Pfizer on Tuesday asked the US Food and Drug Administration (FDA) to authorize extra-low doses of its COVID-19 vaccine for children under five years old, potentially opening the way for the very youngest Americans to start receiving shots as early as next month.
In an extraordinary move, the FDA had urged Pfizer and its partner, BioNTech, to apply earlier than the companies had planned — and before it is settled if the youngsters will need two shots or three.
The US’ 19 million children younger than five are the only group not yet eligible for vaccination against COVID-19. Many parents have been pushing for an expansion of shots to toddlers and preschoolers, especially as the Omicron variant of SARS-CoV-2 sent record numbers of youngsters to the hospital.
Photo: AFP
“I would say the parents in my office are desperate” to get young kids vaccinated, said Dyan Hes, who runs a pediatrics practice in New York City, where vaccination rates are high.
For many, “that’s the first thing they ask when they walk through the door: ‘When do you think the shot is going to come out?’” he added.
Pfizer aims to give children as young as six months shots that contain one-10th of the dose given to adults. The company said it had started submitting its data to the FDA and expects to complete the process in a few days.
An open question is how many shots those children would need. Two of the extra-low doses turned out to be strong enough for babies, but not for preschoolers in early testing. Pfizer is testing a third shot and publish its data late next month.
That means the FDA might consider whether to authorize two shots for now, with potentially a third shot being cleared later if the study supports it.
Pfizer CEO Albert Bourla said in a statement that the company’s scientists believe this age group would ultimately need three of the extra low-dose shots, but that FDA action now could let parents begin the vaccination process while awaiting a final decision.
The FDA said it would convene a panel of independent researchers and physicians in the middle of this month to help review the Pfizer data. The agency is not required to follow their advice, but the input is a key step in publicly vetting vaccine safety and effectiveness.
The question of how long to wait for new vaccine data — and how much to require — is a concern for FDA regulators, who face pressure to be more proactive against a virus that has repeatedly confounded health experts.
The FDA asked Pfizer to begin submitting its application now due to Omicron’s “greater toll on children,” an agency spokeswoman said, citing a peak in cases among children under five.
“In light of these new data and the rise in illnesses and hospitalization in this youngest age group, FDA believed that it was prudent to request that Pfizer submit the data it had available,” FDA spokeswoman Stephanie Caccomo said in an e-mailed statement.
The FDA’s ultimate decision could come within the month, but the US Centers for Disease Control and Prevention also has to sign off.
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