America’s New Monkeypox Strategy Rests on a Single Study
August 11, 2022 10:31 PM Subscribe
Will splitting monkeypox vaccines in five work out? And yet the FDA has charged ahead “completely based on” that 2015 study, says Alexandra Yonts, a pediatric infectious-disease physician at Children’s National Hospital. In a statement, the agency explained that it had “determined that the known and potential benefits of Jynneos outweigh the known and potential risks” for green-lighting the intradermal route.
Delivering vaccines into skin leaves little room for error. The tuberculosis skin test is also administered intradermally; Marrazzo has seen “dozens of those messed up.” People have bled or been bruised. Needles have gone too deep—a mistake that can slash effectiveness—or too shallow, letting liquid ooze back out. Intradermal injections are an uncommon and difficult procedure, requiring additional training and specialized needles. “There is going to be some degree of error,” says Kenneth Cruz, a community-health worker in New York. “People are going to wonder if they’re protected, and it’s going to be difficult to check.”
I know someone who can't take intramuscular vaccinations. He has to do either inhaled, or intradermal. He also can't put on a mask, unaided. He's really been salty about Covid-19.
posted by Spike Glee at 6:29 AM on August 12, 2022
posted by Spike Glee at 6:29 AM on August 12, 2022
Maybe someone with better experience with this than me can explain but during Covid I was tasked to help get a relatively unheard of testing company that just so happened to have Swine flu tests (that could and did easily transfer to Covid tests), up and running for the huge influx in orders.
The problem wasn't manufacturing, or at least that's not what I was told, nor was it lack of money or desire. It was at least this company and I assume most just didn't know how to scale rapidly. They spent an inordinate amount of time getting complex, large accounting and supply chain management systems like Oracle up and running from zero to transforming the entire company on it at once. Since money was not an object at all, they just kept throwing more and more people onto the project which is the death of all software projects. Furthermore they wanted custom tracking software and they wanted it to work on a variety of devices, etc.
My suggestion, and this was oversimplified, was to keep their existing system and hire people to do the tracking and sorting manually. It would mean basically ramping up a bunch of people on pretty well defined tasks, which is easy to do, a lot of rote manual entry but not having to account for every exception as the human middleman can usually figure out how to deal with exceptions.
Was it the most cost effective way of doing it? No, but I think it would have been as expensive if not cheaper to do it that way. The problem was that upper management and all the consultants weren't use to thinking this way. And there's a certain momentum in organizations when you get really big consultants and companies like Oracle involved there's no stopping that ball rolling. These people only knew how to do big 5-8 year engagements so accelerating that timeline into 6 months was just basically throw people on it, take the 5-8 year timeline and just shrink every deliverable date by 100%. I look at how WWII production ramped up quickly and I'm sure there was huge waste but it meant you tanks rolling off assembly lines quickly.
Point being I'm seeing the same thing with Monkeypox, someone really needs to step in and just start directing these things.
posted by geoff. at 7:03 AM on August 12, 2022 [3 favorites]
The problem wasn't manufacturing, or at least that's not what I was told, nor was it lack of money or desire. It was at least this company and I assume most just didn't know how to scale rapidly. They spent an inordinate amount of time getting complex, large accounting and supply chain management systems like Oracle up and running from zero to transforming the entire company on it at once. Since money was not an object at all, they just kept throwing more and more people onto the project which is the death of all software projects. Furthermore they wanted custom tracking software and they wanted it to work on a variety of devices, etc.
My suggestion, and this was oversimplified, was to keep their existing system and hire people to do the tracking and sorting manually. It would mean basically ramping up a bunch of people on pretty well defined tasks, which is easy to do, a lot of rote manual entry but not having to account for every exception as the human middleman can usually figure out how to deal with exceptions.
Was it the most cost effective way of doing it? No, but I think it would have been as expensive if not cheaper to do it that way. The problem was that upper management and all the consultants weren't use to thinking this way. And there's a certain momentum in organizations when you get really big consultants and companies like Oracle involved there's no stopping that ball rolling. These people only knew how to do big 5-8 year engagements so accelerating that timeline into 6 months was just basically throw people on it, take the 5-8 year timeline and just shrink every deliverable date by 100%. I look at how WWII production ramped up quickly and I'm sure there was huge waste but it meant you tanks rolling off assembly lines quickly.
Point being I'm seeing the same thing with Monkeypox, someone really needs to step in and just start directing these things.
posted by geoff. at 7:03 AM on August 12, 2022 [3 favorites]
So in theory America had this amazing stockpile of medicine in case of a smallpox terrorist attack affecting millions of people. Instead when we really need the vaccine we find we only have enough for about 300,000 people. And some unknown quantity of a treatment medication that no one can seem to actually use. Getting either Jynneos or TPOXX is incredibly difficult because the bureaucracy has failed to make it available. And now we're going to go with some risky, poorly tested plan to thin out the vaccine and hope for the best. That may be the best option. It's still fucked.
