FDA signs off on COVID vaccines for kids age 5 and younger

The Food and Drug Administration (FDA) on Friday gave the green light to COVID-19 vaccines for children ages 5 and younger, a key step toward making the shots available for the youngest children.

The agency authorized the vaccine from Pfizer and BioNTech for kids ages 6 months to 4 years old, as well as a vaccine from Moderna for kids up to age 5.

More than a year and a half since COVID-19 vaccines began rolling out for adults, kids under 5 are the last group eligible to be vaccinated. There are about 18 million of them eligible.

“Many parents, caregivers and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age. As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” FDA Commissioner Robert Califf said in a statement.

With the authorization, vaccines can start being shipped to states and other jurisdictions that preordered the initial batch.

Advisers to the Centers for Disease Control and Prevention (CDC) are scheduled to meet Friday and Saturday to discuss whether to recommend the use of the shots in young kids. 

If all goes well, CDC Director Rochelle Walensky could sign off on a favorable recommendation as early as Saturday.

The Biden administration is aiming for vaccinations to start by June 21, but it will likely be a challenge to convince parents initially, making it an open question just how strong the demand will be.

Vaccines will be distributed across thousands of different sites, but the administration will focus on front-line providers, including pediatricians and primary care doctors, as that is where they expect many families will want to go. The White House has indicated it recognizes the burden will be on pediatricians to help talk to hesitant families and explain the benefits of getting their kids vaccinated.

“It builds with trusted voices, physicians, faith leaders, others helping people get vaccinated. This is not a one-and-done, this is not an automatic. That’s what we have seen for kids 12 and above. We’re continuing to see that with kids 5 to 11. And we expect that to be an ongoing journey for kids under 5,” White House coronavirus response coordinator Ashish Jha told reporters recently.

FDA said the vaccines are safe and effective and prevent serious disease, though neither performed very well in preventing symptomatic disease, especially against the omicron variant.

Young kids are at risk from COVID-19 even if they don’t get sick as often as adults. According to the FDA, 442 children younger than 5 had died of COVID-19 through the end of May, a toll higher than for many other vaccine-preventable illnesses.

Moderna’s two-dose mRNA vaccine is intended to be administered four weeks apart and is one-quarter the strength of an adult dose. Pfizer’s vaccine is three doses, spread much further apart. 

The first two doses of Pfizer’s shot are given three weeks apart, but the company recommends giving the third dose eight weeks after the second. The doses are also just one-tenth the strength of an adult vaccine, and the company found essentially no protection after two doses. 

Updated at 9:52 a.m.