The FDA Could Authorize Pfizer’s Covid Vaccine for Kids Under 5 Soon
White House chief medical advisor Dr. Anthony Fauci announced this week that children under the age of 5 will still likely need three doses of Pfizer’s Covid vaccine.
Two shots did not induce an adequate immune response in children 2- to 4-years-old in Pfizer’s clinical trials.
The pharma giant said in December that it is planning to submit data to the Food and Drug Administration in the first half of 2022 if the three-dose study proves successful.
Fauci said on Wednesday said the Food and Drug Administration 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,” Fauci said during an interview with Blue Star Families, a nonprofit group that supports military families.
Pfizer said it did not identify any safety concerns with the 3-microgram vaccine doses in children six months to 4-years-old. Adults receive two doses of 30 micrograms apiece as part of their primary series of shots.
Preliminary study in Israel shows fourth Covid vaccine shots are less effective against omicron.
“Sadly, we are seeing the rates of hospitalizations increasing for children zero to four, children who are not yet currently eligible for Covid-19 vaccination,” Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention said earlier this month.
Walensky also added that there’s no indication that the omicron variant causes more severe illness in children.
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