Topline
Pfizer and BioNTech’s Covid-19 vaccine will hopefully be approved for children under 5 by the U.S. Food and Drug Administration “within the next month or so,” White House chief medical advisor Dr. Anthony Fauci said Wednesday, as the number of children hospitalized with Covid has more than doubled since December.
Aiden Arthurs receives a dose of Pfizer Covid-19 vaccine from pharmacist Andrew Mac at the Jewish ... [+]
Key Facts
The vaccine will be available for kids under 5 hopefully “within the next month or so and not much later than that,” Fauci said during a virtual town hall meeting with Blue Star Families, a nonprofit that supports military families.
Younger children will probably require three doses of the vaccine, Fauci said, as a two-dose course produced a weak immune response in trials.
Revising studies to include three doses rather than two has delayed Pfizer from submitting data to the FDA and extended the timeline for authorizing the vaccine for young children, Fauci told Blue Star Families CEO Kathy Roth-Douquet.
Fauci reminded listeners that there is no hard-and-fast timeline for authorizing the vaccine, remarking that he “can’t out-guess the FDA.”
A Pfizer spokesperson said that the company would not speculate on a timeline for the vaccine’s approval, but pointed out that it took just over three weeks to obtain emergency use authorization for a vaccine for kids age 5 to 11.
Key Background
The rapid spread of the highly transmissible omicron variant, which now accounts for 99.5% of U.S. Covid cases, has coincided with a rise in the number of children hospitalized. About 909 children were hospitalized with Covid-19 between January 11 and January 17, according to the Centers for Disease Control and Prevention, a dramatic jump from 140 in late November.
Crucial Quote
"It seems like people have tried to downplay the significance of the disease in children," children’s physician Dr. Mark Kline told NBC. "We've spent two years rebutting myths pertaining to Covid and children, that it's 'harmless' for children. It's not."
Big Number
93,552. That’s how many children have been hospitalized with Covid, according to the CDC.
Contra
Pfizer previously said it intended to submit data to the FDA during the first half of 2022 if trials of a three-dose vaccination course are successful, possibly indicating a slower timeframe than that suggested by Fauci.
Further Reading
“Fauci says FDA could authorize Pfizer’s Covid vaccine for kids under 5 in the next month” (CNBC)
