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March 25, 2022

CDC Endorses Pfizer COVID-19 Vaccine For Younger Teens

CDC Endorses Pfizer COVID-19 Vaccine For Younger Teens

Updated on May 12, 2021 at 5:30pm EDT.

Pfizer and BioNTech’s COVID-19 vaccine has cleared its final U.S. hurdle to become available to kids ages 12 to 15-years old. The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) voted to expand usage of the two-dose vaccine to this younger age group. The ACIP's recommnedation was approved by CDC director, Rochelle P. Walensky, MD, MPH.

Kids as young as 12 may start receiving the vaccine as early as Thursday, May 13.

This is another "important step to getting out of the COVID-19 pandemic, and closer to normalcy," Dr. Walensky said in a May 12 statement. "For vaccination to do its job, we must do our critical part," she added. "That means vaccinating as many people as possible who are eligible. This official CDC action opens vaccination to approximately 17 million adolescents in the United States and strengthens our nation’s efforts to protect even more people from the effects of COVID-19. Getting adolescents vaccinated means their faster return to social activities and can provide parents and caregivers peace of mind knowing their family is protected."

The CDC's decision comes just two days after the U.S. Food and Drug Administration (FDA) expanded its emergency use authorization (EUA) of Pfizer’s vaccine to teens ages 12 to 15 years old. The mRNA vaccine, which was the first coronavirus vaccine to be rolled out in the United States, is now the first shot available for this younger age group. The authorization comes as children across the country get ready for summer camps and other activities, and schools prepare for a return to the classroom in the fall. 

The FDA took about one month to make the decision to authorize the Pfizer vaccine for younger teens.  Pfizer made the request on Friday, April 9—just about one week after the company announced results of its late-stage trials.

The trial results showed that its COVID-19 vaccine is safe and 100 percent effective among teens between 12 and 15-years old. The vaccine, developed in partnership with the German biotech company BioNTech, was shown to be even more effective in this younger age group than it was among older teens and young adults ages 16 to 25, Pfizer said.

The vaccine was also well-tolerated. No serious side effects were reported. 

The Pfizer-BioNTech vaccine is currently one of three authorized in the United States, but it’s the only vaccine authorized for use in teens ages 12 to 17-years old. The Moderna and Johnson & Johnson vaccines are only authorized for use in adults age 18 or older.

“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination,” said Ugur Sahin, MD, CEO and co-founder of BioNTech.

“It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones,” Dr. Sahin added, noting the results of this teen trial are particularly encouraging amid the emergence of worrisome coronavirus variants in the U.S. and many other parts of the world.

Key findings from the trial
The Phase 3 trial involved 2,260 teenagers in the United States between 12 and 15-years old. None of the teens who received the vaccine developed COVID-19—an efficacy rate of 100 percent.

By comparison, 18 cases were detected among the teens in the placebo group who were not vaccinated.

The researchers found the vaccine triggered a strong immune response among this younger age group one month after the teens received their second dose.

Side effects were generally mild and consistent with what was reported by young adults, such as soreness at the injection site, fatigue, headache and muscle pain.

The FDA green-lighted use of the Pfizer shot in December 2020. At that time, controlled clinical trial results involving some 44,000 people age 16 and older found the vaccine was 95 percent effective. A more recent study by the Centers for Disease Control and Prevention (CDC) followed 3,950 health care workers, first responders and other frontline employees across the United States as the initial doses of the COVID-19 vaccines were rolled out. That study found the vaccine to be 90 percent effective in preventing the disease in a real-world setting.

What happens next
All teens included in the Pfizer trial will continue to be monitored for two years after receiving their second dose of the vaccine. Researchers will not only be analyzing the long-term safety of the shots but also tracking the teens’ immunity to COVID-19 over time.

Pfizer is also evaluating the safety and effectiveness of its two-dose COVID-19 vaccine among children ages 6-months to 11-years old. Children will be divided into groups by age: 5 to 11 years, 2 to 5 years and 6 months to 2 years.

Children between 2 and 11-years old have already started receiving injections. Pfizer reportedly hopes to request FDA authorization for this age group in September 2021. Babies and toddlers between 6-months and 2-years old are next in line.

Medically reviewed in May 2021.

Centers for Disease Control and Prevention. "CDC Director Statement on Pfizer’s Use of COVID-19 Vaccine in Adolescents Age 12 and Older." May 12, 2021.
U.S. Food and Drug Administration. “Vaccines and Related Biological Products Advisory Committee Meeting: FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine.” Dec 10, 2021.
Centers for Disease Control and Prevention. “Interim Estimates of Vaccine Effectiveness of BNT162b2 and mRNA-1273 COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers — Eight U.S. Locations, December 2020–March 2021.” Mar 29, 2021.