Health

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Monkeypox: New deal will increase supplies of much-needed vaccine amid global shortages

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The sole supplier of the world’s monkeypox vaccine has struck a deal with an American manufacturer to increase supplies of the much-needed shot.

Bavarian Nordic, a small Danish company, will hand over the production of millions of vaccines to Grand River Aseptic Manufacturing (GRAM), a Michigan-based biotechnology company that makes injectable drugs.

Two weeks after the White House declared monkeypox a national health emergency, the Biden administration announced on 18 August GRAM will fill and finish 2.5 million doses of the vaccine.

The Department of Health and Human Services said the deal will allow Bavarian Nordic to speed up delivery of the 5.5 million vials the US has ordered to try to tackle rising case numbers.

“This announcement, which is the result of extensive coordination between [the Biomedical Advance Research and Development Authority], Bavarian Nordic, and GRAM, will help bolster our current monkeypox response and enhance our smallpox preparedness,” said assistant secretary for Preparedness and Response Dawn O’Connell.

“We look forward to continuing to work with our partners to ensure successful production ramp up and ultimately delivery of additional vaccine doses to those in need sooner.”

Sharing the complex technology needed to make the vaccine with GRAM has already begun, with officials hoping this can be achieved in three months – rather than the standard nine to allow for production by the end of this year.

In this photograph, doctor checks on a patient with monkeypox sores
A doctor checks on a patient with monkeypox sores. (ERNESTO BENAVIDES/AFP via Getty Images)

Bavarian Nordic’s jab – known as Imvanex in Europe, Jynneos in the US and Imvamune in Canada – remains the only widely available vaccine approved by drug regulators in the US and Europe.

Health authorities don’t have many other options. Other drugs have dangerous side effects, while the rollout of Japan’s LC16 KMB has been slowed down by production issues.

There are around 16 million vaccine doses of Jynneos available right now globally, according to World Health Organisation estimates.

Most of the doses are in their bulk form, meaning they have to be taken out of their frozen bags, and put into vials in a months-long process known as a “fill and finish”.

Monkeypox vaccines not reaching Africa

Nearly all ready-to-go vaccines have been snapped up by wealthy nations, however, leaving middle and low-income countries with next to none.

Africa, where the virus has been endemic for years, hasn’t received a single vaccine since the outbreak began in May.

Exacerbating the monkeypox vaccine shortage even further, Bavarian Nordic closed down a key bulk manufacturing facility in Spring to funnel resources into other vaccines.

The assembly isn’t expected to re-open until later this year at the earliest – even then, no doses are expected to leave the production plant until early 2023.

At least 41,000 people have been infected with monkeypox, according to theCenters for Disease Control and Infection.

But Bavarian Nordic has resisted calls from campaigners to make the vaccine public. Patent laws mean other drug-makers cannot help manufacture the jab themselves, forcing the world to solely rely on Bavarian Nordic’s facilities.

Global Justice Now, a social justice group, told PinkNews that the deal sounds better on paper than it is in practice.

“This deal is an admission that medicines monopolies don’t work, but it doesn’t go anywhere near far enough to tackle the global monkeypox outbreak,” said Global Justice Now pharmaceutical campaigner Tim Bierley.

“These doses to be ‘filled and finished’ have been entirely bought up by the US, which means that, as things stand, this deal does nothing to protect people anywhere else in the world.

“Given the continent of Africa has seen more monkeypox deaths than anywhere else, this looks like just another case of one country hoarding all the vaccines and leaving the rest of the world to ransom.

“But countries in the global south cannot, and should not, have to rely on the ‘charity’ of firms and countries in the global north to be able to get their hands on these medicines.”

Bierley said the solution to unequal vaccine access is a simple one – Bavarian Nordic must share its vaccine know-how.

“Just as we saw with COVID-19, this slow and deeply unequal vaccine roll-out shows the urgent need to transform a pharmaceutical system that rewards the hoarding of scientific knowledge with enormous profits, rather than collective effort to save lives.”

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Boston Children’s Hospital warns employees over far-right online harassment campaign

Boston Children’s Hospital has warned employees about mounting threats and is coordinating with law enforcement after far-right activists on social media began targeting the hospital with false claims about its treatment of young transgender people.

It’s the most recent in a series of attempts to target hospitals for their work with trans youth, adding to an ongoing wave of anti-LGBTQ sentiment that has hit libraries, schools and even a trans-inclusive Los Angeles spa.

The public relations office of Boston Children’s Hospital sent an email to employees with guidance on how to respond to harassment and threats earlier this week, citing an “increase of threatening and aggressive” phone calls and emails sent to the hospital commenting on treatment of transgender patients.” The email was confirmed to NBC News by a current employee. 

