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April 9, 2021

Pfizer Asks FDA to Greenlight Its COVID-19 Vaccine For Younger Teens

Pfizer Asks FDA to Greenlight Its COVID-19 Vaccine For Younger Teens

Updated on April 9, 2021 at 3:30pm EDT.

Pfizer has asked the U.S. Food and Drug Administration (FDA) to expand the emergency use authorization (EUA) of its COVID-19 vaccine to teens ages 12 to 15 years old. It’s not clear how long the FDA might take to evaluate this request but, if given the greenlight in the U.S., Pfizer’s vaccine would be the first shot available for this younger age group. It could also be a game-changer this fall as schools across the country prepare to return to the classroom.

The Friday, April 9 request comes just about one week after Pfizer announced results of its late-stage trials, which 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, the company announced.

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 16 and 17-years old. The Moderna and Johnson & Johnson vaccines are only authorized for use in adults age 18 or older.

Pfizer’s CEO, Albert Bourla, PhD, hopes to begin vaccinating younger teens before the start of the next school year. “We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Bourla in March 31 news release.

“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 and BioNTech released topline results, which summarized their key findings. Pfizer says it plans to submit their complete findings to a peer-reviewed scientific journal for publication.

What about younger kids?
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 5 to 11-years old have already started receiving injections. Younger kids, ages 2 to 5-years old, are next in line.

Medically reviewed in March 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.