Pfizer booster approved for children aged 5 to 11

The United States Food and Drug Administration on Tuesday granted emergency use authorization for a third shot of Pfizer-BioNTech's COVID-19 vaccine for children aged 5 to 11.

The booster dose is available to children at least five months after completion of their two-dose primary series.

Peter Marks, head of the FDA division responsible for vaccines, said the FDA determined that a third Pfizer shot can boost protection for children in that age group, and the benefits outweigh the risks.

Pfizer requested the authorization at the end of April, citing company data that showed a third vaccine dose raised Omicron-fighting antibodies by 36 times in that age group.

"While it has largely been the case that COVID-19 tends to be less severe in children than adults, the Omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer-term effects, even following initially mild disease," said FDA Commissioner Robert Califf in a statement on Tuesday.

The Centers for Disease Control and Prevention must still formally recommend the booster dose before shots can go into arms. A CDC Advisory Committee on Immunization Practices will meet on Thursday to discuss COVID-19 vaccine boosters.

The FDA did not convene its independent panel of experts before authorizing the booster dose. Some committee members have grown frustrated that drug regulators had repeatedly pushed for booster dose decisions without holding open public discussions, CNBC reported.

About 28 percent of children aged 5 to 11 have been fully vaccinated as of Tuesday, a rate much lower than the overall population, according to the CDC. As of April, 43.6 percent of eligible children and teenagers, aged 5 to 17, have been fully vaccinated.

More than 93,000 additional child COVID-19 cases were reported in the past week, an increase of about 76 percent from two weeks ago, according to the American Academy of Pediatrics and the Children's Hospital Association. It was the fifth consecutive week of increases and the highest weekly total since late February.

Studies from the New York State Department of Health and the CDC found that the effectiveness of two Pfizer vaccine doses for children aged 5 to 12 dropped substantially during the Omicron surge, falling to 12 percent from 69 percent by four to five weeks after the second dose.

Another CDC study found that two Pfizer vaccine doses reduced the risk of Omicron infection by 31 percent in children aged 5 to 11 and 59 percent in those aged 12 to 15.

Tuesday's decision means all children aged 5 and older in the US can receive at least three vaccine doses. Children under 5 are not yet eligible for a primary vaccination series.

Those who are 50 and older, and people aged 12 and older who have certain kinds of compromised immune systems, are eligible for two booster doses.