Outside advisers to the US Food and Drug Administration (FDA) gave the go-ahead on Wednesday for Moderna and Pfizer’s vaccines against COVID-19 in younger children.
Outside experts unanimously voted that the benefits of vaccines outweigh any risks for children under the age of 5, that is, some 18 million children in the country.
They are the last group left to be vaccinated against COVID in the United States, and many parents have been anxious to protect their young children.
If all the regulatory paperwork is passed, the vaccines should be available next week.
“This is a long-awaited vaccine,” said one panel member, Dr. Jay Portnoy of Children’s Hospital in Kansas City, Missouri. “There are a lot of parents who are desperate to get this vaccine and I think we should give them the option to get vaccinated if they want to,” he added.
Dr. Peter Marks, director of vaccines for the FDA, kicked off the meeting with data showing a “pretty worrying increase” in hospitalizations of young children during the surge driven by the omicron variant of the coronavirus, noting that 442 children under 4 years of age have died during the pandemic. This figure is much lower than that of adult deaths, but should not be discounted when considering the need to vaccinate the very young, he noted.
“Every child that goes missing essentially fractures a family,” Marks said.
FDA reviewers said both brands appear to be safe and effective for children 6 months of age and older in analyzes published before the meeting. Side effects, such as fever and fatigue, were generally mild in both cases and less common than those seen in adults.
The two vaccines use the same technology, but there are differences. In a call with reporters this week, vaccine experts noted that the vaccines haven’t been compared, so there’s no way to tell parents if one is superior.
If the FDA agrees with its advisers and licenses the vaccines, one more step remains. The Centers for Disease Control and Prevention (CDC) will decide whether to make a formal recommendation after its own advisers meet on Saturday. If the CDC gives the go-ahead, the vaccines could be available Monday or Tuesday at doctors’ offices, hospitals and pharmacies.
Pfizer’s vaccine is for children 6 months to 4 years old, while Moderna’s is for children 6 months to 5 years old.
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