Safety Monitoring of COVID-19 Vaccine Boosters Among Adults

Safety Monitoring of COVID-19 Vaccine Booster Doses Among Adults

United States, September 22, 2021-February 6, 2022

Anne M. Hause, PhD; James Baggs, PhD; Paige Marquez, MSPH; Tanya R. Myers, PhD; John R. Su, MD; Phillip G. Blanc, MD; Jane A. Gwira Baumblatt, MD; Emily Jane Woo, MD; Julianne Gee, MPH; Tom T. Shimabukuro, MD; David K. Shay, MD

Disclosures

Morbidity and Mortality Weekly Report. 2022;71(7):249-254. 

In This Article

Abstract and Introduction

Introduction

During September 22, 2021–February 6, 2022, 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 for the primary series. VAERS has received 39,286 reports of adverse events after a COVID-19 mRNA booster vaccination for adults aged ≥18 years, including 36,282 (92.4%) nonserious and 3,004 (7.6%) serious events. Vaccination providers should educate patients that local and systemic reactions are expected following a homologous COVID-19 mRNA vaccine booster; however, these reactions appear less common than those following dose 2 of an mRNA-based vaccine. CDC and FDA will continue to monitor vaccine safety and provide data to guide vaccine recommendations and protect public health.

*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-19-vaccines-us.html
Health surveys are sent for the most recent dose entered via text messages that link to web-based surveys on days 0–7 after receipt of vaccine dose; then weekly through 6 weeks after vaccination; and then at 3, 6, and 12 months after vaccination. Local injection site reactions include itching, pain, redness, and swelling. Systemic reactions include abdominal pain, myalgia, chills, diarrhea, fatigue, fever, headache, joint pain, nausea, rash, and vomiting. Health impacts include inability to perform normal daily activities, inability to work or attend school, and receipt of medical care.
**CDC and FDA encourage all health care providers to report adverse events to VAERS and are required by COVID-19 vaccine Emergency Use Authorizations to report certain adverse events after vaccination to VAERS, including death. https://vaers.hhs.gov/faq.html
††VAERS reports are classified as serious based on the Code of Federal Regulations Title 21 (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr). Reports of serious adverse events receive follow-up by VAERS staff members to obtain additional information, including medical records and, for reports of death, death certificates and autopsy reports, if available.
§§Each VAERS report might be assigned more than one MedDRA preferred term. A MedDRA coded event does not indicate a medically confirmed diagnosis. https://www.meddra.org/how-to-use/basics/hierarchy
¶¶Acute myocarditis was defined as presence of signs and symptoms new onset or worsening of one or more of the following signs or symptoms: chest pain, pressure, discomfort, dyspnea, shortness of breath, pain with breathing, palpitations, or syncope; or two or more of the following signs or symptoms in children aged ≤11 years: irritability, vomiting, poor feeding, tachypnea, or lethargy); and one or more new finding of elevated troponin, electrocardiogram findings consistent with myocarditis, abnormal cardiac function or wall motion on echocardiogram, cardiac magnetic resonance imaging findings consistent with myocarditis, or histopathologic findings consistent with myocarditis; and no other identifiable cause for these findings.
***The odds of reporting an adverse event or health impact following dose 2 and booster were compared for registrants who received homologous COVID-19 mRNA vaccination using a multivariable generalized estimating equations model that accounted for the correlation between registrants and adjusted for demographic variables (i.e., age, sex, race, and ethnicity). The odds of reporting an event following homologous and heterologous booster vaccination were compared using a logistic regression model that adjusted for demographic variables of registrants; p<0.01 was considered significant. Odds ratios were not adjusted for persons who reported a primary Janssen series because of small numbers. The model did not converge for the 476 registrants who reported COVID-19 mRNA vaccination primary dose followed by a Janssen booster, and these registrants were excluded from the analysis.
†††45 C.F.R. part 46, 21 C.F.R. part 56; 42 U.S.C. Sect. 241(d); 5 U.S.C. Sect. 552a; 44 U.S.C. Sect. 3501 et seq.

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