POST 254. June 2, 2022. MONKEYPOX, “Massachusetts General Hospital this week began vaccinating a small group of workers against monkeypox — the first time the new medicine has been used in this country outside of clinical trials. The workers were in close contact with a man diagnosed with the virus and hospitalized at Mass General from May 12 to May 20. The patient was the first person in the United States to be tied to an ongoing outbreak of the rare virus in Europe and North America.”

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“An unusual wave of monkeypox cases in non-endemic regions has raised the possibility of another global health crisis even as COVID-19 persists. But two groups of biopharma experts argue monkeypox likely won’t escalate into another pandemic that humans struggle to contain.

The reason? While COVID was caused by a novel coronavirus, the world already has vaccines and therapeutics against the monkeypox virus, Berenberg analyst Zhiqiang Shu, Ph.D., and GlobalData analyst Emily Martyn said in their separate analyses.

Existing countermeasures suggest “the potential spreading can be effectively halted without implementing draconian containment measures that may hurt the global economy,” Shu wrote in a note on Monday.

As of Saturday, the World Health Organization has recorded 92 lab-confirmed monkeypox cases and 28 suspected cases in non-endemic regions across U.S., Canada, Australia and several countries in Europe. In those territories, at least two vaccines and two antivirals have been approved against monkeypox or its close relative smallpox, which was declared eradicated in 1980.

Bavarian Nordic has a live attenuated vaccine, called Jynneos in the U.S., for both smallpox and monkeypox. The vaccine carries the brand name Imvanex in Europe. Emergent BioSolutions developed smallpox shot ACAM2000. Though not commercially available, the two shots are included in the U.S. government’s strategic stockpile.

A smallpox vaccine could also protect against monkeypox because of the similarities between the two viruses, according to the CDC. Past data from Africa suggests that a smallpox vaccine can be at least 85% effective in preventing monkeypox, the CDC says.

As for whether mRNA vaccine technology could be adopted against monkeypox, Shu said it remains to be seen whether an mRNA shot can encode for a large protein that the virus uses to enter a human cell. The tech made a major debut during COVID, leading to vaccines that saved many lives…

“Additionally, national and international health services can utilize their existing COVID-19 systems to work together to address and control this issue quickly and effectively,” Martyn said.” (A)

“Experts believe the current monkeypox outbreak is being spread through close, intimate skin on skin contact with someone who has an active rash. That should make its spread easier to contain once infections are identified, experts said.

“COVID is spread by respiratory route and is highly infectious. This doesn’t appear to be the case with the monkeypox,” said Dr. Martin Hirsch of Massachusetts General Hospital.

“What seems to be happening now is that it has got into the population as a sexual form, as a genital form, and is being spread as are sexually transmitted infections, which has amplified its transmission around the world,” WHO official David Heymann, an infectious disease specialist, told Reuters.

The recent outbreaks reported so far are atypical, according to the WHO, as they are occurring in countries where the virus does not regularly circulate. Scientists are seeking to understand the origin of the current cases and whether anything about the virus has changed.

Most of the cases reported so far have been detected in the UK, Spain and Portugal. There have also been cases in Canada and Australia, and a single case of monkeypox was confirmed in Boston, with public health officials saying more cases are likely to turn up in the United States.

WHO officials have expressed concern that more infections could arise as people gather for festivals, parties and holidays during the coming summer months in Europe and elsewhere.

The UK has begun to inoculate healthcare workers who may be at risk while caring for patients with the smallpox vaccine, which can also protect against monkeypox. The U.S. government says it has enough smallpox vaccine stored in its Strategic National Stockpile (SNS) to vaccinate the entire U.S. population.

There are antiviral drugs for smallpox that could also be used to treat monkeypox under certain circumstances, a spokesperson for the U.S. Department of Health and Human Services said in a statement.” (B)

The World Health Organization is now counting more than 550 monkeypox cases worldwide, the group’s technical lead for monkeypox, Rosamund Lewis, said Tuesday on CNN International.

