The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) has voted 14-0 in favor of recommending the Pfizer-BioNTech COVID-19 Vaccine for adolescents 12 to 15 years of age. The recommendation follows the Food and Drug Administration’s authorization for this patient population earlier this week.
A review of COVID-19 cases occurring 7 days after the second dose among 12 to 15 year olds without evidence of prior SARS-CoV-2 infection demonstrated that the vaccine was 100% effective in preventing COVID-19. No cases occurred among the 1005 participants who received the vaccine, while 16 were reported among the 978 placebo recipients. Additionally, analysis of immunogenicity data showed that immune responses to the vaccine in the adolescent group were noninferior to those observed in older participants (16 to 25 years).
As for safety, the most common adverse reactions reported included injection site pain, tiredness, headache, chills, muscle pain, fever, and joint pain. These side effects typically lasted 1 to 3 days and occurred more frequently following the second dose.
With regard to coadministration with other vaccines, the ACIP stated that the COVID-19 vaccine may now be administered without regard to timing. This includes simultaneous administration of the COVID-19 vaccine and other vaccines on the same day, as well as coadministration within 14 days.
In a policy statement, the American Academy of Pediatrics (AAP) also recommended vaccinating children 12 years of age and older. “As a pediatrician and a parent, I have looked forward to getting my own children and patients vaccinated, and I am thrilled that those ages 12 and older can now be protected,” said AAP President Lee Savio Beers, MD, FAAP. “The data continue to show that this vaccine is safe and effective.” The AAP also supports giving other childhood and adolescent immunizations at the same time as COVID-19 vaccines.
The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a 2-dose series (0.3mL each) spaced 21 days apart. The updated fact sheet can be found here.
- Clinical Considerations for Pfizer-BioNTech COVID-19 Vaccination in Adolescents. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-05-12/05-COVID-Woodworth-508.pdf. Accessed May 12, 2021.
- American Academy of Pediatrics calls for children and teens age 12 and up to get the COVID-19 vaccine. [press release]. May 12, 2021.