FilmArray Gastrointestinal (GI) Panel Mid, a molecular PCR test for diagnosing gastroenteritis. Designed for use on the BioFire FilmArray 2.0 and Torch PCR platforms, the test detects 11 pathogens from stool samples within an hour, with minimal hands-on time. It complements bioMérieux’s existing 22-target GI panel, offering clinicians a mid-range option for faster, more targeted diagnosis. Acute gastroenteritis is a leading cause of illness worldwide, and this rapid diagnostic tool aims to improve treatment decisions, reduce unnecessary antibiotic use, and enhance patient outcomes. The test is expected to be available in the US by mid-2025.4
FDA Sets PDUFA Date for Lenacapavir For HIV Prevention
The FDA has accepted Gilead’s new drug application for lenacapavir as a twice-yearly HIV pre-exposure prophylaxis (PrEP), with a Prescription Drug User Fee Act (PDUFA) target action date set for June 19, 2025. If approved, it would be the first and only PrEP option requiring just two doses per year. The application is based on phase 3 PURPOSE 1 and 2 trials, which showed significant HIV risk reduction, including 100% efficacy in cisgender women in PURPOSE 1. Gilead is also pursuing regulatory approval in Europe and low-income regions to expand global access to lenacapavir for HIV prevention.5
FDA Declines Invivyd’s EUA Expansion for Pemivibart
The FDA has denied Invivyd’s request to expand the emergency use authorization (EUA) for pemivibart (Pemgarda) to include treatment of mild-to-moderate COVID-19 in immunocompromised individuals. The decision was based on pemivibart’s antiviral activity being comparable, but not clearly superior, to the comparator antibody adintrevimab. Although, pemivibart remains authorized for pre-exposure prophylaxis in immunocompromised patients without other therapeutic options. The monoclonal antibody has demonstrated robust and sustained neutralizing activity against 39 SARS-CoV-2 variants over nearly three years, including dominant strains like XEC.6
FDA Flu Vaccine Advisory Meeting Canceled Amid Concerns Over Delays for 2025 Season
The CDC reports 33 million flu illnesses, 430,000 hospitalizations, and 19,000 deaths so far this season, with Influenza A(H1N1) and A(H3N2) as the primary strains. Meanwhile, the FDA has canceled its March 13, 2025, VRBPAC meeting, which was intended to select flu strains for the 2025-2026 season, potentially delaying vaccine production. This decision, along with the recent cancellation of a CDC immunization advisory meeting, has raised concerns about US vaccine preparedness. Additionally, the first measles death since 2015 has been reported in Texas, emphasizing the importance of vaccination amid ongoing outbreaks.7
