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February 23, 2022

In The News: FDA Delays Shot Push for Children Under 5

The sole age group without access to COVID-19 vaccination will remain on the outside looking in until at least April, reports The New York Times. Roughly 18 million children in the U.S. are affected by the FDA.’s authorization decision, which had been envisioned for mid-February. The schedule change was driven in part by CDC data showing three doses offered better protection than two.

Regulators will now await efficacy data on three doses of Pfizer-BioNTech’s coronavirus vaccine after the company requested the delay as young children, including volunteers in the clinical trial, had a far higher infection rate from Omicron than had previously been seen. Early results from a two-shot regimen showed disappointing antibody levels for children ages 2 through 4 while children aged 6 months to 2 years-old did produce a robust antibody response to the one-tenth dosage of that given to those 12 and older.

Pfizer-BioNTech had already submitted its request for emergency authorization and the FDA had a meeting scheduled when the company alerted the agency of new data featuring the Omicron wave. That new data revealed two doses were not sufficient to prevent symptomatic infection. As a result, regulators opted to adjust its meeting time and data evaluation.

News of the delay presented its own issues. Many parents were eager to finally have their small children vaccinated, even if the efficacy was reportedly less than other age groups. There were also concerns as to how the public may take such news of the vaccine in the politically charged atmosphere. Looming over these discussions was the toll the virus has had, particularly during an Omicron wave that have placed children at even higher risk.

Ultimately, the decision to approve the vaccine for the youngest age group will be made and will be data-driven. “I honestly let out a woo-hoo of elation that reason and science had prevailed, and that [the FDA] actually really did do the right thing,” said PIDS member James Conway who is quoted in the story on the decision to delay. PIDS member Ofer Levy, also in the story, weighed in on the decision, “They’re under intense pressure. I don’t envy them.” Other members quoted inn the story were Kristin Moffitt and Jessica Snowden.

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