Urgent Action for Updated COVID Vaccines for Fall 2025
Priority deadline May 14 noon EDT, final deadline May 23, 11:59 pm EDT; Tell the FDA we need updated COVID vaccines for all ages, prior to the start of the school year
Please join me in making a public comment advocating for continued updates to COVID vaccines to the FDA’s vaccine committee by May 14, 2025, 12pm noon EDT.
Written comments submitted by May 14 at noon will be given to the committee for consideration prior to the committee meeting on May 22. You may continue to submit comments until May 23 at 11:59pm EDT for FDA consideration after the meeting.
View the docket here: https://www.regulations.gov/document/FDA-2025-N-1146-0001
You may also register to make an oral comment at the meeting (via online teleconferencing) by May 14 at 12pm noon EDT. More details on oral comment registration are available on the meeting page linked below. If you are selected for oral comment, you should receive an email by May 16.
See the FDA’s meeting page for additional meeting details and for oral comment registration: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-may-22-2025-meeting-announcement
Below are some key talking points for your comment, and my full comment is below the divider. Please feel free to copy, modify, and share any of the text for your own advocacy.
COVID vaccines must continue to be updated regularly (at least once a year) to match circulating strains.
We need updated COVID vaccines for fall, ideally by July-August prior to the start of the K-12 school year.
COVID vaccines must be made available for people of all ages, 6 months and up.
Because immunity wanes over time, COVID vaccination should be available twice a year for all ages.
You should also include brief comments about why updated COVID vaccination matters to you personally, such as how vaccination has positively impacted you and your community in the face of ongoing COVID exposure risks.
Docket: FDA-2025-N-1146
May 9, 2025
Public Comment for the May 22, 2025 meeting of the Food and Drug Administration Vaccines and Related Biological Products Advisory Committee
To the FDA VRBPAC committee:
I have no conflicts of interest to disclose. As a physician-scientist (MD-PhD) and public health advocate, I am writing to strongly support updated COVID vaccine formulations of all currently approved and authorized types (Pfizer and Moderna’s mRNA vaccines, and Novavax’s protein subunit vaccine) to better match circulating strains.
COVID continues to spread within our communities, and vaccination reduces the risk of symptomatic disease, severe disease, disability, and death. COVID vaccines have gone through regular strain updates, and each update has been both safe and effective. For fall 2025, updates must be made available by July or August and prior to the start of the K-12 school year to provide the most benefit for children, families, and communities. Although COVID spreads in all seasons, the fall start of the K-12 school year, as well as the beginning of university classes in the fall, causes many new groups of people to mix and can be anticipated to lead to increases in COVID spread.
COVID vaccines must be updated to match currently circulating strains. 2024-2025 COVID vaccines have been effective [1] but will diminish in efficacy over time as new variants continue to emerge. The safety and efficacy of these vaccines have been established over many clinical trials and real-world monitoring, including both the original formulations as well as multiple strain updates. The update process mirrors the routine process for seasonal influenza vaccine strain updates and provides the necessary timeframe to minimize delays in updated vaccine availability.
All COVID vaccine updates must be made available for people of all ages, 6 months and up, twice a year. Both children and adults remain at risk of both short- and long-term impacts from COVID infections [2, 3]. Access to vaccination at least twice a year (every 6 months) for all ages is needed to provide the greatest benefit, as immunity wanes over time [4, 5, 6]. Also, restricting vaccine access to limited age groups or people with specific high risk medical conditions would create unnecessary barriers to vaccination for high-risk groups.
Vaccine recommendations must be open and transparent, following the usual process within this committee and with opportunities for public comment. Fall 2025 flu vaccine strain selection occurred within a closed-door meeting without input from the usual range of expert advisors on VRBPAC’s roster [7]. There was no opportunity for public comment. Opportunities for public input as well as open discussions via broadcast public meetings are essential for public trust in vaccines and for trust in our public health institutions.
Anti-vax, anti-science, and anti-public health influences have no place in our trusted public health institutions. Denying everyday people access to safe and effective vaccines harms all of us. Vaccine uptake is already far too low, and recent federal cuts have included research into vaccine hesitancy as well as the “Wild to Mild” CDC flu vaccine campaign [8]. Members of this committee should take every opportunity to advocate for effective vaccination campaigns.
Funding for next-generation vaccine research was recently cut and must be reinstated and strengthened. Successful development of improved vaccines will benefit from significant investments in innovative technologies across a diverse range of vaccine candidates; we must not limit funding to a small number of vaccine candidates. Importantly, vaccine research must proceed without diminishing access to the safe and effective approved and authorized vaccine platforms that are already available.
References
Link-Gelles R, Chickery S, Webber A, et al. Interim Estimates of 2024–2025 COVID-19 Vaccine Effectiveness Among Adults Aged ≥18 Years — VISION and IVY Networks, September 2024–January 2025. MMWR Morb Mortal Wkly Rep. 2025;74. doi:10.15585/mmwr.mm7406a1
Fang Z, Ahrnsbrak R, Rekito A. Evidence Mounts That About 7% of US Adults Have Had Long COVID. JAMA. Published online June 7, 2024. doi:10.1001/jama.2024.11370
Yousaf AR. Notes from the Field: Surveillance for Multisystem Inflammatory Syndrome in Children — United States, 2023. MMWR Morb Mortal Wkly Rep. 2024;73. doi:10.15585/mmwr.mm7310a2
Link-Gelles R. Effectiveness of COVID-19 (2023-2024 Formula) vaccines. Presented at: FDA VRBPAC Meeting; June 5, 2024. Accessed June 12, 2024. https://www.fda.gov/media/179140/download
Wu N, Joyal-Desmarais K, Vieira AM, et al. COVID-19 boosters versus primary series: update to a living review. The Lancet Respiratory Medicine. 2023;11(10):e87-e88. doi:10.1016/S2213-2600(23)00265-5
Menegale F, Manica M, Zardini A, et al. Evaluation of Waning of SARS-CoV-2 Vaccine–Induced Immunity: A Systematic Review and Meta-analysis. JAMA Netw Open. 2023;6(5):e2310650. doi:10.1001/jamanetworkopen.2023.10650
Dillinger K, Goodman B. After canceling meeting of independent advisers, FDA issues 2025-26 flu vaccine recommendations. CNN. March 14, 2025. Accessed May 9, 2025. https://www.cnn.com/2025/03/13/health/fda-flu-vaccine-recommendations
CDC. New Wild to Mild Campaign Drives Key Message to Tame Flu and Reset Expectations. Influenza (Flu). January 31, 2025. Accessed May 9, 2025. https://www.cdc.gov/flu/whats-new/2023-2024-new-campaign-wild-to-mild.html