The Food and Drug Administration on Monday authorized Pfizer booster shots for kids 12 to 15 on Monday. Dr. Peter Marks, director of the FDA group responsible for vaccine safety, told the CDC panel that the rapid spread of omicron prompted the agency to act fast on boosters for adolescents.
Marks said the FDA did not identify any new safety concerns after evaluating real-world data from Israel on more than 6,000 kids ages 12 through 15 who received a Pfizer boosters. Among those kids, there were no new cases of myocarditis or pericarditis, rare side effects where the heart is inflamed or swells.
Dr. Sharon Alroy-Preis, head of public health services in Israel, told the committee there were two cases of myocarditis in the 12 to 15 age group after more than 40,000 booster doses administered.
Myocarditis appears most common after the second Pfizer dose for kids ages 12 to 15. The CDC’s vaccine safety team found 265 cases total in adolescents 12 to 15 who received two Pfizer doses through Dec. 19, 2021. The overwhelming majority of the cases, 221, occurred after the second dose and 90% of patients were boys.
Myocarditis resulted in 251 hospitalizations, but 96% of patients were discharged home. The condition remains rare with 45 cases reported per 1 million second doses administered in boys ages 12 to 15, and 3.8 cases per million second doses among girls in the same age group.
About 47,000 adolescents ages 16 to 17 have received Pfizer booster doses in the U.S., the next age group eligible for boosters, and 95% of reported side effects were not serious, according to the CDC.
Dr. Evelyn Twentyman, a CDC official, told the committee that vaccinations in Israel – where the nation has rolled out a massive booster campaign – showed myocarditis in people ages 16 and older were even more rare following a booster shot.
Dr. Julie Bloom, director of the Texas Children’s Hospital Immunization Project, told the committee that a booster recommendation for kids 12 years and older “cannot come soon enough.”
Bloom said children 12 and older who are vaccinated with Pfizer are already starting to lose their immunity against Covid since they received their first two doses, putting them at increased risk from omicron.
At least 7.8 million children have caught Covid since the pandemic started, according to the American Academy of Pediatrics. More than 1,000 children have died from the virus, according to data from the Centers for Disease Control and Prevention.
“We must do everything in our power to minimize any further detrimental effects to the mental health, physical well being and education of our children,” Bloom said.
White House chief medical advisor Dr. Anthony Fauci, during a press conference Wednesday, said omicron appears less severe for kids than delta, but he cautioned against complacency, urging parents to get their kids vaccinated and boosted when eligible.
— CNBC’s Nate Rattner, Dawn Kopecki and Lauren Feiner contributed to this report