Before Noon TODAY: Submit Comment on Universal Vaccine Access to FDA
Everyone should have access to COVID vaccines, available twice a year.
The deadline for submitting comments which will be submitted to the FDA’s VRBPAC committee before their meeting is today at 12pm EST.
Make your voice heard and ask the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting to:
Ensure an updated COVID vaccine by the Fall of 2025
Recommend updated COVID vaccines for all ages
Strengthen our vaccine drive by recommending more frequent boosting (at least every six months) and more frequent updates to the vaccines
Ensure vaccine manufacturers anticipate future dominant strains of SARS-CoV-2.
Submit a public comment. Feel free to use our sample language below.
You can also register to give Oral Public Comment at the upcoming May 22, 2025 FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting at: https://qualtricsxmjqffz4ktl.qualtrics.com/jfe/form/SV_dnXIVPWod1OPwdU before 12 p.m. Eastern Time on May 14, 2024.
Submitted written comments for the meeting must be received by the FDA via the Federal Register no later than May 14, 2025 at 11:59 pm Eastern Daylight Time for the committee’s consideration and May 23, 2025 for the FDA’s consideration.
It’s important to submit a personalized comment, which could emphasize the importance of maintaining universal access, alignment with the next most likely dominant viral strain, and how the lack of vaccine access has impacted or would impact you, or how out-of-pocket costs are a barrier to the health of your family or community. Feel free to take inspiration from or borrow the language in our sample public comment below.
Step-By-Step Submission Instructions:
Step 1. Go to Regulations.gov to submit your comment.
Step 2. Type your comment under the field, “Comment.”
Step 3 (optional). Submit a PDF or Word version of your comment under “Attach Files.”
Step 4. Select either “Individual” or “Anonymous” depending on whether you want to share your personal information that will be publicly available on the Federal Register.
Step 5. If select “Individual,” provide your first and last name at minimum. If select “Anonymous,” directly submit a comment without sharing your personal information.
Final Step 6. Click “Submit Comment.”
Letter to FDA VRBPAC:
Docket No. FDA-2025-N-1146
Members of the FDA VRBPAC:
The FDA must ensure a four-week public comment period before an upcoming committee meeting. One week prior is not enough time for—and effectively preventing—public feedback.
As COVID infections continue to harm public health during this ongoing pandemic, scientific evidence clearly indicates that vaccines remain one of the most important tools for addressing SARS-CoV-2. Universal access to updated COVID vaccines is needed to address the ongoing changes in variants. Additionally, vaccines must be recommended for individuals of all ages and be fully covered by public funds/or insurance at a regular interval of at least every six months.
The vaccine schedule should address waning efficacy in the months following vaccination [1-3] as well as the emergence of new SARS-CoV-2 strains. FDA decisions will affect the current and future vaccine approach, including what healthcare providers recommend, what health insurance covers, and level of public engagement.
Restricting access to these vaccinations, at any level, neglects the responsibility to protect everyone, as anyone is vulnerable to a COVID infection that could lead to severe health outcomes or Long COVID. Given that there is the potential to update the vaccines to better match perpetually emerging variants, updates to all vaccine types are needed, and ensuring access to all options made by all three manufacturers is very important. In addition, the FDA must continue to support vaccine options in addition to injection, such as through liquids, pills, or nasal sprays.
Any recommendations that regard who or when access is available to these vaccines are barriers for vulnerable people and discourage high risk people from getting needed vaccine boosters.
The FDA must not only ensure the viral variants are addressed by the COVID vaccine, but also provide recommendations that anticipate the next dominant strain in the next six months. This requires that the FDA ensure manufacturers match the variant with future variants.
The FDA must support equitable and affordable access to updated vaccines and address access limitations due to financial and demographic constraints by advocating for programs such as the now defunct CDC bridge program that ensured no-cost access to vaccines. [4]
As Dr. Marty Makary, commissioner of the FDA, has demonstrated support for advisory committees, we seek accountability for his words and request that he listen to the needs of the public and base decisions not on short-term financial or economic analyses, but long-term outcomes of public welfare.
References:
1. Link-Gelles R. COVID-19 vaccine effectiveness updates. Presented at: FDA VRBPAC Meeting; June 15, 2023. Accessed February 9, 2024. https://www.fda.gov/media/169536/download2. 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
3. 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
4. https://www.cdc.gov/vaccines/programs/bridge/index.html
END of LETTER
Full instructions for written and oral comment and meeting information can be found at: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-may-22-2025-meeting-announcement
Information about the FDA Vaccines and Related Biological Products Advisory Committee Meeting at the Federal Register: https://www.federalregister.gov/documents/2025/05/08/2025-08083/vaccines-and-related-biological-products-advisory-committee-notice-of-meeting-establishment-of-a
Vaccination with the latest updated vaccines remains one of the most important parts of the multilayered approach to protection against acute illness from COVID infection or developing Long COVID. Far too few Americans have received the latest vaccines. Only approximately 1 in 5 adults and 1 in 10 children have received the latest 2024-2025 vaccines (as of April 26, 2025), which have been available since fall 2024.
This spring, receiving an updated fall 2025 will be invaluable for an upcoming wave of infections in the Winter of 2026, especially as vaccine efficacy wanes significantly four to six months following vaccination. Per the CDC’s recommendations, only immunocompromised adults are eligible for COVID vaccines more frequently than once a year. Establishing any eligibility criteria is restrictive, putting all of us at risk and leaving those at high risk of severe consequences of COVID infection confused about whether they qualify to receive additional doses. A more frequent vaccination approach and frequent updates to match current variants are needed to better protect all of us amid year-round COVID spread.
With the demise of the CDC’s Bridge Access Program, which provided COVID vaccines to uninsured and underinsured adults free of charge through the end of December 31, 2024, access is now severely limited. It is important to let public health officials know that cost and any restrictions are barriers to access that are detrimental to health across all populations.
Submitted written comments or registration to make oral comment at the meeting must be received by the FDA no later than May 23, 2025 at 11:59 pm Eastern Standard Time. If submitted by May 14, 2025, 12 pm, comments will be received in time for the committee’s consideration.