The Pfizer-BioNTech COVID-19 vaccine is now available for children 12 and older after the Food and Drug Administration (FDA) provided the vaccine with emergency use authorization May 10.
As the COVID-19 vaccines are slowly made available to children, parents naturally have a lot of questions.
“As adults, getting the vaccine may have been a simple decision. However, it can be harder when you are making that decision for someone else – your child,” said Dr. Edna DeVries, pediatrician and service line medical director for Marshfield Children’s.
Clinical trial results for Pfizer-BioNTech COVID-19 vaccine
No safety concerns were found for up to eight weeks following vaccination of the Pfizer-BioNTech COVID-19 vaccine in more than 1,100 adolescents (12-15 years of age) during the phase 3 clinical trial. Similar results were found in teens between the age of 16-17.
For both age groups, the Pfizer-BioNTech COVID-19 vaccine generated a strong antibody response. It was 100% effective against symptomatic COVID-19 during the phase 3 clinical trial for 12-15 year olds and 95% effective for those 16 and older.
Adolescents and teens that received the Pfizer-BioNTech COVID-19 vaccine had similar side effects to other age groups. Pain at the injection site is common. Many adolescents also developed symptoms such as fatigue, headache, chills and muscle aches. These side effects typically only last for 1-2 days.
“These results really compare well to the Pfizer-BioNTech COVID-19 vaccine clinical trial results for older populations,” Dr. DeVries said. “And the CDC continues to generate more positive safety data as we move forward. More than 130 million doses of the Pfizer vaccine have now been administered in the U.S.”
The U.S. Food and Drug Administration (FDA) added a warning about rare cases of myocarditis (heart inflammation) in adolescents and young adults after receiving an mRNA vaccine by Pfizer or Moderna. The rate of diagnosed myocarditis/pericarditis after the second dose of mRNA vaccine is about 13 cases per million doses for people 12 to 39 years old. This is higher than expected by chance, but the absolute risk is very low.
The CDC Advisory Committee on Immunization Practices (ACIP) has reviewed the risk and benefits, concluding that benefits (prevention of COVID-19 hospitalization and death) outweigh the low risk of myocarditis. The CDC will continue to monitor myocarditis and reassess risks and benefits as more data become available.
No changes for dosing
Both adolescents and teens should receive the same amount of the Pfizer-BioNTech COVID-19 vaccine as other age groups.
Like adults, adolescents and teens should also receive the Pfizer-BioNTech COVID-19 vaccine in two doses, three weeks apart.
“This is great news as it will make the vaccination process simpler for everyone involved,” Dr. DeVries said.
What about other concerns?
Like in the older age groups, immediate, severe allergic reactions are very rare when getting any of the COVID-19 vaccines. Your child should not get any COVID-19 vaccine if they have ever had an allergic reaction to a previous dose of the COVID-19 vaccine. To learn more about allergies, check out this blog post.
If you have an adolescent or teen daughter, you may have heard the myth that the vaccine affects fertility. This is completely false as there is no evidence that any of the COVID-19 vaccines cause infertility.
In fact, the American Society for Reproductive Medicine, American College of Obstetricians and Gynecologists and Society for Maternal Fetal Medicine all recommend women considering pregnancy get a COVID-19 vaccine. Learn more from this blog.
If you have any questions about providing the COVID-19 vaccine to your adolescent or teen, talk to your child’s pediatrician.