A vaccine for children between the ages of 6 months and 4 years, the only group still ineligible to get vaccinated against COVID-19, could be granted emergency use approval by the FDA for the age group later this month. The FDA’s advisory group called the Vaccines and Related Biological Products Advisory Committee, is expected to convene on June 15 to offer guidance on the pediatric doses, according to NBC News.
Pfizer-BioNTech’s application to the FDA included clinical trial data that found three doses of the COVID-19 vaccine for young children safe and likely to generate a strong immune response.
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The first two COVID-19 vaccine doses would be given three weeks apart and a third dose at least two months later. All three shots will only be three micrograms each, one-tenth of the dosage given to adults.
Pfizer-BioNTech’s three-dose vaccine was about 80% effective in preventing symptomatic infection in children under the age of 5 and was deemed safe in a trial of nearly 1,700 children between the ages of 6 months 5 years, the company stated in May. The FDA has previously granted Pfizer authorization to administer a low booster dose of its COVID-19 vaccine to children ages 5 to 11.
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Fellow COVID-19 vaccine developer Moderna already requested authorization to give its two-dose COVID-19 vaccine to children under the age of 5 in April.
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Around 77.9% of Americans have received at least one dose of the COVID-19 vaccine, with 66.7% fully vaccinated as of Wednesday. Roughly 46.8% have received a booster shot, according to the Centers for Disease Control and Prevention.
The vaccine regimen is two doses, given three weeks apart, followed by a third dose at least two months later. The shots are 3 micrograms each, one-tenth the dosage given to adults.
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An Advisory Committee meeting to review the two-dose regimen, however, was rescheduled after Pfizer said that two doses didn’t provide a strong enough immune response in an ongoing trial of children ages 2 to under 5.
Pfizer said it would wait for its data on a three-dose vaccine series before seeking authorization.
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Moderna submitted its application for a two-dose vaccine regimen for children under 6 at the end of April, although the company has said it expects to seek authorization for a booster dose for the age group.
That vaccine is given as two 25-microgram doses four weeks apart.
The FDA’s Advisory Committee will review Moderna’s application alongside Pfizer’s at the June 15 meeting.
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