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The U.S. Is Rolling Out Monkeypox Vaccines to the Public

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Image: Shutterstock (Shutterstock)

The U.S. will soon greatly expand its vaccination program for monkeypox. On Tuesday evening, the Biden administration announced that it is planning to release a stockpile of over a million vaccine doses to the public by the end of fall. The vaccines will primarily be given to close contacts of confirmed cases and others with a higher risk of exposure, such as gay and bisexual men who have had multiple recent sex partners in areas where the emerging disease has been spotted.

The updated strategy announced by the U.S. Department of Health and Human Services Tuesday will call for a gradual rollout of the country’s supply of the JYNNEOS vaccine. Nearly 300,000 doses will be distributed nationwide in the coming weeks, including 56,000 doses immediately. Another 750,000 doses will be made available during the summer. And up to 500,000 doses should be released later in the year, assuming that they pass the inspection process. All in all, around 1.6 million doses of the two-dose vaccine are expected to be available through the stockpile this year.

The vaccines became available so quickly because the monkeypox virus is closely related to the now-extinct smallpox virus, which was eradicated through a massive global vaccination campaign in 1980. Countries have still maintained a stockpile of smallpox vaccines to this day, however, in part because there’s always the small possibility that the virus could be resurrected as a bioweapon agent. And these vaccines are also thought to be effective against closely related viruses like monkeypox. Indeed, smallpox vaccines do not contain the virus itself, but another related virus called vaccinia.

The U.S. does have a much larger stockpile of the ACAM2000 smallpox vaccine available as well, and the HHS has said that it will release doses to jurisdictions that request it. But the ACAM2000 vaccine comes with more significant side effects than JYNNEOS, making it less suitable for mass distribution, the agency said. In 2019, JYNNEOS became the first vaccine in the U.S. to be approved for both smallpox and monkeypox. It’s estimated to be 85% effective against monkeypox, but that estimate is based on limited real world data. The vaccine can also be given to people soon after a suspected exposure, which should reduce the risk of illness.

In announcing the expanded rollout of its stockpile, the U.S. is following in the footsteps of other countries like the UK. Like these countries, the U.S. will be allocating doses on a priority basis, depending on people’s risk of exposure. At the top will be people known to be in close, prolonged contact with confirmed or suspected cases, followed by those whose sexual partners have been diagnosed with monkeypox, and finally “men who have sex with men who have recently had multiple sex partners in a venue where there was known to be monkeypox or in an area where monkeypox is spreading.” Within these tiers, considerations like a person’s existing health will be taken into account as well.

“Our goal right now is to ensure that the limited supply of JYNNEOS vaccine is deployed to those who can benefit from it most immediately, as we continue to secure additional vaccine doses,” said HHS Assistant Secretary for Preparedness and Response Dawn O’Connell, in a statement.

Monkeypox is thought to primarily infect rodents. Until recently, it had only occasionally spread from animals to humans following its discovery in the 1950s. But there have been more than 4,000 confirmed or suspected cases reported globally in humans this year, including over 300 in the U.S., which is a caseload far above the sporadic outbreaks previously seen in some parts of Africa. Though it may have been circulating in humans at low levels for several years now, its current spread appears to be fueled by close contact during sex. So far, outbreaks have primarily involved men who sleep with men, but the virus can spread to anyone through close contact with someone’s infected rashes and possibly respiratory particles.

Last weekend, the World Health Organization declined to declare a public health emergency of international concern over monkeypox for the time being, though they continued to stress that greater international cooperation and action will be needed to contain the virus before it can permanently become endemic in more parts of the world.

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We Are Not Ready for Monkeypox

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Photo: Pablo Blazquez Dominguez (Getty Images)

Monkeypox is here, and it’s spreading. The couple of dozen cases in a few countries that we told you about last month are now up to over a thousand cases worldwide, with 35 reported in the United States. But the U.S. almost certainly has more cases than the statistics suggest, and there is reason to suspect that we’re already fucking up the response to the epidemic in some ways that will feel uncomfortably familiar.

