What to Make of Changing COVID-19 Vaccine Indications and Guidance

In May of this year, the leaders of the National Institutes of Health, Health and Human Services (HHS), and FDA, announced the removal of the COVID-19 vaccine from the Centers for Disease Control and Prevention (CDC) immunization schedule for pregnant women and healthy children.¹ Days later, the federal government changed its stance on the vaccine and healthy children. On the CDC's Child and Adolescent Immunization Schedule by Age, the COVID-19 vaccines are available to the pediatric population under what is called shared clinical decision-making in the guidance.

"Shared clinical decision-making vaccinations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian. Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances," CDC writes on its website.

Fast forward to last week, and the FDA approved the Moderna COVID-19 vaccine, mRNA-1273 (Spikevax), in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. It is important to note that the vaccine was previously available for all pediatric populations under the FDA’s Emergency Use Authorization.²

Jeremy Faust, MD, an emergency department clinician at Brigham and Women’s Hospital, and assistant professor, Harvard Medical School, discussed the ongoing vaccine changes in his Inside Medicine blog. In the piece, he makes the point the Moderna vaccine was approved but it will be less available to the pediatric population.

“What the FDA did last week was not what was reported,” Faust said. “Basically, it's been reported that the FDA fully approved Moderna as a pediatric COVID 19 vaccine. The best I could tell, that's not what happened. Moderna submitted their dossier months ago, and the lynchpin of that dossier would be the randomized placebo-controlled trial that they ran in these populations. They did not study just high-risk kids; it studied everybody…So this idea that the approval the FDA granted should be limited to children with documented conditions that increase the risk of severe COVID, in my view, is probably a bit of a non sequitur to what Moderna would have submitted.”

The FDA’s Center Director Decisional Memo on the Moderna vaccine lays out the specific language the mRNA-1273 vaccine is indicated for in the 2 pediatric populations:

• “Children 2 through 11 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19

• Infants and children 6 months through 23 months of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.” ³

Faust points to the problems using this language and thought process in who is eligible. “How on Earth can anybody know what preexisting medical conditions a 6-month old baby has? Faust asked. “It's very common that a virus like influenza, RSV, or even COVID will be the thing that alerts parents and doctors that a child has type 1 diabetes because they show up to the ER needing to go to the intensive care unit because they have diabetic ketoacidosis, a life-threatening condition related to diabetes. That's how it first presents.”

Faust acknowledges there will be a small subset of pediatric patients who will be identified early on, but a large majority will not. “Sure, we're going to know the ones who are born with these very rare inborn errors of metabolism or cardiomyopathies that were diagnosed prenatally,” Faust said. “We'll know those 1% of the kids, but the highest risk kids are those infants who are aged 6 months to 11 months who are hospitalized at the same rates as people who are in their late 50s, early 60s…this is not a low-risk group.”

He says the current actions of the federal agencies are not their traditional roles.

“The Food and Drug Administration is meant to adjudicate whether a product is safe and effective based on the information it's been given. That has no implication on recommendations on who ought to get it. That's for the CDC’s Advisory Committee on Immunization Practices (ACIP)…the FDA has sort of given itself quite a purview here, and they've done it in a way that goes beyond the evidence, as best we can tell.”

The previous ACIP was dismissed by HHS Secretary Robert Kennedy and completely replaced back in June. As the roles of the FDA and CDC continue to evolve, it remains to be seen how the vaccine guidance will be applied going forward, what clinicians and patients should be doing for their children if they want COVID-19 vaccines, and what the insurers will pay for.

In the next installment of the interview with Faust, he will discuss where clinicians, interested stakeholders, and the general public may want to get information on vaccine guidance.

References
1.Parkinson J. Federal Government Changes Course Again on COVID-19 Vaccine Policy. Contagion. June 2, 2025. Accessed July 11, 2025.
https://www.contagionlive.com/view/federal-government-changes-course-again-on-covid-19-vaccine-policy
2. Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine, Spikevax, in Children Aged 6 Months Through 11 Years at Increased Risk for COVID-19 Disease. Moderna press release. July 10, 2025. Accessed July 11, 2025.
https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-Full-U-S--FDA-Approval-for-COVID-19-Vaccine-Spikevax-in-Children-Aged-6-Months-Through-11-Years-at-Increased-Risk-for-COVID-19-Disease/default.aspx
3. FDA’s Center Director Decisional Memo. FDA. July 9, 2025. Accessed July 16, 2025.