Alliance to VRBPAC: COVID-19 Recommendations Needed

Today, Alliance Director of Health Education Katrin Werner-Perez delivered public comment at the FDA’s Vaccines and Related Biological Products Committee (VRBPAC) meeting today. Her comments highlighted a sign-on letter led by the Alliance to VRBPAC featuring support of nearly 50 organizations.

Good afternoon, my name is Katrin Werner-Perez, and I serve as the Director of Health Programs at the Alliance for Aging Research. We are the leading nonprofit organization dedicated to changing the narrative to achieve healthy aging and equitable access to care. The Alliance receives funding from sponsors for non-branded educational and advocacy work on vaccines. Thank you, Commissioner Makary and Director Prasad, for the opportunity to provide public comments.

Today, we are submitting a sign-on letter on behalf of more than 45 organizations who urge the VRBPAC and the FDA to do the following:

• First, provide manufacturers with a timely recommendation regarding the updated strain for the 2025-2026 COVID-19 vaccines.
• Second, ensure continued availability of both mRNA-based and protein-based COVID-19 vaccines for the next season to provide vaccination options for individuals and their providers.
• And third, continue to ensure that the labeling of COVID-19 vaccines applies to both pediatric and adult populations, so that patients, families, and healthcare professionals have the full information they need to make informed choices based on individual risk and health profile.

We make these requests based on data from the CDC, which continue to show that COVID-19 remains a significant cause of severe illness, hospitalization, and death across the lifespan in the United States. The risk of COVID-19-related death is known to be highest in older adults, and the CDC reported more than 36,000 deaths among people aged 65 and older between September 2023 and August 2024. Among children under the age of 18, there were an estimated 152 deaths during that same time—and of those, 53 were in babies under a year old.

We are concerned about new requirements to compare updated COVID-19 vaccines with inert placebos, like saline shots, in clinical trials for children and younger adults. This approach is not aligned with the World Health Organization’s guidelines, which state that using placebos is considered unethical because withholding the existing vaccine would pose a significant risk to participants’ health.

We are also worried about the proposed switch from universal to risk-based recommendations for those under age 65. According to the CDC, nearly three out of four adults 18 and over have at least one condition that puts them at higher risk of severe illness from COVID-19. Therefore, shifting to a risk-based recommendation is a recipe for mass confusion among the public and providers. Health insurance companies will leverage this to save money – leaving vaccines out-of-financial reach for people who need the protection the most. We know this from experience, because we saw it unfold in the fall of 2021. We understand and appreciate the desire to have a more nuanced approach but, in the case of COVID-19 vaccination, we believe that the virus continues to pose a significant threat to millions of Americans. Having clear, consistent guidelines and access to immunization will protect the health and well-being of all of us.

In closing, I want to express our deep appreciation for all of you—those who have dedicated your time, energy, and expertise to serving the American people. We deeply value the contributions of FDA career and political staff and those of you serving on the VRBPAC. We thank you for your continued commitment to our nation and we stand ready to partner with you to advance FDA’s mission to promote and protect public health.

Thank you.