FDA Authorizes Use of Pfizer COVID-19 Vaccine Booster Dose in Children Aged 12 to 15 Years

The US Food and Drug Administration (FDA) announced Monday that adolescents aged 12 to 15 years can now receive a booster dose of the Pfizer-BioNTech mRNA COVID-19 vaccine, as authorized by an amendment to the original emergency use authorization (EUA) for the vaccine.

Update: 1/8/2022: The FDA on Saturday amended the emergency use authorization for the Moderna COVID-19 vaccine to shorten the time between the completion of a primary series of the vaccine and booster dose to at least five months for people 18 years of age and older.

Update1/5/2022: Centers for Disease Control and Prevention director Rochelle Wolensky, in a statement Wednesday January 5, 2022, endorsed the recommendation, as expected, stating: “It is critical that we protect our children and teens from COVID-19 infection and the complications of severe disease. Today, I endorsed ACIP’s vote to expand eligibility and strengthen our recommendations for booster doses. We now recommend that all adolescents aged 12-17 years should receive a booster shot 5 months after their primary series. This booster dose will provide optimized protection against COVID-19 and the Omicron variant. I encourage all parents to keep their children up to date with CDC’s COVID-19 vaccine recommendations.”

The amendment also shortens the time for booster doses of Pfizer’s vaccine in all persons aged ≥12 years to at least 5 months after completion of the primary vaccination series vs the original 6-month interval and allows for a third primary series dose for certain immunocompromised children aged 5 to 11 years.

The FDA’s decision to expand Pfizer vaccine booster eligibility to younger teens comes approximately a month after the agency authorized a single-dose booster for adolescents aged 16 or 17 years at least 6 months after completion of their primary vaccine series.

The agency cited real-world safety data from over 6300 individuals aged 12 to 15 years who received a booster dose of the vaccine at least 5 months after their primary series, which did not show any new safety concerns following the booster dose.

No new safety concerns emerged from a population of 4.1 million individuals aged ≥16 years in Israel who received a booster dose at least 5 months following completion of their primary series, according to the FDA. Additionally, the FDA reviewed prior analyses and concluded that the potential benefits of a third primary series dose of Pfizer’s vaccine given to children aged 5 to 11 years at least 28 days after the second dose of the 2-dose regimen, “outweighed the potential and known risks of the vaccine.” Therefore, the agency authorized a third primary series dose for this group.

“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants. In particular, the omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,” said Peter Marks, MD, PhD, director, Center for Biologics Evaluation and Research, FDA, in the January 3, 2021 press release.

“With this in mind, the FDA has extended the range of individuals eligible to receive a booster, shortened the length of time between the completion of the Pfizer primary series for individuals to receive a booster and is authorizing a third protective vaccine dose for some of our youngest and most vulnerable individuals.”

Common side effects reported by individuals who have received a booster shot or an additional dose of Pfizer’s COVID-19 vaccine are pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, and chills. Of note, swollen lymph nodes in the underarm were reported more frequently following the booster dose than after the second dose of a 2-dose primary series, according to the FDA.