Abstract
As of January 20, 2021, a total of 24,135,690 cases of coronavirus disease 2019 (COVID-19) and 400,306 associated deaths had been reported in the United States (https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days). On December 18, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Moderna COVID-19 vaccine administered as 2 doses, 1 month apart to prevent COVID-19. On December 19, 2020, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of Moderna COVID-19 vaccine (1). As of January 10, 2021, a reported 4,041,396 first doses of Moderna COVID-19 vaccine had been administered in the United States, and reports of 1,266 (0.03%) adverse events after receipt of Moderna COVID-19 vaccine were submitted to the Vaccine Adverse Event Reporting System (VAERS). Among these, 108 case reports were identified for further review as possible cases of severe allergic reaction, including anaphylaxis. Anaphylaxis is a life-threatening allergic reaction that occurs rarely after vaccination, with onset typically within minutes to hours (2). Among these case reports, 10 cases were determined to be anaphylaxis (a rate of 2.5 anaphylaxis cases per million Moderna COVID-19 vaccine doses administered), including nine in persons with a documented history of allergies or allergic reactions, five of whom had a previous history of anaphylaxis. The median interval from vaccine receipt to symptom onset was 7.5 minutes (range=1-45 minutes). Among eight persons with follow-up information available, all had recovered or been discharged home. Among the remaining case reports that were determined not to be anaphylaxis, 47 were assessed to be nonanaphylaxis allergic reactions, and 47 were considered nonallergic adverse events. For four case reports, investigators have been unable to obtain sufficient information to assess the likelihood of anaphylaxis. This report summarizes the clinical and epidemiologic characteristics of case reports of allergic reactions, including anaphylaxis and nonanaphylaxis allergic reactions, after receipt of the first dose of Moderna COVID-19 vaccine during December 21, 2020-January 10, 2021, in the United States. CDC has issued updated interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States (3) and interim considerations for preparing for the potential management of anaphylaxis (4).
Highlights
DiscussionSafety monitoring of Moderna COVID-19 vaccine detected 10 cases of anaphylaxis after reported administration of 4,041,396 first doses of Moderna COVID-19 vaccine (2.5 cases per million Moderna COVID-19 vaccine doses administered) as well as cases of less severe nonanaphylaxis allergic reactions, based on U.S data for December 21, 2020– January 10, 2021
The interval from vaccine receipt to symptom onset was missing in two case reports, both of which documented a history of allergies or allergic reactions
Health care providers can play an important role in vaccine safety monitoring by being vigilant in recognizing and reporting adverse events after immunization to VAERS at https:// vaers.hhs.gov/reportevent.html
Summary
Safety monitoring of Moderna COVID-19 vaccine detected 10 cases of anaphylaxis after reported administration of 4,041,396 first doses of Moderna COVID-19 vaccine (2.5 cases per million Moderna COVID-19 vaccine doses administered) as well as cases of less severe nonanaphylaxis allergic reactions, based on U.S data for December 21, 2020– January 10, 2021. Anaphylaxis is potentially life-threatening and requires immediate treatment (4) Based on this early monitoring, anaphylaxis after receipt of Moderna COVID-19 vaccine appears to be a rare event; comparisons of anaphylaxis risk with that associated with non–COVID-19 vaccines are constrained at this time by the limited data available this early in the COVID-19 vaccination program. Whereas a previous review of anaphylaxis reports to VAERS found that 80% of cases reported in adults involved females (8), the current finding could be affected by the observation that more women than men had received a first dose of Moderna COVID-19 vaccine during the analytic period (61% of doses administered versus 36%, respectively). The clinical and epidemiologic characteristics of anaphylaxis case reports after receipt of Moderna COVID-19 vaccine are similar to those reported after receipt of the Pfizer-BioNTech COVID-19 vaccine (5) For both vaccines, symptom onset after vaccination occurred quickly, usually within minutes. Many persons experiencing anaphylaxis after receiving either vaccine had a history of allergies or allergic reactions, with several having experienced an anaphylaxis episode in the past
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