A Case Report for Acute Myopericarditis After NVX-CoV2373 (Novavax<sup>®</sup>) COVID-19 Vaccination

Kim, Hyung Yoon; Cho, Jae Yeong; Yoon, Hyun Ju; Choi, Yoo-Duk; Ahn, Youngkeun; Jeong, Myung Ho; Cho, Jeong Gwan; Kim, Kye Hun

doi:10.3346/jkms.2022.37.e265

Cited by 7 publications

(3 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…They reported four suspected cases of myocarditis, but no confirmation of cases was described. Korean authors also published a case report of a 30 yearold male with clinically confirmed myocarditis onset 17 days post dose 2 Nuvaxovid as a vaccination complication [32].…”

Section: Discussionmentioning

confidence: 99%

Real-world Nuvaxovid COVID-19 vaccine safety profile after first 100,000 doses in Australia, 2022-2023

Clothier,

Parker,

Mallard

et al. 2024

Preprint

View full text Add to dashboard Cite

Introduction Nuvaxovid became available in Australia from February 2022, a year later than the first COVID-19 vaccines were released. It was a much-anticipated alternative vaccine for people that had either suffered an adverse event to and/or were hesitant to receive one of the mRNA or adenovirus based COVID-19 vaccines. Although safety from clinical trials was reassuring, small trial population size, relatively low administration rates worldwide and limited post-licensure intelligence meant potential rare adverse events were underinformed. Methods We conducted a retrospective observational analysis of adverse events following immunisation (AEFI) spontaneously reported to SAFEVAC, the integrated vaccine safety surveillance system used by Victoria and Western Australia, Australia. Reports received from 14 Feb 2022 to 30 June 2023 were analysed by vaccinee demographics, reported reactions and COVID-19 vaccine dose received and compared as reporting rates (RR) per 100,000 doses administered. Results 356 AEFI reports were received, following 102,946 Nuvaxovid doses administered. Rates were higher post dose 1 than dose 2 (rate ratio 1.5, p=0.0008); primary series than booster (rate ratio 2.4, p<0.0001); in females than males (rate ratio 1.4, p<0.01), especially those aged 30-49 years (RR=1.6, p=0.002). Serious AEFI included 76 chest pain (RR=73.8), two myocarditis (RR=1.9) and 20 pericarditis (RR=19.4). No cases of Guillain Barre or thrombosis with thrombocytopaenia syndromes were reported and no deaths attributable to vaccination. Conclusion The shared SAFEVAC platform enables pooling of clinically reviewed data across jurisdictions, increasing the safety profile evidence base of novel vaccines like Nuvaxovid and improving the odds for identification and description of rare events across all vaccines.

show abstract

Section: Discussionmentioning

confidence: 99%

Real-world Nuvaxovid COVID-19 vaccine safety profile after first 100,000 doses in Australia, 2022-2023

Clothier,

Parker,

Mallard

et al. 2024

Preprint

View full text Add to dashboard Cite

show abstract

“… 69 In a case-control study, CoronaVac’s myopericarditis rate was not higher than controls, in contrast to BNT162b2’s rate that exceeded controls after dose 2 and for doses 1 and combined 69 ( Table S1 ). For NVX-CoV2373/Nuvaxoid recombinant S1 protein vaccine, there is a case report of myocarditis after administration, 74 and myocarditis was also reported in 4 cases out of 40 000 vaccine recipients in Phase III trials where it occurred only in men and within 10 days of vaccine receipt. 75 Novavax released a statement June 3, 2022, that the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%), and there is insufficient evidence to establish a causal relationship.…”

Section: Sars-cov-2 Vaccine-associated Myocarditis and Myocardial Injurymentioning

