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Pfizer to Request “Emergency Use Authorization” of a Two-Dose COVID-19 Vaccine for Children as Young as 6 Months Old

COVID-19 vaccines for children younger than 5 could be available far sooner than expected—perhaps by the end of February—under a plan that would lead to the potential authorization of a two-shot regimen in the coming weeks, people briefed on the situation said Monday (Jan. 31), who spoke on the condition of anonymity because they were not authorized to speak publicly.

Pfizer and BioNTech are expected to submit to the FDA as early as Tuesday (Feb. 1) a request for emergency use authorization of its COVID-19 vaccine for children 6 months to 5 years old. Older children already can receive the shot.

The FDA urged the companies to submit the application so that regulators could begin reviewing the two-shot data, following disappointing results for a two-shot regimen that did not provide a strong enough immune response.

Pfizer and BioNTech in the last few months have been testing a third dose, but data on a third shot will not be available until at least late March. Once that information is submitted, regulators can decide whether to authorize a third dose.

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