“We actually have today a count of over 550 confirmed cases in 30 countries across four of WHO’s six regions,” Lewis said.

“What we’re seeing now is really quite different,” she said, given that the outbreak is happening in multiple places at once.

“We’re seeing cases all appearing in a relatively short period of time. We’re seeing that in a few days, in a couple of weeks, we’re seeing over 500 cases. This is different. This has not been seen before.”

In an update over the weekend, WHO said that as of Thursday, it had received reports of 257 confirmed monkeypox cases and about 120 suspected cases in 23 nations where the virus is not endemic.

Lewis said WHO does not know the source of the outbreak and called on countries to take advantage of the “window of opportunity” to keep cases from unfolding into a greater outbreak.

The group said in its weekend briefing that the global public health risk level is moderate, “considering this is the first time that monkeypox cases and clusters are reported concurrently in widely disparate WHO geographical areas, and without known epidemiological links to non-endemic countries in West or Central Africa.”

However, it added, “The public health risk could become high if this virus exploits the opportunity to establish itself as a human pathogen and spreads to groups at higher risk of severe disease such as young children and immunosuppressed persons.”

WHO is urging health care providers to watch closely for possible symptoms such as rash, fever, swollen lymph nodes, headache, back pain, muscle aches and fatigue, and to offer testing to anyone who has these symptoms.

During a news briefing Monday, Lewis said “we are not concerned of a global pandemic” from monkeypox at the moment.” (C)

“”We are concerned that individuals may acquire this infection through high-risk exposure if they don’t have the information they need to protect themselves,” Lewis said, “and we are concerned that because the global population is not immune to orthopoxviruses since the end of smallpox eradication, that the virus may attempt to exploit a niche and spread more easily between people. But we don’t have the answer to this question yet.”

Both smallpox and monkeypox belong to the same genus of virus, known as orthopoxvirus. Monkeypox is found in wild animals, and people who contract the virus can experience a fever, headache, body aches, fatigue and swollen lymph nodes. After a few days, those ill with virus will develop a rash of raised blisters. It can spread from person to person through close personal contact.

Several U.S. states have started to vaccinate at-risk residents against the virus, which has infected at least 435 people around the world since the beginning of May. Spain and the United Kingdom have most of the infections.

Historically, Lewis said, monkeypox “does not transmit so easily between persons,” which is what’s prompted officials to think it will not develop into a pandemic like COVID-19. The monkeypox virus, she explained, mutates “much more slowly.”

“We don’t have a lot of information on what the genomes of the viruses being detected in this multi-country outbreak are really telling us yet, that is already discussion that is happening in circles of virologists working together and looking at these things.”

According to Reuters, the WHO is considering whether to designate monkeypox as a “potential public health emergency of international concern,” which would accelerate research and funding to contain it.” (D)

“In a public session on Monday, WHO’s Dr. Rosamund Lewis said it was critical to emphasize that the vast majority of cases being seen in dozens of countries globally are in gay, bisexual or men who have sex with men, so that scientists can further study the issue. She urged those at risk to be careful.

“It’s very important to describe this because it appears to be an increase in a mode of transmission that may have been under-recognized in the past,” said Lewis.

“At the moment, we are not concerned about a global pandemic,” she said. “We are concerned that individuals may acquire this infection through high-risk exposure if they don’t have the information they need to protect themselves.”

She warned that anyone is at potential risk for the disease, regardless of their sexual orientation. Other experts have pointed out that it may be accidental that the disease was first picked up in gay and bisexual men, saying it could quickly spill over into other groups if it is not curbed.” (E)

“Lewis said it’s unknown whether monkeypox is being transmitted by sex or just the close contact between people engaging in sexual activity and described the threat to the general population as “low.” Monkeypox is known to spread when there is close physical contact with an infected person or their clothing or bedsheets.

She also warned that among the current cases, there is a higher proportion of people with fewer lesions that are more concentrated in the genital region and sometimes nearly impossible to see.” (F)

““Collectively, the world has an opportunity to stop this outbreak. There is a window,” Lewis said.

