The U.S. Food and Drug Administration has authorized third doses of Pfizer’s COVID-19 vaccine for children ages 12-15. The agency additionally shortened the length of time between any individual’s second dose of the Pfizer vaccine and being eligible for a booster to just five months instead of six.
The FDA also authorized for certain immunocompromised children ages 5-11 to receive a third primary series dose of the Pfizer shot.
The U.S. Centers for Disease Control and Prevention on Tuesday adopted the recommendations for a shortened wait time for the booster as well as a third dose for immunocompromised children ages 5-11. The CDC is expected to meet Wednesday regarding third doses of Pfizer’s vaccine for children ages 12-15.
The FDA reviewed real-world data from Israel, including safety data from more than 6,300 individuals 12 through 15 years of age who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination series.
“The data shows there are no new safety concerns following a booster in this population,” according to the FDA release. “There were no new cases of myocarditis or pericarditis reported to date in these individuals.”
Additionally, the FDA said “No new safety concerns have emerged from a population of over 4.1 million individuals 16 years of age and older in Israel who received a booster dose at least five months following completion of the primary vaccination series.”
The FDA said children 5-11 who have undergone solid organ transplantation, or who have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise, may not respond adequately to the two-dose primary vaccination series. Thus, a third primary series dose has now been authorized for this group.
Children 5 through 11 years of age who are fully vaccinated and are not immunocompromised do not need a third dose at this time, according to the FDA.
“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. “With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight COVID-19.”
Children ages 12-15 first became eligible for the Pfizer vaccine in May, with eligibility expanding to the 5-11 age group in November.
No new recommendations were made regarding the Moderna or Johnson & Johnson vaccines, meaning anyone waiting on a booster for either of those shots should still wait six months before the third dose.