For immediate release:

Today, the United States Food and Drug Administration provides an update on its multi-pronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines, and therapeutics. The agency has also created a dedicated website to provide important information about ongoing FDA regulatory activities related to monkeypox as well as frequently asked questions. The FDA will provide updates as developments occur and will continue to work with federal public health partners and industry to ensure timely access to all available medical countermeasures.

“The FDA has been closely monitoring reports of monkeypox transmissions in the United States with our federal public health partners and has coordinated preparedness efforts accordingly,” said FDA Commissioner Robert M. Califf, MD. “We understand that while we are still living with COVID-19, an emerging disease can leave people worried and uncertain, but it is important to note that we already have medical products in place, in particular an FDA-approved vaccine for prevention of monkeypox and an FDA-approved diagnostic test. The FDA is using the full extent of its powers to make additional diagnostics and treatments available. We will continue to work with our partners across all sectors to broaden accessibility to countermeasures and strengthen the tools in our arsenal, where appropriate.

Monkeypox virus is in the same family of viruses as variola virus, the virus that causes smallpox (a virus that has been eradicated globally). Monkeypox and smallpox fall into the category of “orthopoxviruses”. Monkeypox is usually not fatal and usually resolves on its own without treatment. The current outbreak in the United States usually presents as a rash on the body, face, or genital area. Although there is a very low risk of death, complications have been reported, including severe pain, sometimes requiring hospitalization.

Diagnostic

Since the first case of monkeypox in the United States was detected, the FDA has been working with commercial labs and manufacturers to make monkeypox testing more readily available to consumers who need it. The Centers for Disease Control and Prevention (CDC) has an FDA-approved nonvariola orthopoxvirus test that can detect monkeypox by taking a sample from a monkeypox lesion (rash or growth). At present, it is the only test authorized by the FDA. The FDA is not aware of any clinical data supporting the use of other specimen types, such as blood or saliva, for testing for monkeypox virus. In July 2022, the FDA issued a safety communication advising people to use swab specimens taken directly from a lesion when testing for monkeypox virus.

The FDA-approved monkeypox test is offered by the CDC and at many laboratories that include the CDC’s Public Health Laboratory Response Network. Additionally, federal public health officials have worked with industry to make the test available at five major commercial labs. The agency is working closely with the CDC to increase production of its FDA-approved test, and the FDA has authorized the use of additional reagents and instruments to increase throughput of the CDC test.

The FDA will continue to work with the diagnostics community to increase access to accurate testing to support the response.

Vaccines

In 2019, the FDA approved the JYNNEOS vaccine for the prevention of smallpox and monkeypox in adults 18 and older considered to be at high risk of infection. JYNNEOS is the only vaccine approved for the prevention of monkeypox in the United States. Although clinical trials and data are limited due to the small number of cases so far, the immunological response to vaccine administration is consistent with effective disease prevention.

Following the emergence of the public health crisis, the FDA knew there were nearly 800,000 doses of this vaccine awaiting release this fall following approval of additional manufacturing capacity at one of the factories. where the vaccine is made. With that in mind, the agency worked with HHS partners and expedited the submission of the required application for the company’s manufacturing changes to make these doses available to those who need them. After accelerating the schedule for a fall factory inspection earlier this month, the FDA completed its evaluation of the information required to validate product quality and determined that the vaccine meets its quality standards.

On July 26, the agency approved a supplement to the biologics license for the JYNNEOS vaccine, to enable additional manufacturing capabilities at the facility. Given the emerging public health need, the FDA previously facilitated the shipment of US-made doses so that they would be ready for distribution once manufacturing changes were approved. With the approval of the supplement, these manufactured doses can now be dispensed and administered. Additional doses manufactured at this facility may help meet the need for this vaccine in the future.

Therapeutic

There are no drugs approved or cleared by the FDA for the treatment of monkeypox disease; however, TPOXX (tecovirimat), an antiviral drug, is made available by the CDC under an FDA authority called Expanded Access or “compassionate use.” The FDA continues to work with the CDC to streamline its Expanded Access Program for monkeypox to facilitate access.

There are currently no human data demonstrating the effectiveness of TPOXX for the treatment of monkeypox, or the safety and pharmacokinetic profile (which helps us understand what the human body does to a drug). Although an expanded access program is available, it is essential to conduct randomized controlled trials to evaluate the safety and efficacy of TPOXX in humans with monkeypox infections.

The FDA has more information about TPOXX’s approval for smallpox under the “Animal Rule” regulations on its monkeypox webpage.

###

Master key

The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.