Public engagement and input are vital to the vaccine regulatory process in the United States. Each time the Vaccines and Related Biological Products Advisory Committee (the committee of independent experts who advise the FDA) meets, FDA accepts public comment. Members of the public are invited to submit comments to the federal register in the form of written comments submitted via regulations.gov, and/or by requesting to make an oral public comment at VRBPAC meetings.
Vaccinate Your Family routinely submits written comments and requests oral comments as part of our advocacy for evidence-based vaccine recommendations that protect as many people as possible from vaccine-preventable diseases. We also encourage other advocates and community members to submit your own comments and use your voice in this process. Learn more about submitting comments here.
Vaccinate Your Family submits this comment to reaffirm the importance of the vaccines approved and authorized by the FDA in safeguarding our nation’s health and to call on the Administration to uphold the integrity of vaccine regulatory pathways and safety systems.
Vaccinate Your Family (formerly named Every Child By Two) was formed on the heels of the measles epidemic of 1989-90 which grew to over 50,000 cases. Our co-founders, former First Lady Rosalynn Carter and Betty Bumpers, knew that the 150 lives lost to a vaccine-preventable disease were too many and so they dedicated their lives to vaccine advocacy. VYF has been a nonpartisan voice for 35 years, working with the White House and Congress to protect all of our communities.
We acknowledge that Drs. Makary and Prasad have published an article in the New England Journal of Medicine outlining how the agency will be approaching Covid-19 vaccines moving forward. This new approach, which will limit access to Covid-19 vaccines to those who are 65 and older and people 6 months to 64 years old who are at higher risk from Covid-19 infection, represents a major change in government policy toward Covid-19 vaccines and presents significant questions about access to these important products, particularly for people in the high risk categories.
The risk posed by Covid-19 has waned for most people since the start of the pandemic, largely through vaccine and infection derived immunity. We acknowledge the need for our nation’s vaccine recommendations to be based in the best science available. We want to make sure that the benefits of ongoing vaccination are greater than any potential risks, and that those who can benefit from vaccination are able to access vaccines. We ask: what are the practical barriers to vaccination for someone with a risk condition? Where will they receive a vaccine? How and where will they be asked to disclose their condition(s)? How will insurance coverage for the vaccines work? And, ultimately, who will be left without protection?
We urge you to bring this proposed change to the independent vaccine experts who serve on VRBPAC and ACIP in order to get external input. Meetings of these advisory committees provide an important opportunity to explore the pros and cons of this new approach.
Members of the Vaccines and Related Biological Products Advisory Committee are independent experts who render decisions based on the best available data after examining the risks of not vaccinating vs. the risks of vaccinating. The Committee ONLY votes in favor of the use of a vaccine when the benefits outweigh the risks. Again, we have witnessed this process for three decades and trust in the decisions rendered by these independent bodies.
The public would be best served by a fully vetted policy that includes robust public discussion of implementation challenges and unintended consequences.
The ongoing measles outbreak, as well as whooping cough, flu and COVID deaths, are stark reminders that our nation’s public health is hard fought and fragile. We thank the VRBPAC members for their ongoing work to ensure our nation’s vaccines remain safe, effective, and recommended appropriately.