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Monkeypox 2022 - Stop Sharing Your DIrty Underwear


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1 hour ago, Pancho said:

This is off topic, but it’s clear you don’t know how HIV meds work, what they do to a person’s system, and then how PReP works with HIV negative individuals. 

 

Carry on with Monkeypox 2022 - The Last of Cornholio 

You would assume wrong. I was a major player in developing Glaxo's HIV franchise. And interestingly a close relative of mine at the Hutch set the US AIDS drug regimen back in the early days. https://www.fredhutch.org/en/news/center-news/2016/06/infectious-disease-pioneer-dr-joel-meyers-honored-inaugural-symposium.html Carry on.

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6 hours ago, trauma babe said:

I wish I could provide any sort of concrete data, and I'm going to edit the phrasing that was much more absolute than I meant for it to be (this is an emotional subject for me). Unfortunately I have no access to any stats in my org. All I know is that we have patients from my clinic who were in contact with people experiencing prodromal symptoms, and then both eventually developed lesions that were confirmed to be positive MP.

What data can you provide? How many cases has your facility treated or seen?

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6 hours ago, Nicole44 said:

This thread is moving more now due to participation so reposting the article I posted a few pages back…

https://www.nature.com/articles/d41586-022-01686-z
 

The United States has over 5,000 cases now since patient zero just a few months ago. What am I missing I guess? Why the spread so much here? 

And we have way fewer monkeys here....

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1 hour ago, Bevo said:

You would assume wrong. I was a major player in developing Glaxo's HIV franchise. And interestingly a close relative of mine at the Hutch set the US AIDS drug regimen back in the early days. https://www.fredhutch.org/en/news/center-news/2016/06/infectious-disease-pioneer-dr-joel-meyers-honored-inaugural-symposium.html Carry on.

This was a lovely article.  It was enjoyable to read with my final glass of Sauvignon for the night (maaayabbbeee?)

However, this article doesn’t address how HIV positive people who are on their medications and who test as “undetectable” have virtually no chance of passing along the virus to HIV negative people and how that percentage is virtually 0% if the person is determined as being “undetectable” and their partner is on PReP.  That’s what I was getting at, meaning your first post about “caution” to a person’s sex life if they have HIV.  If they aren’t on their medications, then fuck yeah, more than caution.  If they are on their meds and seeing their PCP regularly, then saying they should still take caution is a bit uneducated because technically, everyone regardless of status or sexuality should take caution—for reals.

If it’s just a misunderstanding between us both, then no problem—beer is on you come the Alabama game.  

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47 minutes ago, Pancho said:

This was a lovely article.  It was enjoyable to read with my final glass of Sauvignon for the night (maaayabbbeee?)

However, this article doesn’t address how HIV positive people who are on their medications and who test as “undetectable” have virtually no chance of passing along the virus to HIV negative people and how that percentage is virtually 0% if the person is determined as being “undetectable” and their partner is on PReP.  That’s what I was getting at, meaning your first post about “caution” to a person’s sex life if they have HIV.  If they aren’t on their medications, then fuck yeah, more than caution.  If they are on their meds and seeing their PCP regularly, then saying they should still take caution is a bit uneducated because technically, everyone regardless of status or sexuality should take caution—for reals.

If it’s just a misunderstanding between us both, then no problem—beer is on you come the Alabama game.  

**Speaking as a person rather than as a medical professional** If you stay undetectable over a 6 month period, there is virtually no risk of transmission. But, personally, if someone told me that they had HIV or herpes, I wouldn't have sex with them even if I wore a condom or in the case of HIV even if I wore a condom and was taking PReP. Something in me I guess but I would have such anxiety about the encounter that I would worry about it for months. So for me, the juice isn't worth the squeeze. I got lucky the first go-round in college, but I have no desire to go back to my 20s and go bar hopping again. That was a past life.

So here is what I said originally: Personally, I think people should learn from their mistakes. Caution should be the response to sex after HIV, not a return to the person's normal sex life. I'll stick by that. After someone contracts HIV, I would hope that they wouldn't go bar hopping and have multiple sex partners. I would hope that they would learn from their past experience and stick with a single partner. Because HIV isn't the only disease around and PReP may be great at preventing HIV and condoms may be great at preventing HIV and herpes, but neither do much of anything at preventing monkeypox or COVID or whatever else may be going around over the next 50 years.