We aren’t testing enough

For the first few months of the COVID pandemic, when we had the chance to contain the virus if only we could locate all the cases and their contacts, testing was woefully inadequate. Plenty of people who had the virus were never tested for it, and people who wanted a test couldn’t always get one. The way we knew at first that the virus was spreading unnoticed was that there were cases in the U.S. that were not related to each other. The genetics of different clusters of a disease outbreak can show that the virus must have been spreading undetected for a while.

That’s what’s beginning to happen here: There are small clusters of monkeypox cases that are genetically different enough from each other that we know there must be far more than the 35 reported U.S. cases. So a lot of cases must be going undetected.

One reason for under-testing is that people who have monkeypox may not realize that they have it. Normally, monkeypox lesions are widespread across the body. In the current outbreak, sometimes a person may only have lesions in one part of the body, and may even have a single lesion. When that happens, you don’t think, “oh my god, this must be monkeypox,” you think, “huh, I wonder what that spot is.” And maybe you’ll see a doctor, or maybe not.

Doctors also aren’t necessarily looking for monkeypox, and might not recognize it at first. It’s not a common disease in the U.S. (or in many of the other areas where it’s spreading) and the symptoms in this outbreak don’t always follow the textbook sequence. Normally you would expect a fever first, and then the rash; but some of the known cases got the rash before the fever. Some people have the lesions only in the anal or genital area, which may look confusingly similar to STIs like herpes or syphilis. (Molecular microbiologist Joseph Osmundson has put together a fact sheet that includes photos of anal and genital monkeypox lesions here.)

So the first obstacle in testing is that not enough tests are being done in the first place. Testing for monkeypox involves collecting secretions or scabs from the lesions, and sending them to one of a few specific laboratories. Former FDA commissioner Scott Gottlieb tweeted that the current bottleneck is the lack of sampling.

But if awareness gets better, we may soon run into a bigger problem: labs’ testing capacity. Currently there is a network of 74 labs that can run a test for orthopoxviruses, and they can process an estimated 7,000 tests per week. Monkeypox is the only orthopoxvirus of concern at the moment, since smallpox has been eradicated and other viruses in the family, like cowpox, are rare. If a sample tests positive for orthopoxvirus, the CDC will do further testing to confirm that it is monkeypox.

People with monkeypox (or orthopoxvirus that is suspected to be monkeypox) are supposed to isolate for 21 days, and in the meantime, health authorities will contact-trace, and offer vaccines to the affected person and their close contacts. There are also antivirals that may be helpful. But the vaccine brings another problem.

We have a vaccine, but we don’t know how well it works

The good news about the vaccine is that we already have one. More than one, actually: Smallpox vaccination dates back hundreds of years, with several modern vaccines still available. (Smallpox was declared to be eradicated worldwide in 1980, the only human virus to have that honor.) People could occasionally have fatal reactions to some of the older smallpox vaccines, so those—the ones that use live virus—aren’t being considered for monkeypox.

In the U.S., there is one vaccine that is licensed for use against monkeypox. It’s known as MVA (for Modified Vaccinia Ankara) and its brand name here is Jynneos. It doesn’t replicate in humans, but it does still trigger an immune response against smallpox. According to a 1988 study, vaccination is 85% effective against monkeypox transmission—but that was a small study and we don’t know if that’s the efficacy we can expect from the current vaccine and the current strain of monkeypox.

We also don’t know if we’ll have enough of it. The U.S. Strategic National Stockpile says they have 36,000 doses and have ordered 36,000 more. The company that makes the vaccine also has lots of recent orders from other countries, for obvious reasons, and they plan to ship out small batches to the various countries so that everybody can start vaccinating quickly.

That’s not enough vaccine to start vaccinating everybody, so the current strategy is “ring vaccination,” in which vaccine is offered to people who were close contacts of a person known to have monkeypox. (Monkeypox vaccine may also be given to the person with monkeypox, since it can reduce the severity of illness if caught early enough.) But contact tracing isn’t perfect, and in many recent cases, people didn’t have names or contact information for all their close contacts. Another possible strategy would be offering the vaccine to everybody in high-risk groups, which currently include men who have sex with men. So far, that strategy is only being tried in Canada.