I've been kind of hoping for a monkeypox post here because as a gay man it's been A Lot. But I just don't have the patience or energy to talk about it all; at this point I need to just talk to other gay people who grew up with AIDS who understand what it's like right now. As one friend said, the contrast between the current stigmatized monkeypox experience and the common, unified, generalised experience of shared Covid is upsetting.
A friend of mine who's an AIDS activist has Monkeypox. It's been absolutely terrible. He published a document about his experience (CW: photos of skin lesions). This link isn't related to the vaccine mess other than being the same disease, but it's remarkable enough I want to share it.
posted by Nelson at 7:20 AM on August 12, 2022 [18 favorites]
I've been kind of hoping for a monkeypox post here because as a gay man it's been A Lot. But I just don't have the patience or energy to talk about it all; at this point I need to just talk to other gay people who grew up with AIDS who understand what it's like right now. As one friend said, the contrast between the current stigmatized monkeypox experience and the common, unified, generalised experience of shared Covid is upsetting.
A friend of mine who's an AIDS activist has Monkeypox. It's been absolutely terrible. He published a document about his experience (CW: photos of skin lesions). This link isn't related to the vaccine mess other than being the same disease, but it's remarkable enough I want to share it.
posted by Nelson at 7:20 AM on August 12, 2022 [18 favorites]
The idea that the US government would embrace an approach that it's not even clear works well, in order to be able to say we've vaccinated more people, completely checks out with the experience of the past two and a half years. Unfortunately, the high-level public health infrastructure of this country has been basically commandeered to serve foremost as a PR organ. It doesn't matter how many people suffer as long as the numbers can be made to look okay.
posted by dusty potato at 7:32 AM on August 12, 2022 [5 favorites]
posted by dusty potato at 7:32 AM on August 12, 2022 [5 favorites]
Yeah, don’t get me started. The sub-standard Russian war effort in Ukraine has been widely sneered at and attributed to corruption hollowing out the defense infrastructure in the RF. But, this just shows that US preparedness (for a potential attack vector no less) is similarly lacking, sacrificed for tax cuts, privatization, slashing of regulations and oversight, and so on - corruption, in other words.
posted by sudogeek at 7:59 AM on August 12, 2022 [3 favorites]
posted by sudogeek at 7:59 AM on August 12, 2022 [3 favorites]
I'm surprised that the intradermal route, like the tuberculosis PPD test, is considered sufficiently more specialized and difficult that it's an issue. I'm not questioning the doctors making this argument; clearly they know more about it than I do. I'm just surprised because I've had dozens of TB tests in my life (had to get them twice annually for many years for my job) and it's always been a pretty quick and simple-seeming process, administered by a vaccinations nurse. Never had anything more than an occasional spot of blood or minor bruise with them, and usually neither of those (obviously this could be very different for another drug like the monkeypox vaccine though, due to tissue reactivity or fluid volume). Perhaps the issue is that properly-trained vaccination nurses can make it look easy, but they're in short supply for the scale of vaccinations we need for monkeypox?
posted by biogeo at 8:19 AM on August 12, 2022
posted by biogeo at 8:19 AM on August 12, 2022
Mpox is a terrible disease to contract. Beyond the excruciating pain that oral and anal lesions cause, some may be left with permanent scarring of the face and other parts of the body.
Vaccine supply in Washington has been abysmal, and continues to be so. Cases in Seattle double each week. Splitting shots may be necessary as this disease spreads within our community, and ultimately to straight people and their kids.
I drove my friend and I from Seattle to Vancouver two weeks ago to get our shots. At that time, the nurses in Canada did not ask either of us for a health services card or other identification, but now they will turn away Americans or Canadian non-residents like myself. This is unfortunate because of the traffic of people — gay people, included — up and down the PNW region in both directions.
Gay men have been begging local, state and federal gov't for shots and treatment for months, but we're pretty much on our own and having to set up informal networks to help each other get vaccinated, as pop-up clinics open and close with the flow of doses.
This is a slow-motion disaster that was avoidable. Further, I'd have expected gay men to be left to get sick under the previous administration, but not this one. Some have started to get mad and organize in ways that echo 80s activism against the government's response to HIV.
posted by They sucked his brains out! at 8:52 AM on August 12, 2022 [6 favorites]
Vaccine supply in Washington has been abysmal, and continues to be so. Cases in Seattle double each week. Splitting shots may be necessary as this disease spreads within our community, and ultimately to straight people and their kids.
I drove my friend and I from Seattle to Vancouver two weeks ago to get our shots. At that time, the nurses in Canada did not ask either of us for a health services card or other identification, but now they will turn away Americans or Canadian non-residents like myself. This is unfortunate because of the traffic of people — gay people, included — up and down the PNW region in both directions.
