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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Some time ago&#44; we published a brief review of treatments available or in development that could be of use in the control of the then incipient outbreak of monkeypox&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">1</span></a> In that review&#44; we highlighted the role of tecovirimat as the only antiviral drug approved by the European Medicines Agency &#40;EMA&#41; for the virus&#44; given its good safety profile and proven efficacy in reducing mortality in animal models&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">In response to that publication&#44; Dr Sookaromdee and Dr Wiwanitkit published a letter entitled <span class="elsevierStyleItalic">Treatments for Monkeypox</span>&#44;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">3</span></a> in which they shared their opinion on the use of tecovirimat and mentioned intravenous immunoglobulin as another potentially effective treatment for monkeypox&#44; now declared a <span class="elsevierStyleItalic">Public Health Emergency of International Concern</span> by the World Health Organization &#40;WHO&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">4</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">One of the affirmations by Dr Sookaromdee and Dr Wiwanitkit is that&#44; although tecovirimat has demonstrated efficacy&#44; it is not a widely used drug in countries in which the <span class="elsevierStyleItalic">Monkeypox virus</span> has traditionally been considered endemic&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">3</span></a> A possible reason for the limited use of tecovirimat in those countries is that their healthcare resources and structure are not comparable to those in European countries&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">5</span></a> In addition&#44; we should add that approval by the EMA<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">2</span></a> is not applicable in Africa&#44; and to date&#44; it is the only health agency to have approved the drug for the indication of monkeypox&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The second aspect that we wanted to comment on is the possibility of using intravenously-administered anti-<span class="elsevierStyleItalic">Vaccinia</span> immunoglobulin&#44; proposed by Sookaromdee and Wiwanitkit&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">3</span></a> This immunoglobulin is indicated only for the treatment of certain complications such as <span class="elsevierStyleItalic">eczema vaccinatum</span>&#44; progressive <span class="elsevierStyleItalic">Vaccinia</span>&#44; and severe generalized <span class="elsevierStyleItalic">Vaccinia</span> caused by administration of the vaccine derived from the <span class="elsevierStyleItalic">Vaccinia virus</span>&#46;<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">6</span></a> The regimen administered is 6000<span class="elsevierStyleHsp" style=""></span>U&#47;kg as soon as possible after onset of the first symptoms of the disease&#44; with possible dose repetitions according to the severity of the condition and response to the initial dose &#40;doses can be increased to 9000<span class="elsevierStyleHsp" style=""></span>U&#47;kg if the patient has not responded to the first dose&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">7</span></a> Although there are factors to support its use against monkeypox&#44; such as the similarity of <span class="elsevierStyleItalic">Orthopoxvirus</span> genomes&#44;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">8</span></a> to date&#44; there have been no human trials on its use in this indication&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Finally&#44; it is necessary to highlight the use of the <span class="elsevierStyleItalic">Vaccinia</span>-based vaccine as post-exposure prophylaxis&#46; The WHO currently recommends administration of a second- or third-generation vaccine for case contacts in the first 4 days after exposure&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">9</span></a> It is estimated that the vaccine could provide cross-immunity against the <span class="elsevierStyleItalic">Monkeypox virus</span> with an efficacy of approximately 80&#37;&#8211;85&#37;&#44;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">10</span></a> given the aforementioned genomic similarity among <span class="elsevierStyleItalic">Orthopoxvirus</span>&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">8</span></a></p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Funding</span><p id="par0030" class="elsevierStylePara elsevierViewall">None declared&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflict of interests</span><p id="par0035" class="elsevierStylePara elsevierViewall">None declared&#46;</p></span></span>"
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Vol. 114. Issue 1.
Pages T92-T93 (January 2023)
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Vol. 114. Issue 1.
Pages T92-T93 (January 2023)
Letter to the Editor
Open Access
Anti-Vaccinia Immunoglobulin and Post-exposure Prophylaxis with Vaccinia-based Vaccine for Management of the Monkeypox Outbreak
Inmunoglobulina anti-Vaccinia y profilaxis postexposición mediante vacuna basada en Vaccinia para el control del brote de viruela símica (Monkeypox)
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F.J. Rodríguez-Cuadradoa,
Corresponding author
, E.L. Pinto-Pulidob, M. Fernández-Parradoc
a Servicio de Dermatología, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain
b Servicio de Dermatología, Hospital Universitario Príncipe de Asturias, Madrid, Spain
c Servicio de Dermatología, Hospital Universitario de Navarra, Pamplona, Spain
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F.J. Rodríguez-Cuadrado, E.L. Pinto-Pulido, M. Fernández-Parrado
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To the Editor,

