Updated coronavirus booster vaccines are now available for children up to 5 years old, following an emergency authorization from the Food and Drug Administration on Wednesday.
Hours after the FDA’s action, Rochelle Walensky, director of the Centers for Disease Control and Prevention, recommended the shots — the final step before vaccines can be administered.
The reformulated promoters are bivalent: They include components from the original strain of the virus and from the omicron subvariants BA.4 and BA.5, which account for about 80 percent of the virus circulating in the United States, according to the CDC.
Health officials said the redesigned boosters are needed to bolster protection that has waned since previous vaccines and to counter new variants that are more transmissible and able to evade immune defenses.
The FDA granted emergency use authorization to Pfizer-BioNTech’s updated booster vaccine for children 5 to 11 years of age. This vaccine was already approved for people 12 years and older. The agency also cleared Moderna’s updated booster for children ages 6 to 17. It was previously licensed for over 18s.
“As children have returned to school in person and people are resuming pre-pandemic behaviors and activities, there is a potential for increased risk of exposure to the virus that causes covid-19,” he said. said Peter Marks, the FDA’s top vaccine official. in a statement. “Vaccination remains the most effective measure to prevent the serious consequences of covid-19, including hospitalization and death.”
Moderna’s new boosters are available immediately in pharmacies and doctors’ offices, federal officials said. The Pfizer-BioNTech boosters are expected to be available next week. The old monovalent booster injections are no longer licensed for these age groups, the FDA said.
The new reinforcements are “very good news for children and their families,” said James Campbell, a professor of pediatrics at the University of Maryland School of Medicine. He said some adults inaccurately downplay the risk covid poses to children.
“It’s a mistake to believe that children don’t get sick or get seriously ill from covid,” Campbell said. “And it is a mistake to persistently compare the severity of covid in children with covid in adults.”
Instead, he said, covid should be compared to other pediatric illnesses, adding that covid is a close cause of death among children.
But whether parents will get their kids retrofitted boosters is far from clear. Since the FDA launched the bivalent boosters for older age groups in late August, uptake has been disappointingly slow. Only about 11.5 million Americans have received the updated shots, according to CDC data through Oct. 6.
On Tuesday, Ashish Jha, the White House’s covid-19 coordinator, called on Americans to get the redesigned boosters by Halloween so that protection kicks in by Thanksgiving.
“If you’re up to date on your vaccines and treated, if you have a breakthrough infection, your risk of dying from covid is now almost zero,” Jha said at a briefing on Tuesday.
He and other Biden administration officials have expressed concern that the cooler weather will lead to an increase in covid cases as people move indoors and respiratory infections spread.
Vaccines for children and adolescents with the two-shot primary series have also been delayed. Only 31 percent of children ages 5 to 11 have received both vaccinations, and 58 percent of children ages 12 to 17 have completed the series, according to an analysis of CDC data by the American Academy of Pediatrics.
Updated boosters can be given at least two months after the initial series of two vaccine injections or after a previous booster.
In authorizing the new boosters for younger people, the FDA said it was based on data on safety and immune responses it had previously evaluated in a clinical study that included adults who got a boost with components of the original strain and the omicron BA.1.
The FDA “views these data as relevant and supportive of vaccines containing a component of the BA.4 and BA.5 omicron variant lineages,” the agency said. The FDA also looked at other data, including the vaccine’s real-world performance.
FDA officials have said that clearance of a bivalent booster for children younger than 5 is several months away.
The federal government bought more than 170 million booster doses of the bivalent coronavirus vaccine to distribute as part of a planned fall and early winter campaign to boost protection against circulating strains of the virus