Here's the latest internet meme about monkeypox:
Absolute insanity: The Biden Admin won't accept 1 million doses of Monkeypox vaccine from Denmark because the FDA failed to do a timely inspection of the plant -- even though EU authorities did inspect the plant and approved its product for use in the EU. https://t.co/quqedbtVHp
— Josh Barro (@jbarro) July 11, 2022
After seeing this, I mouthed off on Twitter about holding off on the vitriol until we got some more detailed reporting on what's really going on here. Certainly something better than clickbait from the New York Post. But I figure I should put my money where my mouth is and at least gather up what I can find out right now. Here we go:
Background:
- Monkeypox is mostly spread by direct contact with the lesions of someone who has it. It's not clear yet if it can be spread through saliva, semen, or vaginal fluids. In any case, compared to COVID-19 it's relatively easy to avoid.
- As I write this, the US has 865 confirmed cases of monkeypox, although the actual number is probably at least double that.
- Monkeypox is unpleasant but almost never deadly. No one in the US has yet died from it. Worldwide, three people have died out of 9,000 cases, all in Africa.
Specifics
- The US has 100 million doses of ACAM2000, a smallpox/monkeypox vaccine. However, it has occasional serious side effects and is not the best vaccine.
- The best vaccine is JYNNEOS, manufactured by Bavarian Nordic. The vaccine is manufactured in a plant in Denmark, and BN has already produced 30 million doses in bulk form under a contact with the Pentagon, which helped pay for its development. We have ordered 4 million doses for delivery by the end of the year and millions more in 2023 and 2024.
- Currently we have about 300,000 doses available in the Strategic National Reserve, some of which have already been used, with another 300,000 arriving over the next few days.
- The vaccine was previously manufactured in a facility that was fully inspected and approved by the FDA. This is why we are continuing to get delivery of smallish numbers of doses. However, in 2020 manufacturing was moved and inspection was delayed, probably due to COVID. I imagine it was a pretty low priority for the FDA at the time. The result is that we can't yet take delivery of any vaccine doses manufactured in the new facility.
- We have agreed to sell about 200,000 of our doses to Europe. This is why European regulators inspected the BN facility a little while back.
- The FDA began its inspection of the BN facility this week. According to BN, this is the result of an "expedited inspection" that was originally scheduled to start on July 1. It is unclear why it was delayed ten days.
- Why didn't the FDA simply accept the European approval and get the doses moving? As near as I can tell, the answer is that they aren't allowed to. They can change this, but there are rules for doing so. They can't just decide on their own to instantly abandon their legal responsibility.
- Should the president have issued some kind of emergency executive order allowing the vaccine to be shipped from Denmark? I don't know. In particular, I don't know if (a) the president can legally do this, or (b) if it would even be a good idea. Something like this always seems like a great idea during a panic—until it eventually backfires, which it will eventually. Acting calmly is often the best response.
- Has this inspection delay had any actual effect? That's unclear. Right now we still have hundreds of thousands of doses available and we haven't used them all. It's quite possible that BN will deliver more doses before we run out of what we have.
- The first case in Europe was reported on May 6. The first vaccine delivery was on June 28. That's 53 days.
- The first case of monkeypox in the US was reported on May 27 in Massachusetts. Health care workers who had had been in close contact with the patient received the JYNNEOS vaccine within hours. That's zero days. On June 24 it was rolled out in New York City to people at high risk of infection who had "presumed" exposures. That's 28 days. Since then distribution has been expanded and will be expanded further as we receive more supplies from BN. Counting off 53 days from May 27 gets you to July 19. We will likely receive hundreds of thousand more doses shortly after that, and millions more over the next few months.
I will change my mind if new evidence arrives, but at this point it doesn't look to me like the FDA or anybody else has done anything especially bad. Things could perhaps have happened faster, but honestly, the rollout happened pretty damn fast—especially for a disease that's not really all that dangerous.
Here's a summary of lessons:
- Inspecting the BN factory was not a high priority in early 2022. Why would it be?
- Monkeypox is a well known virus, but the latest outbreak came out of nowhere.
- We have spent years helping develop a better vaccine and stockpiling doses. There is no country in the world that was better prepared than we were. We have done considerably better than anyone else, and that definitely includes Europe.
- We went through with this preparation even though monkeypox is (a) difficult to spread, (b) not very deadly, and (c) not generally recommended as a candidate for mass vaccination.
- The initial rollout of anything has problems. The first few weeks of the polio vaccine rollout were a mess. The vaccine rollout for the 1957 Asian flu went . . . pretty well!—largely because the vaccine could be manufactured and distributed on one man's orders with no testing. The vaccine for the 1968 Hong Kong flu was ineffective because the pandemic was over by the time the vaccine got rolled out. The 1976 swine flu vaccine rollout was a full-on disaster. And I hardly need to remind you about the endless groaning and faux expertise that overwhelmed social media during the first few weeks of the COVID-19 vaccine rollout. By comparison, the monkeypox vaccine rollout is proceeding with Swiss watch efficiency.
Unless you're a true expert—i.e., someone who's very well informed about how vaccines are approved and distributed—I really don't want to hear crap like "I don't get it. Just put a few guys on planes and get over there." And while I don't blame anyone personally at risk for bitching about difficulties getting vaccinated, the rest of should recognize it for what it mostly is: just routine griping.
But as I said, if the evidence changes, I'll look at it and change my mind if it's warranted. I don't have an axe to grind here. But I recommend that for everyone else too. We are not—repeat not—all experts on pharmaceutical inspections and vaccine distribution. And most of us probably never will be.
