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FDA approves drug to treat smallpox
www.fda.gov ^ | 06.04.2021 | FDA

Posted on 06/10/2021 4:02:38 PM PDT by rxsid

FDA approves drug to treat smallpox
Disease considered eradicated in 1980 but drug development for smallpox is an important component for medical countermeasure response

[6/4/2021] The U.S. Food and Drug Administration today approved Tembexa (brincidofovir) to treat smallpox. Although the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that the virus that causes smallpox, the variola virus, could be used as a bioweapon.

Before its eradication in 1980, the variola virus mainly spread by direct contact among people. Symptoms typically began 10 to 14 days after infection and included fever, exhaustion, headache, and backache. A rash consisting of small, pink bumps progressed to pus-filled sores before it crusted over and scarred. Complications of smallpox included encephalitis (inflammation of the brain), corneal ulcerations (an open sore on the clear, front surface of the eye), and blindness.

Although naturally occurring smallpox no longer exists, concerns about potential uses of variola virus as a bioweapon has made smallpox drug development an important component of the U.S. medical countermeasures response.

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 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.

...

Tembexa received priority review, fast track and orphan drug designations. Priority review directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. Fast track is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Orphan drug designation provides incentives to assist and encourage the development of drugs for rare diseases.

Tembexa was developed in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA). FDA granted approval of Tembexa to Chimerix Inc.


TOPICS:
KEYWORDS: adarkwinter; andrewsairforcebase; barda; bcw; biden; biosecurity; bioweapon; chimerix; chimerixinc; covid19; darkwinter; exercise; fda; hhs; infectious; joebiden; pandemic; peterhenderson; smallpox; smallpoxexercise; tembexa; ushhs; wmds
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Tembexa received priority review, fast track and orphan drug designations. Is there a current smallpox outbreak? No. Perhaps, soon to be outbreak? Would it be beyond possibility for the evil people that currently run this country?

Sounds like they were in a hurry to get this out there into production.

 

Also see....

Joe Biden's "Dark Winter": Was It Code for a Smallpox Plandemic?

1 posted on 06/10/2021 4:02:38 PM PDT by rxsid
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To: Lenora Thompson
Ping!

FDA approves drug to treat smallpox

2 posted on 06/10/2021 4:03:00 PM PDT by rxsid (HOW CAN A NATURAL BORN CITIZEN'S STATUS BE "GOVERNED" BY GREAT BRITAIN? - Leo Donofrio (2009))
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To: bitt; LucyT; null and void; aragorn; AZ .44 MAG; Baynative; bgill; Black Agnes; blueyon; ...
Ping!

FDA approves drug to treat smallpox

3 posted on 06/10/2021 4:03:17 PM PDT by rxsid (HOW CAN A NATURAL BORN CITIZEN'S STATUS BE "GOVERNED" BY GREAT BRITAIN? - Leo Donofrio (2009))
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Correct link...

Joe Biden's "Dark Winter": Was It Code for a Smallpox Plandemic?

4 posted on 06/10/2021 4:05:09 PM PDT by rxsid (HOW CAN A NATURAL BORN CITIZEN'S STATUS BE "GOVERNED" BY GREAT BRITAIN? - Leo Donofrio (2009))
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To: rxsid
Just in time...

Outbreaks of monkeypox and drug-resistant TB in UK

5 posted on 06/10/2021 4:11:03 PM PDT by Oorang (Politicians:-a feeble band of lowly reptiles who shun the light and who lurk in their own dens. )
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To: rxsid

I thought smallpox was eradicated completely?...


6 posted on 06/10/2021 4:11:10 PM PDT by EEGator
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To: rxsid

This headline surprised me as well as smallpox is pretty much extinct except for some samples in labs in the U.S. and Russia (and maybe China?) I think the last case was someone working in a lab.

Those of us of a certain age who sport odd scars on our upper arms may be ok, so I can take some comfort in that.


7 posted on 06/10/2021 4:11:48 PM PDT by hanamizu
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To: rxsid; null and void; aragorn; AZ .44 MAG; Baynative; bgill; bitt; Black Agnes; blueyon; ...
.

PING

8 posted on 06/10/2021 4:12:25 PM PDT by LucyT
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To: rxsid

Drug resistant TB. Brought to you by the homeless. Thanks libs.


9 posted on 06/10/2021 4:17:13 PM PDT by Seruzawa (The political Left is the Garden of Eden of Incompetence - Marx the Smarter (Groucho))
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To: rxsid

Wish the disease was not alive in 1948 when it zapped me with high fevers and dime sized blisters all over my 8 year old body.


10 posted on 06/10/2021 4:17:25 PM PDT by entropy12 (President Trump saved Millions of lives with his warp speed push of vaccines, including my spouse.)
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To: Seruzawa

TB is far worse for people under age 60 than covid is.


