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FDA approves drug to treat smallpox

fda.gov

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Re: FDA approves drug to treat smallpox

#51

Post by redis_mlc »

kokanator wrote: post #10
omegaworks wrote: post #3

> Complications of smallpox included encephalitis (inflammation of the brain), corneal ulcerations (an open sore on the clear, front surface of the eye), and blindness. A tragic reminder of the horror inflicted on indigenous people by the colonies that would become the United States[1]. A bioweapon used to craft the narrative of the empty, pristine continent, bestowed by God for the fulfillment of Manifest Destiny[2]…

From your citation: > Bioterrorism had already started 14 centuries before Christ, when the Hittites sent infected rams to their enemies. The non-modern world was indeed a vary barbarous world. It is amazing how far we have come in such a short time. Continue to vote and push forward.

[dead]

Re: FDA approves drug to treat smallpox

#52

Post by peter422 »

mchusma wrote: post #50

I'm confused by the FDA. So last June, there were 3 COVID vaccines that passed phase I clinical trials and animal challenge studies. There was an active pandemic raging, and vaccines were almost certainly had 100x less risk for those over 65 (a statistical no brained) But somehow, they kept all vaccines banned for another 6 months killing hundreds of thousands. Nothing. But in the last week they approved an Alzheimer…

Not all the vaccines worked. You are taking for granted the knowledge we have now about the vaccine efficacy.

If there were no efficacy studies we could easily have wasted precious manufacturing and logistical resources in an ineffective vaccine which would have cost even more lives.

Not to mention increasing the vaccine hesitancy which is already a massive problem.

Re: FDA approves drug to treat smallpox

#53

Post by jrowley »

mchusma wrote: post #50

I'm confused by the FDA. So last June, there were 3 COVID vaccines that passed phase I clinical trials and animal challenge studies. There was an active pandemic raging, and vaccines were almost certainly had 100x less risk for those over 65 (a statistical no brained) But somehow, they kept all vaccines banned for another 6 months killing hundreds of thousands. Nothing. But in the last week they approved an Alzheimer…

> FDA approved Tembexa under the agency’s Animal Rule, which allows findings from adequate and well-controlled animal efficacy studies to serve as the basis of an approval when it is not feasible or ethical to conduct efficacy trials in humans.

How doesn’t this make sense?

Re: FDA approves drug to treat smallpox

#54

Post by aaomidi »

mchusma wrote: post #50

I'm confused by the FDA. So last June, there were 3 COVID vaccines that passed phase I clinical trials and animal challenge studies. There was an active pandemic raging, and vaccines were almost certainly had 100x less risk for those over 65 (a statistical no brained) But somehow, they kept all vaccines banned for another 6 months killing hundreds of thousands. Nothing. But in the last week they approved an Alzheimer…

Vaccines are usually tested for a much higher standard because

It's generally taken by a LOT of people and to PREVENT something. It's a proactive medicine rather than reactive. FDA is a lot less strict with reactive medication, especially in cases where the disease is just fucking awful.

This is also the technical reason why male birth control hasn't hit the market yet. They don't consider pregnancy to be an issue for men, but do for women. Hence they tolerate the side effects of BC for women a lot more.

Re: FDA approves drug to treat smallpox

#55

Post by [deleted] »

nyokodo wrote: post #26
elliekelly wrote: post #25

If smallpox-as-a-bioweapon is even a slight possibility why don’t we start vaccinating for it again? It seems like it would be much easier to prevent the problem at all rather than to try to respond to it.

> why don’t we start vaccinating for it again? Because vaccination isn’t 0% risk. Very few people are going to acquiesce to vaccination for a functionally extinct virus nor should they. Perhaps those who want to should be able to but that’s another discussion.

[deleted]

Re: FDA approves drug to treat smallpox

#56

Post by mews_ »

OK but this is assuming it isn’t a highly modified virulent strain of smallpox.

