External advisors from the US Food and Drug Administration (FDA) on Wednesday approved Moderna and Pfizer’s vaccines against COVID-19 in young children.
Outside experts voted unanimously that the benefits of vaccines outweigh any risks to children under the age of 5, that is, about 18 million children in the country.
They are the last group to be vaccinated against COVID in the United States, and many parents are concerned about the safety of their young children.
If all regulatory paperwork is passed, the vaccines should be available next week.
“This is a long-awaited vaccine,” said a panel member, Dr. Jay Portnoy of Children’s Hospital in Kansas City, Missouri. “There are many 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 said.
Dr. Peter Marks, director of vaccines for the FDA, began the meeting with data showing a “significantly worrying increase” in hospitalizations of young children during the surge driven by the Omicron version of the coronavirus, noting that 4 years 442 children under age have died during the pandemic. This figure is much lower than adult deaths, but little ones should not be discounted when considering the need for vaccination, he said.
“Every child that goes missing inevitably breaks up a family,” Marx said.
FDA reviewers said both brands appeared to be safe and effective for children 6 months and older in analyzes published prior to the meeting. Side effects, such as fever and fatigue, are 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 vaccines haven’t been compared, so there’s no way to tell parents if one is superior.
If the FDA agrees with its advisors and licenses the vaccines, there is one more step left. The Centers for Disease Control and Prevention (CDC) will decide whether to make a formal recommendation after a meeting of its own advisors on Saturday. If the CDC allows, the vaccines could be available on 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.