- The move comes as the wave of Omicron variants in the United States is waning.
- New pediatric COVID hospitals hit a record high in the United States in December as the Omicron strain spread rapidly.
- The FDA hopes to approve injections for young children by the end of February.
Washington: Pfizer and BioNTech will soon seek emergency approval from US regulators for a COVID-19 vaccine for children under five, US media reported Tuesday.
This is the last age group in the United States not yet eligible for corona shots.
As early as Tuesday, the companies were able to apply for an emergency permit for a two-dose vaccination schedule for children under five and as young as six months, according to The New York Times and other news media.
The move comes as the wave of Omicron variants in the United States subsides, but parents are still grappling with school closures and concerns about their unvaccinated children.
New pediatric Covid hospitals hit a record high in the United States in December as the Omicron strain spread rapidly.
Last month, the Food and Drug Administration approved Pfizer’s COVID-19 booster injection for children as young as 12 years old.
But vaccination rates among this age group are relatively low — less than 22 percent, according to the Centers for Disease Control and Prevention.
As they seek the green light for children under five to receive two doses of the vaccine, Pfizer and BioNTech will also continue to explore a three-shot regimen, the Times reported.
The FDA hopes to approve injections for young children by the end of February. Data on a three-dose regimen would not be submitted until the end of March, the daily reported.
The companies concluded last fall that low doses of the vaccine offered protection in children up to two years old, but not in children two to five years old, and announced in December that they would add a third dose to their trials.
“We know that two doses is not enough, and we understand that,” a source told The Washington Post.
“The idea is, let’s go ahead and start reviewing two doses. If the data in the submission holds, you can start kids on their primary baseline months earlier than if you don’t do anything until the data from the third dose comes in.