People are already misunderstanding how it’s transmitted

Many of the recent cases have been in men who have sex with men. This has led to some people assuming that it’s sexually transmitted, like HIV or other STIs; I’ve already seen social media posts from people misunderstanding this and saying that you can only catch monkeypox from sex with somebody who has it.

Knowing that a virus is sexually transmitted is helpful to know if sexual transmission is the main way that virus spreads, like with HIV. But we know that monkeypox can spread with close contact of any kind, including contact with an infected person’s lesions, or with their respiratory droplets (like from a cough or sneeze) and possibly even with aerosols.

And on that note: The CDC briefly published a recommendation that travelers wear masks to avoid catching monkeypox, and then took down that recommendation saying that it “caused confusion.” Can monkeypox be airborne? Maybe! But if you’re concerned about catching a virus when you travel, you should be wearing a mask anyway. We already know that masks (especially well-fitting N95 style masks) are effective at protecting us against COVID, and COVID cases are on the upswing again—not that they ever went away. So, yes, wear a mask. But also be on the lookout for symptoms of monkeypox, and don’t be afraid to ask for a test or a vaccine if you think you have monkeypox or may have been exposed.

   



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Self-Spreading Vaccine Research Could Spin Out of Control, Experts Warn

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A biologist searches for new variants and mutations of the coronavirus at Greifswald University Medical Center.
Photo: Jens B’ttner/picture-alliance/dpa/AP Images (AP)

Imagine a future scenario in which a dangerous new virus is detected in chimpanzees. To prevent this virus from spreading to humans, biologists decide to deliberately infect scores of wild chimps with a transmissible vaccine—an infectious, lab-grown virus that immunizes, rather than harms, its host. The chimps, now vaccinated, no longer pose a threat to humans.

That solution sounds too good to be true, which is exactly the problem, as scientists warn in a new Policy Forum published today in Science. Self-spreading vaccines are potentially dangerous and difficult to manage, and are “genetically too unstable to be used safely and predictably outside contained facilities,” write the authors, led by Filippa Lentzos from King’s College London and Guy Reeves from the Max Planck Institute for Evolutionary Biology.

This is not just their opinion, the authors argue. Rather, it’s an “evidence-based norm” that’s been around for decades, but this “norm now seems to be challenged,” they write. The result is an increased potential for “risky research on lab-modified self-spreading viruses,” according to the report. This could lead to a normalization of the concept and eventual real-world use without the proper safeguards, the scientists argue.

“Self-spreading vaccine research continues to proceed despite a lack of new information that would compellingly refute long-standing evidence-based norms in virology, evolutionary biology, vaccine development, international law, public health, risk assessment, and other disciplines,” the biologists write.

Vaccines that spread like a disease are an unquestionably powerful concept. They could be used to protect animals from disease and/or prevent them from harboring viruses dangerous to humans. In 2020, biologists Scott Nuismer and James Bull, both at the University of Idaho, argued for this very approach in a paper titled “Self-disseminating vaccines to suppress zoonoses.” (By self-disseminating virus, scientists mean a virus that has been artificially modified to perform a desired function while retaining its ability to spread between hosts.)

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By leveraging the spreading power of viruses, scientists could create biological agents that proliferate quickly through a target population, with the viruses performing specific tasks, such as delivering vaccines or sterilizing invasive species. In the late 1980s, Australian researchers dabbled with lab-modified, contagious viruses, using multiple approaches to exterminate foxes, mice, and rabbits, according to the paper.

More conceptually—and certainly more controversially—this strategy could also be used to spread vaccines among humans.

As the paper points out, interest in this biotechnology has increased significantly over the past several years, with the European Union (through its Horizon 2020 program), the U.S. National Institutes of Health, and the U.S. Defense Advanced Research Projects Agency all currently running programs to explore a wide range of possible applications.