Boston Children’s Hospital first became the target of activists in recent weeks, when well-followed social media accounts such as LibsofTikTok, which has often promoted “groomer” discourse that falsely linked LGBTQ teachers and parents to pedophilia, began to make a variety of false claims. One allegation said that the hospital offered gender-affirming hysterectomies to children under 18 years old. 

Conservative influencers with millions of followers pushed similar false talking points and fanned the flames further. David J Harris, a podcaster and supplement seller, and single-issue activists including Chris Elston, who goes by “Billboard Chris” for the anti-trans statements he wears on sandwich boards, are among the right-wing social media stars  who have spread the allegations online.  

Last week, fact-checking organizations debunked the claims from right-wing accounts, but many of the same accounts continued to spread the false allegations this week. 

“In response to commentary last week critical of our Gender Multispecialty Service (GeMS) Program, Boston Children’s Hospital has been the target of a large volume of hostile internet activity, phone calls, and harassing emails including threats of violence toward our clinicians and staff,” Boston Children’s Hospital said in an emailed statement. “We are deeply concerned by these attacks on our clinicians and staff fueled by misinformation and a lack of understanding and respect for our transgender community.”

“Boston Children’s is proud to be home to the first pediatric and adolescent transgender health program in the United States,” the statement added.

Videos from the YouTube account of Boston Children’s Hospital in which several physicians discuss services provided to trans patients were shared by the accounts to suggest the Center for Gender Surgery was performing genital surgeries on children. The videos, which have since been removed from the hospital’s channel, included one titled, “What Does It Mean To Be Transgender?” and did not suggest such surgeries were provided to minors. 

Boston Children’s Hospital houses the Gender Multispecialty Service, the nation’s first pediatric and adolescent transgender health program, which has treated more than 1,000 families, according to its website. Despite the separate Center for Gender Surgery being within Boston Childrens’ Hospital, treatment is only provided to “eligible adolescents and young adults,” according to the center’s website. “All genital surgeries are only performed on patients age 18 and older,” the site reads. 

A representative for Twitter said they were looking into the harassment campaign. 

Boston Children’s Hospital said in its statement that the online attention “was based on the incorrect statement that Boston Children’s performs genital surgeries on minors in connection with transgender care. For hysterectomies and other genital surgeries performed as part of gender-affirming care, Boston Children’s requires a patient to be capable of consenting for themselves. Age 18 is used to reflect the standard age of majority for medical decision-making. Boston Children’s does not perform genital surgeries as part of gender-affirming care on a patient under the age of 18.”

Nevertheless, the posts demonizing Boston Children’s Hospital quickly spread through the far-right media ecosystem, promoted by right-wing media personalities including The Daily Wire’s Matt Walsh and conservative websites like The Post Millennial and The Daily Caller. 

Anti-trans activists also targeted the individual doctors who appeared in the YouTube videos from Boston Children’s Hospital, leaving vulgar and harassing comments on their social media accounts and flooding their online pages with negative reviews. Some hospital staff have since made their social media profiles private.

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This isn’t the first time that far-right activists have targeted doctors and medical institutions — or even Boston Children’s Hospital. 

Lee Leveille, co-director of Health Liberation Now, a trans rights advocacy group that investigates the effects of policy on trans health, said the hospital was also a target in May 2021 for providing gender-affirming care amid a similar wave of targeted harassment on medical facilities. 

“The original organized network that jump started the clinic protests has been slowing down a bit and is more decentralized,” Leveille said over email. “Local pockets will still operate here and there, but they’re less connected to a central organized push than the original ones. Now we’re seeing new faces rallying the cause — including the likes of Matt Walsh and Libs of TikTok.”

In June, Chaya Raichik, the Brooklyn real estate agent behind the Twitter account LibsofTikTok tweeted about a children’s hospital in Omaha, Nebraska, for hosting an informational booth at a Pride event. Earlier this month, Raichik and right-wing activist Christopher Rufo targeted a children’s hospital in Pittsburgh for its informational video about puberty blockers. The tweets directed waves of harassment to the hospitals’ larger accounts. 

Under a tweet from the Pittsburgh hospital about children with cancer, commenters’ replies included, “Pedophiles,” and “We will destroy you.” 

The targeting of children’s hospitals is just the most recent in a spate of online abuse aimed at institutions that promote pro-LGBT ideas and events. 

“They’ve received just an absolute torrent of abuse, oftentimes, with real, in-person, consequences,” said Alejandra Caraballo, a clinical instructor at the Harvard Law School Cyberlaw Clinic and LGBTQ+ advocate. 

Caraballo cited recent anti-LGBT arson attacks in Baltimore and Brooklyn, widespread threats against organizers of Pride events and Drag Queen Story Hours, and instances where far-right hate groups showed up to protest and were arrested for incitement of violence. 

