The U.S. Food and Drug Administration authorized emergency use of the Moderna and Pfizer-BioNTech COVID-19 Vaccine for children 5 and under.
The move comes after an FDA advisory panel recommended the vaccines. The U.S. Centers for Disease Control and Prevention’s vaccine advisors will vote on whether to recommend it. CDC Director Dr. Rochelle Walensky is expected to sign off on the decision soon after.
​​“Many parents, caregivers, and clinicians have been waiting for a vaccine for younger children and this action will help protect those down to 6 months of age. As we have seen with older age groups, we expect that the vaccines for younger children will provide protection from the most severe outcomes of COVID-19, such as hospitalization and death,” said FDA Commissioner Robert M. Califf, M.D. in a press release. “Those trusted with the care of children can have confidence in the safety and effectiveness of these COVID-19 vaccines and can be assured that the agency was thorough in its evaluation of the data.”
About 18 million children under the age of five are eligible for COVID-19 vaccinations. The FDA’s emergency use authorization allows for manufacturers to begin shipping vaccines across the country.
The Biden administration said the shots could start early next week.
U.S. Surgeon General Vivek Murthy, M.D reported that more than 30,000 U.S. children younger than 5 have been hospitalized with COVID-19, and nearly 500 coronavirus deaths are reported in that age group.
San Diego County officials said the vaccines for children in the youngest age range would be administered in much smaller doses. The Pfizer vaccine would be given in three shots, each containing one-tenth of an adult dose. The first two doses would be given three weeks apart and the final shot at least three months later.
The Moderna vaccine, which currently is only available for adults, is also likely to be approved, county health officials said, for two more age groups: children between 6 and 17 years of age and those under 6. The Moderna shot for kids under 6 is a two-dose series, given about four weeks apart. Each dose contains one-quarter of the adult dose.
Health Officials say that shots designated to children 6 and under are administered with a smaller needle, and most times, in the leg.
Eligible populations may receive the COVID-19 shot at no cost.