Alongside the U.S. Centers for Disease Control and Prevention and the U.K.’s National Health Service, the WHO has outlined a number of ways people can protect themselves against the virus, including practicing good hygiene and safe sex.

Once a suspected case has been identified, they should be isolated until their lesions have crusted and scabs fallen off, and contact tracing should be initiated. Contacts of infected patients should be monitored for the onset of symptoms for a period of 21 days and should not donate blood, cells, tissue, organs, breast milk or semen while under symptom surveillance, the WHO said.

“Any one case should be manageable through contact tracing and isolation,” Lewis added.”” (G)

“When has the U.S. seen monkeypox before?

In 2003 the United States saw 47 confirmed and probable cases of monkeypox across six states, according to the Centers for Disease Control and Prevention. (CDC) Those who developed monkeypox contracted it after having contact with prairie dogs that were being sold as pets.

The 2003 outbreak in the U.S. was the first time human monkeypox was reported outside of the African continent. There were no deaths and no reported human-to-human transmission.

“We think monkeypox lives in small rodents of various kinds. There’s an international trade in exotic pets and some of these small rodents were imported into the U.S., where there are people who sell exotic pets,” said Dr. William Schaffner, professor of preventive medicine in the Department of Health Policy as well as professor of medicine in the Division of Infectious Diseases at the Vanderbilt University School of Medicine. “Rodents from Africa had close contact with prairie dogs, which were also being sold as pets. Those prairie dogs gave it to some people in the U.S.”.

How was monkeypox contained the last time?

There were several factors that contributed to the containment of monkeypox in 2003. The U.S. Department of Agriculture, the U.S. Food and Drug Administration, and the public health departments across the states joined forces for a response that included lab testing, epidemiological investigation, and a treatment guideline for those with the disease.

The efforts also resulted in deployment of smallpox vaccines and treatments, as well as the embargo and banning of importation of certain species of rodents into the United States.

How will this current outbreak be contained?

Unlike the previous outbreak, which was spread from animal to human, this outbreak is spreading from human to human, which is why it is a little more complicated to contain the spread.

Fortunately, monkeypox is often a mild infection in most people, and goes away within a few weeks. That said, monkeypox does respond to certain vaccines, which can be used to control the outbreaks. Smallpox vaccines have been shown to be effective in preventing monkeypox, as well as treating it if administered very quickly after exposure.

Even though the world eradicated smallpox in 1980, many countries do keep stocks of the vaccine in the case of emergencies. The smallpox vaccine can be up to 85 percent effective in stopping monkeypox infection.

“Some of the previous interventions are not relevant, but we will still need a concerted effort on the part of the CDC, local health departments, and healthcare providers in order to recognize any new cases and implement measures for containment of spread,” said Dr. Brandi Manning, an infectious diseases physician at The Ohio State University Wexner Medical Center.

Schaffner said to use a vaccine effectively, public health officials could make sure people exposed to monkeypox get access to the vaccine.

“I think the average person should be interested in this fascinating story. It shows public health very much at work and reinforces again that we are in a very small world. You can’t put up walls to keep these sorts of viruses out. We need to keep our strength in the public health structure,” Schaffner added. “We thought we were beyond all of these infections, and we are not. We have to build up and maintain our public health structure.”” (H)

As more than a dozen countries grapple with outbreaks of monkeypox, health officials worldwide are rushing to assess reserves of vaccines and treatments that may be needed to contain the spread.

The U.S. emergency stockpile holds two vaccines approved by the Food and Drug Administration that could be used to contain monkeypox, officials at the Centers for Disease Control and Prevention told reporters on Monday.

The stockpile contains more than 100 million doses of the original smallpox vaccine. But that vaccine is associated with side effects and shouldn’t be given to certain patients, including those who are immuno-compromised.

