COVID-19 Vaccine For Children: Approval Timeline for Young Age Groups

The Pfizer-BioNTech COVID-19 vaccine could be cleared for use on children ages 11 to 15 this month. Jeff J Mitchell/Getty Images

We are in the fifth month of a nationwide COVID-19 vaccine rollout. As of Tuesday, more than 100 million American adults have been fully vaccinated. Under the current FDA authorization, only people age 16 or older are eligible to receive COVID-19 vaccines. Naturally, the next big question is: when will we have a COVID-19 vaccine for children?

Multiple clinical trials targeting adolescents and younger kids are underway. The Pfizer-BioNTech vaccine, the first to receive the emergency use authorization for adults in the U.S., is close to obtaining the FDA’s approval for use on people ages 11 to 15.

Other vaccine makers, including Moderna, Novavax and Johnson & Johnson are also either actively testing their shots on children or have a plan to do so. (Moderna’s and J&J’s vaccines are authorized for use on people age 18 and above.) Here’s what you can expect:

Children ages 12 to 15: Early May

Pfizer last month officially asked the FDA to expand the emergency use authorization to people ages 12 to 15. The agency could green light the application as soon as next week, according to multiple media reports.

The anticipated decision will allow many middle school and high school students to be fully vaccinated before the start of the next school year.

In a recent trial of 2,260 adolescents ages 12 to 15, Pfizer and BioNTech found their two-dose mRNA-based vaccine to be 100 percent effective against the coronavirus. Of the 16 adolescents infected by COVID-19 in the trial, all had received the placebo, none the active vaccine.

Novavax and Moderna are expected to conclude their teenager trials soon. J&J has plans for similar studies. AstraZeneca’s test on children has been paused due to ongoing investigations into blood-clotting issues.

Children ages 5 to 11: Late Summer

The Pfizer-BioNTech vaccine is also being tested on younger children. BioNTech cofounder and chief medical officer Özlem Türeci said Thursday trial data on kids ages 5 to 11 could be available before the end of this summer.

“We expect the data at the end of the summer or autumn of this year. We will then file it with the regulators and, depending on how fast they react, by the end of the year we might get approval to also immunize younger children,” Türeci told CNBC.

Children under age 5: Unknown

Children younger than five years old are the last group in Pfizer’s and BioNTech’s vaccine testing. The two pharma firms began a clinical trial on healthy kids between 6 months old to five years old in late March. Türeci said in Thursday’s interview that it’s possible data on kids under age 5 could come “a bit later.”