Pfizer and BioNtech soon plan to submit data to the U.S. Food and Drug Administration regarding COVID-19 vaccine booster shots for children age 5 to 11, according to a Thursday press release.
According to the companies, data from a recent clinical trial showed a 36-fold increase in SARS-CoV-2 omicron variant-neutralizing titers following a 10-micrgrogram third booster dose for this age group.
“To evaluate the effectiveness of a third 10 [microgram] dose in children 5 through 11 years of age, Pfizer and BioNTech tested a panel of 30 human immune sera obtained from the blood of individuals that received two or three,” doses of vaccine, the companies said.
“These data reinforce the potential function of a third dose of the vaccine in maintaining high levels of protection against the virus in this age group,” Pfizer added.
Last October, the U.S. Food and Drug Administration first approved the Pfizer BioNTech vaccine for children ages 5 to 11. Use of booster doses were expanded to children as young as 12 in January, but they have not yet been made available in the U.S. for younger kids.
According to the U.S. Centers for Disease Control and Prevention, everyone ages 5 and older should get vaccine unless they have a health issue that prevents them from doing so. For most people, the initial series of COVID-19 vaccination includes two doses around three to four weeks apart. Those who are immunocompromised may be eligible for a three-shot initial series.
The CDC also urges everyone who is at least 12 years old to get one booster shot around five months after their initial series. People who are 50 years old or older, and people with certain immunocompromise may get a second booster dose.
People who received the Johnson & Johnson shot, which has a one-dose initial shot, may have a different booster dose schedule.
Pfizer BioNtech offers the only COVID-19 vaccine approved in the U.S. for children under 5 years old. Moderna, which manufactures vaccines available for adults age 18 and older in the U.S., announced a COVID-19 vaccine for children as young as six months old last month that has yet to be approved by the FDA.
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