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Pfizer Requests FDA Authorize COVID Shots for Kids Under 5

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Children under 5 years old may be eligible for coronavirus shots as soon as the end of February — much earlier than previously expected.

On Tuesday, Pfizer and BioNTech announced that they requested the Food and Drug Administration authorize a two-dose regimen of their vaccine for children under 5. Meanwhile, the companies will continue to research the efficacy of a third shot.

In December, disappointing trial data showing that two smaller doses were safe for youngsters but, in children ages 2 to 4, did not produce a strong enough immune response threatened to extend the timetable before which young children would be eligible for COVID vaccines. But the FDA urged Pfizer-BioNTech to submit their initial trial data so that regulators could begin the review process, then to later submit numbers on a third shot once those become available, The Washington Post first reported. Results from the study of a three-dose regimen are expected to arrive in late March at the earliest.

“If they get the two-dose approved, then they can get going. And by the time the first round of two-dose people are ready to boost … if they have a third dose approved, then they’ll get through this course,” explained Benjamin Linas, professor of medicine at Boston University. “But if they wait until they have all the data for the three-dose course, then they won’t even be able to get started.”

Even if three shots prove to be the optimal vaccination level for the age group, the Massachusetts doctor reassures parents that two doses provide far more protection than zero.

“Absolutely, it should give families some peace of mind having their children two-dose vaccinated,” he told The 74.

The news may bring some long-awaited relief to parents of children under 5 for whom the Omicron surge has been particularly frightening and stressful between spikes in pediatric hospitalizations and widespread day care center closures.

“As a parent of a 3-year-old, this news does feel like light at the end of (the) tunnel,” said Jorge Burmicky, assistant professor at Howard University, in a tweet sharing The Washington Post story.

But nationwide, rates of pediatric vaccination remain low. As of Jan. 26, just 20 percent of children ages 5 to 11 were fully immunized, while 55 percent of those ages 12 to 17, who have been eligible for shots for longer, had received two doses, according to data published by the American Academy of Pediatrics.

As of November, nearly a third of parents of children ages 5 to 11 said they would “wait and see” before immunizing their kids in the most recent poll administered by the Kaiser Family Foundation on parents’ vaccine attitudes.

For this decision around immunizations for children 6 months to 4 years old, Linas believes federal agencies must be upfront about the expected authorization process. Without clear messaging that young kids may ultimately need to receive three shots — but that the initial authorization of a two-shot regime allows youngsters to safely get started — he worries the eventual pivot could erode some parents’ faith in the shots. 

“If you don’t talk about it … it just creates this opportunity for misinformation, lack of trust, and then people shut down,” he said. “This is all about trust right now.”

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