The CDC Advisory Committee on Immunization Practices (ACIP) on Wednesday recommended the Pfizer/BioNTech COVID-19 vaccine for adolescents ages 12 to 15 under emergency use authorization (EUA).
In a 14-0 vote with one abstention, the committee agreed on the interim recommendation for the COVID-19 vaccine for this population.
The committee was fully convinced by safety and efficacy data presented by the sponsor, as well as immunobridging studies showing non-inferior immunogenicity among vaccinated adolescents (ages 12-15) versus vaccinated young people (ages 16-25). In addition, phase II/III studies found zero cases of COVID-19 from 7 days following the second dose in the vaccinated group versus 18 cases in the placebo group.
ACIP members echoed similar themes as the reason for their vote, ranging from personal to population health, from getting adolescents back to summer camp and in-person school, to one more step toward “community immunity.”
Helen Keipp Talbot, MD, of Vanderbilt University in Nashville, shared how thankful she was that the “rest of her family” could be vaccinated, including her younger adolescents.
Katherine Poehling, MD, of Wake Forest School of Medicine in Winston-Salem, North Carolina, reiterated the importance of the vaccine in this population, noting that COVID-19 hospitalizations in children are increasing.
Poehling added that COVID-19 is now “one of the top 10 causes of death for children.”
ACIP chair José Romero, MD, characterized the votes around these vaccines as “significant steps,” and said the country was “one more step closer to gaining immunity and bringing the pandemic closer to the end.”
While the vote itself sailed through the committee, the clinical considerations around the recommendation drew more discussion. Namely, CDC staff presented language that COVID-19 and other vaccines may be administered simultaneously, or administered within 14 days for both children and adults.
The original CDC policy stated not to administer the COVID-19 vaccine within 14 days of another vaccine, out of an abundance of caution.
Liaison members from the American Academy of Pediatrics read a statement in support of the COVID-19 vaccine for children ages 12 and older, and for vaccine co-administration, especially given the decline in routine child and adolescent immunizations occurring during the pandemic.
After some quibbling over the wording, CDC staff finally arrived at language stating COVID-19 vaccines and other vaccines “may now be administered without regard to timing,” although “it is unknown whether reactogenicity is increased with co-administration, including with other vaccines known to be more reactogenic, such as adjuvanted vaccines.”
The language also said providers could factor in whether a patient is behind on recommended vaccines, as well as the reactogenicity profile of the vaccines when considering co-administration.
Liaison member William Schaffner, MD, of the National Federation of Infectious Diseases, not only welcomed the new guidance, but said he would also welcome “data on the subject of co-administration as it becomes available.”
As usual, all recommendations made by the ACIP are not considered final until they are published in the Morbidity and Mortality Weekly Report.