Pfizer-BioNTech aims to expand the availability of its COVID-19 vaccine by seeking authorization from the Food and Drug Administration for young children.
A jab 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 authorization 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 scheduled to meet 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.
The first two COVID-19 vaccine doses would be given three weeks apart and a third dose at least two months later. All three of the 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 and 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.
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.
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.
Pfizer-BioNTech has not responded to the Washington Examiner’s request for comment.