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CDC Ramps Up Testing, Boosts Monkeypox Vaccination Supply

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The Centers for Disease Control and Prevention (CDC) has expanded access to vaccines, tests and treatments for monkeypox, agency officials said at a webinar on Tuesday.

The CDC expects to release more than 750,000 doses of the JYNNEOS vaccine from its strategic stockpile within days, panellists at the Clinician Outreach and Communication Activity (COCA) conference said.

In addition, by working with commercial labs, the agency has expanded U.S. testing capabilities and simplified requirements for the use of the antiviral tecovirimat.

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“We must work together to educate and protect those most at risk, primarily through education, not stigmatization,” said Jennifer McQuiston, DVM, MS, monkeypox response manager. “And we need you, our frontline healthcare providers and public health workers who are critical to controlling the outbreak.”

Monkeypox, which is closely related to smallpox, is spread by close physical contact and usually causes flu-like symptoms and purulent skin lesions. It is endemic in parts of West and Central Africa but has recently spread to at least 66 countries where it has not previously been identified, with 15,000 cases reported in those countries since April of this year, mostly among men who have sex. with men.

The World Health Organization on Saturday declared the monkeypox outbreak a global health emergency, its highest alert level.

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Reported cases of monkeypox have been increasing exponentially since the spring in the United States, with 3,487 cases reported in 45 states, the District of Columbia and Puerto Rico, said Maria E. Negron Sureda, DVM, PhD, MS, CDC Monkeypox Epidemiology. Task Force Leader.

The average age of infected people is 35 years, with 98.4% of cases associated with sexual contact between men. 99% of cases include rash, 70% malaise, 64% fever, and 63% lymphadenopathy.

The CDC has expanded its testing capacity by hiring five commercial labs to process 70,000 tests, in addition to the 10,000 tests the US Laboratory Response Network (LRN) processes per week, said Christina Hutson, PhD, MS, head of the lab and testing task force.

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“We have made significant progress in expanding monkeypox diagnostic testing to these commercial laboratories that have national coverage and can perform tests ordered from anywhere in the country,” she said.

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LRN Laboratories perform FDA-approved PCR testing for non-variola orthopoxvirus, sending samples to CDC for sequencing. And four commercial labs are doing 10,000 tests a week in the same way. A fourth commercial laboratory, Quest Diagnostics, processes an additional 30,000 in-house monkeypox tests per week, Hutson said.

All laboratories accept lesion material from any part of the body as specimens for testing. But clinicians should check with the specific laboratory whether laboratories take dry swabs or swabs in a transport medium. There is no need to pierce or unroof the lesions, Hutson says, just grab the swab vigorously.

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She advised clinicians to take into account epidemiological criteria as well as clinical presentation when deciding whether to conduct testing.

Each commercial laboratory can have its own monkeypox CPT billing code and bill private insurance companies, Medicaid, or Medicare. The government is seeking money to pay for tests for uninsured people, Hutson said.

Patients who test positive can be treated with tecovirimat, an antiviral drug developed to treat smallpox, said Yong Yu, MD, head of the regulatory and clinical guidelines group. The drug has only been tested against monkeypox in animals, but it can be given to humans under an Expanded Access New Drug Research Authorization. State and Territory Health Departments can provide information on where to get the drug, as well as the CDC through their Emergency Center at 770-488-7100 or poxvirus@cdc.gov.

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The CDC has updated its protocol for providing tecovirimat. Patient visits can be done via telemedicine, lab testing is optional and no pre-registration is required for appointment by physicians and healthcare providers.

Clinicians must obtain informed consent, conduct a baseline assessment, and complete a patient admission form. They should document progress once during and once after treatment in the form of clinical outcomes and report any serious side effects, Yu said. The CDC has created a webpage specifically for the tecovirimat guides.

In addition to tecovirimat, the FDA has licensed two vaccines, JYNNEOS (Imvamune or Imvanex) and ACAM2000, for monkeypox.

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The CDC recommends vaccination within 4 days for people with high exposure, but not for those with “short-term interactions and those conducted using appropriate PPE.” [personal protective equipment].” More information is available on the CDC monkeypox vaccination webpage.

Not enough JYNNEOS to meet demand. More than 100 million doses of ACAM2000 are available, according to the CDC, but this vaccine comes with an increased risk of adverse reactions and the agency does not recommend its use in people with certain medical conditions, including a weakened immune system, skin conditions such as atopic dermatitis. / eczema or pregnancy.

In addition, ACAM2000 is made from a live virus that grows at the site of the vaccine and can spread to other parts of the body or infect other people, requiring precautions.

Given JYNNEOS’ limited offering, the CDC recommends prioritizing people who are at risk of side effects from ACAM2000 or severe illness from monkeypox, such as people with HIV or immunocompromised conditions, said Steve Flores, Ph.D., Colead’s vaccination team.

The CDC increased distribution of JYNNEOS from 56,000 doses on June 28, 2022 to 240,000 doses on July 15, 2022, he said. More than 750,000 doses are expected to be reached within days, with an end goal of 1.9 million by 2022 and another 2.2 million in the first half of 2023.

“We do not know if JYNNEOS can fully protect against monkeypox virus infection in the context of the current outbreak,” he warned. “Therefore, it is important that people take additional preventive measures and self-isolate as soon as they develop symptoms such as a rash. Infections can still occur despite vaccination.”

Source

Centers for Disease Control and Prevention (CDC), July 26, 2022, Clinician Outreach and Communications Call (COCA).

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