Gay men have been begging local, state and federal gov't for shots and treatment for months, but we're pretty much on our own and having to set up informal networks to help each other get vaccinated, as pop-up clinics open and close with the flow of doses.
This is a slow-motion disaster that was avoidable. Further, I'd have expected gay men to be left to get sick under the previous administration, but not this one. Some have started to get mad and organize in ways that echo 80s activism against the government's response to HIV.
posted by They sucked his brains out! at 8:52 AM on August 12, 2022 [6 favorites]
As far as I can, this seems like making the best of what we have. Would giving full doses to everyone who might contract the virus be better? 100%. But we don't have that many vaccines. So instead of just twiddling our thumbs it seems like making the best of a bad decision. Compared to the hesitancy we saw with COVID this seems like a much better strategy.
posted by ockmockbock at 8:59 AM on August 12, 2022 [1 favorite]
posted by ockmockbock at 8:59 AM on August 12, 2022 [1 favorite]
As far as I can, this seems like making the best of what we have.I mean, this is maybe true in the world in which the people running the CDC and FDA woke up from a coma today, but it didn't have to be. The ~1 million doses of the vaccine that were sitting in Denmark would most likely have done a lot more to control the spread if they were deployed months ago than 5 million doses now will, but, well, that didn't happen, so maybe this high-risk strategy is the best there is now?
I was actually worried that after COVID, we would over-index our disaster response plans on disease, and not focus enough on other things, but I was clearly way too optimistic. The CDC seems completely asleep at the wheel, it's shocking that the most useful clinical guidance I've seen comes from the DHS.
posted by wesleyac at 4:09 PM on August 12, 2022 [2 favorites]
All of us Boomers has smallpox vaccinations just like this. Poke, poke, poke, poke, poke, up on one shoulder or the other. All of us. So lets not get in the way of lifesaving efforts, and maybe the old school cow pox remedy should be resurrected. People should pay close attention to personal health issues, and re-quarantine, use sanitizers at gyms, theaters, shopping carts again. Stay off the dance floor, if you feel ill. We are all sick of isolation but at least we are not sick from it.
posted by Oyéah at 5:36 PM on August 12, 2022
posted by Oyéah at 5:36 PM on August 12, 2022
These people only knew how to do big 5-8 year engagements so accelerating that timeline into 6 months was just basically throw people on it, take the 5-8 year timeline and just shrink every deliverable date by 100%.
Please tell me they didn't have Gantt charts.
posted by kersplunk at 5:50 PM on August 12, 2022
Please tell me they didn't have Gantt charts.
posted by kersplunk at 5:50 PM on August 12, 2022
All of us Boomers has smallpox vaccinations just like this. Poke, poke, poke, poke, poke, up on one shoulder or the other
About a decade ago I took a weeklong disaster medicine course. On the last day we were taught how to give a smallpox vaccine like this and we actually practiced it (with saline). After we were done the instructor said "Congratulations. You're now in a federal database of people that know how to give smallpox vaccine."
posted by neuron at 9:06 AM on August 16, 2022 [2 favorites]
About a decade ago I took a weeklong disaster medicine course. On the last day we were taught how to give a smallpox vaccine like this and we actually practiced it (with saline). After we were done the instructor said "Congratulations. You're now in a federal database of people that know how to give smallpox vaccine."
posted by neuron at 9:06 AM on August 16, 2022 [2 favorites]
Monkeypox Vaccination Access Project
posted by They sucked his brains out! at 1:25 PM on August 17, 2022
posted by They sucked his brains out! at 1:25 PM on August 17, 2022
Inside America’s monkeypox crisis — and the mistakes that made it worse
posted by Nelson at 7:02 AM on August 18, 2022
But after Health and Human Services officials announced their proposal on Aug. 4, Paul Chaplin, chief executive of Bavarian Nordic, the vaccine’s manufacturer, called a senior U.S. health official and accused the Biden administration of breaching its contracts with his company by planning to use the doses in an unapproved manner. Even worse, said two people with knowledge of the episode, Chaplin threatened to cancel all future vaccine orders from the United States, throwing into doubt the administration’s entire monkeypox strategy.Early information on "Will splitting monkeypox vaccines in five work out?"
“People are begging for monkeypox vaccines, and we’ve just pissed off the one manufacturer,” said one official who spoke on the condition of anonymity because they were not authorized to comment.
posted by Nelson at 7:02 AM on August 18, 2022
Better news: Deal struck to expedite production of monkeypox vaccines in U.S.
Denmark-based Bavarian Nordic will work with Michigan-based Grand River Aseptic Manufacturing to package 2.5 million doses of vaccine that the United States had ordered in July.posted by Nelson at 2:02 PM on August 18, 2022 [1 favorite]
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posted by BWA at 4:52 AM on August 12, 2022