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2 State of Smallpox Medical Countermeasures Readiness
Pages 41-72

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From page 41...
... A variety of medical countermeasures (MCMs) have been developed to detect (diagnostics)
From page 42...
... in 2017. The FDA-approved Variola Virus Nucleic Acid-Based Detection Assay is indicated for "individuals presenting with pustular or vesicular rash illness or other signs and symptoms of Variola virus infection" (FDA, 2024b)
From page 43...
... . During the 2022 mpox outbreak, once CDC and FDA began supporting orthopoxvirus testing in five commercial laboratory companies, clinicians preferred to use these laboratories over the public health laboratories of the LRN due to more streamlined patient data requirements and perhaps the perception of a more rapid availability of actionable results initially made possible by higher throughput testing capabilities at commercial laboratories (APHL, 2023)
From page 44...
... . Any work which uses live variola virus to validate smallpox diagnostics must also be approved by the World Health Organization (WHO)
From page 45...
... . Given the high public health concern regarding smallpox cases, rapid diagnostics aimed at the consumer are unlikely to have a role in most smallpox outbreaks.
From page 46...
... . Although the pathogenic mechanism for this observation may differ between clade IIb monkeypoxvirus infection and variola virus infection, this compares to reports of finding variola virus in saliva, conjunctiva, and urine in patients with hemorrhagic smallpox (Sarkar et al., 1973)
From page 47...
... . Ring vaccination is also still recommended by both WHO and CDC as the first-line response strategy for a smallpox outbreak (CDC, 2019b; WHO, 2023)
From page 48...
... stockpile maintains three different smallpox vaccines, all of which are based on vaccinia virus: two types of live, replicating virus vaccines; and an attenuated live, non-replicating vaccine as well as ancillary supplies for their administration (Table 2-1)
From page 49...
... 1st generation • Emergency Use Formulation contains Live, replicating Authorization (EUA) / live vaccinia virus in vaccinia virus, Investigational New Drug 50% glycerol, 0.4% NYCBOH-derived (IND)
From page 50...
... . Non-replicating vaccines were acquired more recently to provide an alternative for individuals contraindicated to receiving replicating smallpox vaccine.
From page 51...
... • Live vaccinia virus vaccines developed using clonal derivatives of 1st genera tion vaccines (Dryvax)
From page 52...
... . CDC's clinical use guidelines for smallpox vaccine indicate that there are no absolute contraindications for a smallpox vaccination in a post-event setting but that there are certain "relative" contraindications due to the possibility of adverse events associated with certain conditions (Table 2-2)
From page 53...
... , 1–2 deaths per million progressive vaccinia (fatality rate primary vaccinations. nearly 100% and eczema vaccinatum Often in young children or (10% before vaccinia immune globulin those with unrecognized [VIG]
From page 54...
... Non-infectious Generalized rash occurring 1–2 weeks 51.5–164.6 per million rashes (erythema after vaccination. Most resolve primary vaccinations multiforme)
From page 55...
... Reliance on the U.S. Strategic National Stockpile and Concerns with Manufacturing Capacity Dependence on the SNS smallpox vaccine stockpile as the primary form of smallpox readiness has required that sufficient inventory be maintained to respond to a smallpox event where the entire U.S.
From page 56...
... . Research on fourth generation smallpox vaccines could explore potential subunit or nucleic acid vaccines (protein, peptide, mRNA)
From page 57...
... The development of novel smallpox vaccines using multi-vaccine platforms (i.e., use common vaccine vectors, manufacturing ingredients, and processes) would improve the capacity for rapid vaccine production in response to a smallpox event and reduce the need for stockpiling in the SNS at current levels.
From page 58...
... . Brincidofovir Pro-drug of cidofovirf; • Treatment of human smallpox • The lipid modification Oral suspension -- expiry (CMX001/ following phosphorylation infections only (FDA approved)
From page 59...
... CDC = U.S. Centers for Disease Control and Prevention; EA = expanded access; EIND = emergency investigational new drug application; IND = investigational new drug application; OPXV = orthopoxvirus; VARV = variola virus.
From page 60...
... retinitis, was also used "off label" to treat mpox in immunocompromised individuals during the 2022 multicountry mpox outbreak (Siegrist and Sassine, 2023)
From page 61...
... Concerns with Antiviral Resistance and Adverse Events Antiviral resistance is a significant concern for the current antivirals. Stepwise resistance to cidofovir is known to occur when treating CMV, with moderate resistance with single mutations and a higher level of resistance with multiple mutations (Siegrist and Sassine, 2023)
From page 62...
... ; (3) Vaccinia immune globulin intravenous (VIGIV)
From page 63...
... 2023. Strategic National Stockpile​smallpox medical countermeasures​overview.
From page 64...
... population at risk of severe adverse events from replicating smallpox vaccine. Public Health Nursing 34(3)
From page 65...
... 2024b. Product classification: Variola virus nucleic acid-based detection assay.
From page 66...
... 2023. mRNA vaccines encoding fusion proteins of monkeypox virus antigens protect mice from vaccinia virus challenge.
From page 67...
... 2023. Variola virus research: Overview of main activities and use of live virus.
From page 68...
... 2015. Safety and immunogenicity of modified vaccinia Ankara-Bavarian Nordic smallpox vaccine in vaccinia-naive and experienced human immu nodeficiency virus-infected individuals: An open-label, controlled clinical phase II trial.
From page 69...
... 2008. Pregnancy, birth, and infant health outcomes from the national smallpox vaccine in pregnancy registry, 2003–2006.
From page 70...
... 2013. Unintentional transfer of vaccinia virus associated with smallpox vaccines: ACAM2000® compared with Dryvax®.
From page 71...
... 2015. Cardiac safety of modified vaccinia Ankara for vaccination against smallpox in a young, healthy study population.


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