Pfizer Requests FDA Authorize COVID Shots for Kids Under 5

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Updated Version:

It is now anticipated that children under the age of 5 could become eligible for coronavirus vaccinations by the end of February, which is earlier than previously predicted.

On Tuesday, Pfizer and BioNTech revealed that they have requested authorization from the Food and Drug Administration for a two-dose regimen of their vaccine for children under 5. In the meantime, the companies will continue to analyze the effectiveness of a third shot.

Back in December, disappointing trial data indicated that two smaller doses were safe for young children. However, in children aged 2 to 4, these doses did not generate a strong enough immune response. This raised concerns about the timeline for vaccinating young children against COVID. But Pfizer-BioNTech was encouraged by the FDA to submit their initial trial data so that the review process could begin. They were also advised to submit data on a third shot once it becomes available. The Washington Post was the first to report this. The results from the study on a three-dose regimen are expected to be available no earlier than late March.

Benjamin Linas, a professor of medicine at Boston University, explained that if the two-dose regimen is approved, they can move forward with vaccination. By the time the first group of individuals who received two doses is ready for a booster, if the third dose is authorized, the process can continue smoothly. However, if they wait until they have all the data on the three-dose regimen, then they won’t be able to start vaccinating at all.

Even if three shots prove to be the ideal vaccination protocol for this age group, Linas assures parents that two doses offer significantly more protection than none at all. He told that families should feel reassured by having their children vaccinated with the two-dose regimen.

This news may bring some long-awaited relief to parents of children under 5 who have been particularly anxious during the Omicron surge, with increased hospitalizations among children and widespread closure of daycare centers.

Jorge Burmicky, an assistant professor at Howard University and parent of a 3-year-old, tweeted that this news feels like light at the end of the tunnel. He shared The Washington Post story.

However, pediatric vaccination rates nationwide remain low. As of January 26, only 20 percent of children aged 5 to 11 had received full immunization, while 55 percent of those aged 12 to 17 had received two doses, as reported by the American Academy of Pediatrics.

In a recent poll conducted by the Kaiser Family Foundation on parents’ attitudes towards vaccines, nearly one-third of parents of children aged 5 to 11 stated that they would wait and see before vaccinating their children.

Regarding the decision to immunize children aged 6 months to 4 years old, Linas believes that federal agencies must be transparent about the expected authorization process. Without clear messaging that young children may eventually need to receive three shots, but that the initial authorization for a two-dose regimen allows for a safe start, he fears that parents’ trust in the vaccines may be undermined.

He stated, "If you don’t discuss it, it creates an opportunity for misinformation, lack of trust, and ultimately, people become hesitant. Right now, trust is crucial."

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