“We’ve already had months and months of this reinforcing propaganda, that LGBTQ people are groomers, that they’re pedophiles, that they are threats to children,” she said. “It’s very disturbing to see people justify attacking a children’s hospital because of their transphobia and their hatred of trans people.” 

Leveille and Ky Schevers, the other co-director of Health Liberation Now, said they feared violence could come next, targeting doctors, patients and medical facilities that provide gender-affirming care. 

Boston Children’s Hospital said it was working with law enforcement to ensure the safety of its staff.

“We condemn these attacks in the strongest possible terms, and we reject the false narrative upon which they are based,” the hospital said in its statement. “We are working with law enforcement to protect our clinicians, staff, patients, families, and the broader Boston Children’s community and hold the offenders accountable. We will continue to take all appropriate measures to protect our people.”

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New White House monkeypox strategy targets Pride events

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The White House will announce today it is zeroing in on the population most at risk currently of contracting and spreading the monkeypox virus: men who have sex with men. A pilot program rolls out this weekend at Charlotte Pride.

The Biden administration’s deputy director for monkeypox response, Dr. Demetre Daskalakis, described the new effort to LGBTQ Nation ahead of the White House announcement.

That starts with bumping up the supply of the vaccine for local health jurisdictions where large LGBTQ events are happening. The program sets aside 50,000 doses of vaccine from the Strategic National Stockpile that jurisdictions can request on top of their existing vaccine allocations and supply.

The Administration is working with North Carolina, Georgia, and Louisiana health departments to determine dose numbers in preparation for upcoming events including Charlotte Pride this weekend, and Atlanta Black Pride and Southern Decadence in New Orleans over Labor Day weekend.

At Charlotte Pride, Daskalakis says, “we’re going to be providing them 2000 additional doses on top of what they’re already allocated specifically for this event.”

State and local health departments are responsible for getting vaccines to where they’ll be administered.

To get doses in arms, “Charlotte is looking at specific events associated with Pride that are going to include, in effect, what will look like vaccine pop-ups, where people entering the event or going to the event will be able to acquire a vaccine.”

The second part of the pilot focuses on education and outreach, along with in-person technical assistance.

“With public health being really local, we’re going to make sure that we provide them what they need in terms of education, outreach materials and any technical assistance to be able to work on the ground to make sure that we’re providing folks with culturally appropriate information about how to prevent monkeypox, and also awareness of the disease.”

“Part of that package is definitely really clear advice around safer sex and safer gatherings. To make sure that it’s extraordinarily clear, given what we know about the data, that this is affecting gay, bisexual and other men who have sex with men, and that a lot of the transmission has been in the context of sex and sexual activity.”

The pilot also provides guidance to local jurisdictions to develop testing strategies and tools for information-gathering from event participants.

Two weeks ago, New York and California were among several states to declare monkeypox a public health emergency.

CDC data as of August 16 indicates 12,689 total confirmed monkeypox cases in the U.S., with New York, California, Texas, Florida, Georgia, and Illinois topping the list of highest infection rates.

Seven-day averages show the number of daily reported infections skyrocketed from 45 in the week ending July 11, to 528 the week ending August 10, when 1391 cases were reported on a single day.

Federal officials have allocated 1.1 million doses of the Jynneos vaccine to states and say they’ve shipped about 600,000 of those.

Clark Simon, president of Charlotte Pride, welcomed the administration’s new initiative: “The more vaccines the better.”

But with a caveat.

“I know health departments need to state where this specific virus is predominantly being seen, the pronouncement of it. But just to clarify, in terms of language and messaging, this is not an STI [sexually transmitted infection]. It is not a gay disease. It is a community-spread disease. And in this instance, showcases itself predominantly in men who have sex with men. But we’re also seeing instances in which there are children getting it at daycares and things like that. Much like COVID, it’s about community spread.”

Daskalakis was sensitive to the messaging.

“Monkeypox is a virus, it’s not a sentient being,” Daskalakis said. “It doesn’t differentiate between people based on sexual orientation or gender identity. And so making sure that we’re serving the folks who are in populations that are overrepresented in the outbreak, like gay and bisexual men, and men who have sex with men, is really important, while also making sure that there’s an awareness outside. Infections don’t heed orders, they don’t heed sexual networks or social networks. So being vigilant, making sure surveillance is really good, and that providers are tuned in is the most important thing right now.”

Atlanta Black Pride president Terence Stewart, next in line for the pilot program, added to Simon’s pandemic analogy.

“It is like COVID. We didn’t think it would either hit the shores of the United States or would be coming in as fast as it was. Because you want to vaccinate as many people as possible, but you also don’t want to scare people, right? So it’s a lot going on.”

