What happened?

On May 27th, 2025, Health and Human Services Secretary Robert F. Kennedy Jr., along with National Institutes of Health (NIH) Director Jay Bhattacharya and Food and Drug Administration (FDA) Commissioner Marty Makary announced that the Trump Administration had removed COVID-19 vaccines from the childhood immunization schedule and from the recommended schedule for pregnant women.

Earlier in May, Makary and FDA’s director of the Center for Biologics Evaluation and Research Vinayak Prasad released an FDA policy position restricting COVID-19 vaccines to adults 65 and older and those at high risk for severe COVID-19.

Combined, these actions will put children and their families at increased risk of COVID-19 and other health complications as COVID-19 vaccines become more difficult and more expensive to get.

The weak and misleading “evidence” provided by Kennedy and others in the Trump Administration does not make a sufficient case for withholding COVID-19 vaccines from children. Research continues to show that the benefits of vaccinating children far outweigh the few risks. With this position, Kennedy and others — none of whom are trained in infectious diseases or vaccinology — unnecessarily put America’s children at increased risk for COVID-19, long COVID, Multisystem Inflammatory Syndrome (MIS-C), and other  other complications.

What is the immediate effect of this position?

This measure eliminates the recommendation that children receive at least one dose of the most current COVID-19 vaccine after 6 months of age. At the same time, FDA plans to require unnecessarily and unusually strict testing for already approved COVID-19 vaccines for people aged 6 months to 64 years with no other risk factors for severe COVID-19.

Together, these actions mean that many children will go unvaccinated and that insurance companies may no longer cover the vaccine, which costs roughly $140 per vaccine. In addition, even families who can afford the vaccine may not be able to get it without a prescription from a doctor. These obstacles to protecting children come at the same time Congress and the Administration are attacking Medicaid, which provides health insurance to 37 million children.  

In addition, the use of weak, false, and purposefully misleading evidence contributes exponentially to existing vaccine hesitancy and works to further destroy public trust in vital public health agencies, such as the FDA and the Centers for Disease Control and Prevention (CDC).

What could happen next?

Now that Secretary Kennedy has removed the COVID-19 vaccine from the CDC’s childhood vaccine schedule, he may instruct the FDA to revoke the Emergency Use Authorizations (EUAs) for the pediatric COVID-19 vaccines altogether. If the EUAs are revoked, COVID-19 vaccines may become unavailable for children while vaccine manufacturers attempt to get the vaccines re-approved by the FDA. These actions would make it essentially impossible for children to obtain vaccines against COVID-19 in the United States.

Not Recommended vs. No Access: Twisting the research to fit the policy

Kennedy and others have repeatedly claimed that “most countries have stopped recommending [the COVID-19 vaccine] for children” and “all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe Covid-19.” But this is a disingenuous reading of these policies. In fact, “most countries” — which appears to mean the 12 countries identified in the FDA’s position paper on the issue — do continue to recommend an initial COVID-19 vaccine for all people, of all ages, including babies and children. They have, however, cut back on recommending yearly boosters for children. It is obvious the Administration understands this distinction because it is clearly stated in the documents they offer as evidence. It is purposefully misleading then to produce this list as evidence to limit all vaccination for persons under 65 and without risk factors for severe COVID-19.

The 12 countries that the FDA lists derived their booster recommendations from the World Health Organization’s (WHO) COVID-19 vaccine guidance, which states that all persons should receive at least one dose of the COVID-19 vaccine in their lifetime and that previously vaccinated persons as young as 50 years old with comorbidities, pregnant persons, health workers, and individuals with compromised immune systems or increased risk factors for severe COVID-19 should receive additional doses of the vaccine routinely, either per pregnancy or every six to 12 months.

By removing COVID-19 vaccines from the childhood immunization schedule and placing other restrictions on them, Kennedy effectively prevents children and their families from accessing the vaccines at all, which is fundamentally at odds with WHO’s guidance that “everyone, everywhere should have access to COVID-19 vaccines.” Even though FDA’s Prasad and Makary have said they reject the view that “the American people are not sophisticated enough to understand age- and risk-based recommendations,” they apparently accept the idea that American children should not be protected from COVID-19 and that American families should not even be allowed to choose whether they want additional yearly protection.

Everyone, everywhere, should have access to COVID-19 vaccines.

World Health Organization Guidance

No vaccines means higher risk to children

If children and their families are no longer able to be vaccinated against COVID-19 they risk COVID-19 infection, long COVID, and MIS-C. The latest COVID-19 variant, Omicron, has an R0 value of 9.5, meaning one person infected with COVID-19 is expected to infect between nine and 10 other people. This rating means COVID-19 is nearly nine times more infectious than flu and would require 89% of the U.S. population to achieve herd immunity, a form of indirect protection where enough people in the U.S. are immune to a given disease that it makes the disease harder to transmit. Herd Immunity is the only way to protect unvaccinated people in the U.S., especially those who cannot receive the vaccine due to compromised immune systems, allergies, or other complications. By Prasad and Makary’s own admission, only 30-60% of Americans would be eligible to access the COVID-19 vaccine, far below herd immunity and thus jeopardizing the health of millions of Americans. Unvaccinated children and their families could face various risks, including: 

Conclusion

Secretary Kennedy’s decision to remove COVID-19 vaccines from the childhood immunization schedule, in combination with the FDA’s decision to restrict access to the latest COVID-19 vaccines, is anti-scientific, short-sighted, and will put children and their families at unnecessary risk while potentially letting COVID-19 mutate and run wild in the U.S. COVID-19 vaccines are safe, effective, and lifesaving, and these decisions will make it essentially impossible for most people in the United States to be protected from COVID-19. This decision will also further erode public trust in vaccines and public health institutions at the same time that outbreaks of vaccine-preventable diseases, like measles, continue to ravage the country. Instead of accepting scientific consensus, agreeing with what other countries and WHO actually recommend, or trusting parents and doctors to make informed decisions about children’s health, Secretary Kennedy has unilaterally imposed his own false anti-vaccine rhetoric onto America’s children. American children and their families will suffer decades of lasting harm if these decisions stand.