FDA Advisers Endorse Vaccines Starting at 6 Months

COVID-19 shots for US infants, toddlers, and preschoolers moved a step closer to reality on Wednesday. The Food and Drug Administration's vaccine advisers gave a thumbs-up to vaccines from Moderna and Pfizer for the littlest kids. The outside experts voted unanimously that the benefits of the shots outweigh any risks for children under 5—a population of roughly 18 million, the AP reports. It's the last age group in the nation without access to COVID-19 vaccines, and many parents have been eager to protect their children. If all the regulatory steps are cleared, shots should be available next week.

"There are so many parents who are absolutely desperate to get this vaccine, and I think we owe it to them to give them a choice to have the vaccine if they want to," said one panel member, Dr. Jay Portnoy of Children's Hospital in Kansas City, Missouri. Dr. Peter Marks, FDA's vaccine chief, opened the meeting with data showing a "quite troubling surge" in hospitalizations of young children during the omicron wave, and noted that 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.

While endorsing the vaccines, some panel members said chances for severe illness and death in young children are minimal. FDA reviewers said both brands appear to be safe and effective for children as young as 6 months. Side effects, including fever and fatigue, were generally minor in both, and less common than seen in adults. The vaccines use the same technology, but there are differences. Experts noted to reporters this week that the shots haven't been tested against each other, so there's no way to tell parents if one is superior. If the FDA authorizes the shots, and the Centers for Disease Control and Prevention makes a formal recommendation after its own advisers vote on Saturday, shots could be available as soon as Monday at doctor's offices, hospitals, and pharmacies. Pfizer’s vaccine is for children 6 months through 4 years; Moderna’s vaccine is for 6 months through 5 years.

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