The Food and Drug Administration has authorized the use of a Pfizer-BioNTech booster in adolescents 12 to 15 years old.
The agency on Monday also shortened the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and a booster dose to five months from six.
And, the FDA allowed for a third dose of vaccine in immunocompromised children 5 to 11 years of age.
The director of the Centers for Disease Control and Prevention, Rochelle Walensky, must still weigh in with a recommendation on the FDA’s announcement before the changes can take effect.
“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” said Acting FDA Commissioner Dr. Janet Woodcock.
The FDA said it reached its decision after reviewing data from Israel, which included information on 6,300 people ages 12-15 who received a booster shot at least five months after their initial two-dose vaccination. The data showed no new cases of two possible side effects that had been observed in some young people who received the vaccine — myocarditis, an inflammation of the heart, and pericarditis, an inflammation of the saclike tissue surrounding the heart.
The CDC recommended the Pfizer vaccine for children 12-15 in May and for kids 5-11 in November. There is still no vaccine authorized in the U.S. for children under age 5.