A newer vaccine, called Jynneos, was approved in 2019 for prevention of both smallpox and monkeypox. More than 1,000 doses are held in the stockpile, Dr. Jennifer McQuiston, a deputy director at the C.D.C., said.

“We expect that level to ramp up very quickly in the coming weeks, as the company provides more doses to us,” she said. Doses have already been requested from the stockpile for inoculation of some high-risk contacts, she added.

Still, the dimensions of the problem in the United States are not yet clear. As of Monday, officials had confirmed just one case, in Massachusetts, and were evaluating four other patients.

The situation overseas is more concerning. As of Monday, there were more than 100 confirmed cases in 14 countries outside Africa, and dozens more under investigation. That day, the European Center for Disease Prevention and Control urged health officials in Europe to assess the availability of smallpox vaccines, antivirals and personal protective equipment.

The World Health Organization is holding stockpiles of about 31 million smallpox vaccine doses, but they may have lost some potency in the decades since they were made…

President Biden warned on Sunday that “everybody should be concerned,” but added the next day that the United States had enough doses of vaccine to protect Americans. In any event, mass immunization campaigns are unlikely in any country, including the United States, several experts said. And the outbreaks are unlikely to warrant such a campaign.

Instead, officials may recommend immunizing a circle of close contacts around those found to be infected — an approach called ring vaccination that has been used to suppress other outbreaks of rare diseases.

Mass immunization campaigns are not recommended because the older smallpox vaccine can have rare but severe side effects, such as inflammation of the heart muscle. That vaccine also may be risky for immuno-suppressed people, including those with undetected H.I.V. infection. It can be fatal even in people with eczema, which affects an estimated 30 percent of Americans…

Newer generation vaccines like Jynneos are likely to be safer for large groups, and ring vaccination may be enough to contain the virus. “Hopefully, presumably, monkeypox is still relatively rare right now, and a ring vaccination strategy may well be able to keep it completely at bay,” Dr. Hanage said.

In addition to vaccines for prevention, the United States has procured more than two million doses of an antiviral pill called tecovirimat, which is approved to treat smallpox in those who become infected, according to the C.D.C. The agency is also working with the drug’s manufacturer to develop an intravenous form…

Should I be worried? The likelihood of the virus being spread during sexual contact is high, but the risk of transmission in other ways is low. Most people have mild symptoms and recover within weeks, but the virus can be fatal in a small percentage of cases. Studies also suggest that older adults may have some protection from decades-old smallpox vaccinations.

Is monkeypox similar to Covid? Health experts say that monkeypox is unlikely to create a pandemic scenario similar to that of the coronavirus. While Covid-19 is a tiny RNA virus that can spread through aerosols, monkeybox is a larger DNA virus that is transmitted mostly through close physical contact and has a much smaller mutation rate than RNA viruses.” (I)

“Massachusetts General Hospital this week began vaccinating a small group of workers against monkeypox — the first time the new medicine has been used in this country outside of clinical trials.

The workers were in close contact with a man diagnosed with the virus and hospitalized at Mass General from May 12 to May 20. The patient was the first person in the United States to be tied to an ongoing outbreak of the rare virus in Europe and North America…

At Mass General, teams of specialists have been working long hours tracking down each person believed to have been in contact with the patient to determine whether they may have been exposed to infection and, if so, their level of risk. That includes everyone from doctors and nurses to those who may have briefly delivered a meal tray just inside the door.

“This certainly felt novel because this was the first time we were able to use [the monkeypox vaccine] in response to an outbreak,” said Dr. Paul Biddinger, chief preparedness and continuity officer for Mass General Brigham.

MGH workers received the JYNNEOS vaccine, developed by Danish company Bavarian Nordic and approved in the US in 2019.

Dr. Brett Petersen, deputy chief of the CDC’s Poxvirus branch, confirmed in a statement that the Mass General initiative was pioneering.

“We can confirm this is the first one of JYNNEOS outside of clinical trials in the U.S,” Petersen said…

“We have no rigorous studies in humans and little real world experience,” Petersen said.

