Analysis of Myocarditis Among 252 Million mRNA-1273 Recipients Worldwide

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Abstract

Background

Growing evidence indicates a causal relationship between SARS-CoV-2 infection and myocarditis. Post-authorization safety data have also identified myocarditis as a rare safety event following mRNA COVID-19 vaccination, particularly among adolescent and young-adult males after dose 2. We further evaluated the potential risk by querying the Moderna global safety database for myocarditis/myopericarditis reports among mRNA-1273 recipients worldwide.

Methods

Myocarditis/myopericarditis reports from 18 December 2020 to 15 February 2022 were reviewed and classified. The reported rate after any known mRNA-1273 dose was calculated according to age and sex, then compared with a population-based incidence rate to calculate observed-to-expected rate ratios (RRs).

Results

During the study period, 3017 myocarditis/myopericarditis cases among 252 million mRNA-1273 recipients who received at least 1 dose were reported to the Moderna global safety database. The overall reporting rate was 9.23 per 100 000 person-years, which was similar to the expected reference rate (9.0 cases per 100 000 person-years; RR [95% confidence interval (CI)], 1.03 [.97–1.08]). When stratified by sex and age, observed rates were highest for males aged <40 years, particularly those 18–24 years (53.76 per 100 000 person-years), which was higher than expected (RR [95% CI], 3.10 [2.68–3.58]). When considering only cases occurring within 7 days of a known dose, the observed rate was highest for males aged 18–24 years after dose 2 (4.23 per 100 000 doses administered).

Conclusions

Myocarditis/myopericarditis rates were not higher than expected for the overall population of mRNA-1273 recipients but were higher than expected in males aged 18–24 years, with most cases occurring 7 days after dose 2.

Abstract

Based on reports submitted to the Moderna global safety database, rates of myocarditis/myopericarditis after mRNA-1273 vaccination were overall not higher than expected but were higher than expected in males aged 18–24 years, with most occurring 7 days after dose 2.

Graphical Abstract

Graphical summary describing the main outcomes of a surveillance study assessing the rates of myocarditis among 252 million mRNA-1273 recipients worldwide. Reports of myocarditis were obtained from the Moderna global safety database between December 18, 2020 and February 15, 2022. Abbreviations: COVID-19, coronavirus disease 2019; mRNA, messenger RNA; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.

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Most cited references 25

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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)

Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)

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Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

Lindsey Baden, Hana El Sahly, Brandon Essink … (2020)

Abstract Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)

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Myocarditis With COVID-19 mRNA Vaccines

Biykem Bozkurt, Ishan Kamat, Peter Hotez (2021)

Supplemental Digital Content is available in the text.

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Author and article information

Contributors

Walter Straus

Veronica Urdaneta

Daina B Esposito

James A Mansi

Cesar Sanz Rodriguez

Paul Burton

José M Vega

Journal

Journal ID (nlm-ta): Clin Infect Dis

Journal ID (iso-abbrev): Clin Infect Dis

Journal ID (publisher-id): cid

Title: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America

Publisher: Oxford University Press

ISSN (Print): 1058-4838

ISSN (Electronic): 1537-6591

Publication date (Electronic): 06 June 2022

Publication date PMC-release: 06 June 2022

Electronic Location Identifier: ciac446

Affiliations

Clinical Safety and Pharmacovigilance, Moderna, Inc ., Cambridge, Massachusetts, USA

Medical Affairs, Moderna, Inc ., Cambridge, Massachusetts, USA

Clinical Safety and Pharmacovigilance, Moderna, Inc ., Cambridge, Massachusetts, USA

Author notes

Correspondence: W. Straus, Moderna, Inc., 200 Technology Square, Cambridge, MA 02139, USA ( walter.straus@ 123456modernatx.com ).

Potential conflicts of interest. All authors are employees of and shareholders in Moderna, Inc. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Article

Publisher ID: ciac446

DOI: 10.1093/cid/ciac446

PMC ID: 9384217

PubMed ID: 35666513

SO-VID: bd3e4f83-7b10-446c-b0ba-1f0901aa45a2

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

History

Date received : 22 December 2021

Date: 25 May 2022

Date: 08 August 2022

Page count

Pages: 9

Funding

Funded by: Moderna, Inc, doi 10.13039/100019533;

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article-lifecycle PAP

ScienceOpen disciplines: Infectious disease & Microbiology

Keywords: myocarditis,covid-19,sars-cov-2,vaccination,pharmacovigilance

Data availability:

ScienceOpen disciplines: Infectious disease & Microbiology

Keywords: myocarditis, covid-19, sars-cov-2, vaccination, pharmacovigilance

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Analysis of Myocarditis Among 252 Million mRNA-1273 Recipients Worldwide

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Novel Coronavirus Disease COVID-19

Most cited references 25

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine

Myocarditis With COVID-19 mRNA Vaccines

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