The Centers for Disease Control and Prevention (CDC) says the antiviral TPoxx should only be given to high-risk monkeypox patients.

The Centers for Disease Control and Prevention released New instructions On Thursday he recommended that TPoxx, the only drug available to treat monkeypox, be restricted to people at high risk of developing severe disease even as the disease has spread to more than 22,000 Americans. plateau signs.

Recently released data from the Food and Drug Administration indicates that widespread use of TPoxx “could enhance resistance and render antiviral drugs ineffective for some patients,” the CDC said in a statement Thursday. Antivirals, prescribed to tens of thousands of monkeypox patients, have been approved for the related smallpox virus. Its use against monkeypox is experimental and tightly controlled by federal officials, although there is mounting evidence that it benefits many patients.

But advocates have demanded that TPoxx be more widely available He criticized the government’s guidance as being too hasty, given persistent inequality in access to vaccinations and treatment for a disease spread through close contact, including sex.

“There is a theoretical concern that monkeypox virus may rapidly develop resistance to TPoxx – but for now, that’s a theoretical concern,” said James Krelinstein, co-founder of PrEP4All, a group that advocates for access to HIV care. “We need to see more tangible steps from both [National Institutes of Health] And the CDC to determine how much of a threat it actually poses, through better research and monitoring.”

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Fauci, President Biden’s medical advisor, said at a White House briefing on monkeypox Thursday that resistance is always a risk when antiviral drugs are used. He said a recently launched study of TPoxx will track signs of mutations that may lead to resistance. The study is expected to enroll more than 500 patients at 60 US sites.

The updated guidelines on the use of TPoxx come at a time when the growth of new monkeypox cases in the United States and abroad is declining as vaccination and education campaigns improve, Public health officials said individuals have limited risky sexual behaviors linked to the outbreak. New cases in the United States have fallen about 50 percent since their peak in early August.

But Rochelle Wallinsky, director of the CDC, said in The Briefing on monkeypox in the White House. Los Angeles County health officials on Monday announced the death of a county resident with a severely compromised immune system, the first death in the United States from the disease. Texas health officials are still investigating monkeypox’s role in the spread of the virus Houston patient dies Last month.

Two healthy men in their 30s developed encephalomyelitis — inflammation of the brain and spinal cord — suggesting that Neurological complications It is a possible result of monkeypox infection, according to a CDC report last week. Both were treated with TPoxx and recovered but are having difficulty walking.

FDA officials this week to caution That a single molecular change to monkeypox “could have a significant effect on the antiviral activity of TPoxx,” referring to its efficacy.

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Most healthy patients require supportive care and pain control and “do not need antiviral therapy,” said Sapna Bamrah Morris, a CDC official working on the monkeypox response. call the doctors Hosted by the CDC and the Infectious Diseases Society of America.

TPoxx should be reserved for people with severely compromised immune systems – those with uncontrolled HIV, leukemia, lymphomas and solid organ transplants – as well as people who are pregnant or breastfeeding, children under eight, and people with susceptible skin infection, Morris said.

The vast majority of cases in the United States have been in men who have had sex with men, although officials stress the virus can infect anyone.

Jay Pharma, an infectious disease expert at Weill Cornell Medicine in New York City, said it was “reasonable” for the CDC to provide clearer guidance on prescribing TPoxx, especially given the lack of a randomized clinical trial testing the treatment’s effectiveness against monkeypox.

“The challenge comes during implementation,” added Varma, the former New York City health official, warning of the dangers of dissuading providers and patients from receiving treatment. He noted that it is “highly likely” that monkeypox infection will increasingly move from large urban centers toward smaller cities and rural areas, where patients already face barriers when seeking care.

“No limits [TPoxx] Varma said prescribing the drugs could lead to unintended consequences for people at high risk of developing or living with a serious illness.

Health officials and patient advocates point out the disparities in vaccinations against an infected virus disproportionately spread among communities of color He stressed the need to reach deeper into the black and Latino communities.

Efforts to control the outbreak are entering a critical time, “a more difficult phase of the vaccination campaign,” said Dimitri Daskalakis, deputy coordinator of the White House response to monkeypox, referring to the need to reach disadvantaged communities.

Black Americans have received Only 12 percent Of the first doses of the two-vaccine Jynneos vaccine though, they make up 38 percent of new monkeypox cases in the United States, Walinsky said.

The CDC announced Thursday a program to provide up to 50,000 doses to communities that may face barriers to vaccinations due to language differences, the location of vaccination sites, distrust of government, inability to access online scheduling, immigration status and stigma.

search from University of Pennsylvania Released Thursday shows knowledge of the monkeypox vaccine has jumped from about a third of Americans in July to more than 60 percent. The vast majority, 84 percent, know that monkeypox is spread by close contact with an infected person, compared to 69 percent in July. Nearly three-quarters of Americans said they would get vaccinated if they were exposed.

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More than 540,000 doses of the two-dose Jynneos vaccine have been administered in the United States as of Tuesday, according to the CDC. The vaccine was designed to prevent smallpox, and animal studies by the Danish manufacturer showed that it worked against monkeypox as well. But scientists and researchers do not know exactly how effective the vaccine is Humans. newly study from the Netherlands, which has not been peer-reviewed, found that two doses of the vaccine caused relatively low levels of anti-viral antibodies against monkeypox, raising concerns about efficacy.

During the first Senate hearing on monkeypox Wednesday, Democrats and Republicans lobbied Biden on the administration’s initials Struggling to ramp up testing and vaccines The virus spread rapidly in May and June.

“Honestly, a lot of mistakes were made early in the response, and a few hundred cases turned into 21,000,” said Senator Patty Murray (D-Wash), who chairs the chamber’s health committee.

By all accounts, the response from the Biden administration to [the] “The monkeypox crisis was a fiasco,” added Senator Richard Burr (North Carolina), the committee’s largest Republican. “I repeated every single one of the mistakes in the early days of responding to the virus.”

Biden officials defended the administration’s responseAnd the They said they learned from the government’s coronavirus stumbles in 2020 to move quickly to procure medical countermeasures to fight back An outbreak of monkeypox.

Don O’Connell, the assistant secretary at the Department of Health and Human Services who oversees the national stockpile of emergency medical supplies, described her team’s decisions to order tens of thousands of additional doses of monkeypox vaccine in the early days of the outbreak.

“This was all done to stay ahead of the virus, even though the number of cases was very low in the United States,” O’Connell told the committee.