 

 

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18 minutes ago, Bevo said:

**Speaking as a person rather than as a medical professional** If you stay undetectable over a 6 month period, there is virtually no risk of transmission. But, personally, if someone told me that they had HIV or herpes, I wouldn't have sex with them even if I wore a condom or in the case of HIV even if I wore a condom and was taking PReP. Something in me I guess but I would have such anxiety about the encounter that I would worry about it for months. So for me, the juice isn't worth the squeeze. I got lucky the first go-round in college, but I have no desire to go back to my 20s and go bar hopping again. That was a past life.

So here is what I said originally: Personally, I think people should learn from their mistakes. Caution should be the response to sex after HIV, not a return to the person's normal sex life. I'll stick by that. After someone contracts HIV, I would hope that they wouldn't go bar hopping and have multiple sex partners. I would hope that they would learn from their past experience and stick with a single partner. Because HIV isn't the only disease around and PReP may be great at preventing HIV and condoms may be great at preventing HIV and herpes, but neither do much of anything at preventing monkeypox or COVID or whatever else may be going around over the next 50 years.

 

 

Where's the fun in that?

Before "Karen", there was "Debbie Downer".. 00 00 O 0 De·bbie Dow•ner /'dɛb i 'dau nər/ INFORMAL NORTH AMERICAN noun Someone or something that brings down the positive mood of a situation "I hate to be a Debbie Downer, but there's no more toilet "The novel corona virus has been a Debbie Downer for us all." раper." The term originated as the name of a character on Saturday Night Live in 2004 and is still used today as slang in Pittsburgh, Pennsylvania. Rachel Dratch Debbie Downer Saturday Night Live Photo caption Text

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Monkeypox Is About to Become the Next Public Health Failure

By Scott Gottlieb

Dr. Gottlieb is a former commissioner of the Food and Drug Administration and is a senior fellow at the American Enterprise Institute.

 

When about 100 cases of ‌‌monkeypox had been confirmed or suspected in Europe‌ in May, it was clear the virus was spreading outside the areas where it was previously seen‌‌. Some on social media ‌‌suggested it might already be ‌spreading rapidly in communities in Europe and the ‌United States. These reports should have been a code red for federal infectious disease response.

But it wasn’t until late June that the C‌enters for Disease Control and Prevention expanded testing for monkeypox to large commercial labs like Quest Diagnostics and Labcorp for more capacity and access. The C.D.C. had gone through its standard playbook, ticking through its protracted checklist.

Compared with the agency’s botched rollout of a test for the coronavirus, the monkeypox test came at warp speed. But the virus spread even faster. If ‌American leaders wanted to quash the outbreak, ‌‌the United States should have been testing all people who presented with what was presumed to be atypical cases of diseases like genital herpes and zoster infection; both can cause rashes that sometimes resemble monkeypox. That might have required 15,000 tests a week, by my rough estimate. From mid-May to the end of June, the U‌‌nited States tested only about 2,000 samples.

Our country’s response to monkeypox ‌‌has been plagued by the same shortcomings we had with Covid-19. Now if monkeypox ‌gains a permanent foothold in the U‌nited States and becomes an endemic virus that joins our circulating repertoire of pathogens, it will be one of the worst public health failures in modern times not only because of the pain and peril of the disease but also because it was so avoidable. Our lapses extend beyond political decision making to the agencies tasked with protecting us from these threats. We don’t have a federal infrastructure capable of dealing with these emergencies.

The failures that got us here fit a now familiar pattern.

Early on, similar to the early days of Covid, testing access for monkeypox was limited, despite ample evidence that monkeypox was spreading in the United States. The Strategic National Stockpile was meant as a hedge against viral contingencies, but when the coronavirus struck, it lacked adequate supplies of testing equipment, ventilators and masks. With monkeypox, the government hadn’t stockpiled enough of the only vaccine, Jynneos, that was indicated for prevention of the disease and considered safe for use. The United States had on hand fewer than 2,400 doses in mid-May, mostly as a hedge against the risk of smallpox, which was the vaccine’s other indication.

