Pediatrician Offers Insight As FDA Restricts COVID-19 Vaccine Eligibility

By Kyle Davidson, Florida Phoenix

September 3, 2025

At the end of August, the Food and Drug Administration approved updated vaccines for COVID-19. While previous versions of the vaccine were recommended to individuals 6 months of age and older, access to the FDA’s newly approved vaccines is limited to individuals 65 and older and individuals between the ages of 5 and 64 with an underlying condition placing them at high risk for severe COVID-19.

With Secretary of Health and Human Services Robert F. Kennedy, a longtime anti-vaccine activist, taking control of the agency in February, the usual process for issuing guidance on the vaccine has been upended, leading to a split between leading health authorities, and a potential gap in vaccine availability for children, who are among the most at risk for severe illness, hospitalization, and complications from the disease.

“I really don’t fully understand it. I’ll be real honest with you, and I’m not sure most physicians who understand the data can make sense of it either, right? There doesn’t seem to be a good reason for restricting the vaccine to only those with underlying health conditions under the age of 65,” Dr. Molly O’Shea, a pediatrician and member of the teaching faculty for the residency program at the Children’s Hospital of Michigan told the Michigan Advance in a Tuesday interview.

For members of the medical community, suddenly shifting from widespread availability to dialing back access is not something that makes sense for the FDA, O’Shea said, as there has not been a shift in complications from the vaccines or issues with the vaccine’s effectiveness to drive that change.

Additionally, the Centers for Disease Control no longer recommends COVID-19 vaccination for children ranging from 6 months to 17 years of age.

However the American Academy of Pediatrics has offered its own guidance, recommending all children 6 to 23 months old receive the vaccine, and for children 2 to 18 years old at high risk, or whose parents desire to protect their children from the illness.

Vaccines are the safest and most effective way for our immune system to learn how to respond to a virus, O’Shea explained.

Additionally, having the vaccine as your baseline exposure to COVID-19 comes with some safety from complications from the illness including multi-inflammatory system response, Long COVID, and Postural Orthostatic Tachycardia Syndrome, O’Shea said.

“For all of those reasons, it matters for young children to have access to the vaccine while they’re still kind of freshly unaware that COVID exists,” O’Shea said.

Reducing access to the vaccine, O’Shea said, promotes a mindset for families — particularly families who were already somewhat less inclined towards vaccination — that the COVID-19 vaccine isn’t of value.

There’s also been a lot of conversation on how physicians and other healthcare providers can give permission for individuals who want to receive the vaccine outside of the current recommendations, also referred to as off-label use, either in office or through a pharmacy.

“I really think that’s a very nuanced and challenging issue, because in any other circumstance in which we’re writing something off label, for off-label use, it isn’t a scenario in which the data has not been assessed by the FDA,” O’Shea said.

O’Shea also pointed to liability concerns if a vaccine is prescribed for off-label use and a patient has an adverse reaction.

According to a publication from the American Academy of Pediatrics, clinicians prescribing the vaccine could have two layers of protection, stemming from malpractice insurance and the PREP Act, which provides broad immunity from state and federal liability.

However immunity under the PREP Act is not guaranteed, with the academy encouraging physicians to check their malpractice coverage to ensure COVID-19 vaccines are not excluded.

“The goal of this whole thing is to scare people out of giving vaccines,” O’Shea said.

When looking for a list of underlying conditions to qualify for the vaccine, O’Shea pointed to an article published in the New England Journal of Medicine, which lays out which conditions qualify, including conditions like asthma, diabetes, cerebrovascular disorder, chronic kidney disease, chronic lung disease, chronic liver disease, heart conditions, certain mental health disorders and more.

Asked for advice for parents who want to make sure their children are protected in light of the FDA’s restricted access to the COVID-19, O’Shea offered two recommendations.

The first, if parents are uncertain their otherwise healthy child will be able to receive the COVID vaccine, is to go to their local health department.

“[The health department has] made it clear that they’re not going to turn anybody away who wants to receive COVID vaccine. So that’s encouraging,” O’Shea said.

The second: “Please contact your legislators, both in the House and in the Senate,” O’Shea said. With Kennedy set to testify before the Senate Finance Committee on Sept. 4, O’Shea said the more legislators hear from real people, the better.

This story first appeared in the Michigan Advance, a member with the Phoenix in the nonprofit States Newsroom.

The Florida Phoenix, a nonprofit news site that’s free of advertising and free to readers, covers state government and politics through a mix of in-depth stories, briefs, and social media updates on the latest events, editorial cartoons, and progressive commentary. The Phoenix is part of States Newsroom, a national 501(c)(3) nonprofit supported by grants and a coalition of donors and readers.