For immediate release:

Today, the US Food and Drug Administration is renewing its multifaceted response to monkeypox in the United States, including efforts in the areas of diagnostics, vaccines, and therapeutics. The agency has also created a dedicated website to provide important information about FDA’s ongoing monkeypox regulatory actions and frequently asked questions. FDA will provide updates as developments occur and will continue to work with federal healthcare partners and industry to ensure timely access to all medical countermeasures.

“FDA is closely monitoring reports of monkeypox outbreaks in the United States with our federal public health partners and is coordinating preparedness efforts accordingly,” said FDA Commissioner Robert M. Califf, M.D. “We understand that we are still living with COVID-19,” the emerging disease may cause people anxiety and a sense of uncertainty, but we have medical products, including an FDA-approved vaccine to prevent monkeypox and an FDA-cleared diagnostic test. It is important to note that The FDA is using the full scope of its authority to make additional diagnostics and treatments available. We will continue to work with our partners in all sectors to expand access to countermeasures and strengthen the tools in our arsenal accordingly.

Monkeypox virus belongs to the same family of viruses as variola virus, the virus that causes smallpox (a virus that has been eradicated worldwide). Both monkeypox and smallpox fall under the category of “orthopoxviruses.” Monkeypox is usually not fatal and resolves on its own without treatment. The current outbreak in the United States often presents as a rash on the body, face, or genital area. Although the risk of death is very low, cases requiring hospitalization are possible, including severe illness.

diagnostics

Since the first case of monkeypox in the United States, the FDA has been working with commercial laboratories and manufacturers to make monkeypox tests available to consumers who need them. The Centers for Disease Control and Prevention (CDC) has an FDA-cleared non-variola orthopoxvirus test that can detect monkeypox by swabbing a monkeypox lesion (rash or growth). Currently, this is the only FDA-cleared test. FDA is not aware of any clinical data supporting the use of other types of specimens, such as blood or saliva, to test for monkeypox virus. In July 2022, the FDA issued a safety communication recommending that people use swab samples taken directly from the sore when testing for monkeypox virus.

The FDA-cleared monkeypox test is offered by CDC and many laboratories that include CDC’s Public Health Laboratory Response Network. In addition, federal health authorities have worked with industry to make the test available through five large commercial laboratories. The agency is working closely with the CDC to increase production of the FDA-cleared test, and the FDA has decided to use additional reagents and instruments to increase the throughput of the CDC test.

FDA will continue to work with the diagnostic community to increase the availability of accurate testing to support the response.

vaccines

In 2019, the FDA approved the JYNNEOS vaccine to prevent chickenpox and monkeypox in adults 18 years of age and older who have been identified as being at high risk for infection. JYNNEOS is the only vaccine approved to prevent monkeypox in the United States. Although clinical trials and data are limited so far due to small numbers of cases, the immunological response to vaccine administration is consistent with effective disease prevention.

After the public health crisis, the FDA learned that it has about 800,000 doses of the vaccine to be released this fall after additional production capacity was approved at one of the vaccine factories. With that in mind, the agency has worked with HHS partners to expedite the filing of the required company manufacturing changes to make these doses available to those who need them. After accelerating the factory inspection period from the fall to early this month, the FDA has completed an evaluation of the information needed to verify the product’s quality and determined that the vaccine meets its quality standards.

On July 26, the agency approved an addendum to the biologics license for the JYNNEOS vaccine to expand additional manufacturing capabilities at the facility. In recognition of the public health need, the FDA has made it easier to ship previously manufactured doses to the US so they are ready for distribution once manufacturing changes are approved. With additional approval, those produced doses can now be further distributed and administered. Additional doses produced at this facility will help address the need for this vaccine moving forward.

Therapeutics

There is no drug approved or approved by the FDA to treat monkeypox; however, TPOXX (tecovirimat), an antiviral drug, is available through the CDC through the FDA’s Extended Access or so-called “compassionate use” authority. FDA continues to work with CDC to facilitate the expanded access program for monkeypox.

There are currently no human data showing the efficacy, safety, and pharmacokinetic profile (which helps us understand how the human body reacts to the drug) of TPOXX in the treatment of monkeypox. Although an expanded access program exists, it is important to conduct randomized, controlled trials to evaluate the safety and efficacy of TPOXX in humans with monkeypox infection.

The FDA has more information on the approval of TPOXX for smallpox under the Animal Rule regulations on its monkeypox webpage.

###

pot

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, electronic radiation products, and the regulation of tobacco products.