Public Comment to FDA for Updated COVID Vaccines
May 22, 2025 public comment in support of universal updated COVID vaccine access, regardless of medical conditions; Written comments are still open through tomorrow, Friday 5/23 at 11:59pm EDT
I had the opportunity to give oral comment at the FDA VRBPAC vaccine committee meeting. The recent announcement of severe restrictions to the approval of COVID vaccines was the elephant in the room. This top-down decision seems to lack any input from the experts on this committee, and from the outset of the meeting, it was clear that committee members would not be allowed to openly discuss these changes in this public meeting. I urge you to continue submitting public comments in support of universal COVID vaccine access for all ages through tomorrow evening (deadline for submission: Friday, May 23, 11:59pm EDT). Even if you already submitted a comment, you can submit another one in response to this meeting.
How to Take Action
View the docket and submitted comments here: https://www.regulations.gov/document/FDA-2025-N-1146-0001
Below are some key talking points for your comment, and my full oral 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 universally, for people of all ages, 6 months and up, regardless of medical conditions.
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.
Missed the deadline? CDC vaccine committee (ACIP) meeting is coming up in June and will have a related public comment opportunity. I also recommend contacting your elected officials to let them know you support universal COVID vaccine access.
Meeting materials including presentation slides are available: FDA VRBPAC Meeting Materials
Video of the meeting is included below via YouTube. My comments begin at about 4:54:44.
The text of my oral comment is available below. For the full text and references of my written comment, please see my previous substack post.
My name is Kaitlin Sundling, and I have no conflicts of interest to disclose.
First, I want to thank Commander Valerie Marshall and all the FDA staff whose work in making this meeting go smoothly under very challenging circumstances is very much appreciated.
As an MD-PhD physician-scientist and public health advocate, I am speaking today in strong support of updated COVID vaccines. We need updated formulations of all currently approved and authorized types to better match circulating strains, and we need universal vaccine access for people of all ages and regardless of medical history.
As Dr. Sarah Meyer very rightly alluded to, it is critically important to consider the practical effects of changing the vaccine target in light of the newly announced regulatory framework. Strain selection is a false choice if this committee must choose between a strain update that would be more effective but require costly and time-prohibitive clinical trials or keeping the current strain target, which would result in a loss of efficacy over time. If these issues cannot be discussed openly amongst the members of this committee, there is a very real concern that this committee is being used as a pawn to eliminate vaccine access for the US population.
It is ridiculous to suggest that posting on social media is a substitute for an open public meeting with expert discussion and opportunities for both written and oral public comment. Why are two individuals making top-down decisions about vaccine policy? Although it has been stated in this meeting that those policies are preliminary, when will an open meeting about those policies occur? There is no reason why fall flu vaccine strain selection should have occurred behind closed doors without any opportunity for public comment, and this is a dangerous and unacceptable precedent. Our democracy needs true transparency and accountability in our trusted public health institutions.
Based on the success of previous formula updates, including the references included in section 3.1 of the posted briefing document for this meeting, an update to strain LP.8.1 or another currently circulating JN.1 sublineage, is the best option rather than keeping the current JN.1/KP.2-based formulations. Current formulations have been effective but will diminish in efficacy over time as variants continue to genetically diverge, with ongoing antigenic drift.
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. Non-clinical data is appropriate evidence to support a new variant-updated formulation. Placebo-controlled trials can only be ethically conducted when there is doubt as to whether a vaccine candidate may perform better than a saline injection, and where no other effective comparison vaccine exists. With our currently available COVID vaccines, and with future variant updates, there is no such doubt. Treating variant updates as an entirely new product does a disservice to public health and should not be used as an excuse to deny access to safe and effective vaccines for any group of people.
All COVID vaccine updates must be approved universally for people of all ages, 6 months and up, twice a year, and regardless of medical history. 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. More than 70% of COVID spread in households starts with a child. Children continue to be susceptible to acute disease and more serious consequences including MIS-C and Long COVID, and recent vaccination reduces the risk of these consequences.
Restricting vaccine access to limited age groups or people with specific high risk medical conditions creates unnecessary barriers to vaccination for high-risk groups, including significant problems in getting vaccinated at pharmacies and problems with insurance coverage. All people, regardless of age and medical history, need broad access to regularly updated COVID vaccine formulations. Thank you.