The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) recommends the use of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine in individuals 12 to 15 years of age at least 5 months after completion of the primary series. 

The advisory panel’s recommendations follow a similar decision made by the Food and Drug Administration (FDA) earlier this week, which authorized the emergency use of a booster dose of the Pfizer-BioNTech COVID-19 vaccine in individuals 12 to 15 years of age and shortened the time for administration of a booster from 6 months to 5 months. 

“This booster dose will provide optimized protection against COVID-19 and the Omicron variant,” said CDC Director, Dr Rochelle Walensky. “I encourage all parents to keep their children up to date with CDC’s COVID-19 vaccine recommendations.”

The FDA authorization was based on a review of real world data from Israel, which included safety data from more than 6300 individuals 12 to 15 years of age who received a booster dose of the vaccine at least 5 months after completion of the primary series. The FDA determined that the protective health benefits of a single booster dose outweighed the potential risks in this patient population. No new cases of myocarditis or pericarditis were reported in the data.

The Israeli data also showed no new safety concerns when a booster dose was administered at least 5 months following completion of the primary series in individuals 16 years of age and older. Peer-reviewed data from multiple laboratories indicate that administering the booster dose sooner may provide better protection against the highly transmissible Omicron variant. Based on the evidence, the FDA determined that the benefits of an earlier booster dose outweighed the potential risks in children ages 12 and older as well.

“The Omicron variant appears to be more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “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.”

The CDC advisory panel also recommends a third primary series dose of the Pfizer-BioNTech COVID-19 vaccine at least 28 days after the second dose in immunocompromised individuals 5 to 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. 

Updated fact sheets for the Pfizer-BioNTech COVID-19 Vaccine are available here.

References

  1. CDC expands booster shot eligibility and strengthens recommendations for 12-17 year olds. News release. Centers for Disease Control and Prevention. January 5, 2022. Accessed January 6, 2022. https://www.cdc.gov/media/releases/2022/s0105-Booster-Shot.html
  2. Coronavirus (COVID-19) update: FDA takes multiple actions to expand use of Pfizer-BioNTech COVID-19 vaccine. News release. US Food and Drug Administration. January 3, 2022. Accessed January 4, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-multiple-actions-expand-use-pfizer-biontech-covid-19-vaccine.
  3. Pfizer and BioNTech receive US FDA Emergency Use Authorization of COVID-19 vaccine booster for individuals 12 years of age and older. News release. Pfizer and BioNTech SE. January 3, 2022. Accessed January 4, 2022. https://www.businesswire.com/news/home/20220103005218/en/Pfizer-and-BioNTech-Receive-U.S.-FDA-Emergency-Use-Authorization-of-COVID-19-Vaccine-Booster-for-Individuals-12-Years-of-Age-and-Older.