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LGBTQ+ charities and Truvada-maker Gilead launch $5 million monkeypox fund

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Leading LGBTQ+ charities including GLAAD, and pharma company Gilead have teamed up to support responses to the monkeypox outbreak.

The coalition, which also includes the Human Rights Campaign, the National Black Justice Coalition, the National Center for Lesbian Rights, and the National Minority AIDS Council, was announced on 9 August.

Gilead, which makes PrEP pills Truvada and Descovy, has pledged up to $5 million in global grant funding to support a public education and vaccine hesitancy campaign, a public policy response and a global outbreak emergency fund.

The fund will issue grants of up to $50,000 to pre-existing Giliead grantee organisations that work in regions that have the highest active monkeypox outbreaks.

“Funds may be used to cover expenses such as community mobilisation activities specifically addressing MPV outbreak in communities disproportionately impacted by HIV, operating costs related to HIV testing and service interruptions and essential safety materials,” said GLAAD.

Charities such as GLAAD and HRC will focus on providing critical information about monkeypox to demographics and regions that are being significantly affected by the outbreaks, predominantly gay and bisexual man, and those living with HIV.

“As we saw with HIV, COVID-19, and now [monkeypox], disinformation continues to challenge the LGBTQ+ community,” GLAAD president and CEO Sarah Kate Ellis said.

“This new collaboration will enable creating and distributing content and resources to help our community know the facts and to understand prevention and treatment.

“When communities receive accurate, timely information, they are empowered to take appropriate action, leading to long-lasting, positive health outcomes.”

Giliead executive vice president of corporate affairs and general counsel Deborah Telman said the collaboration would ensure that the “immediate needs of impacted communities” were met, while steering groups away from disinformation which can lead to further spread of the disease.

In an interview with Reuters, spokesperson Rich Ferraro said that “with this partnership, we’ll be able to do more.”

There are currently a total of 31,800 confirmed monkeypox cases around the globe, according to regularly updated statistics from the Centers for Disease Control and Provention (CDC), with 31,425 of those coming from countries that have not historically reported monkeypox.

Because the disease has been found to disproportionately affect gay and bisexual men, there is a fear the outbreak could lead to homophobic stigma.

In America, far-right Republican Marjorie Taylor Greene has become notorious for spreading misinformation on the subject, saying that the disease is a “scam”.

“It’s not a threat to most of the population, and so it’s not a global pandemic, it’s really not, and people just have to laugh at it, mock it, and reject it. It’s another scam,” she said.

The CDC has said that research is still determining whether monkeypox can spread through “semen, vaginal fluids, urine, or faeces” and has only currently determined that it can spread through skin-to-skin contact, which can happen during “intimate contact.”

After the World Health Organization declared the growing outbreak a global health emergency, experts emphasised that anyone can get monkeypox and warned against reinforcing “homophobic and racist stereotypes and exacerbating stigma”.

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New 988 Suicide Lifeline seeks to meet LGBTQ community’s unique needs

LGBTQI+ individuals are more likely than their counterparts to exhibit suicidal behavior. According to data reported by the Centers for Disease Control and Prevention, in 2019, nearly half of students identifying as gay, lesbian or bisexual reported seriously considered suicide. These students experienced a near fourfold increase in suicide attempts compared with heterosexual students. LGBTQI+ adults are also at greater risk of suicide. According to the Substance Use and Mental Health Services Administration’s (SAMHSA) 2020 National Survey on Drug Use and Health, 15.9 percent of LGB respondents ages 26 to 49 reported serious suicidal thoughts within the past year, and 2.1 percent reported a suicide attempt.

The experiences of stigmatization, rejection, trauma, victimization, microaggressions, homophobia and transphobia all contribute to this elevated risk. Conversely, support and connection between LGBTQI+ youth and their family or caregiver, peers, school and community, can promote better mental health, fewer negative outcomes and stronger resilience. The federal government, along with public and private sector partners, plays an important role toward building this affirming support and connection.  

On July 16, SAMHSA led the nationwide transition to 988 as the easy-to-remember number to reach the 988 Suicide & Crisis Lifeline — an important step forward to strengthen and transform crisis care in our country. 

Historically there have been notable gaps in accessing needed care for suicidal, mental health and substance use concerns with marginalized groups often facing additional barriers and inequitable outcomes. 

SAMHSA is committed to enhancing access to crisis services for LGBTQI+ youth, including through the 988 Suicide and Crisis Lifeline, and has outlined a number of critical activities. These include enhanced training, service linkage to specialized care and creation and testing of direct chat portals and interactive voice response menu options. 

In addition, research shows the training and expertise of the counselors who respond to crisis contacts matters. A recent survey of 12- to 25-year-old callers conducted by the Trevor Project revealed that nearly half indicated they called specifically because of LGBT-affirming counselors.

