Monkeypox appears to be in decline, but risks and uncertainties remain

Nearly four months after the first report of monkeypox in the United States, the virus is showing promising signs of retreat, alleviating concerns that it could spill over into populations of older adults, women and children. pregnant and young children.

Vaccine supplies have improved and federal health officials have begun clinical trials to better understand who benefits, and by how much, from both the vaccine and the drugs used to treat it. infected people.

That is a good news. But unfortunately, the file number speeding up in several states and jurisdictions, including Indiana, Virginia, and Massachusetts. Black and Hispanic men account for nearly two-thirds of those infected, but only about a quarter of those vaccinated so far.

“Our progress has been very uneven,” said David Harvey, executive director of the National Coalition of STD Directors.

“This outbreak is far from over,” he added.

Recent reports suggest that a single dose of the vaccine, Jynneos, may not be protective enough, raising new concerns about the Biden administration’s fractional dose distribution scheme.

And federal health officials have warned that the virus could become resistant to tecovirimat, the only safe treatment for those infected.

“When you only have one drug in your arsenal, it can be a little precarious,” said Dr. Anthony S. Fauci, the top medical adviser to the Biden administration. “But you have to do with what you have at the same time as you try and develop additional drugs.”

As of Friday, there were nearly 25,000 cases monkeypox in all 50 states, the District of Columbia and Puerto Rico. The United States accounts for nearly 40 percent of the global total.

But new cases have been falling steadily for weeks, from more than 500 cases in early August to a daily average of 208 on September 22.

Recently Los Angeles Department of Public Health confirm the nation’s first death from monkeypox, in a severely immunocompromised person. Texas health officials are investigating another death may be related to infection.

BILLIONcase wo encephalitis – inflammation in the brain and spinal cord – has been reported, even in previously healthy gay men in their 30s.

Overall, however, federal health officials are optimistic that the outbreak is waning. While testing and vaccines will continue to be important, officials envision a future where monkeypox does not go away, but can be controlled with contact tracing, vaccination, and control. early treatment.

“I think it’s going to be a little bit like more episodic cases, smaller clusters,” said Dr Demetre Daskalakis, deputy coordinator for the White House monkeypox response.

The recent decline is most likely the result of a combination of vaccination, acquired immunity to infection in the highest-risk population, and behavioral changes in this group, Dr. Dr. Daskalakis said.

In one survey conducted by the CDC in August, about half of men who have sex with men reported having reduced the number of sexual partners and the number of times they had sex once.

But the falling number of cases may soon lead these men to believe that the threat is over. “We can’t ask people to change their behavior forever,” says Dr Daskalakis. “That doesn’t really work for HIV, so it won’t work here either.”

Vaccination could be a more effective prevention strategy in the long term, he added.

As of September 20, health officials managed nearly 700,000 doses of Jynneos in 48 jurisdictions for which data are available. While that’s a significant improvement in the early weeks of the outbreak, it represents only 22% of the dose needed to protect the 1.6 million Americans estimated to be at high risk.

Even as infections decline, the rate of cases among Black and Hispanic men developed to 70% in mid-September from 37% at the end of May. Black men, however received less than 9 percent of doses used to date, and Hispanic men about 16 percent.

Federal health officials are ramping up efforts to reach high-risk groups and have vaccinated at least 11,000 people at large gatherings where black and Hispanic men gather. episodes, such as the Atlanta Black Pride.

CDC announced a new program that would make up to 10,000 vials of vaccine – or 50,000 doses, under the new dose-saving strategy – for communities where hesitation, language barriers, immigration or other impediments prevent access. widespread vaccination.

Vaccine eligibility is a snapshot by location, and the criteria are often unclear, according to an analysis by the Kaiser Family Foundation. Some states, like Indiana and New Mexico, do not provide information online about who is eligible. Laboratory workers and healthcare workers who may be exposed to the virus are only eligible in 18 states and cities.