There are more parallels between our failings ‌‌to combat Covid and monkeypox. Each time, the reflex has been to blame political leadership for poor planning, lack of urgency‌‌ and clumsy execution. It’s true that ‌‌both responses have been plagued by an absence of coordination among federal agencies like the Food and Drug Administration, which I led under the first two years of the Trump administration; the C.D.C.; and the components of the Health and Human Services Department that are responsible for different aspects of response. But systemic failings also rest with the bureaucracy charged with countering these threats.

The C.D.C. should lead America’s response to viral exigencies. But the agency isn’t a crisis organization. It lacks the infrastructure to mobilize a rapid response and is too hidebound and process driven to move quickly. Its cultural instinct is to take a deliberative approach, debating each decision. With Covid, the virus ‌‌gained ground quickly. With ‌‌monkeypox, which spreads more slowly, typically through very close contact, the shortcomings of C.D.C.’s cultural approach haven’t been as acute yet. But the shortfalls are the same.

Take the scant information available about the domestic outbreak and how it has spread. The C.D.C. has publicly complained that it can’t compel sufficient reporting from states and that it lacks insight into the scope and nature of reported monkeypox cases. That’s true. But the C.D.C. still possesses information from states that do share case reports, which the agency could have used to provide a better clinical mosaic on how the virus was spreading and presenting to physicians.

It’s very hard for the agency to self-organize around a new mission in the setting of a crisis or lead an internal effort to reform long‌standing processes. ‌But it has proved equally hard for Congress to take meaningful action to reorganize the agency to make it more robust and quicker to respond. Proper reform would require empowering public health agencies with new tools, funding and authority, but from my conversations with congressional members and their staffs, I believe there’s scant appetite for such a move not just on the political right but on the left as well. After Covid, there’s a view among some that public health agencies used flawed analysis and miscalculated their advice. Securing a political consensus that the C.D.C. needs to be further empowered to complete its mission ‌‌ — for example, invested with the authority to compel reporting from states ‌‌ — is politically unobtainable.

That leaves it up to the Biden administration. But its late stab at reform also falls short. It has effectively created an agency out of an office inside ‌the Department of Health and Human Services that is charged with coordinating the federal response to bioterrorism, among other things. The reordering puts the new Administration for Strategic Preparedness and Response on equal footing with the C.D.C. It’s a classic Washington response to a problem: create an agency around it. The move will only add to the muddle.

The pandemic mission must remain with the C.D.C., which has the requisite tools and expertise to respond to these crises. I know from my time at the F.D.A. that it’s the agencies that have the operational know-how and capabilities. The C.D.C. has the boots on the ground that provide the frontline needs for attacking these kinds of outbreaks, with its sophisticated tools for detection and surveillance. What it lacks is the authority‌ and a national security mind-set.

The Biden administration needs to get the C.D.C. back to its disease control roots, by transferring some of its disease prevention work to other agencies. The F.D.A. can handle smoking cessation, leveraging its regulatory toolbox. The National Institutes of Health can tackle cancer and heart disease. Focus the C.D.C. more on its core mission of outbreak response. And imbue the agency with the national security mind-set that it had at its origins. If the C.D.C.’s mission were more tightly focused on the elements required for handling contagion, Congress might be more willing to invest it with the robust authority to do that targeted mission well. Congress would need to reprogram budget lines to get it done, but someone needs to start that conversation.

Time is running out. Diseases like Zika, Covid‌ and ‌‌monkeypox are a dire warning that dangerous pathogens are on the march. The next one could be worse — a deadly strain of flu or something more sinister like Marburg virus. We’ve now had ample notice that the nation continues to be unprepared and that our vulnerabilities are enormous.

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More than 1,000 new cases worldwide yesterday, a new record. Another case of a kid getting it in California.

Good news is the SF gays are lining up like crazy to get the vaccine. Nearly everyone in the long ass line yesterday got a vax so that’s nearly 2,000 in 2 days.

 

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3 hours ago, Pancho said:

More than 1,000 new cases worldwide yesterday, a new record. Another case of a kid getting it in California.

