Dr. Anthony Fauci – White House chief medical advisor – said the Food and Drug Administration could approve Pfizer and BioNTech’s vaccine for children under 5-years-old in the next month.
Fauci said younger children will likely need three doses, because two shots did not induce an adequate immune response in 2- to 4-year-olds in Pfizer’s clinical trials.
Pfizer plans to submit data to the Food and Drug Administration in the first half of 2022 if the three-dose study proves successful.
Pfizer said 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 right now because they are the only age group that is not currently eligible for vaccination.
Hospitalizations of children with Covid are rising as the highly contagious omicron variant has rapidly spread through communities across the U.S. over the past month.
Nearly 8 out of every 100,000 children under 5-years-old were hospitalized with Covid as of Jan. 8, more than double the rate in early December before the omicron became the dominant variant in the U.S., according to CDC data collected from 250 hospitals across 14 states.
Source: White House, US.