FDA advisers weigh COVID-19 shots for babies, young children

U.S. government advisers met Wednesday to decide whether to endorse COVID-19 shots for babies, toddlers and preschoolers, moving the nation closer to vaccinations for all ages.

Kids under 5 are the last remaining age group in the U.S. to get vaccinated and many parents have been anxiously awaiting Food and Drug Administration action to protect their little children. If all the regulatory hurdles are cleared, shots should be available next week.

The independent advisory panel is considering tot-sized doses from two coronavirus vaccine makers — Pfizer and Moderna.

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.

“Each child that’s lost essentially fractures a family,’’ Marks 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.

The two vaccines use the same technology but there are differences. In a call with reporters earlier this week, vaccine experts noted that the shots haven't been tested against each other, so there’s no way to tell parents if one is superior.

“That is a really important point,"' said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. “You can’t compare the vaccines directly.’’

If the FDA clears the shots, there's one more step. The Centers for Disease Control and Prevention will decide on a formal recommendation...