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Reactogenicity of Simultaneous COVID-19 mRNA Booster and Influenza Vaccination in the US

Educational Objective
To identify the key insights or developments described in this article
Key Points

Question  Are systemic reactions more common after simultaneous administration of COVID-19 mRNA booster and seasonal influenza vaccines than after COVID-19 mRNA booster alone?

Findings  In this cohort study of self-reported data from 981 099 persons aged 12 years or older, simultaneous administration of a COVID-19 mRNA booster dose and an influenza vaccine was associated with 8% to 11% increases, respectively, in systemic reaction compared with COVID-19 mRNA booster alone. These differences were statistically significant.

Meaning  Findings from this study suggest that simultaneous administration of COVID-19 mRNA booster and influenza vaccines may be associated with increased likelihood of systemic reactions.

Abstract

Importance  COVID-19 and seasonal influenza vaccines are essential in preventing respiratory infections and their potentially severe complications. Simultaneous administration of vaccines is efficient and may improve coverage with each vaccine. However, the safety of simultaneous administration of COVID-19 and influenza vaccines has not been well described.

Objective  To evaluate adverse events and health impacts associated with simultaneously administered COVID-19 mRNA booster and seasonal influenza vaccines in the US population.

Design, Setting, and Participants  In this retrospective cohort study, self-reported vaccine data were collected on days 0 to 7 after vaccination from September 22, 2021, through May 1, 2022, through v-safe, a voluntary smartphone-based monitoring system established by the Centers for Disease Control and Prevention. Participants were persons who voluntarily registered in v-safe following COVID-19 vaccination.

Exposure  Receipt of simultaneously administered COVID-19 mRNA booster and seasonal influenza vaccines or COVID-19 mRNA booster alone.

Main Outcomes and Measures  Local injection site and systemic reactions (eg, fatigue, headache, and myalgia) and health impacts reported by v-safe respondents in the week following COVID-19 mRNA booster vaccination. Adjusted odds ratios (aORs) were estimated for simultaneous administration compared with booster dose alone, controlling for sex, age, and week of vaccination.

Results  Of a total of 981 099 persons aged 12 years or older registered with v-safe, simultaneous administration of COVID-19 mRNA booster and seasonal influenza vaccines was reported by 92 023 (9.4%) v-safe respondents; of these respondents, 54 926 (59.7%) were female, 36 234 (39.4%) were male, and sex was unknown for 863 (0.9%). In the week following vaccination, any systemic reactions were reported by 36 144 (58.9%) of 61 390 respondents who simultaneously received Pfizer-BioNTech booster and influenza vaccines and 21 027 (68.6%) of 30633 respondents who simultaneously received Moderna booster and influenza vaccines. Respondents who simultaneously received influenza and Pfizer-BioNTech booster vaccines (aOR, 1.08; 95% CI, 1.06-1.10) or influenza and Moderna booster vaccines (aOR, 1.11; 95% CI, 1.08-1.14) were slightly more likely to report any systemic reaction in the week following simultaneous vaccination than respondents who received only a COVID-19 mRNA vaccine booster.

Conclusions and Relevance  In this study, compared with administration of COVID-19 mRNA booster vaccines alone, simultaneous administration of COVID-19 mRNA booster and seasonal influenza vaccines was associated with significant increases in reports of systemic reactions during days 0 to 7 following vaccination. These results may help better characterize the outcomes associated with simultaneously administered COVID-19 booster and influenza vaccines in the US population.

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Article Information

Accepted for Publication: May 8, 2022.

Published: July 15, 2022. doi:10.1001/jamanetworkopen.2022.22241

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2022 Hause AM et al. JAMA Network Open.

Corresponding Author: Anne M. Hause, PhD, MSPH, Centers for Disease Control and Prevention, 1825 Century Center Blvd, Atlanta, GA 30345 (voe5@cdc.gov).

Author Contributions: Dr Hause and Mr Zhang had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Hause, Gee, Shimabukuro, Shay.

Acquisition, analysis, or interpretation of data: Hause, Zhang, Yue, Marquez, Myers, Parker, Su, Shimabukuro, Shay.

Drafting of the manuscript: Hause, Zhang, Yue, Marquez, Parker, Shay.

Critical revision of the manuscript for important intellectual content: Hause, Myers, Gee, Su, Shimabukuro, Shay.

Statistical analysis: Hause, Zhang, Yue, Marquez.

Administrative, technical, or material support: Myers, Parker, Gee, Su, Shay.

Supervision: Hause, Myers, Shimabukuro, Shay.

Conflict of Interest Disclosures: None reported.

Funding/Support: This work was internally funded by the Centers for Disease Control and Prevention (CDC).

Role of the Funder/Sponsor: The authors affiliated with the CDC along with the other coauthors conducted the investigations; performed collection, management, analysis, and interpretation of the data; were involved in the preparation, review, and approval of the manuscript; and made the decision to submit the manuscript for publication.

Disclaimer: The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the CDC. Mention of a product or company name is for identification purposes only and does not constitute endorsement by the CDC.

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