Many high-risk men have chosen a single dose, which may not be protective enough. Although the second dose rate has increased, to date 77% of the doses used have been the first dose.

That won’t be enough to prevent infection or serious symptoms, a new study suggests. Dutch researchers found that a full dose of Jynneos make lows antibodies to monkeypox.

Dr Marion Koopmans, head of virology at Erasmus Medical Center in Rotterdam, Netherlands, who led the study, said two full doses were better but still “modest”.

“It raises the question of how good the protection will be,” she said. “Since we don’t know much about this, I think we really need to find out what’s going on.”

In an effort to extend vaccine supplies, the Biden administration has adopt a split dose strategy, where one-fifth of the usual dose is put into the skin – a method known as transdermal therapy – rather than the underlying fat. This approach has been tested in other vaccine shortages.

But activists and some scientists have voiced disapproval of the administration’s reliance on dosing, noting that federal officials have been slow to deliver millions of doses of Jynneos produced by the manufacturer. held in Denmark.

“The very strange thing about this whole thing is that we should never have been in this situation,” said James Krellenstein, founder of PrEP4All, a group that promotes access to HIV care.

Mr Krellenstein notes that there is little research to support fractional dosing rather than the usual full dosage: “They may be equivalent, but it’s very likely they are not.”

The Dutch team did not look at how a 1/5 dose of Jynneos protected against smallpox in monkeys. But in an earlier study, they tested an avian flu vaccine similar to Jynneos and found that two fractional doses produced much lower levels of antibodies than two full doses.

However, it is possible that a combination of a full dose and a split dose could work well, Dr. Koopmans said.

Little is known about the effectiveness of conventional dosages, let alone fractional dosage, because Jynneos was approved primarily on animal databases. But evidence so far suggests that two doses are better than one, said Dr. Peter Marks, the top vaccine regulator for the Food and Drug Administration.

“Having two doses of Jynneos is the correct way to get here, and the fact that the intradermal route allows us to have enough doses to move forward in that direction, is a smart idea,” he said.

“We are working on a public health emergency,” he added. “I think we’re doing our best with the data that we have on hand, the data that we trust, and the data as it comes out.”

There is some evidence that a third dose given a year after the first two doses produces a strong immune response. If that turns out to be true, a three-dose regimen might be ideal for controlling monkeypox infections in the long run. Dr Marks said federal scientists are still debating whether to test a third dose.

A new trial led by the National Institutes of Health, starting at the beginning of this monthwill enroll 200 adults and compare the standard dose with the intradermal distribution of doses of 1/5 and 1/10.

If split doses are shown to be relatively effective, the split dose approach would significantly expand supply around the world, including in countries where vaccines are not currently available.

Researchers will collect information about antibody levels in vaccinated participants. But they won’t monitor other immune cells that may be equally important for protection from the virus, said Dr. John Beigel, the NIH researcher who led the trial.

“This is an effective decision,” he said.

A separate NIH trial aimed to test the activity levels of tecovirimat, also known as Tpoxx, in 500 adults and children infected with monkeypox.

Tecovirimat is the only drug used to treat monkeypox in the United States, because alternative drugs can have toxic side effects. The drug was approved in 2018 on the basis of animal studies and has never been rigorously tested in humans.

Small clinical studies, as well as recent anecdotal observations of patients, show that the drug works well. A small percentage of patients experience minor side effects, such as headache and nausea.

Given the initial data, the Biden administration has been harshly criticized for making it difficult for doctors to prescribe drugs. And the CDC has called on clinicians reserve tecovirimat for patients who are severely immunocompromised, pregnant or lactating, or those with lesions in certain sensitive areas, as well as children under 8 years of age.

Federal officials said the decision to restrict access stemmed from concerns that indiscriminate use could lead to Tpoxx-resistant monkeypox. Some studies show that even small changes in genes can cause viruses resistaccording to FDA

The new test will provide a clearer picture of the risk. “We want to make this easier and much more confident, giving Tpoxx to people who are infected,” Dr. Fauci said.

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