The Food and Drug Administration on Tuesday approved a booster dose of the Pfizer-BioNTech Covid-19 vaccine for children ages 5 to 11.
Children in the age group can receive a booster shot at least five months after receiving the primary two-dose series, the FDA said in a statement.
Full coverage of the Covid-19 pandemic
The booster dose is 10 micrograms, the same dose as the primary series for the age group and a third of the dose given to people 12 years and older.
The FDA’s decision now goes to the Centers for Disease Control and Prevention, which will make a recommendation on how the age group boosters should be used.
The CDC’s independent advisory group, known as the Advisory Committee on Immunization Practices, is expected to discuss the booster shot during a scheduled meeting Thursday. CDC Director Dr. Rochelle Walensky is expected to make a final recommendation after this meeting. Recording could begin as early as Friday.
Less than a third of the 28 million 5- to 11-year-old children in the United States have received two doses of a Covid vaccine, according to the CDC.
dr Peter Marks, the FDA’s top vaccines authority, noted on Tuesday that parents can protect their children from “potentially serious consequences” of Covid by getting them vaccinated with the two-dose basic series.
dr Paul Offit, a vaccines expert at Children’s Hospital of Philadelphia, said the booster dose should provide better protection against mild illnesses caused by Omicron and its family of subvariants, which appear to be more adept than previous strains at boosting immunity to vaccinations or earlier to bypass infection.
Clinical trial results released in April found that a booster dose of Pfizer’s vaccine in children aged 5 to 11 increased antibody levels against the original strain of coronavirus as well as the Omicron variant. Results did not show how long antibodies remain elevated, although higher antibody levels from booster shots in adults usually last for about four months.
Offit said the extra dose in children should raise antibody levels enough to provide a high level of protection against mild disease for at least “a couple of months.”
“The third dose will probably give you better protection for three to six months,” he said.
The results came two months after researchers at the New York State Department of Health reported that two doses of the Pfizer vaccine offered little protection from infection in children ages 5 to 11, with the vaccine’s effectiveness peaking in December and January 12 percent fell.
The CDC later reported that two doses for children still provided strong protection against serious consequences from Covid, including hospitalization and death.
Two doses protected very well against mild disease from the Delta variant, “but not very well against Omicron,” Offit said.
The FDA has already approved a third dose of Pfizer for children ages 5 to 11 with compromised immune systems as part of its three-dose primary series.
Children under the age of 5 are the only group in the US who remain ineligible for the Covid vaccine, although that could change soon.
The FDA is currently reviewing Moderna’s regulatory submission for its two-dose vaccine for children ages 6 months to 5 years. A final decision is expected in June.
Pfizer has yet to submit its application to the FDA for a three-dose vaccine for children under 5, but expects to do so in the coming weeks, Pfizer CEO Albert Bourla said this month.
Follow NBC HEALTH At Twitter & Facebook.