Questions and answers about COVID-19 shots for children under 5
On Friday, Food and Drug Administration officials said ongoing studies by Pfizer and BioNTech did not support authorization of the first two doses of COVID-19 vaccine for children ages 6 months to 4. Credit: TNS/NICOLAS TUCAT
Parents and guardians must wait until at least April to get their children under 5 years old vaccinated against COVID-19 after federal regulators postponed approval of the first two shots of what will ultimately be a three-dose regimen.
On Friday, Food and Drug Administration officials said ongoing studies by Pfizer and BioNTech did not support authorization of the first two doses on a fast-track basis for children ages 6 months to 4 and more research is needed.
Here is everything you need to know.
I thought the FDA was planning to approve the vaccine for young children later this month. What happened?
The FDA was scheduled to begin the authorization process for the pediatric vaccine at its Tuesday meeting. The initial approval was for two doses while Pfizer conducts clinical trials on the efficacy of a third shot. But in an unexpected decision, the FDA said it wanted to see data from the third dose before proceeding with authorization.
"The goal was to understand if two doses would provide sufficient protection to move forward with authorizing the use of the vaccine in this age group," Acting FDA Commissioner Janet Woodcock said in a statement Friday. "Our approach has always been to conduct a regulatory review that’s responsive to the urgent public health needs created by the pandemic, while adhering to our rigorous standards for safety and effectiveness."
The FDA had asked Pfizer to speed up its application as the omicron variant caused a surge of infections nationwide, including among young children.
What have Pfizer's pediatric clinical trials shown about the vaccine's safety and effectiveness in young children?
The trials of approximately 8,300 children from 6 months to 12 showed varying immune responses for kids of different ages. Children 6 months to 2 showed better protection, Pfizer found, but the two-dose regimen failed to provide robust immunity to kids ages 2 to 4.
The second shot would come 21 days after the first, and the third eight weeks later.
When will data on a third shot be available?
Pfizer is expected to release that information in early April.
"Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group," the companies said in a statement last week.
Will young children get the same amount of vaccine as older children or adults?
The dose for children 6 months to age 4 would be 3 micrograms. Children ages 5 to11 receive a 10-microgram dose and those 12 and older receive 30 micrograms.
The nation’s 18 million children under 5 make up the only age group not yet eligible for vaccination.
What about other drugmakers?
Moderna is testing its vaccine with this younger age group and plans to submit data to the FDA in March. Johnson & Johnson is also expected to conduct vaccine trials for children under 5.
Even if the FDA approves the vaccine, how many parents allow their child to get the shot?
That's unclear. A Kaiser Family Foundation poll taken last month found just over 30% parents of children under 5 would get their youngster vaccinated as soon as shots were authorized, while 38% said they would not vaccinate their children or only do so if required. The rest said they would take a wait-and-see approach.
While 95% of adults in New York State have received at least one dose of the vaccine, those numbers drop to 76% for children ages 12 to 17, and to 38% for kids ages 5 to 11, according to state health department data.
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Robert Brodsky is a breaking news reporter who has worked at Newsday since 2011. He is a Queens College and American University alum.
