COVID-19 Vaccine Safety in Adolescents Aged 12–17 Years

United States, December 14, 2020-July 16, 2021

Anne M. Hause, PhD; Julianne Gee, MPH; James Baggs, PhD; Winston E. Abara, MD; Paige Marquez, MSPH; Deborah Thompson, MD; John R. Su, MD, PhD; Charles Licata, PhD; Hannah G. Rosenblum, MD; Tanya R. Myers, PhD; Tom T. Shimabukuro, MD; David K. Shay, MD

Disclosures

Morbidity and Mortality Weekly Report. 2021;70(31):1053-1058. 

In This Article

Discussion

The findings summarized in this report are consistent with the safety data observed in preauthorization trials for Pfizer-BioNTech after vaccination among persons aged 12–25 years, with the exception of myocarditis, a serious adverse event detected in postauthorization safety monitoring.[3] Trial participants who received vaccine (1,131 aged 12–15 years; 537 aged 16–25 years) reported local and systemic reactions that were mostly mild (i.e., did not interfere with activity) or moderate (some interference with activity); no serious adverse events related to vaccination were reported.[3] Similarly, local and systemic reactions were commonly reported by U.S. adolescents aged 12–17 years who enrolled in v-safe; a minority (<25%) reported they were unable to perform normal daily activities the day after receipt of dose 2. A small number of v-safe participants reported they were hospitalized after vaccination; however, v-safe does not record reason for hospitalization, and it cannot be determined whether hospitalization was related to vaccination.

Among 8.9 million adolescents vaccinated during the study period, VAERS reports were received for approximately one per 1,000 vaccinees, and 90% of these reports were for nonserious conditions. Syncope was among the events most commonly reported to VAERS in this age group and is common among adolescents after any vaccination.[9] Other conditions associated with vasovagal response to vaccination were also frequently reported. Among the serious reports, myocarditis and other conditions that might be associated with myocarditis were among the most common terms reported; however, these terms did not account for a large proportion of VAERS reports overall. No reports of death to VAERS were determined to be the result of myocarditis. Impressions regarding cause of death did not indicate a pattern suggestive of a causal relationship with vaccination; however, cause of death for some decedents is pending receipt of additional information. ACIP conducted a risk-benefit assessment based in part on the data presented in this report and continues to recommend the Pfizer-BioNTech COVID-19 vaccine for all persons aged ≥12 years.[6] An updated EUA now includes information on myocarditis after mRNA COVID-19 vaccines.§§§

The findings in this report are subject to at least five limitations. First, VAERS is a passive surveillance system and is subject to underreporting and reporting biases;[7] however, under EUA, health care providers are required to report all serious events following vaccination. Second, medical review of reported deaths following vaccination is dependent on availability of medical records, death certificates, and autopsy reports, which might be unavailable or not available in a timely manner. Third, lack of a statistical safety signal in planned monitoring does not preclude a safety concern. For example, although a statistically significant data mining alert has not been observed for myocarditis following Pfizer-BioNTech vaccination, myocarditis has been identified as an adverse event following mRNA COVID-19 vaccines in multiple surveillance systems.[10] Fourth, this study was not designed to identify all cases of myocarditis; only reports that listed the MedDRA term "myocarditis" were included. Finally, v-safe is a voluntary self-enrollment program that requires children aged <15 years be enrolled by a parent or guardian and relies on vaccine administrators to promote the program. Therefore, v-safe data might not be generalizable to the overall vaccinated adolescent population.

The initial safety findings of Pfizer-BioNTech vaccine administered to U.S. adolescents aged 12–17 years are similar to those described in the clinical trials, with the exception of myocarditis, a rare serious adverse event associated with receipt of mRNA-based COVID-19 vaccines; follow-up of reported myocarditis cases is ongoing.[6] CDC and FDA will continue to monitor for adverse events, including myocarditis, after mRNA COVID-19 vaccination and share available data with ACIP to guide risk-benefit assessments for all COVID-19 vaccines.

§§§An updated letter of authorization for the Pfizer-BioNTech COVID-19 vaccine is available at https://www.fda.gov/media/150386/download.

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