Pfizer, the pharmaceutical giant behind one of the three main COVID-19 vaccines in the U.S., is reportedly set to officially ask the Food and Drug Administration for Emergency Use Authorization of the COVID-19 vaccine for children ages six months to five years old. If the FDA were to grant Pfizer the request, shots could reportedly be available by the end of February. The possible move comes as several European nations have recommended against COVID-19 vaccines for children under 12 years old.
According to NBC News, a source close to the potential development said that “Federal regulators want to begin reviewing the data on two doses of the vaccine for this age group while the companies continue to gather data on a potential three-dose regimen.”
That source added that “The FDA is expected to eventually sign off on three doses for kids under 5, but regulators believe two doses in the meantime should provide enough — though less than ideal — protection against the omicron variant.”
As noted by The New York Times, the head of Pfizer has publicly stated in the past that the company’s goal was to have vaccine and boosters ready for children under five:
Kathrin Jansen, Pfizer’s head of vaccine research, said in December that the company would seek F.D.A. clearance for three doses for young children, a strategy that she said would allow for “a consistent three-dose vaccine approach for all ages.” The company switched its plan because the F.D.A. was pressing for more urgent action, two people said. If authorized, young children will receive their second dose three weeks after the first, and a third dose two months after that.
On Tuesday, NPR reported that a Pfizer representative did not confirm or deny that the company would be submitting the approval this week, but rather that, at this time, “we have not filed a submission, and we’re continuing to collect and analyze data from both two and three doses in our younger age cohort.”
While COVID-19 cases have increased amongst children, recent data indicates that the overwhelming number of hospitalizations with COVID-19 are adults. One New York epidemiologist recently told HealthLine.com that children under age the of one are more likely to be admitted to the hospital simply because of a “lower threshold” for admittance:
According to Dr. Jennifer Lighter, hospital epidemiologist at NYU Langone Health and pediatric epidemiologist and pediatric stewardship director, children still represent only 2 percent of COVID hospitalizations.
That said, there are a variety of reasons why hospitalizations for children are rising amid the surge of Omicron.
“Our hospitalization rate is higher for children less than 1 years of age than it is for children between 5 and 11, and that is because there is a lower threshold to admit babies with COVID. Also, if a baby under 2 months of age has a fever, they are automatically admitted,” said Lighter, as one of the reasons for a higher hospitalization rate.
The potential EUA-approval from the FDA comes as European nations like Sweden are forgoing recommending the COVID-19 vaccine for young children, saying the risks of COVID-19 do not outweigh the benefits of the vaccine.
On Friday, The Daily Wire reported that the Swedish government said in a press release that “children are at a significantly lower risk of developing severe COVID-19 disease compared with adults. In general, the younger the child, the lower the risk.”