Lentzos, Reeves, and colleagues say it’s time to pump the brakes and consider the consequences of this research and all the moving parts needed to make such a thing work. It’s not immediately clear, they argue, that self-disseminating viruses can be contained or removed from an environment once released, or who would be responsible for the biocontrol agent, should the virus behave unexpectedly or cross national boundaries.

Advocates of the idea say these viruses could be modified to have short lifespans or be made incapable of mutating, but “it remains to be experimentally tested if [manipulations] could simultaneously limit viral replication transmissibility to the extent that they could be perceived as controllable while maintaining sufficient transmissibility to be considered useful as vaccines in continually dynamic environments,” according to the report.

As for using transmissible vaccines to limit the spread of diseases from animals to humans, the scientists say the “the vast majority of virus species that currently exist are undescribed by science,” making it “very difficult to imagine how the considerable effort necessary to develop and test self-spreading vaccines could identify and then prioritize single viral species circulating in wildlife.” That viruses are constantly mutating makes this task all the more onerous, they add.

In terms of what’s needed, the authors call for various safeguards, cost-benefit analyses, and measures such as regulatory oversight. This would involve “a concerted, global governance effort with coherent regional, national, and local implementation.” The essay suggests that national governments update their legislation and guidelines on the matter, while developers and funders of this research “articulate comprehensive and credible regulatory paths through which they believe the safety and efficacy of self-spreading approaches could be established.”

In an email, Bull, co-author of the 2020 paper advocating for research into this biotechnology, said the authors of the new report “raise several valid points,” and he agrees that “informed regulatory oversight is essential,” adding that “public acceptance is also essential.”

“Until we undertake preliminary studies of transmissible vaccines (in contained environments), we will have little evidence on which to base estimated risks and benefits,” Bull told Gizmodo. “It is to be expected that early papers on transmissible vaccines explore the theoretical possibilities, many of which will never be practical or, as further work may show, never be safe.”

In an effort to move ahead cautiously, Bull recommended conservative approaches, such as creating a vaccine from a benign virus that already exists in a target population, as opposed to modifying an otherwise harmful virus. Work into gene drives, a related technology in which modified organisms engineer an entire species, could also help. “Just as gene drive developers have responded to regulatory concerns and have invented new designs with limited potential for spread, it is expected that investment in laboratory studies of transmissible vaccines will also lead to methods that mitigate risks,” Bull argued.

The idea of transmissible vaccines might die on the vine, whether on account of technical issues, safety concerns, or lack of public acceptance. But, clearly, dedicated research attention is needed, since the potential benefits—and risks—are immense.

More: Genetically Engineering Nature Will Be Way More Complicated Than We Thought

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Health

Starbucks Worker Tests Positive for Hepatitis A, Prompts Mass Vaccination of Customers

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Beverage cups featuring the logo of Starbucks Coffee.
Photo: Stephen Chernin (Getty Images)

Health officials in New Jersey are scrambling to prevent an outbreak of hepatitis A after a Starbucks employee reportedly tested positive for the virus last week. The location where the employee worked was temporarily shut down, and hundreds of people have received a vaccine against the virus, including the employee’s co-workers. Potentially thousands of people may be at risk of contracting the foodborne illness, however, and officials are recommending that unvaccinated customers who visited the store in early to mid November get a shot.

Camden County officials say they were notified of the case on November 17 by a health care provider treating the patient, who is a food handler at the Starbucks location on 1490 Blackwood Clementon Road in Gloucester Township. Health inspectors visited the store and found no signs of food safety violations, but nonetheless made the decision to shut its doors until all workers were vaccinated. The county also held vaccine clinics into the weekend and reportedly vaccinated hundreds of possibly exposed people.

Hepatitis A is one of five major viruses known to cause liver inflammation, or the titular hepatitis. Its symptoms include fever, vomiting, diarrhea, dark-colored urine, and jaundice, and typically appear 28 days after exposure. Hepatitis A usually isn’t life-threatening, nor a potentially chronic infection like hepatitis B and C, though older people are more likely to become seriously sick. The illness it causes usually lasts less than two months, but it can last up to six months for 10% to 15% of sufferers. The virus is highly contagious to boot, especially during the first two weeks following symptoms. It’s usually spread through food and water contaminated with someone’s infected feces, though close and sexual contact can spread it as well.

