White House chief medical advisor Dr. Anthony Fauci on Wednesday said the Food and Drug Administration (FDA) could approve Pfizer and BioNTech’s vaccine for children under 5 years old in the next month. “My hope is that it’s going to be within the next month or so and not much later than that, but I can’t guarantee that,” Dr. Fauci said during an interview with Blue Star Families, a nonprofit group that supports military families.
Since two shots did not induce an adequate immune response in children 2 to 4 years old in Pfizer’s clinical trials. Dr. Fauci said younger children will likely need a total of three vaccine doses.
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 January 8th, more than double the rate in early December before omicron became the dominant variant in the U.S., according to data from the Centers for Disease Control and Prevention (CDC) collected from 250 hospitals across 14 states. “Sadly, we are seeing the rates of hospitalizations increasing for children zero to 4, children who are not yet currently eligible for Covid-19 vaccination,” CDC director Dr. Rochelle Walensky told reporters during a conference call earlier this month.
The FDA could authorize Pfizer’s COVID-19 vaccine for children under age 5 in the next month, Dr. Anthony Fauci said this week. https://t.co/kYxnV7OPU2
— WebMD (@WebMD) January 20, 2022
Dr. Walensky said the unprecedented levels of virus transmission in the broader community are likely behind the increase in hospitalizations of children.
— Will Humble (@willhumble_az) January 20, 2022
Pfizer plans to submit data to the FDA in the first half of 2022 if the three-dose study proves successful, the company announced in December. Pfizer said it did not identify any safety concerns with the 3-microgram vaccine doses in children 6 months to 4 years old. Adults receive two doses of 30 micrograms apiece as part of their primary series of shots.