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Safety of Simultaneous Administration of Bivalent mRNA COVID-19 and Influenza Vaccines in the Vaccine Adverse Event Reporting System (VAERS)

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Abstract

Introduction

Bivalent mRNA coronavirus disease 2019 (COVID-19) vaccines may be simultaneously administered with other recommended vaccines, including seasonal influenza vaccines. However, few studies have evaluated the safety of co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines.

Objective

The aim was to describe reports to the Vaccine Adverse Event Reporting System (VAERS) after co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines.

Methods

We searched the VAERS database for reports of adverse events (AEs) following co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines during the period of September 1, 2022–March 31, 2023. We assessed the characteristics of these reports and described the most frequently reported AEs. Clinicians reviewed available medical records for reports of serious AEs and adverse events of special interest (AESI).

Results

During the period of 1 September 2022 through 31 March 2023, VAERS received 3689 reports of AEs following co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines. The median age of vaccinees was 59 years (interquartile range 39, 70 years); 342 reports (9.3%) were classified as serious. The most common AEs among non-serious reports were severe-acute-respiratory-syndrome-related coronavirus (SARS-CoV-2) infection (785, 23.5%), cough (592, 17.7%), and fatigue (568, 17.0%). The most common AEs among serious reports were Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection (88, 25.7%), dyspnea (81, 23.7%), and condition aggravated (55, 16.1%).

Discussion

Reports of AEs following co-administration of bivalent mRNA COVID-19 and seasonal influenza vaccines did not reveal any unusual or unexpected patterns of AEs. Increased reporting of certain events (e.g., COVID-19) was expected due to Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) reporting requirements. CDC and FDA will continue to monitor the safety of co-administration of mRNA COVID-19 and seasonal influenza vaccines.

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Acknowledgements

We thank the staff of the Immunization Safety Office, and General Dynamics Information Technology, for their work and dedication to public health during the COVID-19 pandemic.

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Authors and Affiliations

  1. Immunization Safety Office, Division of Healthcare Quality Promotion, NCEZID, Centers for Disease Control and Prevention, 1600 Clifton Rd, MS V18-4, Atlanta, GA, 30329-4027, USA

    Pedro L. Moro, Carol Ennulat, Hannah Brown, Gina Woody, Bicheng Zhang, Paige Marquez & John R. Su

  2. Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA

    Emily Jane Woo

Authors
  1. Pedro L. Moro
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  2. Carol Ennulat
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  3. Hannah Brown
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  6. Paige Marquez
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Corresponding author

Correspondence to Pedro L. Moro.

Ethics declarations

Funding

No funding from any organization, agency, or entity was received for this study.

Conflict of interest

None of the authors have conflicts of interest that are directly relevant to the content of this article.

Ethics approval and consent to participate

This activity was reviewed by the CDC and was considered to be consistent with applicable federal law and CDC policy. Informed consent was not obtained for this secondary use of existing information; see 45 CFR part 46.102(l)(2), 21 CFR part 56, 42 USC §241(d), 5 USC §552a, and 44 USC §3501 et seq.

Consent for publication

Not applicable.

Availability of data and materials

Data from the VAERS system is available to everyone through the VAERS Wonder database available at https://wonder.cdc.gov/vaers.html. Anyone with internet access may reach this site and conduct basic analysis to confirm some of the findings described in the article. However, there are data in this paper that come from review of medical records of the patients who experienced an AE. These data cannot be shared openly, to protect patient privacy

Code availability

Not applicable.

Author contributions

PLM originated the study, supervised its implementation, conducted the analysis, and led the writing of the manuscript summarizing the findings. BZ, CE, HB, GW, PM, EJW, and JRS assisted in one or more aspects, including study design, review of VAERS reports and medical records, technical advice, administrative support, and writing of the report. All author read and approved the final version.

Declarations

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention (CDC) or the US Food and Drug Administration (FDA). Mention of a product or company name is for identification purposes only and does not constitute endorsement by the CDC or FDA.

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Moro, P.L., Ennulat, C., Brown, H. et al. Safety of Simultaneous Administration of Bivalent mRNA COVID-19 and Influenza Vaccines in the Vaccine Adverse Event Reporting System (VAERS). Drug Saf 47, 487–493 (2024). https://doi.org/10.1007/s40264-024-01406-8

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