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The AAP recommends adolescents ages 12 and older get vaccinated against COVID-19 now that federal health officials have signed off on the Pfizer-BioNTech vaccine for these ages.
In addition to approving the vaccine’s use for adolescents on Wednesday, the Centers for Disease Control and Prevention (CDC) updated its clinical guidance to allow COVID-19 vaccines to be administered at the same time as other routine vaccines. The AAP supported both moves in a new policy statement.
“This is truly an exciting development that allows us to protect a large population of children and help them regain their lives after a really rough year,” AAP President Lee Savio Beers, M.D., FAAP, said in a press release. “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. The data continue to show that this vaccine is safe and effective. I urge all parents to call their pediatrician to learn more about how to get their children and teens vaccinated.”
The CDC director’s approval followed a 14-0 vote in favor by the agency’s Advisory Committee on Immunization Practices (ACIP) Wednesday and comes two days after the Food and Drug Administration (FDA) extended emergency use authorization of the Pfizer-BioNTech vaccine down to age 12 from the previous age of 16. The CDC is expected to publish its official recommendations this week.
President Joe Biden on Wednesday promised fast roll-out of the vaccines for adolescents at pediatrician and family physician offices in addition to pharmacies. Some jurisdictions already have announced adolescent vaccination will begin Thursday.
“The vaccine for kids between the ages of 12 and 15 are safe, effective, easy, fast and free,” Biden said. “So my hope is parents will take advantage of the vaccine and get their kids vaccinated.”
Since the pandemic began, more than 1.5 million adolescents ages 12-17 years have been diagnosed with COVID-19 and more than 13,000 have been hospitalized, according to CDC data. The pandemic also has taken a toll on children’s mental and emotional health, social well-being and their educational experience.
Pfizer and CDC officials reviewed data on safety and efficacy of the vaccine during Wednesday’s ACIP meeting. Pfizer and BioNTech conducted trials in more than 2,000 adolescents ages 12-15 with half randomized to receive the vaccine and half to receive a placebo.
The most common side effects in adolescents were pain at the injection site, fatigue, headache, chills, muscle pain, fever and joint pain, consistent with trials in older teens and adults.
About 6% of vaccine recipients experienced an adverse event, including seven cases of swollen lymph nodes. There were five serious adverse events in the vaccine group (0.4%) including one person with abdominal pain, constipation and neuralgia and others with depression, anxiety and suicidal ideation. None of the serious events were determined to be related to the vaccine and no deaths were reported. There also were no reports of blood clots, serious allergic reactions or Bell’s palsy.
Vaccine efficacy for this age group was 100%. Among just over 1,000 vaccine recipients, there were no cases of COVID-19, while 16 were reported among more than 970 placebo recipients. An immunogenicity analysis in 190 participants also showed their response was even better than the response for those ages 16-25 years.
“I think this will provide protection for 12- to 15-year-olds,” said ACIP member Henry Bernstein, D.O., M.H.C.M., FAAP, professor of pediatrics at the Zucker School of Medicine at Hofstra/Northwell. “It will decrease transmission within their families, and it will contribute to community immunity and allow kids to more safely go back to camps this summer and back to in-person school.”
The vaccine will be given to adolescents in two doses 21 days apart, the same as for adults. The need for consent from a parent or guardian will depend on state or local laws.
The vaccine should not be given to anyone with a history of severe or immediate allergic reaction to a previous dose or component of the vaccine, according to the CDC.
Children or adults with a history of multisystem inflammatory syndrome linked to COVID-19 may be vaccinated but should consider waiting until 90 days after the diagnosis of this syndrome.
The CDC updated its clinical guidance for vaccine administration for all ages to say COVID-19 vaccines can be given on the same day as other routine vaccines instead of waiting 14 days. The move is intended to help boost rates of routine adolescent immunizations, which have seen a sharp decline during the pandemic leaving children vulnerable to myriad diseases.
Allowing coadministration of vaccines sparked debate among ACIP members on Wednesday. CDC officials said they based the decision on safety data for administering COVID-19 vaccines alone and years of experience administering other vaccines together. Some ACIP members said they believe more data are needed, specifically on giving COVID-19 vaccines with other vaccines, but AAP policy supports coadministration, which provided reassurance to others.
“In my judgment, the known benefit of COVID vaccination and the known risks of missing routine vaccination combine to justify the modification to the coadministration recommendations to allow COVID and the routine vaccines to be given without regard to intervals,” said David W. Kimberlin, M.D., FAAP, editor of the 2021 Red Book and a liaison to ACIP.
ACIP members said they are excited to see adolescent vaccination begin.
“I think the childhood experience our kids have gone through will have long-lasting consequences that may extend across generations to be honest,” said ACIP member Grace M. Lee, M.D., M.P.H., associate chief medical officer for practice innovation at Stanford Children’s Health. “We don’t really fully yet understand the total … physical health, mental health and educational impact of the pandemic on our kids.”