Because the employee had been working all throughout their most infectious period, it’s possible that thousands of people may have been exposed to the virus, health officials have said. Anyone who visited the store on November 4 through 6, as well as November 11 through 13, are advised to get the hepatitis A vaccine. They should get the vaccine as soon as possible and no later than 14 days after a possible exposure, since it’s unlikely to work after then.

Camden health officials say that those born after 2000 are likely to have gotten vaccinated already, though people or their guardians should check with a doctor to make sure. The hepatitis A vaccine has been recommended for all children after the first year of life in the U.S. since 2006, though only 68% of teens have gotten the full two-dose schedule as of 2017, and some states do not mandate it for entering public school. Both infection and vaccination are thought to confer lifelong immunity to the virus.

Despite being vaccine-preventable, annual cases of hepatitis A have been on the rise in recent years. In 2019, there were nearly 20,000 cases reported in the U.S. This upswing has been fueled by outbreaks among people experiencing homelessness as well as people who use drugs. But earlier this year, a large outbreak tied to a restaurant chain in Virginia sickened at least 50 residents and left three dead.

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FBI, CDC Investigating Vials Labeled ‘Smallpox’ Found in Lab Freezer

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A vial of dried smallpox vaccination is shown December 5, 2002 in Altamonte Springs, Florida.
Image: Scott A. Miller (Getty Images)

A scenario ripe for a zombie-horror movie has just happened. The U.S. Centers for Disease Control and Prevention revealed Tuesday that vials labeled “smallpox”—an extremely deadly virus that was eradicated in the 1970s—were found at a vaccine research facility in Pennsylvania. Despite the scary find, officials say there is no evidence that anyone’s been exposed to the pathogen.

According to the CDC, the frozen vials were found by a lab worker as they were cleaning out a freezer. The vials don’t appear to have been opened, and the worker was wearing gloves and a face mask at the time of the discovery. The facility is one of many that conduct vaccine research for the CDC.

“There is no indication that anyone has been exposed to the small number of frozen vials,” the CDC said in a statement to CNN. “CDC, its Administration partners, and law enforcement are investigating the matter and the vials’ contents appear intact.”

The CDC will transport the vials to another location for testing on Wednesday, Yahoo News reported, citing an alert sent to Department of Homeland Security leadership. According to the DHS alert seen by Yahoo News, there were 15 vials; five were labeled “smallpox” and 10 were labeled “vaccinia.”

Smallpox, named for the characteristic pockmarks it causes on the skin, is one of the more fearsome germs that has plagued humanity. It’s been responsible for countless epidemics and is estimated to have killed 300 million people in the 20th century alone. However, the virus was also the first to be beaten back through vaccination, when the technique of inoculation was improved and popularized by Edward Jenner in the late 18th century. The disease was finally eradicated worldwide in 1977, a feat aided by the fact that humans are the only known natural host of smallpox.

Though smallpox is (probably) gone from the wild, there do remain legally allowed samples of the virus at select labs in the U.S. and Russia—a decision that’s earned a fair share of controversy. In recent years, there have been discoveries of undocumented smallpox, such as when workers at the National Institutes of Health found six vials preserved from the 1950s during a move. Two of these vials were later shown to contain viable virus, though no cases of smallpox occurred as a result.

As scary as an accidental release of smallpox would be, there are smallpox vaccines available, though they’re only given to people who could be at risk of exposure, such as certain lab workers. Today, Americans are no longer routinely vaccinated against smallpox. In 2018, the Food and Drug approved the drug tecovirimat as the first antiviral specifically meant to treat smallpox, based on data from tests in the lab on smallpox and its cousins.

There are occasional cases of other related diseases in the U.S., such as monkeypox and Alaskapox, though none of these are as serious or prevalent as smallpox was in its heyday.

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