Pfizer might search FDA’s OK for COVID vaccine for youths beneath 5 as quickly as Tuesday: studies

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Federal authorities are expected to be asked as early as Tuesday to approve Pfizer’s COVID-19 vaccine for children as young as 6 months, and the first vaccinations could come by the end of February, according to news reports Monday night.

The New York Times and Washington Post both reported Pfizer Inc. PFE, -3.02% and its vaccine partner, BioNTech SE BNTX, +6.08%,
will seek emergency use authorization from the Food and Drug Administration to allow the shot to be used in children between the ages of 6 months and 4 years. Regulators are reportedly requesting data on a two-dose vaccine that may lead to approval in the coming weeks.

According to the reports, a three-dose regimen is likely to be recommended for children under the age of 5, but health officials are keen to start vaccinations as soon as possible to protect against the highly infectious Omicron variant.

“We know that two doses isn’t enough, and we understand that,” an unnamed source familiar with the situation told the Post. “The idea is that we go ahead and start checking two cans. If the data persists in the filing, you could start children months earlier on their primary baseline than if you do nothing until the third dose data arrives.

A child-sized version of Pfizer’s vaccine is currently available for 5- to 11-year-olds at a third the dose given to everyone else aged 12 and over.

For children under 5, Pfizer is testing an even lower dose, just 3 micrograms, or one-tenth the adult dose, the Associated Press has reported.

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