Tina Tan, MD, discusses impact of FDA's stricter COVID-19 vaccine policy for children

On May 20, 2025, the FDA announced a new COVID-19 vaccination regulatory framework for future seasonal vaccines and additional clinical trial requirements for approval of vaccines intended for healthy individuals. According to the framework, published in the New England Journal of Medicine (NEJM), the FDA will use a immunogenicity basis to make favorable benefit-risk findings for adults older than 65, and for all persons aged 6 months and older with at least one risk factor that increases risk for severe COVID-19 outcomes.¹

"Unfortunately, that basically does eliminate access of vaccination to the majority of the pediatric population," said Tina Tan, MD, FIDSA, FPIDS, FAAP, editor in chief, Contemporary Pediatrics; president, Infectious Diseases Society of America (IDSA). Tan is also the Infectious Diseases attending at Ann & Robert H. Lurie Children's Hospital of Chicago, and professor of Pediatrics Northwestern University's Feinberg School of Medicine.

"COVID-19 is a disease that occurs in children, even though there is all this misinformation out there that COVID-19 doesn't cause infection in children, but it does cause infection in children. Some kids can actually get quite sick with it, and they can develop long-COVID symptoms," added Tan. "This is really just not addressing the public health issue that this particular organism can cause in the pediatric population."

The NEJM publication, authored by Martin Makary, MD, MPH, commissioner of the FDA, and Vinay Prasad, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research, stated that for healthy individuals aged 6 months to 64 years, with no risk factors for severe COVID-19, the FDA "anticipates the need for randomized, controlled trial data evaluating clinical outcomes," before biologic license applications for the vaccines can be approved.

For those in high-risk group categories, the FDA will "encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their post-marketing commitment," stated Makary and Prasad in the publication.

This approach differs from the creation of the previous COVID-19 vaccines, and, according to Tan, could impact availability of approved vaccines. Given available safety and efficacy data for previous COVID-19 vaccines, Tan said clinical trials are not warranted.

"[The trials could] be a major factor in delaying whether or not individuals are going to be able to receive the vaccine, and that that is not how this should be done, because we know these vaccines work," said Tan. "The vaccines are being reformulated every year to take into account the circulating sub serotypes. We know the vaccines work, we know the vaccines are safe. To do [this is] really going to delay availability."

On May 19, 2025, the FDA approved the NVX-CoV2705 (Nuvaxovid; Novavax) COVID-19 vaccine. The framework announced by the FDA mirrors the restrictions seen in the approval of NVX-CoV2705, as the recombinant protein-based vaccine is indicated only for those aged 12 to 64 years with at least one underlying health condition that puts individuals at increased risk for severe COVID-19 outcomes. Underlying conditions such as cancer, asthma, diabetes, obesity, or smoking were used as examples in a company press release of the approval announcement.²

"If [that restriction isn't removed], then healthy individuals are not going to be able to receive the vaccine this fall," said Tan of the newly-approved vaccine. For other vaccines though, it is unclear what the framework changes mean for those who want a COVID-19 vaccine in the fall but do not fit into one of the new eligibility categories, according to The Associated Press (AP).³

READ MORE: FDA approves NVX-CoV2705 COVID-19 vaccine

The AP quoted Paul Offit, MD, of Children's Hospital of Philadelphia, in the article, who said "The only ting that can come of this will make vaccines less insurable and less available."³

Sharon Nachman, MD, chief of pediatric infectious diseases at Stony Brook Children's Hospital echoed a similar sentiment as Offit in an interview with our sister publication, Contagion.⁴

“I think that pediatricians will not have it in their office, so that means families will have to figure out how to get it,” said Nachman. "The children are in school, the families are working, and most of the pharmacies did not want to vaccinate children under 5 and sometimes even under 8. So, that means for the school-aged children that we would like to vaccinate, there's not going to be a whole lot of access for them, even if they're willing to pay for the vaccine.”⁴

The FDA criticized the United States' vaccination strategy for all individuals, saying the "one-size-fits-all" approach differs from other countries in Europe that recommend seasonal and booster vaccines based on age, risk, along with other factors.^1,3

"My thoughts are, this is really going back on the preventative measures that should be taken to protect an individual against COVID-19," said Tan. "By putting those types of restrictions on the vaccine, you are not allowing individuals to protect themselves by getting the vaccine, and that's really not the way that public health works. Public health really is there to protect individuals and prevent them from becoming ill, and this is removing that prevention for all individuals," she concluded.

References:

1. Prasad V, Makary MA. An evidence-based approach to covid-19 vaccination. N Engl J Med. Published online May 20, 2025:NEJMsb2506929. doi:10.1056/NEJMsb2506929

2. Fitch J. FDA approves NVX-CoV2705 COVID-19 vaccine. Contemporary Pediatrics. May 19, 2025. Accessed May 22, 2025. https://www.contemporarypediatrics.com/view/fda-approves-nvx-cov2705-covid-19-vaccine

3. Perrone M, Neergaard L. New Trump vaccine policy limits access to COVID shots. The Associated Press. May 20, 2025. Accessed May 22, 2025. https://apnews.com/article/vaccines-fda-kennedy-covid-shots-rfk-trump-bb4de15b6ff955d6cd0b406aaec3cdc5

4. Parkinson J. How will the new FDA COVID-19 vaccine policy affect the pediatric population. Contagion. May 22, 2025. Accessed May 22, 2025. https://www.contagionlive.com/view/how-will-the-new-fda-covid-19-vaccine-policy-affect-the-pediatric-population-