Recent federal appropriations direct $7.2 million to provide specialized services for LGBTQ youth within the 988 Lifeline. SAMHSA has been working closely with its partners to do so. Given both youth preferences for digital tools like text and chat and the particular needs of LGBTQI+ youth, such enhancements in access are critically important strategies to promote engagement. 

The implementation of 988 and expanding access to affirming support for struggling LGBTQI+ youth is a critical first step in saving lives, decreasing stigma and linking those in need to compassionate and effective care. If you or someone you know may be struggling with suicidal thoughts, call or text 988 or chat at 988lifeline.org  

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If monkeypox spreads through sexual contact, is it an STD?

For most of the six decades that monkeypox has been known to affect people, it was not known as a disease that spreads through sex. Now that has changed.

The current outbreak is by far the biggest involving the virus, and it’s been designated a global emergency. So far, officials say, all evidence indicates that the disease has spread mainly through networks of men who have sex with men.

“It clearly is spreading as an STI (sexually transmitted infection) at this point,” said Dr. Tom Inglesby, director of the Johns Hopkins Center for Health Security.

WHO declares monkeypox a global health emergency as cases skyrocket

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To protect the people at highest risk while trying to contain the spread, public health agencies are focusing their attention on those men — and attacking the virus based on how it’s behaving now.

On Wednesday, the head of the World Health Organization advised men at risk for monkeypox to consider reducing their sexual partners “for the moment.”

But this is a complicated outbreak that may shift in how it spreads and which population groups are most affected. There is also debate about whether monkeypox should be called a sexually transmitted disease, with some critics complaining that the term creates a stigma and could be used to vilify gay and bisexual men.

Monkeypox can spread in nonsexual ways too, and it’s not enough to use condoms or other typical measures for stopping STDs, Inglesby and other experts say.

Here’s what we know.

What makes something an STD? 

A sexually transmitted disease is commonly defined as one that mainly spreads through sexual contact. But some STDs can be spread in other ways, too. HIV can spread through shared needles. Syphilis can spread through kissing. A common, parasite-caused sexual infection called trichomoniasis has been found to spread through the sharing of damp, moist objects like sponges or towels.

Monkeypox has not usually spread easily among people, and experts are still trying to understand exactly how it moves from person to person. In Africa, where small outbreaks have been common for years, people have been infected through bites from rodents or small animals.

But in May, cases began emerging in Europe, the United States and elsewhere that showed a clear pattern of infection through intimate contact with an infected person, like many other sexually transmitted diseases.

The public health workers who respond to outbreaks play a large role how they are framed. Much of the work on monkeypox has been done by professionals who operate sexual health clinics or specialize in STDs.

Indeed, the U.S. government’s response needs to be led by people with that expertise, said David C. Harvey, executive director of the National Coalition of STD Directors.

“The STD field has a wealth of knowledge and expertise in these areas developed over decades fighting various outbreaks and diseases affecting the very communities … we’re seeing monkeypox taking a toll on today,” Harvey said in a statement.

Who is getting monkeypox? 

WHO officials said last week that 99% of all the monkeypox cases beyond Africa were in men and that of those, 98% involved men who have sex with men. Experts suspect that monkeypox outbreaks in Europe and North America were ignited by sex at two raves in Belgium and Spain.

The statistics are the same for cases reported in the United States, according to the Centers for Disease Control and Prevention. As in Europe, cases have emerged in other groups too, including at least 13 people who were female at birth and at least two children.

CDC confirms two monkeypox cases in children in the U.S.

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Last week, the New England Journal of Medicine published a study of hundreds of monkeypox infections in 16 countries. It found that the suspected means of transmission in 95% of the cases was sexual close contact, as reported by doctors. The researchers noted that it was impossible to confirm sexual transmission.

That idea seemed to be further supported by the finding that most of the men had lesions in the genital or anal areas or in the mouth — areas of sexual contact, the researchers said.

Why is there a debate about calling it an STD? 

While there is broad agreement among health officials that monkeypox is being transmitted during sexual encounters, some experts debate whether it should be called an STD. They worry that the term unfairly stigmatizes and that it could undermine efforts to identify infections and tame the outbreak.

When a disease is defined as a sexually transmitted infection that mainly affects men who have sex with men, many people may begin to think of it as “a gay disease” that poses no risk to them, said Jason Farley, an epidemiologist at the Johns Hopkins School of Nursing.

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That’s what happened in the early days of the AIDS epidemic in the 1980s, which contributed to the spread of HIV to other groups. Farley said.

“We learn nothing from our history,” said Farley, who is gay.

The WHO recommendation that at-risk men limit their sexual partners is sensible public health advice, he said. But it also amplifies “the message that this is a gay disease,” he said.

