The Food and Drug Administration's vaccine advisers on Wednesday approved Moderna and Pfizer’s COVID-19 vaccine for infants, toddlers and preschoolers.
The outside experts voted unanimously that the benefits of the shots outweigh any risks for children under 5, reported The Associated Press. They are the last age group in the US without access to COVID-19 vaccines and many parents have been anxious to protect their little children.
If all the regulatory steps are cleared, shots should be available next week.
Dr. Peter Marks, FDA's vaccine chief, opened the meeting with data showing a “quite troubling surge” in young children's hospitalizations during the Omicron wave, and noted 442 children under 4 have died during the pandemic. That's far fewer than adult deaths, but should not be dismissed in considering the need for vaccinating the youngest kids, he said.
FDA reviewers said both brands appear to be safe and effective for children as young as 6 months old in analyses posted ahead of the all-day meeting. Side effects, including fever and fatigue, were generally minor in both, and less common than seen in adults.
If the FDA agrees with its advisers and authorizes the shots, the Centers for Disease Control and Prevention will have to decide on a formal recommendation after its own advisers meet Saturday.
Pfizer's vaccine is for children 6 months through 4 years; Moderna's vaccine is for 6 months through 5 years.
The same FDA panel on Tuesday backed Moderna's half-sized shots for ages 6 to 11 and full-sized doses for teens.
Pfizer originally announced in February it had begun submitting data to US regulators seeking emergency use authorization (EUA) of their COVID-19 vaccine for children under age 5. A week later, however, it postponed the application.