FDA Delays Decision on COVID Vaccine for Kids Under 5

Parents of young kids nationwide recently received some disappointing news. On February 11, 2022, the Food and Drug Administration (FDA) announced that it was postponing an advisory committee meeting set for the following week where experts would choose whether to recommend the authorization of Pfizer’s COVID-19 vaccine for children younger than 5.

Health experts and parents were anticipating a final recommendation for vaccines in younger children, and a discussion about its safety and effectiveness. But now the FDA says it will wait for data on how well three doses of the Pfizer vaccine, instead of two, work in children under 5 before deciding whether to authorize the vaccine.

That age group is the only one for whom the Pfizer vaccine is not yet authorized. (Moderna and Johnson and Johnson’s COVID-19 vaccines are authorized for people 18 and older. Both companies are still studying pediatric doses.)

Why Exactly Was It Delayed?

According to reporting by Stat News, the Pfizer vaccine version for kids under 5 was originally tested in a two-dose regimen. Each dose had a tenth of the amount in an adult dose.

Pfizer, however, announced late last year that in a clinical trial of children ages 2 to 4, the two doses didn’t generate antibody levels high enough to protect against the virus. (Surprisingly, the two doses did mount a sufficient response in kids 6 months to 23 months.) Now, a third dose may be added into the mix.

“The data that we saw [from Pfizer in advance of the advisory committee meeting] made us realize that we needed to see data from a third dose in the ongoing trial in order to make a determination that we could proceed with doing an authorization,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Research and Evaluation, said in a briefing with reporters to explain the delay. 

Concerns about COVID-19 and children have recently increased. While serious illness among children who contract COVID-19 remains rare, Marks told reporters on Friday that the recent surge of the Omicron variant caused higher rates of hospitalization among children than at any previous point during the pandemic.

Pfizer announced in January 2022 that it had been asked by the FDA to seek emergency use authorization from the FDA for the two-dose regimen in children 6 months to 5 years. According to reporting by USA Today, the FDA request was unusual. Typically, the company decides when it wants to submit, not the other way around.

Marks explained to reporters why the agency had urged Pfizer to seek the two-dose authorization.

“Given the recent Omicron surge and the notable increase in hospitalizations in the youngest children to their highest levels during the pandemic so far, we felt it was our responsibility as a public health agency to act with urgency and consider all available options, including requesting that the company provide us with initial data on two doses from its ongoing study,” Marks said.

But that data proved insufficient to ask the advisory committee for a review. 

“Evaluating this initial data has been useful in our review,” Marks added. “But at this time, we believe additional information regarding the ongoing evaluation of a third dose should be considered.”

Will This Decision Make Parents Hesitate?

The delay was unexpected. Healthcare experts are concerned that the delay in reviewing the vaccine for the youngest age group could decrease confidence among parents, especially since it’s already low.

According to January 2022 data from the Kaiser Family Foundation, only 31% of parents say they will immediately vaccinate their children under 5 once there is a vaccine available. Twenty-nine percent said they would wait and see, 12% said they would vaccinate children 5 and older only if required, and 26% said they would definitely not have their children vaccinated against COVID-19. 

Health experts expect some parents to be more hesitant toward the shots. But others will likely be disappointed that the vaccines for this age group are not yet authorized.

"Many parents have been anxiously waiting for months to vaccinate their young children,” Andrew Pavia, MD, chief of pediatric infectious diseases at the University of Utah, told Verywell. “They thought the vaccine would at long last be available.”  

But rather than worry that the delay could add to parents’ hesitancy, Pavia was more worried that “authorizing the first two doses without knowing about the effectiveness of the third dose would be more likely to undermine trust in the process.”

Julie Morita, MD, executive vice president of the Robert Wood Johnson Foundation, the largest private healthcare philanthropy in the U.S., told Verywell that many parents are likely to find the news on the authorization delay confusing and upsetting. She advised parents of young children to begin talking to their doctors, trusted community health leaders, and local departments of health about the vaccine.

“Even before authorization, experts can talk to you about the review process for the vaccines in all age groups, why it will be important to vaccinate your child once the shot is available, and any specific concerns you have about your child,” Morita added.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.