Submit public comment: The FDA must update the COVID vaccine and facilitate no cost access twice a year
The FDA, between now and May 8, is accepting public comments for their upcoming vaccine committee meeting. Let them know that all of us need access to COVID vaccines at least twice a year.
Make your voice heard and ask the FDA Vaccines and Related Biological Products Advisory Committee Meeting to:
Ensure vaccine manufacturers anticipate the upcoming dominant strain of SARS-CoV-2.
Recommend updated COVID vaccines for all ages AND
Strengthen our vaccine drive by recommending more frequent boosting (at least every six months) and more frequent updates to the vaccines, adjusted for the latest variants.
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 16 online FDA Vaccines and Related Biological Products Advisory Committee Meeting at: CBERVRBPAC@fda.hhs.gov on May 1, 2024. THAT’S TONIGHT!
Submitted written comments for the meeting must be received by the FDA via the Federal Register no later than May 8, 2024 at 11:59 Eastern Daylight Time.
It’s important to submit a personalized comment, which could include the importance of anticipating the next dominant viral strain, the lack of vaccine access that has impacted or would impact you, or how out-of-pocket costs are a barrier in your family or community. Feel free to take inspiration from or borrow the language in our sample public comment below.
Docket No. FDA–2024–N–0970
Scientific evidence indicates updated vaccines are needed to address the ongoing changes in COVID variants, and they should ideally be allowed, available, and fully covered by public funds and/or insurance, for people of all ages at least every six months.
The vaccine schedule should address waning efficacy in the months following vaccination [1-3] as well as emergence of new SARS-CoV-2 strains. The FDA’s decision will affect the current and future vaccine approach including what healthcare providers recommend, what health insurance covers, and level of public engagement.
It is of utmost importance that the FDA anticipates the newest viral variants and provides recommendations that anticipates the next dominant strain in the next six months. This requires that the FDA ensure that manufacturers anticipate the newest variants.
Restricting vaccinations to only annual updates misses an opportunity, given that there is the potential to update the vaccines to better match perpetually emerging variants. Updates to all vaccine types are needed, and mRNA vaccines are particularly suited to frequent updates.
The recommendation for only annual vaccination also creates barriers for vulnerable people and discourages high risk people from getting needed vaccine boosters.
The FDA must ensure support equitable and affordable access to updated vaccines and prevent limited access because of financial constraints or demographics by advocating for programs such as the CDC’s bridge program that ensures no cost access. [4]
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
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-16-2024-meeting-announcement
FDA Vaccines and Related Biological Products Advisory Committee Meeting on the Federal Register: https://www.federalregister.gov/documents/2024/03/04/2024-04523/vaccines-and-related-biological-products-advisory-committee-notice-of-meeting-establishment-of-a