Good news is the SF gays are lining up like crazy to get the vaccine. Nearly everyone in the long ass line yesterday got a vax so that’s nearly 2,000 in 2 days.

 

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  • immamac changed the title to Monkeypox 2022 - Stop Sharing Your DIrty Underwear

fun post from the austin subreddit

female who might have caught it from a toilet seat?    

 

Quote

Update 2 : Thanks for all the thoughtful words. It helped me just sit rationally and process how not cool that doc experience was. The plan is to call Kind in the AM. Try to follow up with APH and ask my GP what the heck they can do to actually test for stuff if it's not MPX. Y'all take care. 

Update: I saw my regular GP at a Family medical Practice, they didn't know what to do. Held me there for several hours and told me I was highly contagious until I proved I wasn't. APH has my name now (they were put on hold for over an hour with no info given just to leave a message. Told to go to a STD clinic if I don't hear from APH. 

They did not swab for shingles or scabies but did take blood for Herpes Zoster. I still feel like it's so unlikely I caught Monkeypox even if I have a Pokemon situation with my immune system and diseases (gotta catch em all) 

Presentation: Looks like mild Shingles clusters in a few places. 4-5 very angry larger open sores. One part looks a little like poison ivy or scabies row but isn't spreading the same. Mostly looks like weird pimples/ingrown hairs that feel very deep and not boil like or have a indent in center like a lightly off ant bite (but they ain't ant bites). I don't think I have fever but they didn't take it- I have incredible fatigue and pain in body and at sites. 

---////

I'm a CIS female. Have a child. Got very sick this weekend (aches, sore throat- post Covid 1 month), incredibly painful blistering and spreading rash that doesn't present on only one side (like shingles although it looked like shingles on some places). Mostly along right leg, where you'd sit on the toilet, lower back/butt and on left hip/side where I'd pull up my pants. And some places that looked like ingrown hairs but felt different, very electric painful, like a wire being pulled out of them. 

I don't have insurance. Can't see specialist. They tested blood for basic stuff (but kept me quarantine in the room for several hours while they made calls and had 5 people come and look at me and take pictures). Brought me a new fancier mask and gloves, a trash bag for anything I touched, told me not to touch anything and gave me the APH number(that even they couldn't get through) and then told me just to go to a STD clinic (that I also can't get ahold of). They said I have to quarantine me and my child and anyone in contact but I don't know what to tell his father or anyone. The letter just says I have to do that until I can prove I'm not contagious! But doesn't say Monkeypox, scabies, shingles, or anything. 

I'm sick and tired and scared. I have like $280 in my account. 

What can I do?

 

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On 7/31/2022 at 5:43 PM, ONE YARD said:

so dumb questions time

 

isnt the vaccine actually the small pox vaccine which is really nasty? like causes major boil and can spread the live virus to kids causing them to be paralyzed for life?  

 

if that is the case, wouldn’t it be better to let this painful, but temporary and non-lethal disease run it’s corse rather than paralyze a bunch of kids?  

 

again, sorry if this is a dumb question. 

 

edit: i asked my wife who grew up in a third world country that still gives the small pox shot and has the scar.

she was too young to remember, but said it was horrible when they gave it to her little brother

 

really hope we have made upgrades or something 

No.

 

Do you think the CDC would allow a vaccine that causes kids to be paralyzed to be released?  Or more importantly, do you believe vaccines from the 1950s are the exact type of vaccines still used today and no improvements were made?  Just a question, not trying to be a dick. 

 

I think you’re describing the Cutter incidence of the 1950s.  I can assure you, medicine has advanced since then. 

 

Also, you *can* use the smallpox vax for MP, and America has a huge stockpile of that.  America would rather use the actual MP vax though.

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9 minutes ago, Pancho said:

No.

 

Do you think the CDC would allow a vaccine that causes kids to be paralyzed to be released?  Or more importantly, do you believe vaccines from the 1950s are the exact type of vaccines still used today and no improvements were made?  Just a question, not trying to be a dick. 

 

I think you’re describing the Cutter incidence of the 1950s.  I can assure you, medicine has advanced since then. 

 

Also, you *can* use the smallpox vax for MP, and America has a huge stockpile of that.  America would rather use the actual MP vax though.

