Enhanced safety surveillance study of ACAM2000 smallpox vaccine among US military service members

Decker, Michael D.; Garman, Patrick M.; Hughes, Hayley; Yacovone, Margaret; Collins, Limone; Fegley, Christopher D.; Lin, Grace; DiPietro, Gina; Gordon, Daniel M.

doi:10.1016/j.vaccine.2021.08.041

Cited by 20 publications

(19 citation statements)

References 23 publications

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“…411 Taken together, ACAM2000 is likely effective at preventing monkeypox; however, due to its potential for replication, it may cause severe side effects, including progressive vaccinia, eczema vaccinatum, and myopericarditis. 388,409,[413][414][415][416][417][418][419][420][421] A person with a weak immune system, including someone with HIV, pregnant women, and those who suffer from skin conditions like eczema, are not advised to use it. 150,422 The third-generation vaccine, modified vaccinia Ankara (MVA, JYNNEOS in the United States, IMVANEX in the European Union, and IMAMUNE in Canada), was approved in individuals 18 years of age or older considered to be more susceptible for smallpox or monkeypox infection in US to prevent both smallpox and monkeypox disease in 2019.…”

Section: Monkeypox Preventionmentioning

confidence: 99%

Monkeypox: epidemiology, pathogenesis, treatment and prevention

Huang

Wang

2022

Sig Transduct Target Ther

145

120

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Monkeypox is a zoonotic disease that was once endemic in west and central Africa caused by monkeypox virus. However, cases recently have been confirmed in many nonendemic countries outside of Africa. WHO declared the ongoing monkeypox outbreak to be a public health emergency of international concern on July 23, 2022, in the context of the COVID-19 pandemic. The rapidly increasing number of confirmed cases could pose a threat to the international community. Here, we review the epidemiology of monkeypox, monkeypox virus reservoirs, novel transmission patterns, mutations and mechanisms of viral infection, clinical characteristics, laboratory diagnosis and treatment measures. In addition, strategies for the prevention, such as vaccination of smallpox vaccine, is also included. Current epidemiological data indicate that high frequency of human-to-human transmission could lead to further outbreaks, especially among men who have sex with men. The development of antiviral drugs and vaccines against monkeypox virus is urgently needed, despite some therapeutic effects of currently used drugs in the clinic. We provide useful information to improve the understanding of monkeypox virus and give guidance for the government and relative agency to prevent and control the further spread of monkeypox virus.

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Section: Monkeypox Preventionmentioning

confidence: 99%

Monkeypox: epidemiology, pathogenesis, treatment and prevention

Huang

Wang

2022

Sig Transduct Target Ther

145

120

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“…The “take” risked inadvertent autoinoculation when left uncovered (529.2 cases per million primary vaccinations), and most commonly occurred to the face including eyes and lips, genitalia, and rectum. Serious adverse events were rare and included myocarditis or pericarditis (occurring in 5.7 per 1000 primary vaccinations), encephalitis (12.3 per million primary vaccinations), and progressive vaccinia (1.5 per million primary vaccinations) [ 67 – 69 ]. People who had atopic dermatitis or other eczematous conditions were at higher risk of developing eczema vaccinatum.…”

Section: Resultsmentioning

confidence: 99%

Human monkeypox: a comparison of the characteristics of the new epidemic to the endemic disease

2022

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In May 2022, a new global outbreak of mpox (formerly, human monkeypox) emerged that was declared a public health emergency of international concern by the World Health Organization on July 23, 2022. With new patterns of person-to-person spread within sexual networks in nonendemic countries and several differences from the classic disease course, we performed a comprehensive review of existing literature on human monkeypox to discuss epidemiology, modes of transmission, clinical presentation and asymptomatic infection, diagnostics, therapeutics, and vaccines with the primary aim to identify important areas for future research of this new epidemic form of the disease. A comprehensive literature search was performed of all published literature to August 15, 2022. Historically, in regions of monkeypox virus endemicity, human outbreaks have occurred related to discrete zoonotic events. The animal reservoir is unknown, but the virus has been isolated from rodents. Traditionally, transmission occurred by direct or indirect contact with an infected animal. In nonendemic countries affected in the 2022 outbreak, almost exclusive person-to-person spread has been observed, and most cases are connected to sexual networks of gay, bisexual, and other men who have sex with men. After an incubation period of approximately 13 days, in traditional human cases affected persons developed a febrile prodrome preceding a rash that started on the face and body, spread centrifugally to the palms and soles and healed monomorphically over two to four weeks. However, in the 2022 outbreak, the febrile illness is often absent or occurs after the onset of the rash. The rash presents primarily in the anogenital region and face before disseminating throughout the body, with lesions displaying regional pleomorphism. There is a paucity of data for the role of antiviral agents or vaccines. The epidemiology and clinical course of mpox has changed in the 2022 epidemic from that observed with the endemic disease. There is an urgent need to establish rapid and collaborative research platforms to diagnose, treat and prevent disease and inform important public health and other strategies to stop the spread of disease.

