(The Hill) – Pfizer and BioNTech are reportedly close to submitting a request for emergency authorization for a COVID-19 vaccine that can be administered to children under the age of 5.
Sources familiar with the matter told The Washington Post that the companies are expected to submit a emergency use authorization request for their two-dose vaccine to the Food and Drug Administration (FDA) as early as Tuesday, potentially allowing for the vaccine to be available by the end of the month.
According to the sources who spoke with the Post, the FDA urged the companies to submit their request so that regulators could review the data on the vaccine.
“The idea is, let’s go ahead and start the review of two doses,” one source, who asked to remain anonymous, told the newspaper. “If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don’t do anything until the third-dose data comes in.”
A Biden administration official told the Post that there was a consensus among health officials in “seeing this move forward,” speaking on the companies’ plans of submitting their request.
The Hill has reached out to Pfizer and the FDA for comment.
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The two-dose vaccine had a good safety profile in young children and was shown to be effective at preventing numerous COVID-19 cases, according to a source.
Currently, Pfizer’s COVID-19 vaccine is the only shot approved for children as young as 5 in the U.S. Pediatric vaccinations have remained low. As of mid-January, around 28 percent of children aged 5 to 11 are at least partially vaccinated, according to the Kaiser Family Foundation
The lack of COVID-19 vaccines for young children has become a source of anxiety for some parents with children under the age of 5, especially as the omicron variant caused cases to once again skyrocket across the country. However, many parents continue to express hesitance and skepticism about getting their children vaccinated at all.
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