White House chief medical advisor Dr. Anthony Fauci on Wednesday said he hopes the Food and Drug Administration approves Pfizer and BioNTechās vaccine for children under 5 years old in the next month.
āMy hope is that itās going to be within the next month or so and not much later than that, but I canāt guarantee that,ā Fauci said during an interview with Blue Star Families, a nonprofit group that supports military families. āI canāt out guess the FDA. Iām going to have to leave that to them.ā
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 Pfizerās 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, 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.
He later sent CNBC a statement clarifying that heās not involved in the decision making process at the FDA and didnāt know when the agency will clear the shots.
Read more at CNBC News.