Children younger than 5 in the United States could begin receiving Covid-19 vaccinations this month or next if the US Food and Drug Administration moves quickly to authorize the shot for this age group.
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.
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.
Pfizer’s child-sized vaccine fails to produce expected immunity in younger kids; company adds third dose to trials.
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.”