Fauci said that FDA could authorize Pfizer’s Covid vaccine for kids under 5

January 21, 2022: On Wednesday, White House chief medical advisor Dr. Anthony Fauci said the Food and Drug Administration could approve Pfizer and BioNTech’s vaccine for children less than 5-years-old in the coming month.

“I hope that it’s going to be within the coming month or so and not much later than that, but I can’t guarantee that,” Fauci said in an interview with Blue Star Families. This nonprofit group supports military families.

In Pfizer’s clinical trials, Fauci said younger children would likely need three doses as two shots did not induce an adequate immune response in 2- to 4-year-olds.

Pfizer is planning to submit data to the Food and Drug Administration in the first few months of 2022 if the three-dose study proves successful, the company announced in December. Pfizer said that it did not identify any safety concerns with the 3-microgram vaccine doses in children six months to 4-years-old.

Children under 5 are particularly vulnerable because they are the only age group that is not currently eligible for vaccination. Hospitalizations of children with Covid are increasing as the highly contagious omicron variant has spread through communities across the U.S. over the past month rapidly.

“Sadly, we see the rates of hospitalizations increasing for children zero to four, children who are not yet eligible for Covid-19 vaccination,” Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, told reporters in a conference call earlier this month.

Almost 8 out of every 100,000 children under 5-years-old were hospitalized with Covid as of January 8, more than double the rate in early December before the omicron is the dominant variant in the U.S., according to CDC data collected from 250 hospitals across 14 states.

Walensky said earlier this month there’s no indication that the omicron variant causes more severe illness in children. She told the delta variant also led to increased hospitalizations among children. Still, research later indicated that the variant did not make kids sicker compared with past variants. Real-world data from the U.S., U.K., and South Africa has shown that omicron appears to cause less severe illness in adults.

Walensky said the unprecedented levels of virus transmission in the broader community are likely behind the increase in hospitalizations of children.