US FDA Update on Agency Response to Monkeypox Outbreak in the United States

By U.S. Food and Drug Administration

US FDA Update on Agency Response to Monkeypox Outbreak in the United States

On July 29, 2022, the U.S. Food and Drug Administration presented an update on its multipronged response to the monkeypox outbreak in the United States. This response includes the agency's activities in the areas of diagnostics, vaccinations, and treatments (therapeutics). In addition, the FDA has launched a specialized website containing commonly asked questions and essential information regarding the continuing regulatory operations linked to monkeypox. FDA will offer updates as new information becomes available and will continue to collaborate with federal public health partners and industry to ensure timely access to all medical countermeasures that are currently available.

"The FDA has been closely tracking reports of monkeypox transmissions in the United States with our federal public health partners and coordinating preparedness efforts accordingly," said FDA Commissioner Robert M. Califf, M.D. "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. We will continue to collaborate with our partners across all sectors to expand accessibility to countermeasures and bolster the tools in our arsenal as appropriate."


The virus that causes monkeypox is related to the variola virus, which also causes smallpox  (a virus that has been eradicated globally). Both viruses belong to the same family of viruses - "orthopoxvirus". In most cases, monkeypox does not result in death, and the condition clears up without needing therapy. The rash is the most common symptom of the current outbreak in the United States, which can appear anywhere on the body, including the face and genital area. Although there is minimal danger of dying, there have been reports of complications, some of which include intense discomfort (pain) and may necessitate admission to the hospital.


Diagnostics


Since the first case of monkeypox in the U.S. was detected, the FDA has been working with commercial laboratories and manufacturers to make monkeypox tests more readily 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 a swab from a monkeypox lesion (rash or growth). At this time, this is the only FDA-cleared test. The FDA is unaware of clinical data supporting other sample types, such as blood or saliva, for monkeypox virus testing. Therefore, in July 2022, the FDA issued a safety communication advising people to use swab samples taken directly from a lesion when testing for the monkeypox virus.


The CDC offers the FDA-cleared monkeypox test throughout many laboratories, including the CDC's public health Laboratory Response Network. In addition, federal public 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 the production of its FDA-cleared test, and the FDA has cleared the use of additional reagents and instruments to increase the throughput of the CDC test. 


The FDA will continue to work with the diagnostic community to augment 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 years of age and older determined 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 because of the small number of cases until now, the immunological response to vaccine administration is consistent with the effective prevention of the disease.


Following the emerging public health crisis closely, the FDA was aware that there were close to 800,000 doses of this vaccine pending release this fall following approval of additional manufacturing capabilities at one of the plants where the vaccine is made. With this in mind, the agency worked with HHS partners and expedited the submission of the required application for the company's manufacturing changes in order to make these doses available to those in need. After accelerating the timeline for an inspection of the plant from fall to earlier this month, the FDA has finished its evaluation of the required information to validate product quality and has 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 allow for additional manufacturing capabilities at the facility. Given the emerging public health need, the FDA previously facilitated the shipment of manufactured doses to the U.S. so that they would be ready to be distributed once the manufacturing changes were approved. With the supplement approval, those manufactured doses may now be further distributed and administered. Additional doses manufactured at this plant can help address the need for this vaccine moving forward.


Therapeutics


There is no FDA-approved or authorized medicine for the treatment of monkeypox disease; however, TPOXX (tecovirimat), an antiviral medication, is being made available through the CDC under an FDA authority called Expanded Access or "compassionate use." The FDA continues to work with the CDC to streamline their Expanded Access Program for monkeypox to facilitate access.


There are currently no human data demonstrating the efficacy 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 the expanded access program is available, conducting randomized, controlled trials to assess TPOXX's safety and efficacy in humans with monkeypox infections is essential. 


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


Further information;


WHO Monkeypox Factsheet


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IndraStra Global: US FDA Update on Agency Response to Monkeypox Outbreak in the United States
US FDA Update on Agency Response to Monkeypox Outbreak in the United States
By U.S. Food and Drug Administration
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