Children as young as 5 can now receive COVID-19 bivalent booster shots that target the omicron subvariants thanks to swift action yesterday by two federal agencies.
Almost immediately after the Food and Drug Administration (FDA) approved the boosters, the Centers for Disease Control and Prevention (CDC) recommended that children get them under emergency use authorization. The move comes as healthcare officials sound the alarm of a possible fall and winter surge, and scientists continue to unearth unsettling information about long COVID, which some data suggest can strike asymptomatic people with COVID, as well as children.
The approvals are for boosters manufactured by Moderna and Pfizer-BioNTech.
“This follows the Food and Drug Administration’s authorization of updated COVID-19 vaccines from Pfizer-BioNTech for children ages 5 through 11 years, and from Moderna for children and adolescents ages 6 through 17 years,” the CDC said in a statement.
The boosters target the omicron subvariants BA.4 and BA.5 and will hopefully bolster protection as the effectiveness of the original vaccines wane, according to the CDC.
“FDA’s authorization of updated (bivalent) COVID-19 vaccines for this younger age group, and CDC’s recommendation for use, are critical next steps forward in our country’s vaccination program—a program that has helped provide increased protection against severe COVID-19 disease and death,” the CDC states.
Peter Marks, M.D., an FDA vaccine regulator, said in a statement that “while it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease. We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible.”
The FDA based its approval of the Pfizer-BioNTech bivalent vaccine in part on a clinical study of its effectiveness for people 55 and older who’d been infected by the omicron BA.1 subvariant as well as on the agency’s previous analysis of the safety and effectiveness of a booster shot on children 5 to 11 years old.
Authorization of the Moderna bivalent booster shot for children 6 through 11 years old is based in part on a clinical study of adults 18 years old and older who received a bivalent booster shot in the investigational stage that targeted the original COVID-19 as well as the omicron BA.1 subvariant.
“These bivalent COVID-19 vaccines include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant,” the FDA said in its statement. “The mRNA in these vaccines is a specific piece of genetic material that instructs cells in the body to make the distinctive “spike” protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical.”
The bivalent booster shot should be given “at least two months following completion of primary or booster vaccination” according to the FDA and those inoculated might experience side effects similar to what many experienced after getting the first COVID-19 vaccines.
The approval of the bivalent booster shots for children comes at a time when many Americans have returned to pre-pandemic activities and believe that COVID-19 doesn’t pose that much of a threat anymore. The uptake of the bivalent booster shot has been slow. As of October 13, about 11.5 million Americans have gotten the bivalent booster, or 5.3% of those eligible, according to the CDC.
Ashish Jha, M.D., the White House Coronavirus Coordinator, said at a press briefing Tuesday that the U.S. will almost certainly see more COVID-19 infections in November, December and January. “That’s what we saw the last couple of winters, so that’s not surprising,” Jha said.
He also urged people to get vaccinated and/or a booster shot before Halloween, because it takes a couple of weeks for the vaccine to generate the antibodies needed to fight off infection. He added that “if you do it before Thanksgiving, you’re going to see family and friends before the holidays, a lot of socializing that goes on in December, it’s going to be a really good time to get it done before Halloween.”