The move comes as the Omicron variant wave is declining in the United States.
Washington:
Pfizer and BioNTech will soon ask US regulators for emergency authorization for a COVID-19 vaccine for children aged five and under, US media reported on Tuesday.
This is the last age group in the United States not yet eligible for coronavirus shots.
The New York Times and other news outlets said that as early as Tuesday, companies may seek emergency authorization for a two-dose vaccination for children under five and six months old.
The move comes as the Omicron version is waning in the United States, but parents are still grappling with school closures and concerns for their illiterate children.
New pediatric COVID hospitalizations in the United States reached a record high in December as the Omicron strain spread rapidly.
Last month, the Food and Drug Administration approved Pfizer’s COVID-19 booster shot for children under the age of 12.
But according to the Centers for Disease Control and Prevention, vaccination rates in this age group are relatively low — less than 22 percent.
The Times said that as they want the green light to get two doses of the vaccine for children under the age of five, Pfizer and BioNTech will also continue studies on the three-shot regimen.
The FDA expects to approve the shots for young children by the end of February. Added Daily, data on the three-dose regimen will not be presented until the end of March.
The companies, which concluded last fall that the low dose of the vaccine provided protection in children up to two years of age, but not in children between the ages of two and five, announced in December that they would be adding a third dose to their trials.
“We know two doses are not enough, and we get that,” a source told The Washington Post.
“The idea is, let’s go ahead and start the review of the two doses. If the data stays in the submission, you can start the kids on their primary baseline months earlier if you don’t get anything until the data for the third dose. I do.”
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