FDSFDA Announces Monkeypox Plan of Action

The FDA has announced updates to its approach to the monkeypox disease. According to the announcement on July 29, the agency has issued new explanations of the diagnostic, vaccine, and therapeutic responses and an FAQ page.

According to the CDC, monkeypox is a rare viral condition similar to smallpox. However, unlike smallpox, the CDC states that monkeypox is often non-fatal. The West Nile variant of monkeypox has a 1% lethality rate when untreated, while the Congo Basin variant can have a mortality rate of up to 10%. Since August 3, there have been 6,617 confirmed cases of monkeypox in the U.S. and over 26,000 cases worldwide. Unlike airborne-transmitted diseases such as COVID-19, monkeypox can only be transmitted via physical contact with an infected rash or sores.

Despite its relatively low lethality, the presence of monkeypox in the U.S. has caused the FDA and CDC to be on alert, tracking new cases and potential spikes in infections.

The agency stated that it is working with commercial laboratories and manufacturers to increase access to monkeypox diagnostic tests. Monkeypox diagnostic tests take swab samples from lesions and send them to a laboratory for analysis. However, as of this time, the FDA does not have clinical data suggesting that blood or saliva samples would be able to provide conclusive results for affirming monkeypox infections.

A monkeypox vaccine was approved by the FDA in 2019. The JYNNEOS vaccine was approved by the agency for the prevention of smallpox and monkeypox in adults at least 18 years old. At this time, the FDA and CDC are not recommending the monkeypox vaccine for anyone who is not at high risk for contracting the disease. High-risk individuals are those who either have lowered immune function or a high likelihood of interacting with an individual infected with monkeypox.

The FDA is working with manufacturers to make 800,000 monkeypox vaccines available to high-risk individuals in the fall of 2022 once additional manufacturing capabilities are approved.

While there are no FDA-approved or authorized medicines to treat monkeypox, there is an antiviral medication, TPOXX, (tecovirimat), that is being allowed under the compassionate use program.

FDA Commissioner Robert M. Califf M.D. commented on the announcement, stating, “We understand that while we are still living with COVID-19, an emerging disease may leave people feeling concerned and uncertain, but it’s important to note that we already have medical products in place, specifically an FDA-approved vaccine for the prevention of monkeypox disease and an FDA-cleared diagnostic test. The FDA is using the full breadth of its authorities to make additional diagnostics and treatments available.”

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