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July 8, 2021

Moderna Says Its COVID-19 Vaccine is Highly Effective Among Teens

Moderna Says Its COVID-19 Vaccine is Highly Effective Among Teens

Updated on May 25, 2021 at 8:45am EDT.

Moderna says that its COVID-19 vaccine is safe and effective for teens between 12 and 17-years old. The company plans to request expanded authorization from the U.S. Food and Drug Administration (FDA) in early June. If given the green light, it will be the second mRNA vaccine available to teens in the United States.

On May 12, Pfizer and BioNTech’s COVID-19 vaccine cleared its final U.S. hurdle to become available to kids as young as 12-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.

Pfizer was originally authorized for use among people age 16 and older. Moderna’s vaccine is currently only authorized for adults age 18 and older.

Results from the teen trials
Results of Moderna’s late-stage trails, involving 3,732 young people ages 12 to 17-years old found no cases of COVID-19 among those who received two doses of the vaccine. Among this younger age group, the vaccine had an efficacy rate of 93 percent 14 days after the first dose and an efficacy rate of 100 percent 14 days after the second shot.

“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection,” said Stéphane Bancel, Moderna’s chief executive officer in a May 25 news release. “We will submit these results to the U.S. FDA and regulators globally in early June and request authorization. We remain committed to doing our part to help end the COVID-19 pandemic.”

Moderna says it will also submit data from its teen trial to a peer-reviewed publication.

Is Moderna’s vaccine safe for teens?
The Moderna vaccine was well-tolerated among the teens, with mostly mild side effects similar to those experienced by adults who received the shot. The most commonly reported complaint after the first dose was pain at the injection site. After the second dose, the most common side effects were headache, fatigue, muscle pain and chills.

All teens included in the Moderna trial will continue to be monitored for 12 months 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.

How the vaccine works
The vaccine candidate, mRNA-1273, is an mRNA vaccine.

Traditional vaccines for viruses are made from a weakened or inactive virus, but Moderna’s vaccine is not made from SARS-CoV-2, the coronavirus that causes COVID-19.

Instead, it works by delivering pieces of genetic material that carry instructions for making the COVID-19 spike protein, which is the protein that SARS-CoV-2 uses to infect cells.

The genetic code, or mRNA, is packaged inside a slippery coating that allows it to slide into cells and tell them to make the spike protein. This prompts an immune response to protect you from catching COVID-19.

Medically reviewed in May 2021.

Sources:
Moderna. “Moderna Announces TeenCOVE Study of its COVID-19 Vaccine in Adolescents Meets Primary Endpoint and Plans to Submit Data to Regulators in Early June.” May 25, 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.

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