FDA Panel Endorses Moderna and Pfizer COVID Vaccines for Kids as Young as 6 Months
If the recommendations are backed by the FDA commissioner and the CDC, toddlers could receive their first dose as early as next week.
An FDA panel voted unanimously to recommend both Moderna and Pfizer COVID-19 vaccines for children as young as 6 months.
A US Food and Drug Administration panel on Wednesday voted unanimously to recommend COVID-19 vaccines from both Moderna and Pfizer-BioNTech for infants as young as 6 months.
The Moderna two-dose vaccine, submitted for approval for children 6 months through 5 years old, is 25 micrograms per dose, one-fourth of each dose for adults.
Pfizer's vaccine is slightly different. It's intended for kids 6 months through 4 years old and is administered as a series of three doses of 3 micrograms each, one-tenth of each dose for adults.
The Vaccines and Related Biological Products Advisory Committee approved each recommendation on a 21-0 vote.
If these emergency use authorizations are supported by FDA Commissioner Robert M. Califf and the Centers for Disease Control and Prevention, as is expected, children could receive their first injection as early as Tuesday, according to the White House.
Anticipating agency approvals, the Biden administration authorized preorders of up to 10 million free doses for young children, split evenly between Moderna's and Pfizer-BioNTech's vaccines.
As of May 28, 442 US children under the age of 4 have died from COVID, according to Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
On Tuesday, the FDA panel unanimously endorsed that Moderna's vaccine should be approved for kids ages 6 through 17. The two-dose version for kids 12 to 17 is the same strength as the company's adult vaccine, while the one for children 6 to 11 is half the adult strength.