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The FDA has accepted Pfizer’s application for a COVID-19 vaccine for children under age 5, which clears the way for approval and distribution in June.
Pfizer announced Wednesday that it completed the application for a three-dose vaccine for kids between 6 months and 5 years old, and the FDA said it received the emergency use application.
Children in this age group — the last to be eligible for COVID-19 vaccines — could begin getting shots as early as June 21, according to White House COVID-19 response coordinator Ashish Jha, MD.
Meanwhile, COVID-19 cases are still high — an average of 100,000 cases a day — but death numbers are about 90% lower than when they were when President Joe Biden first took office, Jha said.
The FDA’s advisory group, the Vaccines and Related Biological Products Advisory Committee, is scheduled to meet June 14 and June 15 to discuss data submitted by both Pfizer and Moderna.
If the FDA gives them the green light, the CDC will then weigh in.
“We know that many, many parents are eager to vaccinate their youngest kids and it’s important to do this right,” Jha said at a White House press briefing Thursday. “We expect that vaccinations will begin in earnest as early as June 21 and really roll on throughout that week.”
States can place their orders as early as Friday, Jha said, and there will initially be 10 million doses available. If the FDA gives emergency use authorization for the vaccines, the government will begin shipping doses to thousands of sites across the country.
“The good news is we have plenty of supply of Pfizer and Moderna vaccines,” Jha said. “We’ve asked states to distribute to their highest priority sites, serving the highest risk and hardest to reach areas.”
Pfizer’s clinical trials that found three doses of the vaccine for children 6 months to under 5 years were safe and effective, and proved to be 80% effective against Omicron.
This week, the FDA announced its meeting information, with a conversation about the Moderna vaccine for ages 6 to 17 scheduled for June 14 and a conversation about the Pfizer and Moderna vaccines for young children scheduled for June 15.
Moderna applied for FDA authorization of its two-dose vaccine for children under age 6 on April 28. The company said the vaccine was 51% effective against infections with symptoms for children ages 6 months to 2 years and 37% effective for ages 2 to 5.
Pfizer’s 3-microgram dose is one-tenth of its adult dose. Moderna’s 25-microgram dose is one-quarter of its adult dose.
ABC News: “FDA accepts Pfizer application for COVID vaccine in kids under 5, clearing way for June timeline.”
Pfizer: “Pfizer-BioNTech COVID-19 Vaccine Demonstrates Strong Immune Response, High Efficacy and Favorable Safety in Children 6 Months to Under 5 Years of Age Following Third Dose.”
FDA: “Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement.”
Moderna: “Moderna Files for Authorization of Its COVID-19 Vaccine in Young Children Six Months to Under Six Years of Age.”