FDA and CDC approve new Omicron COVID boosters for children as young as 5

Children as young as 5 are now eligible to receive the new updated COVID-19 boosters, which target the Omicron variant of the coronavirus. Both the Food Drug and Administration and the Centers for Disease Control and Prevention signed off on the shots for this age group on Wednesday.

Kids who have received the two-dose primary series or a previous booster of either Pfizer’s or Moderna’s vaccine are now eligible for the updated boosters. They must wait at least two months after their last dose to receive it.

“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement released by the agency following the decision.

Marks noted that while COVID-19 can be less severe in children than adults, many children have been hospitalized throughout the pandemic. They can also experience long-term effects following an infection. Vaccination, he said in the statement, “remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death.”

The approved booster is what’s known as a bivalent vaccine, which can protect from more than one virus or subtype of a virus. This vaccine is designed to target both the original strain and the BA.4 and BA.5 Omicron subvariants. The BA.5 subvariant continues to dominate infections, accounting for about 80% of cases in the United States, according to the latest CDC data.

A child getting a shot.
A child receives a COVID-19 vaccination. (Joseph Prezioso/AFP via Getty Images)

The FDA authorized Pfizer-BioNTech's bivalent vaccine for kids ages 5 to 11. This shot had been previously authorized by the agency in late August for people ages 12 and older. The Moderna bivalent booster, which had already been approved for people 18 and older, was cleared for kids 6 through 17.

In making the decision to approve the updated boosters for younger kids, the FDA said it relied on immune response and safety data that it had previously evaluated from a clinical study in adults who received a bivalent booster targeting the original strain and Omicron BA.1, an earlier version of the virus that is no longer circulating in the U.S. But that bivalent booster and the one approved, the FDA has said, have similar formulations and give the agency confidence that the approved booster shots will also be as safe and as effective.

“These data and real-world experience with the monovalent mRNA COVID-19 vaccines, which have been administered to millions of people, including young children, support the EUA of the bivalent COVID-19 vaccines in younger age groups,” the agency said.

After Wednesday’s authorization, the monovalent COVID-19 vaccines developed by Moderna and Pfizer, which target the original strain of the coronavirus only, will no longer be authorized as a booster shot for these age groups, the FDA said. But the monovalent vaccine will “continue to be authorized for primary series administration in individuals six months of age and older,” the agency noted in Wednesday’s statement.

Vaccinations of children and adolescents with the primary two-dose series have lagged. According to CDC data, only 31% of children ages 5 to 11 have gotten their two shots, and 60% of those ages 12 to 17 have completed the primary series.

Health experts say it is important for everyone who is eligible, including children, to get the Omicron boosters as soon as possible. This is because the nation could encounter a surge of COVID-19 as winter approaches.

“The best way to minimize the risk of severe illness and hospitalization, whatever your age, whatever your underlying conditions, is to get fully up to date on your SARS-CoV-2 immunizations, including the new bivalent boosters,” Dr. Michael Chang, pediatric infectious diseases specialist at UTHealth Houston and Children’s Memorial Hermann Hospital, told Yahoo News.

The new Moderna boosters should become available in pharmacies and health care providers offices as early as this week, the Washington Post reported. The Pfizer-BioNtech shots are expected to be available next week.