On July 29, 2022, the FDA released an update on its response to the monkeypox outbreak in the United States. The update provided insight into diagnostics, vaccines and therapeutics. The FDA also launched a webpage dedicated to providing updates about the disease. Monkeypox is part of the family of viruses that causes smallpox and is generally not fatal. It can be resolved without treatment, but it is known to cause severe pain and lesions sometimes requiring hospital admission.
The FDA is working with commercial laboratories and manufacturers to make monkeypox tests more readily available to at-risk individuals. There is currently only one FDA-approved test available. The test is most accurate when samples are taken directly from a lesion. Along with pushing for more accessible testing, the FDA is working to increase availability of the monkeypox vaccine. The JYNNEOS Vaccine was approved by the FDA in 2019 for the prevention of smallpox and monkeypox in adults 18 years and older. In recent weeks, it has been available primarily to patients determined to be at high risk of monkeypox infection. On July 26, the FDA approved a supplement to the vaccine’s biologics license which increases the capabilities of the manufacturer’s facility to meet the increasing need. Currently, there is no FDA-approved or authorized medication for the treatment of monkeypox. TPOXX (tecovirimat) is being made available for use as a treatment under the “compassionate use” program called Expanded Access, but this medication is still being studied for safety and efficacy in humans.