Just catching up, but I assume either previously having Chicken pox or the chicken pox vaccine doesn't help in any way?

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2 hours ago, JesusSweatDuck said:

Just catching up, but I assume either previously having Chicken pox or the chicken pox vaccine doesn't help in any way?

Correct, chickpox is caused by the varicella-zoster virus. It is a herpes virus, not a Pox virus.

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Bad news first (always, as taught to me by Dr. Daly—I hated the UTC tho):

- US had millions of vaccines ready to go (16 million) in their amazon shopping cart, but they forgot.  By the time they pressed “purchase order” the vax was on back order and now we have to wait months for our shipment. 

 

Good news:

- Global daily cases are going down, albeit only by like 150-200.

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1 hour ago, Pancho said:

- US had millions of vaccines ready to go (16 million) in their amazon shopping cart, but they forgot.  By the time they pressed “purchase order” the vax was on back order and now we have to wait months for our shipment. 

 

It even worse than that in the details. We apparently had millions of doses already paid for sitting in bulk containers, and didn't just ask them to run the final fill and finish into distribution ready form. Once the FDA did their final plant authorizations, and we got around to asking them to do the final fill process, we were stuck in line behind others. So we've already bought it, it is just sitting in big bulk bags in a warehouse in germany. 

https://www.nytimes.com/2022/08/03/us/politics/monkeypox-vaccine-doses-us.html

U.S. Could Have Had Many More Doses of Monkeypox Vaccine This Year

Spoiler

The Department of Health and Human Services delayed asking the manufacturer to process the bulk vaccine the government already owned into vials.

Give this article

Demonstrators in Manhattan protested the U.S. response to monkeypox. The government is scrambling to find a firm that can handle bottling, capping and labeling the vaccine it owns.Credit...Caitlin Ochs for The New York Times

By Sharon LaFraniere, Noah Weiland and Joseph Goldstein

Aug. 3, 2022

Sign Up for On Politics, for Times subscribers only.  A Times reader’s guide to the political news in Washington and across the nation. Get it in your inbox.

WASHINGTON — The shortage of vaccines to combat a fast-growing monkeypox outbreak was caused in part because the Department of Health and Human Services failed early on to ask that bulk stocks of the vaccine it already owned be bottled for distribution, according to multiple administration officials familiar with the matter.

By the time the federal government placed its orders, the vaccine’s Denmark-based manufacturer, Bavarian Nordic, had booked other clients and was unable to do the work for months, officials said — even though the federal government had invested well over $1 billion in the vaccine’s development.

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. 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.

To speed up deliveries, the government is scrambling to find another firm to take over some of the bottling, capping and labeling of frozen bulk vaccine that is being stored in large plastic bags at Bavarian Nordic’s headquarters outside Copenhagen. Because that final manufacturing phase, known as fill and finish, is highly specialized, experts estimate it will take another company at least three months to gear up. Negotiations are ongoing with Grand River Aseptic Manufacturing, a Michigan factory that has helped produce Covid-19 vaccines, to bottle 2.5 million of the doses now on order, hopefully shaving months off the timetable, according to people familiar with the situation.

Health and Human Services officials so miscalculated the need that on May 23, they allowed Bavarian Nordic to deliver about 215,000 fully finished doses that the federal government had already bought to European countries instead of holding them for the United States.

At the time, the nation had only eight confirmed monkeypox cases, agency officials said. And it could not have used those doses immediately because the Food and Drug Administration had not yet certified the plant where the vaccine, Jynneos, was poured into vials.

But it could now. Some states are trying to stretch out doses by giving recipients only one shot of the two-dose vaccine. California, Illinois and New York have declared public health emergencies. In New York City, every available slot for a monkeypox shot is taken.

Lawrence O. Gostin, a former adviser to the Centers for Disease Control and Prevention who has consulted with the White House about monkeypox, said the government’s response has been hobbled by “the same kinds of bureaucratic delays and forgetfulness and dropping the ball that we did during the Covid pandemic.”

