Peter J. Hotez, “New COVID-19 Vaccine Restrictions and Their Impact,” Rice University’s Baker Institute for Public Policy, September 5, 2025, https://doi.org/10.25613/PMS7-GW18.
On Aug. 27, 2025, the U.S. Food and Drug Administration (FDA) authorized new COVID-19 vaccines from Moderna, Pfizer, and Novavax ahead of the fall release of updated annual immunizations. The new vaccines ensure protection from the most recent strain and variants of the COVID-19 virus (the LP.8.1 virus and related XFG variant, also known as “Stratus”). However, the authorization of updated COVID-19 vaccines now comes with additional restrictions.
The updated COVID-19 vaccine will be made available to adults 65 years old and older as well as other individuals with certain underlying health conditions. Previously, COVID-19 vaccines were approved for all individuals aged 6 months and older. In another major change from past authorizations, the U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. announced that his department will now halt the use of this new COVID-19 vaccine for younger age groups in the absence of underlying health conditions. Importantly, these health conditions have yet to be specified and may be revised.
In addition, the FDA rescinded the emergency use authorization for administering COVID-19 vaccines for healthy young children. This move differs from the recommendations of the American Academy of Pediatrics (AAP), a divergence that has not happened in 30 years. The AAP advises that children who are vaccine-eligible should receive the updated COVID-19 vaccine according to the association’s specific guidelines, as these vaccines “are safe and effective” and promote “the prevention of severe COVID-19 in children.” Recently, the Centers for Disease Control and Prevention (CDC) reported that from July 2024 to May 2025, 41% of COVID-19-associated hospitalizations among vaccine-eligible children and adolescents occurred in the 6–23 months age group.
In the meantime, the Moderna vaccine will still be made available to children with underlying health conditions, which are to be determined. Currently, Novavax is an option for children over 12 years of age.
My new publication in the journal, Vaccine, details the rationale for maintaining vaccinations in younger age groups. Evidence demonstrates that COVID-19 vaccinations protect against long COVID and other long-term side effects that occur more than 30 days following infection, which is also known as post-acute sequelae.
Among the most concerning of COVID 19’s long-term side effects is on one’s heart health. The SARS-2 virus that causes COVID-19 is both a respiratory virus and a thromboembolic virus, meaning it causes clots and obstructions in coronary arteries and arteries going to the brain. Thus, the virus can lead to heart attacks and strokes, respectively.
Therefore, ensuring access to COVID-19 vaccines for younger age groups, even those without underlying health conditions, is important to maintaining the health not only of one’s respiratory system but also of one’s heart.
The Department of Health and Human Services’ (DHHS) recent actions regarding vaccine restrictions may not be limited to COVID-19 vaccines, which is a significant cause of concern. For example, the DHHS secretary has replaced the U.S. federal vaccine advisory panel with several individuals known to have spread vaccine misinformation. This recent change to vaccine oversight along with alterations to ingredients within vaccines are not evidence-driven actions.
DHHS’ limitations on COVID-19 vaccine access comes at a time when vaccine skepticism is on the rise, which is evinced by the continued decline in pediatric immunizations. Also, the “Make America Healthy Again” movement’s links to the wellness and influencer industry’s critical view of vaccines could also play a role in shaping DHHS’ policies.
Importantly, vaccine hesitancy does not only concern viruses and infections. The DHHS secretary has a long-standing track record of promoting the widely discredited view that vaccines are a possible cause of autism. As a vaccine scientist, pediatrician, and parent of an adult daughter with autism and intellectual disabilities, my book “Vaccines Did Not Cause Rachel’s Autism” and other work demonstrate that vaccines do not have a causal link to autism. However, the CDC now plans to conduct and fund research to understand vaccine’s potential contributions to autism.
As a number of new DHHS policies tend to deviate from evidence-based approaches, continuing to recognize, examine, and speak on how these actions depart from established medical research and science’s best practices is paramount to protecting U.S. public health.
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