FDA Authorizes Pfizer Boosters for 12-15 Years Old

The Food and Drug Administration (FDA) approved, on Monday, Pfizer boosters for 12- to 15-year-olds amid the omicron surge.

In a release, the FDA said it has amended the emergency use authorization for the Pfizer vaccine to children as schools reopen after the holiday break.

It also shortened the time between the completion of primary vaccination of the Pfizer vaccine and a booster dose to at least five months, instead of six.

"Authorizing booster vaccination to take place at five months rather than six months may therefore provide better protection sooner for inpiduals against the highly transmissible omicron variant," the FDA stated.

The agency said it had determined that the protective health benefits and the "continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death, outweigh the potential risks in inpiduals 12 through 15 years of age."

Moreover, the FDA noted that it had "reviewed real-world data from Israel, including safety data from more than 6,300 inpiduals 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 Centers for Disease Control and Prevention is expected to review the FDA recommendations and its director, Dr. Rochelle Walensky, must still sign off.

"Children 5 through 11 years of age 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."

In addition, the FDA said children 5 through 11 years of age who are fully vaccinated and are not immunocompromised do not need a third dose at this time, but it will "continue to review information and communicate with the public if data emerges suggesting booster doses are needed for this pediatric population."