Safety Monitoring of COVID-19 Vaccine Booster Doses Among Adults — United States, September 22, 2021–February 6, 2022
Anne M. Hause, James Baggs, Paige Marquez, Tanya R. Myers, John R. Su, Phillip G. Blanc, Jane Baumblatt, Emily Jane Woo, Julianne Gee, Tom T. Shimabukuro, David K. Shay
Abstract
approximately 82.6 million U.S. residents aged 18 years received a COVID-19 vaccine booster dose.* The Food and Drug Administration (FDA) has authorized a booster dose of either the same product administered for the primary series (homologous) or a booster dose that differs from the product administered for the primary series (heterologous). These booster authorizations apply to all three COVID-19 vaccines used in the United States (1-3). The Advisory Committee on Immunization Practices (ACIP) recommended preferential use of an mRNA COVID-19 vaccine (mRNA-1273 [Moderna] or BNT162b2 [Pfizer-BioNTech]) for a booster, even for persons who received the Ad26.COV2.S (Janssen [Johnson & Johnson]) COVID-19 vaccine for their single-dose primary series. To characterize the safety of COVID-19 vaccine boosters among persons aged 18 years during September 22, 2021-February 6, 2022, CDC reviewed adverse events and health impact assessments following receipt of a booster that were reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system managed by CDC and FDA. Among 721,562 v-safe registrants aged 18 years who reported receiving a booster, 88.8% received homologous COVID-19 mRNA vaccination. Among registrants who reported a homologous COVID-19 mRNA booster dose, systemic reactions were less frequent following the booster (58.4% [Pfizer-BioNTech] and 64.4% [Moderna], respectively) than were those following dose 2 (66.7% and 78.4%, respectively). The adjusted odds of reporting a systemic reaction were higher following a Moderna COVID-19 vaccine booster, irrespective of the vaccine received * https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic The FDA has authorized a booster dose of either the same product administered for the primary series (homologous) or a booster dose that differs from the product administered for the primary series (heterologous). These booster authorizations apply to all three COVID-19 vaccines used in the United States: 1) Pfizer-BioNTech COVID-19 vaccine 5 months after dose 2 for persons aged 12 years, 2) Moderna COVID-19 vaccine 5 months after dose 2 for persons aged 18 years, and 3) Janssen COVID-19 vaccine 2 months after a single dose for persons aged 18 years. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19vaccines-us.html