How Will the New FDA COVID-19 Vaccine Policy Affect the Pediatric Population?

Pediatrician Sharon Nachman, MD, discusses the potential effects of the new policy including how things like vaccine access, incidence rates, and participation in placebo-controlled trials may change.

This is the second piece in a series on the new FDA COVID-19 vaccine policy being proposed.

On Tuesday, in an article published in the New England Journal of Medicine, FDA Commissioner Marty Makary, MD, MPH, and Vinay Prasad, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research (CBER), laid out their plan to change policy as it relates to COVID-19 vaccines.

Whereas, previously everyone who was 6 months and older were recommended to get vaccines, now the FDA is no longer recommending annual COVID vaccinations for healthy people younger than 65. For those who are 65 and older they are still recommended to get their annual vaccinations as well as those 6 months and older who have underlying health conditions such as diabetes, cancer, asthma, etc.

With these new rules this will likely change how insurers cover these vaccines, leaving the cost to families. And this will likely leave clinicians without easy access to COVID-19 vaccines for those families who would like to still vaccinate their children.

“I think that pediatricians will not have it in their office, so that means families will have to figure out how to get it,” Sharon Nachman, MD, chief of pediatric infectious diseases at Stony Brook Children's Hospital, said. “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.”

FDA COVID-19 Vaccine Policy Changes

This is an ongoing series on the newly proposed changes to these vaccines and the schedules going forward.

Read our first article in the series:

FDA Shifts COVID-19 Vaccine Policy, Requires Further Testing

Nachman acknowledges children do not suffer the same severe disease and mortality that adults do with COVID-19; however, she does caution against changing variants and Long COVID.

“Most children handle COVID quite well, but as we see new variants, we don't know what damage those new variants will do— I am concerned," Nachman said. “And furthermore, when we look at the data on who got Long COVID, not only just among children, but adults, there is fascinating information now from multiple studies that people that got vaccinated had a much lower risk of Long COVID.”

Another prospective issue is placebo-controlled trials for COVID-19 vaccines. Nachman believes this will be problematic for future studies and a hard sell for families to participate in.

“I think there's a lot of concern from infectious disease doctors about the idea that you have to test every new variant of COVID with the vaccine against a placebo,” Nachman said. “Certainly, as a parent, do I really want to give my kids a placebo vaccine when I know that we're seeing another rise of COVID in the children in schools and at home? So, I think that families will have a hard time signing on to a clinical trial when a licensed vaccine is available.”