On Tuesday, vaccine makers Pfizer and BioNTech initiated a request for the FDA to authorize their child-sized coronavirus vaccine for emergency use in the United States among children age 6 months to up to 5 years.
The Pfizer/BioNTech vaccine is already authorized for use in people as young as 5, and if authorized, this shot will be the first coronavirus vaccine available for the youngest children.
The companies asked the FDA to grant emergency use authorization for a two-dose regimen of the vaccine. Meanwhile, the vaccine makers plan to continue testing a three-dose regimen in this younger age group.
The move comes “in response to the urgent public health need in this population,” the companies said in a news release.
“As hospitalizations of children under 5 due to COVID-19 have soared, our mutual goal with the FDA is to prepare for future variant surges and provide parents with an option to help protect their children from this virus,” Pfizer Chairman and CEO Albert Bourla said. “Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants.”
What happens next could determine how soon parents can get their toddlers vaccinated.
What needs to happen before shots can roll out?
Before the Pfizer/BioNTech coronavirus vaccine can be administered to children under 5, the FDA needs to authorize it for emergency use among that age group.
The FDA’s vaccine advisory committee will meet February 15 to discuss the submission. The FDA will review the data from clinical trials in Pfizer/BioNTech’s EUA request and then decide whether to grant emergency authorization.
Once the FDA authorizes the vaccine for young children, vaccine advisers to the US Centers for Disease Control and Prevention — the Advisory Committee on Immunization Practices — would meet to discuss the EUA, review data on the vaccine and vote on advising the CDC to recommend using the vaccine.
“The FDA uses data submitted by the manufacturer. ACIP can use all kinds of other data to consider in their deliberations,” Dr. Sean O’Leary, vice-chair of the American Academy of Pediatrics Committee on Infectious Diseases, told CNN on Tuesday.
Next, CDC Director Dr. Rochelle Walensky reviews ACIP’s vote and could recommend the vaccine for children under 5, giving the green light for vaccines to be administered to that age group.
“At that point, then, it just depends on getting the vaccine shipped into places that they’re going to be delivering the vaccine,” said O’Leary, who is also a professor of pediatric infectious disease at the University of Colorado School of Medicine and works with Children’s Hospital Colorado.
How soon can young kids get vaccinated?
Federal regulators encouraged Pfizer to seek authorization for a two-dose vaccine regimen, which would allow an EUA to possibly be granted by late February, according to a person familiar with the plan. Waiting on data for three doses could extend the wait until March.
This means young children age 6 months to up to 5 years could get vaccinated as early as sometime in late February or early March.
In December, Pfizer announced that it decided to add a third dose to the primary vaccine regimen for babies and children ages 6 months to up to 5 years. That decision came after initial trials in children ages 2 to 5 showed that the original two-dose regimen of the child-sized vaccine did not provide the expected immunity in the 2- to 5-year-olds, although it did so for the babies up to age 2.
The companies said Tuesday that data on a third dose given at least eight weeks after the second dose is expected in the coming months and will also be submitted to the FDA.
Where can my young child get vaccinated?
Pediatricians’ offices are expected to be among the main sites where children younger than 5 will be able to receive their Covid-19 vaccinations, according to O’Leary.
He added that public health departments and pharmacies could be some other locations, as well.
“It gets a little trickier under 5 because a lot of pharmacies may not be accustomed to giving vaccines to children under 5, so that will depend on the various pharmacies,” he said. “We know that a lot of the current vaccination is happening in pharmacies, but more and more are happening in primary care offices, where pediatricians and family medicine physicians are very used to giving vaccines to younger kids.”
O’Leary added that many of the pediatricians’ offices that are now administering Covid-19 vaccinations to children ages 5 to 11 are likely to also be sites for vaccinations for younger children.
The vaccine will be administered as an injection in the muscle, given as two doses, about three weeks apart.
Why was the EUA request delayed?
Pfizer’s decision to extend its vaccine trial in younger children and test a three-dose regimen delayed its initial application to the FDA for authorization of its vaccine for children under 5.
The company decided to add the third dose — a 3-microgram dose given at least two months after the second dose — for all children and babies ages 6 months to 5 years after its independent outside advisers, the Data and Safety Monitoring Board, viewed the data, which showed the vaccine doses were not providing the protection from infection expected among 2- to 5-year-olds.
There were no safety concerns.
“Previously, we had data showing that the childhood vaccine for 6 months to 4 years wasn’t as protective against infection as the adult vaccine. That’s the reason why they pushed it out and asked for that third dose,” Gottlieb told Brennan on Sunday.
“But now, if the goal of the vaccine is to get baseline immunity in the kids — to prevent really bad outcomes — and you’re really not using the vaccine as a tool to prevent infection in the first place, two doses could do that,” Gottlieb said. “I think that may be why federal health officials are rethinking this.”
How is the vaccine for younger children different from the others?
For children younger than 5, Pfizer and BioNTech already had reduced the vaccine dosage size. For the 12-and-up age group, the dosage has been 30 micrograms of vaccine. Pfizer and BioNTech stepped that down to 10 micrograms for children 5 to 11 and took it even lower to 3 micrograms per dose for children younger than 5.
“In the under 5, the dose that they landed on — based on looking at different doses in earlier trials — was three micrograms, so one-tenth of what we saw in what we’re using in the adults,” O’Leary said.
Early tests had indicated that this 3-microgram dose would produce a strong immune response in the children and minimize the risk of side effects.
What do we know about parents’ willingness to get kids vaccinated?
Once vaccine doses are authorized for children younger than 5, 31% of parents of children in this age range say they’ll get their child vaccinated right away, up from 20% in July, according to survey results from the Kaiser Family Foundation published Tuesday.
The survey of more than 1,500 adults, conducted in January, found that another 29% say they will “wait and see” before getting their child under 5 vaccinated, down from 40% in July. Around 1 in 10 parents, or 12%, say they’ll vaccinate their child under 5 “only if required,” while about a quarter or 26% say they will “definitely not” vaccinate their young child.
Until younger children are eligible to get vaccinated, “we’ve got to do our best to protect them,” Dr. Stephen Parodi, national infectious disease leader for Kaiser Permanente, told CNN in November.
“For the youngest children that we have, we still got to take those protective measures when it comes to distancing, and ideally, if people are coming into the household, that they have gotten vaccinated so that you’re minimizing the risk,” Parodi said, adding that mask-wearing is key too.