“This is the fine line between having a public health approach that focuses on the epidemiology of now, compared to the likelihood of the continued emergence of new cases in” the general community, he said.

“Monkeypox is not a sexually transmitted infection,” he said. “It is an infection that can be transmitted with sexual contact.”

What is known about transmission? 

Some researchers have found evidence of the monkeypox virus in semen. A study in Spain found monkeypox virus DNA in the semen of some infected men, as well as in saliva and other body fluids. But the study didn’t answer whether the virus actually has spread through semen.

Sorting that out could affect the understanding of not only how men spread the infection, but also how long they might be contagious. Evidence of some other viruses — like Ebola and Zika — has been found in the semen of some men months after they were thought to be fully recovered.

Monkeypox now a public health emergency: How to stay safe

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Meanwhile, scientists believe the primary route of transmission during the current outbreak has been skin-to-skin contact during sexual encounters with someone who has symptoms. In that respect, it’s similar to herpes, some experts noted.

The virus also may spread through saliva and respiratory droplets during prolonged, face-to-face contact, such as during kissing and cuddling — a kind of spread that can occur outside of sex.

Researchers are exploring how often, and in what situations, that kind of spread might happen, said Christopher Mores, a professor of global health at George Washington University.

“We would do ourselves a disservice to try and exclude anything from the realm of possibility at this point,” he said.

Officials also say people can catch monkeypox from touching items that previously touched an infected person’s rash or body fluids, such as towels or bedsheets. That is thought to explain the infections of the U.S. children.

Why are these details important? 

It’s important to understand exactly how monkeypox spreads in order to give people the information they need to protect themselves, health officials say.

That said, health officials believe those who are currently at the highest risk are gay or bisexual men who have sex with multiple partners. That understanding has shaped much of the work to contain the outbreak, including prioritization of the supply of vaccines and treatments.

Demand for monkeypox vaccines rises as cases spread

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The government has been shipping a monkeypox vaccine, but the supply is limited. So far it’s only been recommended as a post-exposure treatment or for people who have had multiple sex partners in the past two weeks in a place where monkeypox cases have been reported.

The vaccine is new, and officials are trying to gather data on exactly how well it works.

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Monkeypox outbreak in the U.K. may be peaking, health officials say

British health authorities said Friday the monkeypox outbreak across the country may be peaking and that the epidemic’s growth rate has slowed.

The U.K.’s Health Security Agency said in a statement there were “early signs that the outbreak is plateauing,” with 2,859 cases detected since May. No deaths have been reported. Last month, authorities estimated the outbreak was doubling in size about every two weeks, but the number of new infections has dropped in recent weeks.

“While the most recent data suggest the growth of the outbreak has slowed, we cannot be complacent,” said Dr. Meera Chand, Director of Clinical and Emerging Infections at the Health Security Agency. She said anyone who thought they might have monkeypox should skip meeting friends, social gatherings and avoid sexual contact.

The Health Security Agency said its most recent analysis of the outbreak “shows that monkeypox continues to be transmitted primarily in interconnected sexual networks of gay, bisexual, or men who have sex with other men.” More than 70% of the U.K.’s cases are in London.

British officials noted a small number of infections among women, but said there was not enough evidence to suggest there was sustained spread of monkeypox beyond gay and bisexual men; 99% of all cases in the U.K. are in men.

Scientists who analyzed monkeypox viruses in the U.K. noted a number of mutations compared to viruses circulating in Africa, but said there was no evidence those genetic changes made monkeypox any more transmissible.

Experts suspect the monkeypox outbreaks in North America and Europe may have originated in Africa long before the disease started spreading via sex at two raves in Spain and Belgium.

The World Health Organization said this week that 92% of monkeypox cases beyond Africa were likely infected through sex and its Director-General recently appealed to vulnerable gay and bisexual men to consider reducing their sexual partners “for the moment.”

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To date, more than 26,000 monkeypox cases have been reported in nearly 90 countries, with a 19% increase in the last week.

In June, British authorities expanded their vaccination strategy, offering vaccines not only to health workers treating monkeypox patients and high-risk contacts of patients, but to some men who are gay or bisexual and at high risk of catching the virus, including those with multiple sexual partners or who participate in group sex.

Last month, the U.K. downgraded its assessment of the monkeypox outbreak and dropped a recommendation for the contacts of monkeypox cases to isolate for three weeks unless they have symptoms. The change was prompted by data showing that only a small number of contacts are ultimately sickened by monkeypox and a lack of evidence that the disease spreads without close, intimate or sexual contact.

On Thursday, the U.S. declared its outbreak of monkeypox to be a national emergency, WHO designated it a global emergency last month.