11 posted on 06/10/2021 4:18:34 PM PDT by entropy12 (President Trump saved Millions of lives with his warp speed push of vaccines, including my spouse.)
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To: EEGator

It still lives in sections of Central and South America as well as Third world countries who are sending their citizens to the US as illegal immigrants who pay to be smuggled across the US/Mexico border. They are also bringing in other diseases that were thought to be eradicated 20 years ago in the nation.


12 posted on 06/10/2021 4:18:42 PM PDT by GreyFriar (Spearhead - 3rd Armored Division 75-78 & 83-87)
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To: rxsid

Smallpox is the wrong name for this disease. The blisters are large, dime sized and itch like crazy at the end. I know because I had it at age 8. I call it Bigpox.


13 posted on 06/10/2021 4:20:28 PM PDT by entropy12 (President Trump saved Millions of lives with his warp speed push of vaccines, including my spouse.)
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To: rxsid

Several years ago during an Ebola outbreak in Africa, it was reported that scientists from Iran arrived and took samples from numerous dead and dying people. Why would Iran, which is probably close to the bottom of the world’s powers in medicine need a sample of Ebola? There are surely enough medical problems already in Iran to occupy their national medical budget. The conclusion was they have a bio weapon’s research program.

While the world’s major nations spend millions of dollars on their labs, such an expenditure is not necessary if the thing you are developing is already damned deadly without enhancement. Just a few well designed rooms on a, hopefully, remote military base will do just fine.

So, what other horrible diseases are out there that are as easily harvested. It turns out most developed nations kept samples of deadly diseases and they have been shared with universities around the world. They are out there and if you have the money, you can get them. The recent arrests of scientists accused of working for the CCP is evidence of that.

Do other nations have bio weapons programs? Almost certainly. Nukes are expensive. Bio weapons are not nearly so expensive.

When you have an apocalyptic world view, then using them becomes a real option. If some nation starts threatening your existence, then you have an equal threat to make them stop. Especially if your view is, if you’re dead, then the rest of the world won’t matter anyway. (Hitler tried to erase Germany from the map but his systematic destruction was halted by the people who were supposed to execute it.)


14 posted on 06/10/2021 4:21:50 PM PDT by Gen.Blather (Wait! I said that out loud? )
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To: rxsid

since it was ERADICATED,
did the CDC make some new patents and then release
this, too, as a chaser for MORE PROFITS?


15 posted on 06/10/2021 4:22:06 PM PDT by Diogenesis (Tuitio Fidei et Obsequium Pauperum)
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To: rxsid

FDA is wholly corrupt. A purge is necessary. Approving a drug without a problem in this case. Yesterday approving a drug for Alzheimer’s that doesn’t work and an independent advisory panel voted something like 9 to 1 against approval. It will cost tens of billions against Medicare as spineless Doctors won’t go against not prescribing it. Studies were stopped for non efficacy. I think a Civil War is inevitable to clean up Science, Government, politicians, big business. I hope I’m wrong.


16 posted on 06/10/2021 4:22:11 PM PDT by DAC21
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To: rxsid

Logically:

You have an elitist strata on the planet that believes that climate change requires immediate drastic action. They say this constantly.

Then the same people also, less publicly, call for a world population figure of 500,000,000. A reduction of 6.5 billions.

There are too many armed people in this world to just start rounding them up. The logistics of that are impossible anyhow.

To the elites then there are only two effective routes. The first is to cut off food supplies. But there you run into the armed population problem and the fact that you soldiers might not remain loyal when their families are being starved.

The other avenue is disease. This can backfire, but the elites have set up redoubts for themselves and their picked henchmen.

Outlandish? I don’t think so. I expect to see the plan t starve the world become a planned plagues.


17 posted on 06/10/2021 4:29:45 PM PDT by Seruzawa (The political Left is the Garden of Eden of Incompetence - Marx the Smarter (Groucho))
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To: rxsid

Wasn’t there a suspected resurgence of smallpox here in recent years?

I thought something seemed to reappear in the Pacific Northwest. Maybe it was some other well-known disease? We were blaming anti-vaxxers.


18 posted on 06/10/2021 4:29:54 PM PDT by the OlLine Rebel (Common sense is an uncommon virtue./Federal-run medical care is as good as state-run DMVs. I )
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To: GreyFriar
There is a place, in North America, where one could dig into a mass grave of 3,000 who died of smallpox.

Who knows, might get it going again from that?

19 posted on 06/10/2021 4:30:21 PM PDT by Mogger
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To: GreyFriar

It states the WHO declared it gone...totally....in 1980. Or is that the wrong interpretation?


20 posted on 06/10/2021 4:35:10 PM PDT by the OlLine Rebel (Common sense is an uncommon virtue./Federal-run medical care is as good as state-run DMVs. I )
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