Updated October 29, 2021 at 6:10 PM ET
Updated Nov. 2, 8:10 p.m. ET
Children as young as 5 will be able to get vaccinated against COVID-19 in the U.S. within the next several days.
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 has to happen before the Pfizer-BioNTech shots can start going into kids' arms.
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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
Next, the FDA — the agency itself — considered the advisers' vote on Pfizer's smaller-dose shot for kids. On Friday, FDA officials decided to extend the emergency use authorization for Pfizer's COVID-19 vaccine to younger kids. Acting commissioner Dr. Janet Woodcock, assured parents in a statement that the agency had rigorously evaluated the data and "this vaccine meets our high standards."
Step 4: More independent scientists debate and vote
But wait, there's more. Yet another federal health agency and its advisers had to weigh in before the shots can 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 met Tuesday and voted to recommend the vaccine for all children in the 5-11 age group. 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, explained the difference between the two federal advisory groups that weigh in on these kinds of decisions:
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 follow the FDA's lead in their recommendations, or they could "make more focused or nuanced recommendations," Cohn said. For instance, they could have recommended 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. On Tuesday night she greenlit the advisers' recommendation. If she had chosen to, she could have changed the recommendation from what the committee voted on — as she did with boosters — but she followed their lead and recommended them to all kids aged 5-11.
Only after the CDC director issues an official recommendation can 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.
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