confidence: 99%

Vaccination-Associated Myocarditis and Myocardial Injury

Altman

Berning

Mann

et al. 2023

Circulation Research

View full text Add to dashboard Cite

SARS-CoV-2 vaccine–associated myocarditis/myocardial injury should be evaluated in the contexts of COVID-19 infection, other types of viral myocarditis, and other vaccine-associated cardiac disorders. COVID-19 vaccine–associated myocardial injury can be caused by an inflammatory immune cell infiltrate, but other etiologies such as microvascular thrombosis are also possible. The clinical diagnosis is typically based on symptoms and cardiac magnetic resonance imaging. Endomyocardial biopsy is confirmatory for myocarditis, but may not show an inflammatory infiltrate because of rapid resolution or a non-inflammatory etiology. Myocarditis associated with SARS-COVID-19 vaccines occurs primarily with mRNA platform vaccines, which are also the most effective. In persons aged >16 or >12 years the myocarditis estimated crude incidences after the first 2 doses of BNT162b2 and mRNA-1273 are approximately 1.9 and 3.5 per 100 000 individuals, respectively. These rates equate to excess incidences above control populations of approximately 1.2 (BNT162b2) and 1.9 (mRNA-1273) per 100 000 persons, which are lower than the myocarditis rate for smallpox but higher than that for influenza vaccines. In the studies that have included mRNA vaccine and SARS-COVID-19 myocarditis measured by the same methodology, the incidence rate was increased by 3.5-fold over control in COVID-19 compared with 1.5-fold for BNT162b2 and 6.2-fold for mRNA-1273. However, mortality and major morbidity are less and recovery is faster with mRNA vaccine–associated myocarditis compared to COVID-19 infection. The reasons for this include vaccine-associated myocarditis having a higher incidence in young adults and adolescents, typically no involvement of other organs in vaccine-associated myocarditis, and based on comparisons to non-COVID viral myocarditis an inherently more benign clinical course.

show abstract

“…5,6 Few cases of acute myocarditis have been reported in association with the protein-based subunit COVID-19 vaccinations. 7,8 Here, we report a case series involving 11 patients who developed symptoms of myocarditis after receiving the Taiwanapproved COVID-19 vaccination and fulfilled the imaging diagnostic criteria confirmed by cardiovascular magnetic resonance imaging (MRI).…”

Section: Introductionmentioning

confidence: 99%

The application of cardiac MRI in Myocarditis after COVID-19 vaccines: Case series from single medical center in Taiwan

Wang,

Lu,

Chan

et al. 2023

Journal of the Chinese Medical Association

View full text Add to dashboard Cite

During the coronavirus disease 2019 (COVID-19) pandemic, reports of vaccine-induced myocarditis, particularly messenger ribonucleic acid (mRNA)-based myocarditis, were widely spread. This case series describes various cases of COVID-19 vaccine-induced myocarditis confirmed by cardiac magnetic resonance imaging (MRI), including those who were administered rare protein-based vaccines. Eleven patients comprising eight males and 3 females with suspected myocarditis underwent cardiac MRI at Taichung Veterans General Hospital between October 2021 and May 2022. The median age of the patients was 33.5 years old (range: 22–57 years). The onset of myocarditis was mainly observed following mRNA vaccine inoculation. One patient received the MVC COV1901 vaccine, a unique protein-based COVID-19 vaccine in Taiwan, and met the 2018 Lake Louise Criteria for the diagnosis of myocarditis, confirmed by cardiac MRI. Most patients reported chest discomfort after receiving various vaccine types. Among four patients with reduced left ventricular ejection fraction (LVEF), two showed LVEF restoration during the follow-up period, and the other two were lost to follow-up. Cardiac MRI characterizes myocardial features such as edema, inflammation, and fibrosis, and has been proven to diagnose myocarditis accurately with a sensitivity of 87.5% and a specificity of 96.2% according to the 2018 Lake Louise criteria. This diagnosis was achieved without invasive procedures such as endomyocardial biopsy or coronary angiography.

show abstract

A Case Report for Acute Myopericarditis After NVX-CoV2373 (Novavax^®) COVID-19 Vaccination

Cited by 7 publications

References 14 publications

Real-world Nuvaxovid COVID-19 vaccine safety profile after first 100,000 doses in Australia, 2022-2023

Real-world Nuvaxovid COVID-19 vaccine safety profile after first 100,000 doses in Australia, 2022-2023

Vaccination-Associated Myocarditis and Myocardial Injury

The application of cardiac MRI in Myocarditis after COVID-19 vaccines: Case series from single medical center in Taiwan

Contact Info

Product

Resources

About

A Case Report for Acute Myopericarditis After NVX-CoV2373 (Novavax®) COVID-19 Vaccination

Cited by 7 publications

References 14 publications

Real-world Nuvaxovid COVID-19 vaccine safety profile after first 100,000 doses in Australia, 2022-2023

Real-world Nuvaxovid COVID-19 vaccine safety profile after first 100,000 doses in Australia, 2022-2023

Vaccination-Associated Myocarditis and Myocardial Injury

The application of cardiac MRI in Myocarditis after COVID-19 vaccines: Case series from single medical center in Taiwan

Contact Info

Product

Resources

About

A Case Report for Acute Myopericarditis After NVX-CoV2373 (Novavax^®) COVID-19 Vaccination