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“…Twenty-three studies reported on 830,585,553 doses of COVID-19 vaccines, 3,23-44 3 studies reported on 154,220,042 doses of HPV vaccines, 6,45,46 5 studies on 513,115,509 doses of influenza vaccines, 25,47-50 2 studies on 4,952,349 doses of acellular pertussis vaccines, 51,52 3 studies on 1,386,209 doses of smallpox vaccines, 50,53,54 and 2 studies on 24,200,000 doses of mixed vaccines (epidemic cerebrospinal meningitis and pneumococcal conjugate vaccine). 55 In the 23 studies involving COVID-19 vaccination, 647,308,174 doses of mRNA vaccines and 183,238,205 doses of non-mRNA vaccines were administered.…”

Section: Resultsmentioning

confidence: 99%

Cardiac Arrhythmia after COVID-19 Vaccination versus Non–COVID-19 Vaccination: A Systematic Review and Meta-Analysis

Shi

Tang

Xia

et al. 2022

Preprint

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Aims: Cardiac arrhythmia is a rare complication after vaccination. Recently, reports of arrhythmia after COVID-19 vaccination have increased. Whether the risk for cardiac arrhythmia is higher with COVID-19 vaccines than with non-COVID-19 vaccines remains controversial. This meta-analysis explored the incidence of arrhythmia after COVID-19 vaccination and compared it with the incidence of arrhythmia after non-COVID-19 vaccination. Methods: We searched the MEDLINE, Scopus, Cochrane Library, and Embase databases for English-language studies reporting the incidence of arrhythmia (the primary endpoint) after vaccination from January 1, 1947 to October 28, 2022. Secondary endpoints included incidence of tachyarrhythmia and all-cause mortality. Subgroup analyses were conducted to evaluate the incidence of arrhythmia by age (children [<18 years] versus adults [≥18 years]), vaccine type (mRNA COVID-19 vaccine versus non-mRNA COVID-19 vaccine; individual non-COVID-19 vaccines versus COVID-19 vaccine), and COVID-19 vaccine dose (first versus second versus third). Random-effects meta-analyses were performed, and the intrastudy risk for bias and the certainty of evidence were evaluated. This study was registered with PROSPERO (CRD42022365912). Results: The overall incidence of arrhythmia from 36 studies (1,528,459,662 vaccine doses) was 291.8 (95% CI 111.6-762.7) cases per million doses. The incidence of arrhythmia was significantly higher after COVID-19 vaccination (2263.4 [875.4-5839.2] cases per million doses; 830,585,553 doses, 23 studies) than after non-COVID-19 vaccination (9.9 [1.3-75.5] cases per million doses; 697,874,109 doses, 14 studies; P<0.01). Compared with COVID-19 vaccines, the influenza, pertussis, human papillomavirus, and acellular pertussis vaccines were associated with a significantly lower incidence of arrhythmia. The incidence of tachyarrhythmia was significantly higher after COVID-19 vaccination (4367.5 [1535.2-12,360.8] cases per million doses; 1,208,656 doses, 15 studies) than after non-COVID-19 vaccination (25.8 [4.5-149.4] cases per million doses; 179,822,553 doses, 11 studies; P<0.01). Arrhythmia was also more frequent after the third dose of COVID-19 vaccine (19,064.3 [5775.5-61,051.2] cases per million doses; 7968 doses, 3 studies) than after the first dose (3450.9 [988.2-11,977.6] cases per million doses; 41,714,762 doses, 12 studies; P=0.05) or second dose (2262.5 [2205.9-2320.7] cases per million doses; 34,540,749 doses, 10 studies; P<0.01). All-cause mortality was comparable between the COVID-19 and non-COVID-19 vaccination groups. Conclusions: The overall risk for arrhythmia after COVID-19 vaccination was relatively low, although it was higher in COVID-19 vaccine recipients than in non-COVID-19 vaccine recipients. This increased risk should be evaluated along with other important factors, such as the incidence of local outbreaks and the risk for arrhythmia due to COVID infection itself, when weighing the safety and efficacy of COVID-19 vaccines.

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Enhanced safety surveillance study of ACAM2000 smallpox vaccine among US military service members

Cited by 20 publications

References 23 publications

Monkeypox: epidemiology, pathogenesis, treatment and prevention

Monkeypox: epidemiology, pathogenesis, treatment and prevention

Human monkeypox: a comparison of the characteristics of the new epidemic to the endemic disease

Cardiac Arrhythmia after COVID-19 Vaccination versus Non–COVID-19 Vaccination: A Systematic Review and Meta-Analysis

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