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Adverse effects represent the flip side of efficacy for drugs and vaccines — and this side of the coin is particularly significant when millions of people receive the agent. The Pfizer-BioNTech vaccine was conditionally authorized for U.S. adolescents (age range, 12–17) in May of 2021 based on a Phase 3 trial. Beginning in June of 2021, reports emerged of myocarditis (primarily in males) following the second dose of vaccine. Although the initial risk/benefit estimation favored administering the vaccine, CDC and the FDA undertook a further study during December 14, 2020–July 16, 2021, of adverse effects in this age group using data from the Adverse Event Reporting System (VAERS) and a phone-based reporting system (v-safe).
According to VAERS …