The FDA has now canceled two significant vaccine-related meetings, and the pharmaceutical industry is buzzing about it. What happened with these cancellations, and what might they mean for companies developing vaccines?
The most recent meeting, slated for March 13, 2025, was to identify what flu strains should be included in vaccines for the 2025-26 flu season. Each spring, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meets to make this decision. This annual meeting has been happening since the late 1960s, and even occurred during the COVID-19 pandemic.
The VRBPAC includes a group of outside experts, who volunteer their time and expertise to review, discuss, and advise onvaccines and other biological products. They are non-governmental employees, and generally include professors and administrators in medicine and epidemiology, as well as industry representatives.
Members of the committee were informed by an email from the FDA on February 26. The email stated that the meeting was canceled (not simply postponed), and it gave no cause or reason.
The FDA has also announced that it will make recommendations to manufacturers in time for vaccines to be produced for the 2025-26 season. So will these recommendations be released without the expert advisory? When will they be released? No date is given. Additionally, VRBPAC advisory meetings normally provide for public commentary via oral presentations. This will also apparently be missing from this year’s decisions.
Additionally, the CDC Advisory Committee on Immunization Practices (ACIP) had a meeting scheduled for late February. This meeting was postponed to allow for additional public comment prior to the session.
The ACIP typically convenes multiple times a year to review scientific data and make vaccine recommendations. The postponed meeting was set to include several votes, notably one concerning the management of influenza inoculations within a key government vaccine distribution program, as well as reviews of the GSK meningococcal vaccine and AstraZeneca flu shot.
These changes to normal meeting schedules are causing disruption for vaccine manufacturers. There is a potential for disruption in vaccine production schedules, which can in turn make timely distribution of vaccines difficult. "The abrupt cancellation of the FDA's next vaccine advisory committee meeting is a deeply concerning development that could delay and disrupt a critical step in production of the annual flu vaccine," Partnership to Fight Infectious Disease said in a statement.
This also fuels regulatory uncertainty. Typically, FDA advisory meetings provide a structured process where industry experts assess data, discuss safety and efficacy, and make formal recommendations that influence regulatory decisions. These recommendations help vaccine manufacturers determine which formulations to produce, ensuring compliance with federal guidelines and minimizing risks of delays or rejections. When this advisory process is disrupted, manufacturers may face confusion regarding compliance, approval pathways, and production timelines. The lack of independent expert advice on vaccine-related decisions could decrease public and physician trust in vaccination programs.
Finally, delays and uncertainties can lead to increased costs and resource allocation issues for companies. Companies may need to adjust their production and distribution strategies, potentially leading to financial strain.
Industry stakeholders are urging the FDA and HHS to provide clear communication regarding the reasons for cancellations and future plans. The Partnership to Fight Infectious Disease also stated that: "Canceling transparency and public expert committees undermines vaccine confidence and sows doubt in a process that has long safeguarded public health. The consequences are not theoretical. They're deadly.”
As vaccine manufacturers await further guidance, the industry remains in limbo—underscoring the urgent need for regulatory clarity and public trust in the vaccination process.
Sources:
https://time.com/7262388/fda-flu-vaccine-meeting-canceled/
https://www.fda.gov/media/173168/download
https://www.axios.com/2025/02/27/fda-flu-vaccine-meeting-canceled-rfk-jr