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Monkeypox: Updated Clinical Guidance, Additional Vaccine Allocation

The World Health Organization on July 23 declared the escalating monkeypox outbreak a global health emergency. As of July 29, the Centers for Disease Control and Prevention (CDC) report more than 5,100 monkeypox cases in the United States across 47 states, Washington D.C., and Puerto Rico.

CDC has issued clinical considerations for monkeypox infection in multiple populations, including people with HIVchildren and adolescents, and people who are pregnant or breastfeeding.

Vaccines and Treatment

Two vaccines licensed by the Food and Drug Administration (FDA) are available for preventing monkeypox disease: JYNNEOS and ACAM2000. Both vaccines are available from the Strategic National Stockpile.

The U.S. Department of Health and Human Services announced July 28 plans to allocate an additional 786,000 doses of JYNNEOS vaccine to states and jurisdictions. More than 340,000 doses have already been delivered to jurisdictions. However, some areas, such as San Francisco, report that the vaccine continues to be in short supply.

CDC also issued a July 28 health alert to clinicians with updated guidance on commercial testing capability, collection of clinical specimens for testing, and use of TPOXX (tecovirimat) for treating monkeypox. FDA has approved TPOXX to treat human smallpox disease in adults and children. Its use for other infections, including monkeypox, is not FDA-approved. However, CDC has released an expanded access Investigational New Drug application (EA-IND) to allow access to and use of TPOXX to treat monkeypox.


To increase testing capacity, several commercial laboratories, including Aegis, Quest, Labcorp, and Mayo Clinic Laboratories, have announced they will begin testing for monkeypox. CDC advises that any laboratory that performs diagnostics testing for monkeypox should report test results to state, local, territorial, or tribal health departments.

Contact Senior Director of Policy Erin O’Malley at or 202.585.0127 with questions.


About the Author

Maryellen Guinan is a principal policy analyst at America's Essential Hospitals.

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