Some time ago, we published a brief review of treatments available or in development that could be of use in the control of the then incipient outbreak of monkeypox.1 In that review, we highlighted the role of tecovirimat as the only antiviral drug approved by the European Medicines Agency (EMA) for the virus, given its good safety profile and proven efficacy in reducing mortality in animal models.2

In response to that publication, Dr Sookaromdee and Dr Wiwanitkit published a letter entitled Treatments for Monkeypox,3 in which they shared their opinion on the use of tecovirimat and mentioned intravenous immunoglobulin as another potentially effective treatment for monkeypox, now declared a Public Health Emergency of International Concern by the World Health Organization (WHO).4

One of the affirmations by Dr Sookaromdee and Dr Wiwanitkit is that, although tecovirimat has demonstrated efficacy, it is not a widely used drug in countries in which the Monkeypox virus has traditionally been considered endemic.3 A possible reason for the limited use of tecovirimat in those countries is that their healthcare resources and structure are not comparable to those in European countries.5 In addition, we should add that approval by the EMA2 is not applicable in Africa, and to date, it is the only health agency to have approved the drug for the indication of monkeypox.

The second aspect that we wanted to comment on is the possibility of using intravenously-administered anti-Vaccinia immunoglobulin, proposed by Sookaromdee and Wiwanitkit.3 This immunoglobulin is indicated only for the treatment of certain complications such as eczema vaccinatum, progressive Vaccinia, and severe generalized Vaccinia caused by administration of the vaccine derived from the Vaccinia virus.6 The regimen administered is 6000U/kg as soon as possible after onset of the first symptoms of the disease, with possible dose repetitions according to the severity of the condition and response to the initial dose (doses can be increased to 9000U/kg if the patient has not responded to the first dose).7 Although there are factors to support its use against monkeypox, such as the similarity of Orthopoxvirus genomes,8 to date, there have been no human trials on its use in this indication.

Finally, it is necessary to highlight the use of the Vaccinia-based vaccine as post-exposure prophylaxis. The WHO currently recommends administration of a second- or third-generation vaccine for case contacts in the first 4 days after exposure.9 It is estimated that the vaccine could provide cross-immunity against the Monkeypox virus with an efficacy of approximately 80%–85%,10 given the aforementioned genomic similarity among Orthopoxvirus.8

Funding

None declared.

Conflict of interests

None declared.

References
[1]
F.J. Rodríguez-Cuadrado, E.L. Pinto-Pulido, M. Fernández-Parrado.
Potential treatments for monkeypox.
Actas Dermosifiliogr, S0001–7310 (2022), pp. 00601-609
[2]
European Medicines Agency.
Tecovirimat SIGA (tecovirimat): an overview of tecovirimat SIGA and why it is authorised in the EU.
European Medicines Agency, (2022),
[3]
P. Sookaromdee, V. Wiwanitkit.
Treatments for monkeypox.
Actas Dermosifiliogr, (2022),
[4]
World Health Organization.
Second meeting of the International Health Regulations (2005) (IHR) Emergency Committee regarding the multi-country outbreak of monkeypox, (2022),
[5]
E. Tambo, A.M. Al-Nazawi.
Combating the global spread of poverty-related Monkeypox outbreaks and beyond.
Infect Dis Poverty, 11 (2022), pp. 80
[6]
R. Wittek.
Vaccinia immune globulin: current policies, preparedness, and product safety and efficacy.
Int J Infect Dis, 10 (2006), pp. 193-201
[7]
J.G. Rizk, G. Lippi, B.M. Henry, D.N. Forthal, Y. Rizk.
Prevention and treatment of monkeypox.
[8]
S.N. Shchelkunov, A.V. Totmenin, I.V. Babkin, P.F. Safronov, O.I. Ryazankina, N.A. Petrov, et al.
Human monkeypox and smallpox viruses: genomic comparison.
FEBS Lett, 509 (2001), pp. 66-70
[9]
World Health Organization.
Vaccines and immunization for monkeypox: Interim guidance, (2022),
[10]
A.W. Rimoin, P.M. Mulembakani, S.C. Johnston, J.O. Lloyd Smith, N.K. Kisalu, T.L. Kinkela, et al.
Major increase in human monkeypox incidence 30 years after smallpox vaccination campaigns cease in the Democratic Republic of Congo.
Proc Natl Acad Sci U S A, 107 (2010), pp. 16262-16267
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