FDA Flu Vaccine Advisory Meeting Canceled Amid Concerns Over Delays for 2025 Season

The FDA’s advisory committee meeting to select strains for next season’s flu vaccines has been canceled, raising concerns about potential delays in vaccine production. The Vaccines and Related Biological Products Advisory Committee (VRBPAC), scheduled for March 13, was set to determine which influenza strains should be included in the 2025-2026 seasonal flu vaccines. Although, panel members were notified on February 26 of the cancellation. No reasons were provided, and there is no indication of whether the meeting will be rescheduled.¹

The last CDC report showed the US has been experiencing a spike in flu cases, with seasonal influenza activity remaining elevated through Week 7 (ending February 15, 2025). Clinical labs reported 26.9% of specimens testing positive for influenza, primarily driven by Influenza A(H1N1)pdm09 and A(H3N2). Outpatient visits for respiratory illness accounted for 6.8% of total visits, continuing above the national baseline for the twelfth consecutive week.²

Hospitalizations were at 43,367, with a cumulative rate of 88.9 hospitalizations per 100,000. Pediatric deaths have risen to a total of 86 for the season, with 18 additional deaths reported in Week 7. The CDC estimates at least 33 million flu illnesses, 430,000 hospitalizations, and 19,000 deaths so far this season.²

The VRBPAC meeting typically brings together independent experts to decide which influenza strains will be included in the seasonal flu vaccine. Its cancellation has raised concerns about how vaccine manufacturers will proceed. The committee reviews and evaluates the safety, effectiveness, and use of vaccines and related biological products for human disease prevention, treatment, or diagnosis. It also assesses the quality of FDA research programs supporting these products and provides recommendations to the FDA Commissioner.³

This marks the second major advisory meeting canceled since Robert F Kennedy Jr. was confirmed as Health and Human Services Secretary. Last week, the CDC’s Advisory Committee on Immunization Practices (ACIP) also had its February meeting canceled, reportedly to allow for public comment.¹ Additionally, a government contract with Vaxart, a biotech company developing an oral COVID-19 vaccine, was suspended, after completing a Phase 2b COVID-19 vaccine trial after receiving a positive safety review from the DSMB.⁴

In addition to flu-related concerns, the US has reported its first measles death since 2015, highlighting concerns about the impact of shifting vaccine policies. The Texas Department of State Health Services (DSHS) confirmed the first death in the ongoing measles outbreak in the South Plains and Panhandle regions. A school-aged child, unvaccinated, died after being hospitalized in Lubbock last week and testing positive for measles.⁵

As of February 25, 124 measles cases have been confirmed since late January, with 18 people hospitalized. Most of the cases are in children. Measles, a highly contagious disease, can cause serious complications, including pneumonia, brain swelling, and death. The best prevention is the measles-mumps-rubella (MMR) vaccine, which is highly effective when administered in two doses.⁵

The cancellations of key meetings have raised concerns about the future of US vaccination policy, with experts questioning whether the VRBPAC meeting will be rescheduled and how this might affect vaccine preparedness for the upcoming season.

References

1. Dennis M. FDA advisory meeting to select strains for flu vaccines cancelled. FirstWorldPharma. February 27, 2025. Accessed February 27, 2025. https://firstwordpharma.com/story/5938324

2. CDC. Weekly US Influenza Surveillance Report: Key Updates for Week 7, ending February 15, 2025. February 21, 2025. Accessed February 27, 2025. https://www.cdc.gov/fluview/surveillance/2025-week-07.html

3. FDA. Vaccines and Related Biological Products Advisory Committee. April 26, 2019. Accessed February 27, 2025. https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/vaccines-and-related-biological-products-advisory-committee

4. Maalac T. Meeting of FDA’s Vaccines Advisory Panel Canceled as Kennedy Settles Into HHS. Biospace. February 27, 2025. Accessed February 27, 2025. https://www.biospace.com/policy/meeting-of-fdas-vaccines-advisory-panel-canceled-as-kennedy-settle-into-hhs

5. DSHS. Texas announces first death in measles outbreak. February 26, 2025. Accessed February 27, 2025. https://www.dshs.texas.gov/news-alerts/texas-announces-first-death-measles-outbreak