First Month of COVID-19 Vaccine Safety Monitoring

United States, December 14, 2020-January 13, 2021

Julianne Gee; Paige Marquez; John Su; Geoffrey M. Calvert; Ruiling Liu; Tanya Myers; Narayan Nair; Stacey Martin; Thomas Clark; Lauri Markowitz; Nicole Lindsey; Bicheng Zhang; Charles Licata; Amelia Jazwa; Mark Sotir; Tom Shimabukuro

Disclosures

Morbidity and Mortality Weekly Report. 2021;70(8):283-288. 

In This Article

Abstract and Introduction

Introduction

Two coronavirus disease 2019 (COVID-19) vaccines are currently authorized for use in the United States. The Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020, and for the Moderna COVID-19 vaccine on December 18, 2020; each is administered as a 2-dose series. The Advisory Committee on Immunization Practices issued interim recommendations for Pfizer-BioNTech and Moderna COVID-19 vaccines on December 12, 2020,[1] and December 19, 2020,[2] respectively; initial doses were recommended for health care personnel and long-term care facility (LTCF) residents.[3] Safety monitoring for these vaccines has been the most intense and comprehensive in U.S. history, using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, and v-safe,* an active surveillance system, during the initial implementation phases of the COVID-19 national vaccination program.[4] CDC conducted descriptive analyses of safety data from the first month of vaccination (December 14, 2020–January 13, 2021). During this period, 13,794,904 vaccine doses were administered, and VAERS received and processed 6,994 reports of adverse events after vaccination, including 6,354 (90.8%) that were classified as nonserious and 640 (9.2%) as serious.§ The symptoms most frequently reported to VAERS were headache (22.4%), fatigue (16.5%), and dizziness (16.5%). A total of 113 deaths were reported to VAERS, including 78 (65%) among LTCF residents; available information from death certificates, autopsy reports, medical records, and clinical descriptions from VAERS reports and health care providers did not suggest any causal relationship between COVID-19 vaccination and death. Rare cases of anaphylaxis after receipt of both vaccines were reported (4.5 reported cases per million doses administered). Among persons who received Pfizer-BioNTech vaccine, reactions reported to the v-safe system were more frequent after receipt of the second dose than after the first. The initial postauthorization safety profiles of the two COVID-19 vaccines in current use did not indicate evidence of unexpected serious adverse events. These data provide reassurance and helpful information regarding what health care providers and vaccine recipients might expect after vaccination.

VAERS is an existing national passive surveillance system for adverse events after vaccination that accepts reports from health care providers, vaccine manufacturers, and the public. Reported signs and symptoms are coded using Medical Dictionary for Regulatory Activities (MedDRA) terminology. Serious adverse events are followed up by the VAERS program to obtain additional information, including medical records, information from health care providers, and, in the case of death, death certificates and autopsy reports.[4]

V-safe is a safety monitoring system established by CDC specifically for the COVID-19 vaccination program. V-safe participants voluntarily self-enroll and receive smartphone text messages providing hyperlinks to web surveys.** During the first week after vaccination, enrollees complete daily surveys asking about local injection site and systemic reactions. Enrollees are asked if they missed work, were unable to perform normal daily activities, or received care from a medical professional because of reported symptoms or heath conditions. Enrollees who report seeking medical care are contacted, and a VAERS report is completed if clinically indicated. Persons who do not report their sex as male are asked about pregnancy status at time of vaccination (initial survey) and about a positive pregnancy test result (3- and 6-week surveys); reported pregnancies are followed up through the v-safe pregnancy registry.††

CDC conducted descriptive analyses of data from VAERS and v-safe during December 14, 2020–January 13, 2021, a period when the first and second doses of Pfizer-BioNTech vaccine and the first dose of Moderna vaccine were administered. Because LTCF staff members were vaccinated at LTCF facilities, residents of LTCFs were presumptively identified by restricting examination of VAERS reports to adults aged ≥65 years with a documented vaccination at an LTCF. To ensure that LTCF residents with serious adverse events were identified, manual review was conducted of all reports of serious adverse events among those vaccinated in LTCFs, regardless of vaccine recipient's age. Administered vaccine doses were reported to CDC.§§ These activities were reviewed by CDC and are consistent with applicable federal law and CDC policy.¶¶ All analyses were conducted using SAS software (version 9.4; SAS Institute).

During December 14, 2020–January 13, 2021, a total of 13,794,904 COVID-19 vaccine doses were administered in the United States; 8,436,863 (61.2%) doses were administered to women. VAERS received 6,994 reports of COVID-19–associated adverse events during this period. Among all reports, 6,354 (90.8%) were classified as nonserious and 640 (9.2%) as serious, including 113 (1.6%) deaths. The median age of vaccine recipients in VAERS reports was 42 years (range = 15–104 years); 5,505 (78.7%) reports were submitted for adverse events in women. Headache (22.4%), fatigue (16.5%), and dizziness (16.5%) were the most frequently reported symptoms after vaccination with either vaccine (Table 1). Sixty-two reports of anaphylaxis have been confirmed, 46 (74.2%) after receipt of the Pfizer-BioNTech vaccine and 16 (25.8%) after receipt of the Moderna vaccine.

*https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafe.html
Processed VAERS reports are those that have been MedDRA-coded, been deduplicated, and undergone quality assurance and quality control.
§Based on the Code of Federal Regulations, a serious adverse event is defined as occurring if one of the following is reported: death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, congenital anomaly, or birth defect. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr
A single VAERS report might be assigned more than one MedDRA Preferred Term; not all terms are medically confirmed diagnoses. https://www.meddra.org/how-to-use/basics/hierarchy
**V-safe enrollees receive daily health check-ins via smartphone text messages that link to web-based surveys for the first 7 days after vaccination, then weekly through 6 weeks postvaccination and then at 3, 6, and 12 months. The health check-in process resets when a person receives a second dose of vaccine.
†† https://www.cdc.gov/vaccinesafety/pdf/vsafe-pregnancy-surveillance-protocol-508.pdf
§§ https://covid.cdc.gov/covid-data-tracker/#datatracker-home
¶¶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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