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The obstacles to filling and finishing vials follow other missteps that have limited vaccine supply. The United States once had some 20 million doses in a national stockpile but failed to replenish them as they expired, letting the supply dwindle to almost nothing. It had 372,000 doses ready to go in Denmark but waited weeks after the first case was identified in mid-May before requesting the delivery of most of those doses. Another roughly 786,000 doses were held up by an F.D.A. inspection of the manufacturer’s new fill-and-finish plant but have now been shipped.

The government also owns the equivalent of about 16.5 million doses of bulk vaccine produced and stored by Bavarian Nordic. But by the time the health agency ordered 500,000 doses worth to be vialed on June 10, other countries with outbreaks had submitted their own orders and the earliest delivery date was October.

Another order for 110,000 doses for European nations soon followed. When the United States came back with two more orders of 2.5 million doses each on July 1 and July 15, the bulk could only be delivered next year.

Image

Xavier Becerra, who oversees both the C.D.C. and the Food and Drug Administration, has been under attack for months for what critics describe as his hands-off approach to public health crises.Credit...Pete Marovich for The New York Times

Mr. Gostin, who now directs the O’Neill Institute for National and Global Health Law at Georgetown University, predicted that President Biden’s decision to appoint two new monkeypox response coordinators would help “light a fire” under federal health agencies. The White House announced Tuesday that Robert Fenton, an administrator at the Federal Emergency Management Agency, and Dr. Demetre Daskalakis, a C.D.C. official, will lead the response.

Mr. Gostin said the nation’s public health agencies have been “kind of asleep at the wheel on this,” and the new coordinators should help with “unblocking all of the obstacles to procuring and delivering vaccines and drugs, which has been deeply frustrating.”

Two senior federal officials, who requested anonymity in order to speak frankly, said Mr. Biden is upset by the vaccine shortage. His administration has often touted its success delivering hundreds of millions of coronavirus shots to Americans, and is stung by criticism that a lack of foresight and management has left gay men — the prime risk group for monkeypox — unprotected.

Some critics blame a failure of leadership at the Health and Human Services Department, saying the department’s secretary, Xavier Becerra, has taken a hands-off approach to an increasingly serious situation. His department not only oversees both the C.D.C. and the Food and Drug Administration, but also runs the Biomedical Advanced Research and Development Authority, or BARDA, which helps develop and buys vaccines, tests and treatments to protect against highly contagious viruses, bioterrorism and other hazards.

During a press call on monkeypox last week, Mr. Becerra said his department is doing all it can to ensure that “we not only stay ahead of this virus but that we end this outbreak.” He noted that he had recently elevated the agency’s Office of Strategic Preparedness and Response so it can respond more quickly to public health emergencies.

Sarah Lovenheim, the department’s chief spokeswoman, said in a statement: “Our response has accelerated to meet evolving needs on the ground, and it will keep accelerating. We will use every lever possible to continue allocating doses ahead of timelines, as possible.”

So far, according to the C.D.C., 6,326 cases of monkeypox have been reported. For now, the virus is spreading almost entirely among gay and bisexual men, and those with multiple or anonymous partners are considered especially at risk. Mr. Becerra noted that while more than a million Americans have died of Covid-19, no one in the United States has died of monkeypox.

The official case count is widely considered an underestimate. Not only is testing limited, but public health officials like Dr. Joseph Kanter, the top medical official in Louisiana, said that monkeypox can be hard to diagnose. “It can be one or two solitary lesions, so if it’s not on a clinician’s radar,” he said, it can be missed.

With too few doses, health officials apparently plan to rely heavily on the “test and trace” strategy that figured heavily in the early stages of the Covid pandemic. As the pandemic escalated, the sheer torrent of cases overwhelmed the ability of health officials to contact people who might have been infected by someone who had tested positive for the coronavirus. Once Covid vaccines became available, they became the cornerstone of the administration’s pandemic response.

Image

Working on a monkeypox vaccine at a laboratory near Munich on Tuesday.Credit...Lukas Barth/Reuters

Through early June, Health and Human Services officials appeared firmly convinced that the United States had more than enough supply of the monkeypox vaccine, called Jynneos, to handle what appeared to be a handful of cases.