Which would be my main concern, because god knows what happened to Russia’s stockpile of weaponized smallpox after the fall of the USSR. It wouldn’t surprise me if some of that is still floating around somewhere in a freezer…

Re: FDA approves drug to treat smallpox

#57

Post by thebeardisred »

ohazi wrote: post #36
kps wrote: post #28

Earlier quoted context omitted.

The current smallpox vaccines stockpiled in the US use a live virus¹ and have a fairly high rate of serious side effects (1–2%) for a disease that doesn't currently exist. The vaccines are also still effective a few days after exposure to smallpox. ¹ https://en.wikipedia.org/wiki/Vaccinia

Also, the way the smallpox vaccine is administered is mildly gruesome: > A droplet of ACAM2000 is administered by the percutaneous route (scarification) using 15 jabs of a bifurcated needle . ACAM2000 should not be injected by the intradermal, subcutaneous, intramuscular, or intravenous route. (emphasis mine) https://en.wikipedia.org/wiki/Smallpox_vaccine https://en.wikipedia.org/wiki/Bifurcated_needle

It's not bad at all. Post 9/11 I had it done as a part of a trial on diluting the vaccine (result: you could).

At the time it was just a shading tattoo needle.

5 points, 3 jabs. It was nothing.

Re: FDA approves drug to treat smallpox

#58

Post by rolleiflex »

parsecs wrote: post #49
LeifCarrotson wrote: post #18

Earlier quoted context omitted.

No, if the slide was prepared for storage the sample would have been embedded in a preservative with the cover glass glued down around the perimeter. The sample would likely be mixed with a mixture of alcohol, glycerin, and acetic acid known as AGA to prevent decomposition, this would kill any bacteria or viruses in the sample. I have a microscope from my uncle, also a doctor, which came with a ton of slides he prepa…

How the hell can they get all these bits of humans for so cheap? As much as I love high value chinese stuff on amazon this one sorta creeps me out

You might like to hear about Henrietta Lacks, arguably the first immortal human being, now called HeLa. Her living cells are one of the most widely distributed living human tissue available, still alive, still replicating because they have activated telomerase, which means the cells are not 'aging' in the way normal human cells do. I think it's about $400 for about a vial's size of tissue.

Re: FDA approves drug to treat smallpox

#59

Post by makomk »

retrac wrote: post #47
elihu wrote: post #24

Earlier quoted context omitted.

From the article: > Because smallpox is eradicated, the effectiveness of Tembexa was studied in animals infected with viruses that are closely related to the variola virus. Effectiveness was determined by measuring animals’ survival at the end of the studies. More animals treated with Tembexa survived compared to the animals treated with placebo. FDA approved Tembexa under the agency’s Animal Rule, which allows findi…

Vaccinia, the smallpox vaccine, is a very closely related virus. You infect someone with it, they maybe get a bad rash at worst, and then they are immune to many of the poxes. Cowpox can and has been used the same way, too. This is why vaccination is named after cows. Some poxes are awful for the primary host. Camelpox apparently kills about a quarter of camels that contract it. Just like smallpox (humanpox?) kills a…

Speaking of which, guess what showed up in Wales recently? https://www.bbc.co.uk/news/uk-wales-57431322

(This kind of thing is why the UK has national-level contract tracing capabilities. Occasionally something shows up that's not particularly easy to spread, but bad enough that it needs stopping sooner rather than later. I think we've had a few SARS and MERS cases too.)

Re: FDA approves drug to treat smallpox

#60

Post by est31 »

bpodgursky wrote: post #7
riffic wrote: post #6

Earlier quoted context omitted.

there's no need for that when samples of the virus itself are still retained by two laboratories: https://en.wikipedia.org/wiki/Smallpox_virus_retention_debat...

There are a lot more people who will soon have access to genome fabrication technology (there are already companies that do this as a service) than can break into a BSL4+ laboratory and steal one of the few remaining smallpox samples.

FTR if you try to order that even remotely looks like a known human virus from these companies, they will reject your order.

But yes, the more accessible this technology becomes, the greater the danger.

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