Pfizer, the pharmaceutical giant behind one of the three main COVID-19 vaccines in the U.S. in partnership with BioNtech, announced Friday that they will be postponing their official request of the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the COVID-19 vaccine for children ages six months through 4 years of age. It had previously been reported Pfizer would be making their request by the end of February.
According to Axios, “The companies said they ‘will wait for the three-dose data’ because they ‘believe it may provide a higher level of protection in this age group.'”
CNN also reported that the companies said in a press release that since “the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group.”
“This is also supported by recent observations of three dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen,” the release added.
As noted by The New York Times, the head of Pfizer’s vaccine research 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.
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.
In January, 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.”
“With the knowledge we have today, with a low risk for serious disease for kids, we don’t see any clear benefit with vaccinating them,” Health Agency official Britta Bjorkholm said at a news conference in late January.
“As before during the pandemic, children are at a significantly lower risk of developing severe COVID-19 disease compared with adults,” the Swedish government added in a press release at the time. “In general, the younger the child, the lower the risk. Since the end of October 2021, the Swedish Public Health Agency has been recommending general vaccination against covid-19 from the age of 12 in Sweden. This is based on the benefit to the individual child.”
“Discussions about the decision have been held with the Pediatricians’ Association, the School Medical Association, the National Association of School Nurses, the Child Psychiatric Association, the Swedish Society for Infectious Diseases, vaccine coordinators within the regions, Swedish Municipalities and Regions (SKR), the Medical Products Agency and the Swedish Medical Council (Smer),” the Swedish government noted.
As for America, the data to determine the efficacy and necessity of vaccines for children under 5 is expected to be available in April, according to Pfizer and BioNTech.
This is a developing story; Additional information has been added after publication.