CDC Panel Backs First Covid-19 Boosters for 12- to 15-Year-Olds

The experts’ endorsement is one of the final steps before doctor’s offices, schools and other vaccination sites make booster shots from Pfizer Inc. PFE 2.02% and partner BioNTech SE BNTX -5.65% available to 12- to 15-year-olds. The CDC must make a decision next.

Until now, only people who are 16 and older have been able to get an extra dose, unless they have a weak immune system.

Health authorities have been trying to make the shots available to younger ages, however, as the Omicron variant spreads through communities, sickening hundreds of thousands, and threatens to disrupt schools trying to stay open.

As part of the effort to make boosters available to 12- to 15-year-olds, the Food and Drug Administration on Monday cleared the shots for the group, among other moves. Yet that decision only permits use of the shots outside clinical trials. Many vaccination sites and states wait for the CDC to issue an endorsement before administering the extra doses.

The CDC on Tuesday backed the shots for immunocompromised children aged 5 to 11, who had also received an FDA green light this week. The CDC said it would decide on adolescent boosters after its advisers weighed in.

The experts, part of the CDC’s Advisory Committee on Immunization Practices, makes recommendations for childhood vaccines and other shots. The panel includes medical doctors, immunologists, pediatricians and other experts.

The CDC generally backs the panels’ recommendations. Once the agency issues its recommendation, the boosters should become quickly available for 12- to 15-year-olds because they take the same dose as older people.

At least 16 million children aged 12 to 17 have received the Pfizer-BioNTech vaccine since its authorization in May, which means immune defenses might have started to wane in children who got the shots early on.

Children and adolescents are less likely than adults to contract Covid-19 and generally experience milder symptoms when infected. Yet some have been hospitalized and, in rare cases, died. Some hospitals and health authorities have reported an increase in pediatric hospitalizations during the Omicron wave.

Early studies indicate boosters might be needed to fight the highly contagious new variant, and health authorities have been urging those eligible to get the extra doses. Boosters will help protect adolescents from severe cases of Covid-19 and could also help reduce the spread of the disease, FDA officials have said.

“The hope is by reducing the number of 12- to 15-year-olds who get Covid-19 of any form that we will help reduce the transmission of Covid-19,” Peter Marks, the FDA’s top vaccine regulator, said Monday.

Vaccines, including booster shots, remain critical public-health tools for educators and school administrators seeking to limit disruptions as the pandemic enters its third year. Many are pressing to keep classrooms open as Omicron’s rapid spread generates staffing challenges. Limited access testing has also created delays.

More than 4,500 schools have announced closures for at least one day this week, according to Burbio, a Pelham, N.Y., data company that is monitoring K-12 school closures in 5,000 districts across the country. Burbio co-founder Dennis Roche said the average closure is roughly five days but varies from one day to two weeks as schools implement testing or receive results back that have led some teachers to stay home.

The Pfizer-BioNTech vaccine was found to be safe and 92% effective in adolescents, according to a recent study published by the CDC. Still, some parents have expressed concerns about the risks of rare heart-related conditions, including myocarditis, associated with the use of messenger RNA vaccines, especially in younger males. Health experts have said the myocarditis risk is low in children who are vaccinated and outweighed by the threat Covid-19 poses to children.

Dr. Marks said the risk of teens contracting myocarditis after a third dose has been found to be about one-third lower than the risk after a second dose. Those who have developed the condition, he said, generally have mild inflammation and experience a median hospital stay of one day.

A senior Israeli health official presented data to the expert panel that found two cases of myocarditis after Israel administered more than 41,000 booster doses to adolescents. The 13-year-old and 15-year-old males both recovered, the official said.

Among 12- to 15-year-olds given a total of 18.7 million doses of the Pfizer-BioNTech vaccine in the U.S., there were 265 confirmed cases of myocarditis, and most have fully recovered, a CDC official said.

There were 12 verified cases of the heart-related condition among 5- to 11-year-olds who were administered 8.7 million doses, and most of the cases have also fully recovered, the official said.

Among 976,882 boosters administered to 16- to 24-year-olds, there were 13 preliminary cases of myocarditis with a median age of 21 and a median onset time of one day, the official said.

Write to Felicia Schwartz at [email protected]