“However, JYNNEOS induced a rapid, robust antibody response in clinical trials and limited animal studies suggest it is effective as post-exposure prophylaxis as well,” he said.

In general, the sooner the vaccine is administered after an exposure, the higher likelihood of success, Petersen said.

“The effect of … timing in relation to exposure is something we are interested in following and learning more about to inform optimal use of this vaccine,” he said

A CDC official earlier this week said as many as 200 people may have come in contact with the MGH patient, but said the vast majority of them were health care workers.

That meant calls and long discussions with each worker to determine exposure, and then a second conversation for anyone offered the vaccine about its benefits and risks.

“It’s been quite labor intensive,” Biddinger said.

“It took a huge number of people working all last week and through the weekend to make sure we could deliver the vaccines to those who wanted it and needed it,” he said.

Monkeypox is transmitted through close skin-to-skin contact that involves bodily fluids, or indirect contact, such as contaminated bedding materials, with fluid from the lesions the virus produces. It can also be transmitted through respiratory droplets when a patient has lesions in the mouth.

Biddinger said officials separated the pool of workers thought to be exposed into three groups: those believed to have very low exposure, those with intermediate risk, and those at high risk. The pool also included anyone who may have been exposed but who does not work at Mass General, such as visitors to the room the patient was in before he was isolated, Biddinger said.

Fewer than 10 people were in the high risk category, and less than 50 in the intermediate pool, he said. Ultimately some who were offered the shots declined, and, to date, fewer than 10 have been vaccinated, Biddinger said…

“It has been a real, real-time learning effort,” he said.” (J)

• A.Monkeypox outbreak won’t be the next global pandemic thanks to vaccines, drugs: analysts, By Angus LiuMay, https://www.fiercepharma.com/pharma/monkeypox-outbreak-wont-be-next-covid-19-thanks-vaccines-drugs-analysts
• B.WHO expects more cases of monkeypox to emerge globally, Explainer-How Concerned Should We Be About Monkeypox?, By Michael Erman, https://www.usnews.com/news/world/articles/2022-05-21/explainer-how-concerned-should-we-be-about-monkeypox
• C.More than 550 monkeypox cases have been reported in 30 countries, WHO official says, By Virginia Langmaid, Arnaud Siad and Emmet Lyons, https://www.cnn.com/2022/05/31/health/monkeypox-update-who/index.html
• D.World Health Organization says it’s “not concerned” about monkeypox becoming pandemic, BY LI COHEN, https://www.cbsnews.com/news/monkeypox-world-health-organization-pandemic-not-concerned/
• E.WHO: Monkeypox won’t turn into pandemic, but many unknowns, By MARIA CHENG, https://apnews.com/article/covid-health-pandemics-world-organization-smallpox-260f127f54016fca402e88f8bdb3ace3
• F.Monkeypox won’t turn into pandemic, WHO says, By Associated Press, https://www.nbcnews.com/news/world/monkeypox-wont-turn-pandemic-says-rcna31108
• G.WHO can’t rule out monkeypox pandemic risk, says there’s a window of opportunity to stop outbreak, by Karen Gilchrist, https://www.cnbc.com/2022/05/30/monkeypox-who-says-there-is-a-window-of-opportunity-to-limit-outbreak.html
• H.How Officials Stopped a Monkeypox Outbreak Nearly 20 Years Ago, https://www.healthline.com/health-news/how-officials-stopped-a-monkeypox-outbreak-nearly-20-years-ago
• I.As Monkeypox Cases Rise, Nations Are Urged to Examine Vaccine Stores, By Apoorva Mandavilli, https://www.nytimes.com/2022/05/23/health/monkeypox-vaccines.html?referringSource=articleShare
• J.MGH vaccinating workers against monkeypox, the first time the shots have been used in the US, By Kay Lazar, https://www.bostonglobe.com/2022/05/26/metro/mgh-vaccinating-workers-against-monkeypox-first-time-shots-have-been-used-us/
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