FDA Update on U.S. Monkeypox Outbreak

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Definition

2022 U.S. Monkeypox Outbreak

The U.S. CDC is tracking an outbreak of monkeypox that has spread across several countries that don't usually report monkeypox, including the United States. The monkeypox virus spreads mainly through close, intimate contact with someone who has monkeypox. You can take steps to prevent getting monkeypox and lower your risk during sex. CDC recommends vaccination for people who have been exposed to monkeypox and people who are at higher risk of being exposed to monkeypox. If you have any symptoms of monkeypox, talk to your healthcare provider, even if you don't think you had contact with someone who has monkeypox. CDC is urging healthcare providers in the United States to be alert for patients with rash illnesses consistent with monkeypox - (cdc.gov/poxvirus/mpox/response/2022/index.html)

Main Digest

The U.S. Food and Drug Administration is providing an update on its multipronged response to monkeypox in the United States, including its diagnostics, vaccines, and therapeutics efforts. The agency has also established a dedicated website to provide important information about the FDA's ongoing regulatory activities related to monkeypox, along with 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 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 collaborating with our partners across all sectors to expand accessibility to countermeasures and bolster the tools in our arsenal as appropriate."

The monkeypox virus is part of the same family of viruses as the variola virus, which causes smallpox (a virus that has been eradicated globally). Both monkeypox and smallpox fall into the category of "orthopoxviruses." Monkeypox is generally not fatal and typically resolves on its own without treatment. The current outbreak in the U.S. usually presents as a rash on the body, face, or genital area. Although there is a shallow risk of dying, there have been reported complications, including severe pain, at times requiring hospital admission.

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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 lacks clinical data supporting other sample types, such as blood or saliva, for monkeypox virus testing. 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 to prevent 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 submitting the required application for the company's manufacturing changes 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. to 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 an 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.

Resources That Provide Relevant Information

• Monkeypox Incubation Period
• 1 In 5 Americans Fear Getting Monkeypox
• WHO Declares Monkeypox a World Health Emergency

Attribution/Source(s):

This peer reviewed article relating to our Monkeypox Virus section was selected for publishing by the editors of Disabled World due to its likely interest to our disability community readers. Though the content may have been edited for style, clarity, or length, the article "FDA Update on U.S. Monkeypox Outbreak" was originally written by U.S. Food and Drug Administration (FDA), and published by Disabled-World.com on 2022/07/31 (Updated: 2023/02/27). Should you require further information or clarification, U.S. Food and Drug Administration (FDA) can be contacted at fda.gov. Disabled World makes no warranties or representations in connection therewith.

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