News

Pfizer-BioNTech Vaccine Is Safe and Effective for Ages 12 to 15, Trial Shows

A nurse with a mask and face shield gives a teenage girl a shot.
valentinrussanov / Getty Images.

Key Takeaways

  • On March 31, Pfizer-BioNTech released a statement announcing that their COVID-19 vaccine proved to be safe and effective in a trial of adolescents, aged 12 to 15.
  • Pfizer-BioNTech and outside medical experts believe adolescents could start receiving the COVID-19 vaccine before the school year begins in September.
  • Until children are vaccinated, they can still carry COVID-19 and must maintain social distancing measures.

On Wednesday, March 31, Pfizer-BioNTech announced the results of their COVID-19 vaccine study in adolescents. According to a company press release, its recent clinical trial of 2,260 participants aged 12 to 15 had 100% efficacy, robust antibody responses, and participants tolerated it well.

On average, adolescents in the study produced higher levels of antibodies than people aged 16 to 25 in an earlier trial by Pfizer-BioNTech.

There were no instances of COVID-19 reported in the vaccinated group, while the placebo group had 18 cases. “The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination,” said Ugur Sahin, 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.”

Though the results are positive, Pfizer-BioNtech will first have to submit their full report to the Food and Drug Administration and request emergency use authorization to expand their vaccine to anyone above the age of 12. The company hopes to start vaccinating this age group before the school year begins in September, said Albert Bourla, Pfizer chairman and CEO, in the release.

Christina Johns, MD, FAAP, a senior medical advisor for PM Pediatrics, concurs. “We are all optimistic that by the time school starts in the fall, that we really could be on a very mass distribution plan to middle schoolers and high schoolers,” she says of herself and fellow experts following vaccine safety and distribution for children.

In the United States, the minimum age approved for the Pfizer-BioNTech vaccine is 16. The cut-off is even higher for the Moderna and Johnson & Johnson vaccines at 18.

While currently necessary due to available trial data, these minimums exclude a large segment of the population. As of 2019, there were about 73 million people under the age of 18 living in the United States.

The Necessity of Vaccinating Children 

As of March 25, 2021, over 3.4 million children have tested positive for COVID-19 in the United States. This number represents about 13.4% of overall cases. While children have shown to have much fewer instances of mortality due to COVID-19, they can still become sick and act as carriers.

Social distancing measures are necessary until vaccines are approved for and given to children. “If a child is infected, it is still possible they can transmit the virus to a vaccinated adult,” says William W. Li, MD, a physician and scientist.

“The data shows the vaccines protect against severe illness and death, so that’s a reassurance. However, until most people are vaccinated, including children, it is still important for safety to wear a mask and social distance with people who are outside of your daily bubble,” says Li.

Christina Johns, MD

The more of the population, in its entirety, that we can get fully vaccinated, the quicker we can get to total virus suppression, which also means variance suppression.

— Christina Johns, MD

Understanding the COVID-19 vaccine's effect on children is critical to reach herd immunity. Researchers estimate that at least 80% of people will need to receive a COVID-19 vaccine to accomplish this. As of March 31, 2021, 29.4% of people in the U.S. have received their first dose, and 16.4% are fully vaccinated.

“The more of the population in its entirety, that we can get fully vaccinated, the quicker we can get to total virus suppression, which also means variance suppression,” says Johns. “Getting this next subset of the population into that immunized mix, that's going to help with that.”

Additional COVID-19 Vaccine Trials Involving Children

In the same press release, Pfizer-BioNTech provided an update on their study of the vaccine’s effect in children six months to 11 years old. Last week, the first children in the five to 11 age group received their vaccines, and the company plans to start vaccinating children in the two to five age group next week.

William W. Li, MD

Until most people are vaccinated, including children, it is still important for safety to wear a mask and social distance with people who are outside of your daily bubble.

— William W. Li, MD

Pfizer-BioNTech is not the only company working to expand eligibility. Moderna has also worked on a trial for adolescents aged 12 to 17 and is beginning to test the vaccine on children aged 6 months to 11 years. Johnson and Johnson has also started testing their vaccines on young people. 

What This Means For You

COVID-19 vaccinations may be widely available for children aged 12 and above by the start of the new school year. Trials on the safety and effectiveness of the vaccine on younger children are still in the process.

Check the status of these studies regularly to get a better idea of when your child will have the opportunity to be vaccinated.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.

Was this page helpful?
Article Sources
Verywell Family uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Pfizer. Pfizer-BioNTech announce positive topline results of pivotal COVID-19 vaccine study in adolescents. March 31, 2021.

  2. Annie E. Casey Foundation: KIDS COUNT Data Center. Total population by child and adult populations in the United States. Updated September 2020.

  3. American Academy of Pediatrics. Children and COVID-19: State-level data report. Published March 22, 2021.