FDA Recommends COVID-19 Vaccines for Children 5 and Younger
A U.S. Food and Drug Administration advisory panel voted unanimously on Wednesday to recommend two COVID-19 vaccines for children 5 and younger.
The two vaccine options come from Pfizer/BioNTech and Moderna. The move has been long awaited in order to help vaccinate the youngest population in the country; there are about 18 million children under 5 who have not yet been eligible for protection against the virus.
The 21-0 vote in favor of the two companies indicates that the FDA may move quickly to make the formal decision to authorize the mRNA vaccines.
While trials for the youngest group showed protection against severe disease, hospitalization and death, data also revealed the same reduction in protection against infection in the kid group as in adults.
From Pfizer, parents will be faced with choosing two 25-microgram doses delivered one month apart or three, 3-microgram doses. The first two doses will be three weeks apart, with the third dose coming after two months.
Pfizer trials, which took place as the Omicron variant dominated, found a 28.3% efficacy in the two doses compared to 80% in three.
“Our robust clinical study shows that three doses can provide protection for the circulating Omicron variant and offers promise for protection against potential future waves of COVID-19. The committee’s support today is imperative to providing a critical tool for pediatricians, parents, and caregivers who eagerly await an option for children under five,” said Pfizer’s Dr. Bill Gruber, Vaccine Clinical Research and Development head.
Moderna’s two-dose vaccine for kids aged 6 months to 6 years captured a reduced protection against infections as well.
The youngest group saw efficacy of 51%, while 2- to 5-year-olds saw efficacy of 37%. These trials were also conducted during the Omicron wave.
The FDA is poised to distribute these vaccines as early as next week.