FDA authorizes Covid omicron booster shots for kids as young as 5 years old

CNBC — The Food and Drug Administration on Wednesday authorized Covid booster shots that target the omicron variant for preschoolers through elementary school students.

Pfizer’s new omicron boosters are authorized for children ages 5 to 11 and Moderna’s shots for kids ages 6 through 17. The shots are administered two months following completion of the two-dose primary series or the most recent booster shot with the first generation vaccines.

The Centers for Disease Control and Prevention still has to issue its recommendations before pharmacies can administer the new shots to kids. The CDC’s advisory committee has meetings set for next week when independent vaccine experts will review the available data.

Pfizer, in a statement, said its boosters will ship as soon as the CDC gives the final go ahead. Vaccinations are expected to start as the school year gets into full swing and just ahead of the holidays when health officials are expecting a spike in infections.

The FDA hopes the new boosters, which target the dominant omicron BA.5 subvariant, will provide substantially better protection against infection and disease compared to the first generation of Covid shots.

Pfizer’s new boosters were authorized for people ages 12 and up in September, while Moderna’s have been authorized for adults ages 18 and older.

The FDA authorized the shots without direct human data on their effectiveness. The agency cleared the boosters based on human data from a similar shot that targets the omicron BA.1 subvariant as well as animal studies that looked directly at the BA.5 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 shots will provide durable protection even as the virus continues to evolve because they cover a broad range of mutations.

The first generation of Covid shots were developed in 2020 to target the original strain of Covid. They are no longer providing meaningful protection against infection and mild illness because they do not match the dominant omicron variant, which has mutated to evade the antibodies that block the virus from invading human cells.

More than 11 million Americans have received the bivalent shots so far, according to CDC data.

It’s unclear how strong demand for the new shots will be among parents. Just under 50% of people ages 5 and older received a booster shot with the first generation of vaccines.