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The Science Behind the Decision: New COVID-19 Vaccine Guidelines for Children 12–15

by Inspira Health

The Food and Drug Administration (FDA) has extended its emergency use authorization (EUA) of the Pfizer-BioNTech vaccine to adolescents 12 years of age and older. These new guidelines come following several clinical trials showing participants between 12 and 15 years of age who received Pfizer’s vaccine were protected against laboratory-confirmed COVID-19 illness. Being vaccinated is our strongest defense in the fight against COVID-19 and now our teens can be protected too.

“The Pfizer-BioNTech COVID-19 vaccine is an mRNA vaccine—it tells the body how to create antibodies against COVID-19 and does not contain any virus particles,” said Haytham Hamwi, M.D., a Nemours Children’s Health pediatrician and pediatric hospitalist at Inspira Medical Center Mullica Hill. “As these new recommendations come out, we need to trust the same science that kept us safe throughout the pandemic.”

Data-Driven Decisions: In the United States study of participants aged 12 to 15, there were no laboratory-confirmed cases of COVID-19 in the 1,005 vaccine recipients and just 16 cases of COVID-19 in the 978 placebo recipients— the vaccine was 100% effective against COVID-19 infection.

“Compared to adults, COVID-19 is less severe in children and adolescents who test positive for the virus. But this virus does not discriminate. It can cause lifelong complications, hospitalizations and, in extreme cases, death,” said Dr. Hamwi. “If you have the opportunity to vaccinate your child, we strongly recommend doing so. It could save your child and those around them.”

Easing Vaccine Concerns with Science: A common concern about adolescents getting a COVID-19 vaccine is the potential side effects. Scientific evidence to date shows that side effects have been manageable.

“Vaccine side effects are common. They’re your body’s way of learning how to fight the virus without having to be exposed to it,” said Dr. Hamwi. Adolescent clinical trial participants reported symptoms like those reported by adults who received the Pfizer-BioNTech COVID-19 vaccine, including pain at the injection site, headache, chills, fever, and fatigue.

“There have been some reports of myocarditis—inflammation of the heart muscle—and pericarditis—inflammation of the outer lining of the heart—in children who received the vaccine. However, these cases responded to medication and rest,” said Dr. Hamwi. “Compared to the side effects of COVID-19, which can include permanent damage to the lungs, heart and brain, the benefits of the vaccine outweigh the risks.”

We are still learning about COVID-19 and how vaccines will play a continuing role in our ability to return to some normalcy. We don’t know how long the vaccines protect us from COVID-19 illness, but we do know that getting vaccinated should not be delayed.

“The vaccines are safe and effective. Parents should not be afraid of getting their children vaccinated. While wearing a mask, social distancing and proper handwashing have kept us safe, we now have another tool in our arsenal against the virus—and it’s the best one we have,” said Dr. Hamwi.

For more information about the new COVID-19 vaccination guidelines, go to cdc.gov/coronavirus