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New, Reassuring Safety Data on the COVID-19 Vaccine in Adolescents

April 25, 2023

While it was such a relief to have the COVID-19 vaccine approved for use in 12–15-year-olds in May 2021, many parents were uneasy about potential side effects of the vaccine, especially the reports of myocarditis in adolescent boys who had received the vaccine.

Now it’s almost 2 years later, and we have administered more than 32 million COVID-19 vaccine doses to adolescents. However, some parents are still reluctant to have their adolescent receive the vaccine without more data.

We now have more data.

This week, Pediatrics is early releasing an article entitled, “COVID-19 Vaccine Safety First Year Findings in Adolescents” (10.1542/peds.2022-060295).

In this article, Dr. Elizabeth Hesse and colleagues at the CDC and FDA describe the results of data from the first year after the vaccine was approved for use in younger adolescents.

The authors analyzed data from 2 vaccine safety systems:

  • V-Safe: Daily health surveys completed for 1 week after the vaccine by 172,000 adolescents (16–18-year-olds) or their parents/guardians (for 12–15-year-olds).
  • Vaccine Adverse Event Reporting System (VAERS): A voluntary system that accepts reports of adverse events after vaccination from any source (including patient, parent, and health care provider). VAERS received 20,240 reports about the COVID-19 vaccine in adolescents.

While you will definitely want to read the entire report (there are a lot of data!), here are some of the highlights:

In the V-Safe data, approximately half of adolescents reported systemic reactions (fatigue, headache, and myalgia were most common) after the first dose, and two-thirds had these reactions after the second dose. Only 1% and 4%, respectively said that the reactions after the first and second doses caused the adolescent to miss school or work.

The VAERS data showed that:

  • More than 90% of the reports were nonserious. These included reports of dizziness, headache, fever, nausea, fatigue, and pain.
  • There were 63 reports of anaphylaxis in the week after vaccination; the vast majority (56) occurred on the day of or after vaccination. This is 1.95 reports per 1 million doses, a rate that is comparable to rates of anaphylaxis after influenza vaccine (31 per 1 million doses).

Regarding myocarditis, there were 570 confirmed cases:

  • 90% of cases were in boys.
  • The group with the highest reporting rate was boys who were 16–17-years-old and who had received the second dose (84 cases per million second doses).
  • Of note, this rate is lower than the 122 cases per million vaccinated adolescent boys that had been reported in the clinical trials.
  • Three quarters of reports of myocarditis indicated that the adolescent had fully recovered at the time of the report.

The results are very reassuring, as there are no new or serious safety concerns that had not already been reported in the clinical trials. I will definitely be using some of these data when I am counseling adolescents and their parents about the risks and benefits of the COVID-19 vaccine.

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