Monkeypox spreads when people have close, physical contact with an infected person’s lesions, their clothing or bedsheets. Most people recover without needing treatment, but the lesions can be extremely painful and more severe cases can result in complications including encephalitis and death.

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Biden administration shifts monkeypox vaccine approach amid shortage

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The Biden administration, amid criticism it was slow to act on the monkeypox outbreak and still not meeting the demand for vaccines as the number of cases continues to grow, has announced a shift in guidance for implementation of the shot in an effort to enhance availability.

As the estimated number of monkeypox cases in the United States reaches 8,900, top health officials announced the new move on Tuesday as part of a decision by Secretary of Health & Human Services Xavier Becerra to issue a determination under Section 564 of the Federal Food, Drug and Cosmetic Act to justify emergency use authorization of vaccines. The announcement follows up on the Biden administration’s announcement last week declaring the monkeypox outbreak a public health emergency.

Becerra said in a conference call with reporters the 564 determination and change in approach to vaccines would “boost and strengthen” the Biden administration’s response to monkeypox, which has overwhelmingly affected gay and bisexual men, and “safely accelerates and multiplies our supply of effective vaccines by up to fivefold.”

“Today’s action also reaffirms HHS and this administration’s commitment to using all available resources and capabilities to end the monkeypox outbreak and provide the best possible care to those suffering from the virus,” Becerra added.

The new vaccine approach, which may may be considered minor to non-medical observers, would change injections of the JYNNEOS vaccine from the subcutaneous route (delivery of the vaccine under the fat layer underneath the skin) to the intradermal route (delivery of the vaccine into the layer of skin just underneath the top layer). In theory, that would allow for greater accessibility of monkeypox vaccines as it increases the number of doses from each vial of vaccine.

The change was made amid criticism the Biden administration failed to meet the demand for vaccines during the outbreak and geographic inequity as certain metropolitan areas of the country have more access to vaccines than other places.

As The New York Times reported last week, the Biden administration has faced criticism for not moving quickly enough in acquiring and distributing vaccines, including bulk stocks already owned by the U.S. government manufactured in Denmark by Bavaria Nordic now being given to other clients.

“The government is now distributing about 1.1 million doses, less than a third of the 3.5 million that health officials now estimate are needed to fight the outbreak,” the Times reported. “It does not expect the next delivery, of half a million doses, until October. Most of the other 5.5 million doses the United States has ordered are not scheduled to be delivered until next year, according to the federal health agency.”

Biden officials, nonetheless, touted the numbers of vaccines and tests in response to monkeypox as a positive, acknowledging the 1.1 million vaccines being made available as well as delivery of more than 620,000 of those doses, deployment more than 15,000 courses of the monkeypox treatment and increasing the country’s capacity to administer tests on a weekly basis to around 80,000. Meanwhile, officials also promoted the change in approach in vaccines as means to allow greater accessibility to the shots.

Rochelle Walensky, director of the Centers for Disease Control & Prevention, promoted during the conference call the use of intradermal injections and said they’re “often used for TB skin tests and have been used for other types of vaccines.”

Although Walensky conceded some health care providers “may not be as familiar with intradermal administration” as they are with subcutaneous injection, she said CDC would make additional guidance materials available, including a clinician alert message to the Association of State & Territorial Health Officials, outreach to key clinician partners and an education resource video. The change in guidance, Walensky said, is for vaccine implementation in adults and children — where single digit monkeypox cases have been reported — would continue to receive vaccination in the traditional subcutaneous approach.

But health experts aren’t responding with overwhelming praise to the decision to change the guidance on vaccine implementation from subcutaneous injections to intradermal injections, expressing concerns the new approach may be insufficient.

Jennifer Kates, director of global health & HIV policy at the Kaiser Family Foundation, was among those saying the change in guidance on vaccine approach was a mixed bag and told the Blade more data is needed to emulate the effectiveness.

“As we saw with COVID, using these authorities in the context of public health emergencies is an important strategy,” Kates said. “In this case, this step will significantly expand access to vaccines for those most at risk. However, there remain questions about the effectiveness of this approach — real world studies are needed — and challenges to translating vaccines into vaccinations.”

Peter Marks, director of the Center for Biologics Evaluation & Research (CBER) at the Food & Drug Administration, was asked during the conference call with reporters to respond to concerns the change in guidance was insufficient and downplayed the novelty of implementing the vaccines through the intradermal route as “not at all new.”

“In fact, the reason why the Bavaria part of this equation comes from the fact that in Germany, this vaccine was given intradermally originally, in an effort to replicate the original version of the smallpox vaccine,” Marks said. “It’s been given to thousands of people intradermally, so this isn’t the first time it’s been done.”

