CDC Recommends Use of Pfizer's COVID Vaccine in 12- to 15-Year-Olds

Kerry Dooley Young

Disclosures

May 12, 2021

Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

The Centers for Disease Control and Prevention's (CDC) Director Rochelle Walensky, MD, signed off on an advisory panel's recommendation Wednesday endorsing the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents ages 12 to 15.

Earlier Wednesday the CDC's Advisory Committee on Immunization Practices (ACIP) voted 14-0, with one recusal, in favor of the safety and effectiveness of the vaccine in younger teens.

"CDC now recommends that this vaccine be used among this population, and providers may begin vaccinating them right away," Walensky said in an official statement following the panel's vote.

Before the CDC considered the use of the vaccine in younger teens, the US Food and Drug Administration (FDA) on May 10 issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 in individuals 12-15 years old. The FDA first cleared the Pfizer-BioNTech vaccine through an EUA in December for those ages 16 and older. 

Walenksy urged parents to seriously consider vaccinating their children now that the federal endorsements were in place.

“Understandably, some parents want more information before their children receive a vaccine,” she said. “I encourage parents with questions to talk to your child’s healthcare provider or your family doctor to learn more about the vaccine.”

Vaccine "Safe and Effective"

Physician groups welcomed the advisory panel's decision. Susan R. Bailey, MD, president of the American Medical Association, said in a statement that the ACIP recommendation "brings us one critical step closer to our nation's goal of achieving widespread vaccination among the US population."

Ada D. Stewart, MD, president of the American Academy of Family Physicians, said her group was "encouraged that adolescents can now receive this safe and effective vaccine, as recommended by...ACIP."

The American Academy of Pediatrics (AAP) also issued a statement on Wednesday in support of vaccinating all children ages 12 and older who are eligible for the federally authorized COVID-19 vaccine.

"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, in a statement. "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 expanded clearance for the Pfizer vaccine is seen as a critical step for allowing teens to resume activities they had to put on hold during the pandemic.

"We've seen the harm done to children's mental and emotional health as they've missed out on so many experiences during the pandemic," Beers said. "Vaccinating children will protect them and allow them to fully engage in all of the activities — school, sports, socializing with friends and family — that are so important to their health and development."

Catch-Up Strategy?

Many Americans of all ages have also fallen behind on preventative healthcare during the pandemic. So visits to physicians for COVID-19 vaccines could provide a chance to consider what other shots are needed, some members of the CDC panel said on Wednesday.

Walensky underscored this point. If "your adolescent is behind on routinely recommended vaccines due to the pandemic or for other reasons, now would be a good time to work with your child's nurse or doctor to make sure they get caught up," she said in her statement.

Still, some panelists expressed reservations about this approach. ACIP panelist Helen Keipp Talbot, MD, of Vanderbilt University, noted that the COVID-19 vaccine represents a special case of a medicine that health officials intend to introduce widely and rapidly in the US population. She said she worried that there might be confusion about which shot caused any possible side effects if several vaccines were given to a patient in short order.

"I do not want to discourage anyone from getting vaccinated," Talbot said. "I'm probably being overly cautious, but if possible, I would separate the appointments."

Background Rate of Psychiatric Conditions

ACIP panelists also considered reports of serious adverse events while testing the Pfizer vaccine.

John L. Perez, MD, MBA, representing Pfizer, fielded ACIP members' questions about cases of psychiatric disorders. Of the 1131 study participants who received the vaccine, there were three reports of depression, one of anxiety, and one of suicidal ideation. None of these were listed among serious events for the placebo group of 1129 patients, according to the presentation given by Perez.

ACIP panelist Sarah S. Long, MD, of Drexel University, Philadelphia, Pennsylvania, asked about the prevalence of psychiatric disorders generally among participants in the study. Many of the teens already had some type of psychiatric diagnosis on entering the trial, with attention-deficit disorder being a common diagnosis, Perez said.

He added that the Pfizer COVID-19 vaccine trial was in keeping with other studies involving adolescents, with 20% to 25% of participants having had a diagnosis of this kind.

FDA staff had also reported earlier that the serious adverse events during the study of adolescents appeared unrelated to the vaccination.

In a memo posted on the FDA website about the expanded authorization for use of the Pfizer vaccine in adolescents, agency staff provided details about study participants who had serious adverse events. Among events seen from the first dose through 1 month after the second dose of the vaccine, three participants in the active group were hospitalized for medical management of depression exacerbation.

These participants had pre-existing anxiety and depression and all had reported treatment with a selective serotonin reuptake inhibitor (SSRI) that began within 1 to 2 months prior to vaccination. "Worsening suicidal ideas with initial SSRI treatment in adolescents is a recognized risk and provides a reasonable alternative explanation for depression exacerbation in these BNT162b2 recipients," FDA staff noted in the memo.

Kerry Dooley Young is a freelance journalist based in Washington, DC. She is the core topic leader on patient safety issues for the Association of Health Care Journalists. Young earlier covered health policy and the federal budget for Congressional Quarterly/CQ Roll Call and the pharmaceutical industry and the Food and Drug Administration for Bloomberg. Follow her on Twitter at @kdooleyyoung.

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