Children as young as 5 may be able to get vaccinated against COVID-19 in the U.S. as soon as next week.
While some parents aren’t sure how they feel about this, others are waiting eagerly for a chance to protect their children from COVID-19.
But federal agencies can’t be rushed. Here’s what still needs to happen before the Pfizer-BioNTech shots can start going into kids’ arms.
Currently, Pfizer is the furthest along in this process, but Moderna has shared some promising results from its vaccine trial with this age group, and Johnson & Johnson is expected to begin vaccine trials for young kids in the future as well. Here are more details on what the regulatory process entails and how it is going for the Pfizer vaccine.
Step 1: Drugmakers complete the clinical trial
Pfizer and BioNTech have completed a three-phase clinical trial in children 5 to 11 years old. The companies submitted all of the data from that trial and an application for emergency use authorization to the Food and Drug Administration on Oct. 7.
The main study included 2,250 kids and found that the lower-dose version of the vaccine was 90.7% effective in preventing symptomatic COVID-19. It was given as a series of two shots, 21 days apart, and the dose was 10 micrograms, a third of the dose given to adults and teenagers.
No serious side effects such as heart inflammation were reported, although with only a few thousand children included in the research, that sort of rare problem wouldn’t necessarily be detected.
Step 2: Independent scientists review the data
This week, on Oct. 26, a panel of outside scientists considered Pfizer’s safety and efficacy data, along with an analysis from FDA scientists on the risks and benefits of the vaccine in different pandemic scenarios.
After some lively discussion, the group overwhelmingly voted yes, that the benefits of the Pfizer vaccine outweigh the risks for use in this age group.
Step 3: FDA officials weigh in
Now, the FDA — the agency itself — needs to consider the advisers’ vote on Pfizer’s smaller-dose shot for kids and decide on whether to extend the emergency use authorization for Pfizer’s COVID-19 vaccine to this age group.
Step 4: More independent scientists debate and vote
But wait, there’s more. Yet another federal health agency and its advisers need to weigh in before the shots will become available — this time, it’s the Centers for Disease Control and Prevention.
You can think of it like this: When it comes to vaccines, the FDA is in charge of the what, and the CDC is in charge of the who.
The CDC’s advisory group is scheduled to meet on Nov. 2. Dr. Amanda Cohn served until recently as the executive secretary for the CDC’s vaccine advisory group, and she’s a voting member of the FDA’s vaccine advisory group, so she’s uniquely positioned to explain the difference between the two:
The FDA decides whether a vaccine (or other product) is safe and effective, she explained at the FDA advisory meeting this week. The CDC’s group then considers and votes on “who would benefit from the vaccine and who should get vaccinated.” Their deliberations include factors such as equity, feasibility and the “potential impact of recommendations on a population,” she said.
When they vote, the CDC’s advisers could recommend the vaccine for all children in the 5-11 age group, or they could “make more focused or nuanced recommendations,” Cohn said. For instance, they could recommend it for a certain subgroup, like children with underlying conditions or those who haven’t had a prior coronavirus infection.
Step 5: CDC director makes final recommendation
Even then, a vote from the CDC’s advisers isn’t an official recommendation — that comes from the CDC’s director, Dr. Rochelle Walensky. She can simply greenlight the advisers’ recommendation, or — as she did with boosters — she can change it. There’s no prescribed timeline on when her recommendation must come down, but she’s widely expected to rule next week.
Only after the CDC director issues an official recommendation will shots get distributed to pediatricians and pharmacies around the country.
Step 6: The shots get distributed to providers and pharmacies
Experts have been reassuring the public that the rollout of this new lower-dose vaccine won’t be a repeat of the disarray of the original COVID-19 vaccine rollout last winter.
“We will be ready immediately following FDA and CDC’s decisions so that parents can get their kids vaccinated quickly, easily and conveniently,” Jeffrey Zients, the White House’s COVID-19 response coordinator, said at a news conference Wednesday.
The immunization managers planning the rollout in each state feel much more ready this time, says Claire Hannan, executive director of the Association of Immunization Managers.
“We have plenty of vaccine, and I think that we’re very well prepared,” she says.
Still, she warns that parents shouldn’t expect that they’ll be able to get their kid vaccinated the instant the regulatory hurdles are cleared. There will be challenges getting the vaccine to the right providers to meet the demand.
Experts suggest looking out for guidance from your child’s pediatrician and school. Parents will also be able to find pharmacies with pediatric COVID-19 shots in stock at vaccines.gov, a CDC website launched in February to help people who want COVID-19 vaccines figure out where to go.