Walkensky said the intradermal vaccine approach has been implemented amid policies among localities to implement a one-dose approach to the JYNNEOS vaccine through the subcutaneous route. (The D.C. government is one of the jurisdictions that had enacted a one-dose approach amid a vaccine shortage.) There is not data, Walkensky said, to support that approach and “in fact, if anything, there are data saying that that is not protective enough.”

“So by using this alternative strategy of intradermal dosing, not only do we have more doses, but we actually allow people to get two doses in a way that shows immunologic response that’s superimposable from the subcutaneous dosing,” Walkensky said. “So we have more doses, and in fact, we have the ability to doubly vaccinate people so that they get the protection that they need.”

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Monkeypox vaccine: Australia secures 450,000 doses as EU struggles to roll out jab

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The Australian government is to import 450,000 monkeypox vaccine doses to help tackle a rise in cases.

Health minister Mark Butler told reporters on Thursday (4 August) the government had negotiated at least 450,000 doses of the third-generation Bavarian-Nordic vaccine to be prioritised for specific at-risk groups including gay and bisexual men.

The government began negotiating vaccine distribution on 20 May, according to Butler, just one day after the first confirmed case in Australia.

At the current time of reporting, the US Centers for Disease Control and Prevention (CDC) estimates that at least 53 cases of the disease have been reported in Australia

While cases may seem low right now, Butler assured the public numbers had “increased quite quickly” around the world, with countries like the US currently seeing cases reach more than 6,000, and more than 4,000 in Spain.

While Australia has secured 450,000 doses, other countries are struggling to roll out the vaccine.
The EU has purchased just 163,000 vaccines through its central Health Emergency Preparedness and Response Authority (HERA). France has purchased 250,000, with the UK having purchased just over 100,000.

On Friday (5 August) LGBTQ+ representatives from all major UK political parties urged the government to start taking monkeypox more seriously.

Australia declared monkeypox a “communicable disease incident of national significance” on 28 July, just days after the World Health Organisation declared it a global health emergency.

Butler said that the first 100,000 doses are expected to reach Australia over the remaining months of 2022, with 22,000 arriving this and next week. The remaining 350,000 will be distributed in 2023.

He said the vaccine was “by far the most effective and user-friendly for patients with compromised immunity” and could also be administered in vulnerable groups such as pregnant women, children, and those with pre-existing conditions.

“I’m very pleased with the work the chief medical officer and the department have been able to do in a short period of time, particularly to secure the supply of vaccines in a highly contested global market,” he continued.

Patient receives a dose of the monkeypox vaccine at a pop-up vaccination clinic

Patient receives a dose of the monkeypox vaccine at a pop-up vaccination clinic. (Mario Tama/Getty)He also warned against “stigma and discrimination” after several misinformed pundits had suggested monkeypox was a “gay disease” and is only sexually transmitted. The CDC reports researchers arestill determining whether the disease can transmit sexually and have not referred to it as an STI.

UK Health Security Agency (UKHSA) epidemiologist Mateo Prochazka toldPinkNews in May that the “discourse around this infection is going to become more prevalent and intersect with discourses that are homophobic”.

“Gay and bisexual men usually have larger numbers of sex partners and are more likely to have anonymous sexual partners as well,” he said, “and this can lead to direct contact that may not be seen in other sexual networks with the same frequency”.

“It might be that the pathogen has now entered those networks and is being spread that way. It does not mean that gay or bisexual men are doing anything inherently wrong, or that the virus has changed or that it’s sexually transmitted, it just means that this behaviour facilitates transmission in these networks.”

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Moderna May Create mRNA-Based Monkeypox Vax

ABC News reports:

Amid growing concerns over the potential threat of monkeypox, executives from Moderna said Wednesday they have initiated a research program to consider whether the company could create a monkeypox vaccine with mRNA technology. “We’re obviously very aware of the monkeypox concern and obviously very sensitive to recent announcements,” Moderna President Stephen Hoge said during an investor call.

“Our platform is pretty well established and our ability to rapidly scale has been demonstrated. If we were to go after a monkeypox clinical development program, it would be to very quickly progress toward an approvable set of endpoints in a clinical study,” he explained. As seen with the rollout for the COVID-19 vaccines, any new vaccine would still need to go through the regulatory authorization process, which can take weeks to months, even in special circumstances.

CNBC reports:

CDC Director Rochelle Walensky told reporters on a call Thursday that gay and bisexual men who are HIV positive or who are taking medicines, called PREP, to reduce their chance of contracting HIV face the greatest health risk from monkeypox.

“That’s the population we have been most focused on in terms of vaccination,” Walensky said.

The U.S. has secured 1.1 million doses of the two-dose vaccine Jynneos so far, according to the Health and Human Services Department. The federal government has delivered more than 600,000 doses of the vaccine since May, according to HHS.

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