Monkeypox is a rare disease that is caused by infection with monkeypox virus. This virus can spread to anyone through close, personal, often skin-to-skin contact. Currently, a high rate of the known cases in the U.S. are among gay and bisexual men and transgender and non-binary people, but this virus is not limited by sexuality or gender.
2. What products are authorized to diagnose, prevent or treat monkeypox?
There is an approved vaccine and a cleared diagnostic test that can be used to help address the virus.
3. If someone received a smallpox vaccine, do they have immunity against monkeypox?
Individuals who received a smallpox vaccine may have some protection against monkeypox. However, there are several factors that could affect whether immunity was actually present, including the “take” (the lesion that develops at the site of inoculation) of the vaccine when administered and the time since vaccination.
*Vaccines for Monkeypox
-The FDA approved JYNNEOS Vaccine in 2019, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.
-This is the only currently FDA-approved vaccine for the prevention of monkeypox disease.
-The vaccine does not contain the viruses that cause smallpox or monkeypox.
-Given the emerging public health need, the FDA and government partners worked to accelerate submission of information needed to make additional U.S. doses of JYNNEOS available much more quickly than scheduled.
The vaccine is part of the Strategic National Stockpile, overseen by the Department of Health and Human Services’ Assistant Secretary for Preparedness and Response, which helps ensure that the vaccine is accessible in the U.S. if needed.
*Therapeutics for Monkeypox
-Currently, there are no FDA-approved treatments for monkeypox; however, TPOXX (tecovirimat), an antiviral medication, is being made available through the CDC under an FDA authority called Expanded Access, or “compassionate use.”
-As background, in 2018, the FDA approved TPOXX for treatment of smallpox in adults and children. Because smallpox has been eradicated globally, TPOXX was approved under the FDA’s “Animal Rule” regulations, as it was neither ethical nor feasible to test the efficacy of the drug in humans. TPOXX was approved for treatment of smallpox based on efficacy data obtained from animal studies, specifically non-human primates infected with monkeypox virus and rabbits infected with rabbitpox virus. Such studies were relevant since the viruses that cause smallpox, monkeypox, and rabbitpox are in the same family of viruses called “orthopoxviruses.”
-Unlike smallpox, monkeypox was endemic in other parts of the world (e.g., the Democratic Republic of the Congo) at the time of TPOXX’s initial approval. Consequently, it remained both ethical and feasible to conduct clinical trials in humans to study TPOXX for the treatment of monkeypox disease. Therefore, TPOXX for the treatment of monkeypox disease was not eligible for approval under the pathway described in the FDA’s Animal Rule regulations.
*Diagnostics for Monkeypox
-Laboratory diagnostic testing for monkeypox virus is available in designated CDC Laboratory Response Network (LRN) and other CDC-designated laboratories using the CDC’s FDA-cleared orthopoxvirus tests.
-In June 2022, the HHS, through the CDC, began shipping FDA-cleared orthopoxvirus tests to five commercial laboratory companies to quickly increase monkeypox testing capacity and access.
-Cleared orthopoxvirus diagnostic tests
-The CDC Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set was first cleared in 2018 for in vitro qualitative presumptive detection of non-variola orthopoxvirus DNA extracted from human pustular or vesicular rash specimens and viral cell culture lysates submitted to a LRN reference laboratory. Additional 510(k)s were cleared on June 10, 2022 (K221658), to clear the use of additional reagents and automation, and June 24, 2022 (K221834), to clear the test for use in CDC-designated laboratories outside the LRN.
-Laboratory Developed Tests
-There may also be laboratory developed tests (LDTs) available for orthopoxvirus or specifically for monkeypox. LDTs are tests designed, manufactured, and used within a single CLIA-certified laboratory that meets the requirement for high complexity testing.
-The FDA generally exercises enforcement discretion with respect to LDTs, including those developed by hospitals or academic laboratories, meaning the FDA generally does not exercise its authority to enforce the regulatory requirements for these devices, although it maintains that authority.
-The general enforcement discretion approach for LDTs is not appropriate in all circumstances, for example, for tests used for declared emergencies under the Federal Food, Drug, and Cosmetic Act. In the case of an emergency involving an outbreak, inaccurate tests can lead to greater spread of the disease and poor management of the outbreak due to false results. The FDA, therefore, generally has expected Emergency Use Authorizations for LDTs during all prior declared emergencies, starting with H1N1 in 2009 and continuing through the COVID-19 emergency.
-The FDA is monitoring the situation with respect to considering appropriate policies, including enforcement discretion policies, for LDTs and other tests for monkeypox, taking into account lessons learned from COVID-19.
*2022 Outbreak Cases and Data
as of August 22, 2022
US Cases: 20,733
US Deaths: 0
Global Cases: 54,911
*Source of Information
-https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/fda-monkeypox-response#facts
-https://www.cdc.gov/poxvirus/monkeypox/response/2022/index.html#Healthcare-Professionals