Thank you for this, Kevin. The Twitter bludgeoning of our health officials has been ugly and frenzied of late.
https://youtu.be/Wzr12gBrXA8 …
Irony is Kevin Drum taking a shot at Nate Silver over being the Dunning-Kruger Chair of Research at the Lamestream Institute. All that, & we tell where to get the best Mission style burritos in Irvine on the next 538 Podcast.
https://www1.nyc.gov/site/doh/about/press/pr2022/monkeypox-next-allocation-vaccines-new-appointments.page
Talks about appointments coming available. Doesn’t talk about doses actually administered.
An inspection of a facility is a big deal. It' not done in a day or two. It needs to go to a level of detail that outsiders can not possibly imagine.
That said: Why is it that the US and the EU run two agencies doing the exact some work (if not in the exact same way)? This results in a huge waste of resources. Every facility is inspected twice (these inspections are disruptive to the inspectees!) just because of--what? American exceptionalism?
There are countries we trust and countries we don't trust. I don't see why we don't establish formal relationships (with procedures accept each other's results) between the FDA and its sister agencies in the EU, Japan and South Korea. It would save quite a bit of money AND speed up the response to pandemics. The fact that monkey pox is not as bad as COVID is a piece of luck that we can't count on every time.
BTW we have now a COVID variant that is practically not covered by the vaccine. Everybody knew this was coming. A vaccine that would cover it exists (Moderna) but it is stuck somewhere in the approval process. How come we can approve and produce a new, modified flu shot every year within three months (most of this time due to production in chicken eggs) and have to jump through endless hoops for a suitably updated COVID vaccine?
One could say the same thing about MD training. There's no good reason foreign doctors from high income countries with top-notch medical training have to complete full-length residencies to practice in the US.
Trust, but verify?
As for annual flu vaccine versus COVID, the flu vaccine machinery as it were has been operating for decades. It is very well established.
There are a lot of good reasons to have at least two reliable agencies doing this kind of inspection and approval work. The Royal Society's motto is "nullius in verba", don't take anyone's word for it. That's served in good stead since the 17th century.
Can you imagine the political crapstorm that would follow if some EU approved medication turned out to be dangerous?
You should see this:
https://www.cdc.gov/flu/vaccines-work/past-seasons-estimates.html
The viruses and vaccines are quite different. The Covid-19 vaccines have been much more effective against multiple variants of the virion than the influenza vaccines have generally been. The lower efficacy of the flu vaccines is acceptable because of its generally lower mortality rates. This, and longer experience with the influenza strains may affect the approval process.
The takeaway here is how the conservative media and to a certain extent the mainstream media sensationalizes everything, and it is exhausting. I for one appreciate your post.
My sense is the non-stop shit-posting re: FDA/CDS is a good example of right-wing ref working wearing down the MSM.
Why not just have the Supreme Court change the rules about accepting vaccine shipments from BN under the "major questions doctrine?" They're big experts in things chemical and biological.
LOL !
And to add to the irony of all this information is that the Supreme Court's decision to be in charge of the Executive Branch in West Virginia v. EPA means that any change to regulations or rules without an explicit Congressional bill is illegal.
I really hope that's not how things are going to play out. I would hope that executive branch departments will simply A) be a bit more savvy about how they formulate rules and interpret statutory language, and B) let affected parties sue, if need be.
Mr. Roberts has made his decision, now let him enforce it.
John Roberts is a snake. Behind that snarling smile is a person who would gladly deputize the Proud Bois as the Supremes military wing if Mac Innes's lads were just a little less coarse.
John Roberts is a hard right movement conservative. The main difference between Roberts and the other righties is that Roberts pays somewhat more attention to electoral politics (foolishly, in the mind of someone like Justice Thomas, who perceives clearly that elections aren't going to matter after 2024), and he also would prefer to continue to receive invitations to Georgetown soirees.
Condoms? Will that do it as a stop-gap?
Only the full body ones...
It's not an STD in the traditional sense. The spread is by close contact with the lesions on the person, contaminated clothing, bedding etc. Sex is not needed.
Should also not, it is not readily transmitted. No worries about casual contacts, sharing a chair, etc.
Like anal warts.
Your account of the issue is as good as any I have seen. Unless there is something hidden out there, our sluggish response is definitely not a disaster. One could argue that we should be able to do better if something else like COVID appears, but monkeypox is not as dangerous as COVID and is much harder to spread.
As for getting an FDA team out there to inspect the facility, I have two responses.
One is that you don't just send out a few folks with a notebook. You have to work out the inspection protocol which means going over the provider's production statement which was tied to its approval and making sure everyone on the team knows what to look for. Assume the inspection itself takes at least a week.
My other response, and weak attempt at humor, is to ask if you have tried traveling to any European destination lately? In today's headlines, Heathrow is supposedly asking airlines to stop selling tickets. Europe's airports and air system is saturated. Maybe we should ask Greta Thunberg if she has any space on board her ship.
Yeah, an FDA inspection is not just two guys showing up with white gloves to see if there's dust in the facility.
I’m sorry but this literally doesn’t matter. A non-lethal disease where 40-50% of those who catch it report having “group sex within the past month”? So undeserving of the coverage it’s gotten
If this is our COVID hangover I guess it could be worse but people have gotta calm down
In other words, things are actually working well. The gay community was pretty good about keeping track of close contacts in one of the covid outbreaks (Providence), and that should help with this outbreak.
Of course, with this "news", all people will remember is something about Biden botching a vaccine roll out--no matter of explanations will help once the story is repeated.
Nobody cares
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