Bavarian Nordic was able to develop the vaccine, which also works against smallpox, largely thanks to the federal government’s backing, which surpassed $1 billion in 2014 and is now edging toward $2 billion. Dawn O’Connell, the federal health agency’s assistant secretary for preparedness and response, told reporters in early June: “The world has Jynneos because we invested in it.”

The company opened a new $75 million fill-and-finish plant in 2021 that is now bottling as many as 200,000 to 300,000 doses a week. At the time, the United States was counting on Jynneos to protect against smallpox, not monkeypox, and the government had a large stockpile of another effective smallpox vaccine. No F.D.A. inspection was scheduled until after the monkeypox outbreak, and it did not conclude until July 27.

In early June, Health and Human Services officials agreed to essentially loan back about 215,000 finished doses of vaccine to Bavarian Nordic so the firm could supply them to European countries that were suffering outbreaks.

“It didn’t make sense while we were waiting for F.D.A. to get the inspection done — which is coming — that we sit on doses that our international colleagues in Europe could actually use,” Ms. O’Connell said on June 10. Now the government is trying to reschedule delivery of those doses for later this year, a company spokesman said.

The final stage of putting the liquid vaccine into vials accounts for a substantial share of the cost of vaccine production. Some federal officials say the health department was slow to submit its orders for that work because officials at BARDA argued they were short on funds.

When the demand for vaccines became an outcry, though, the agency found the money to pay for five million more doses to be vialed. Officials are now contemplating shifting half the work to another firm that may be able to finish and fill doses more than twice as fast.

Some experts say it can take as long as six to nine months for a plant to gear up to handle a vaccine like Jynneos, which contains a live virus in a weakened state. Carlo de Notaristefani, who oversaw coronavirus vaccine manufacturing for the federal government until last year, said that such factories must operate at a high “biological safety level,” including a fully enclosed, segregated manufacturing line.

But he and other experts said it should be possible to streamline the transfer of Bavarian Nordic’s process so another plant could be ready in about three months. A company spokesperson said Bavarian Nordic agreed to pay $10 million of the cost of such a transfer after federal officials said they did not have the budget for it.

 

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https://www.taipeitimes.com/News/taiwan/archives/2022/08/09/2003783223

 

Quote

Zoonotic Langya virus found in China, CDC says
UNDER WATCH: Taiwan will have to establish a standardized nucleic acid testing method to identify the virus and monitor its spread, the CDC said

The Langya henipavirus, which can be transmitted from animals to humans, has been discovered in China, with 35 human infections reported so far, Taiwan’s Centers for Disease Control (CDC) said, adding that the nation would establish a nucleic acid testing method to identify the virus.

A study titled “A Zoonotic Henipavirus in Febrile Patients in China” that was published in the New England Journal of Medicine on Thursday said that a new henipavirus associated with a fever-causing human illness was identified in China.

The study said an investigation identified 35 patients with acute infection of the Langya henipavirus in China’s Shandong and Henan provinces, and that 26 of them were infected with the Langya virus only, with no other pathogens.

The 26 patients developed symptoms including fever (100 percent), fatigue (54 percent), a cough (50 percent), loss of appetite (50 percent), muscle pain (46 percent), nausea (38 percent), headache (35 percent) and vomiting (35 percent).

They also showed a decrease in white blood cells (54 percent), low platelet count (35 percent), liver failure (35 percent) and kidney failure (8 percent).

When asked for confirmation, CDC Deputy Director-General Chuang Jen-hsiang (莊人祥) on Sunday that said according to the study, human-to-human transmission of the virus has not been reported, and that a serological survey of domestic animals found 2 percent of the tested goats and 5 percent of the tested dogs were positive.

Test results from 25 wild animal species suggest that the shrew might be a natural reservoir of the Langya henipavirus, as the virus was found in 27 percent of the shrew subjects, he said.

Chuang said the 35 patients in China did not have close contact with each other or a common exposure history, and contact tracing showed no viral transmission among close contacts and family, suggesting that human infections might be sporadic.

However, as the CDC has yet to determine whether the virus can be transmitted among humans, people need to pay close attention to further updates about the virus, he said.

As the Langya virus is a newly detected virus, Taiwan’s laboratories will need to establish a standardized nucleic acid testing method to identify the virus, so that human infections could be monitored, if needed, Chuang added.

 

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