The Food and Drug Administration on Wednesday approved Covid booster shots targeting the micron variant for preschoolers through elementary school students.
Pfizer’s new omicron boosters are now approved for children ages 5 to 11, and Moderna’s vaccines for children ages 6 to 17. Vaccinations are given two months after the completion of the two-dose main series or the most recent booster with the first-generation vaccines.
The Centers for Disease Control and Prevention has yet to issue its recommendations before pharmacies can administer the new vaccines to children. The CDC’s advisory committee has scheduled meetings for next week when independent vaccine experts will review the available data.
by Pfizer new boosters were cleared for people aged 12 and over in September, while of Moderna approved for adults aged 18 and over.
Pfizer, in a statement, said its children’s boosters will ship once the CDC gives the go-ahead. Vaccinations are expected to begin as the school year gets into full swing and just before the holidays, when health officials expect a spike in infections.
Dr. Peter Marks, head of the FDA’s division of vaccines, said children face an increased risk of exposure to the virus as they return to school in person and families return to their pre-pandemic lives.
Although Covid is generally less severe in children than adults, children are being hospitalized with the disease, Marks said. Health officials are also concerned about the potential risk of long-term Covid even in children who have had mild illness from the virus, he said.
“We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible,” Marks said.
The FDA hopes that the new boosters, which target the dominant subvariant of omicron BA.5, will provide substantially better protection against infection and disease compared to the first generation of Covid vaccines.
The FDA approved the BA.5 shots for children without direct human data on their effectiveness. The agency deleted boosters based on adult data from a similar download targeting the omicron BA.1 subvariable. The agency also reviewed clinical studies in children who received the original vaccines as boosters.
The new boosters target omicron BA.5 as well as the original strain of Covid that first emerged in Wuhan, China in 2019. The FDA hopes the vaccines will provide durable protection even as the virus continues to evolve because they cover a wide spectrum mutations.
The first generation of Covid shots were developed in 2020 to target the original strain of Covid. They no longer provide substantial protection against infection and mild disease because they don’t match the dominant micron variant, which has mutated to avoid the antibodies that prevent the virus from invading human cells.
More than 11 million Americans age 12 and older have received the new booster shots so far, according to CDC data.
It’s unclear how much demand parents will have for the new plans. Just under 50% of people aged 5 years and older received a booster shot with the first generation of vaccines.