Expert reactions to new COVID-19 vaccine policies | Image Credit: © myskin
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Recent changes from the FDA and CDC regarding COVID-19 vaccination policies may affect access for children and pregnant individuals. Pediatric infectious disease experts have noted the potential implications for clinical practice and vaccine distribution, citing concerns for decreased protection and eligibility for the pediatric population.^1,2

Below, find quick recaps of the recent federal agency changes and their potential impacts on the pediatric population. Then, click through the slideshow for expert reaction from Tina Tan, MD, FIDSA, FPIDS, FAAP; Sharon Nachman, MD; Donna Hallas, PPCNP-BC, CPNP, PMHS, FAANP, FAAN; and Paul Offit, MD.

FDA updates framework for COVID-19 vaccine approval

On May 20, 2025, the FDA released revised guidance requiring randomized controlled trial (RCT) data to support full licensure of COVID-19 vaccines for healthy individuals aged 6 months to 64 years. This represents a departure from prior reliance on immunobridging and real-world effectiveness studies. The agency will continue to use an immunogenicity-based approach for adults aged 65 years and older and individuals of any age with underlying health conditions.¹

Medical professionals have raised questions about how this policy may affect the availability of reformulated vaccines for healthy children, despite established safety and efficacy data from earlier vaccine iterations.

CDC pulls COVID-19 vaccine recommendation for healthy children, pregnant individuals

A week later, on May 27, 2025, the Centers for Disease Control and Prevention (CDC) removed its recommendation for routine COVID-19 vaccination in healthy children and pregnant individuals. Clinicians have expressed concern about the practical implications of this change, including eligibility determinations and insurance coverage issues.²

The change also affects provider planning, as vaccine ordering and administration workflows often rely on broad CDC guidance.

Health and Human Services Secretary Robert F. Kennedy Jr., in a video posted to his X account, stated the following about the recommendation removal:
"I couldn't be more pleased to announce that, as of today, the COVID vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule."

Novavax approval aligns with FDA criteria

The May 19 approval of Novavax’s NVX-CoV2705 COVID-19 vaccine reflects the FDA’s updated regulatory direction, though the approval predated the updated policies. The vaccine is authorized for individuals aged 12 to 64 with at least one underlying condition associated with higher risk of severe outcomes.³

Healthcare professionals note that this narrower indication may create challenges in vaccine access and distribution logistics for otherwise healthy individuals seeking immunization.

Reaction to COVID-19 vaccine policy changes

Editor's note: This is the third article in a series highlighting changes to COVID-19-vaccine-related changes from federal agencies.

Click here for the first article highlighting the FDA's stricter COVID-19 vaccine policy.

Click here for the second article, highlighting the CDC pulling the vaccine recommendation for healthy individuals.

References:

1. Tan T, Fitch J. Tina Tan, MD, discusses impact of FDA's stricter COVID-19 vaccine policy for children. Contemporary Pediatrics. May 23, 2025. Accessed May 30, 2025. https://www.contemporarypediatrics.com/view/tina-tan-md-discusses-impact-of-fda-s-stricter-covid-19-vaccine-policy-for-children

2. Fitch, J. CDC pulls COVID-19 vaccine recommendation for healthy children, pregnant individuals. Contemporary Pediatrics. May 27, 2025. Accessed May 30, 2025.

3. Fitch, J. FDA approves NVX-CoV2705 COVID-19 vaccine. Contemporary Pediatrics. May 19, 2025. Accessed May 30, 2025. https://www.contemporarypediatrics.com/view/fda-approves-nvx-cov2705-covid-19-vaccine