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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.


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KEYWORDS: 202106; 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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To: entropy12
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.

That's ok, you can still go on cruises /broken record repeats itself>

41 posted on 06/10/2021 6:01:53 PM PDT by grey_whiskers (The opinions are solely those of the author and are subject to change with out notice.)
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To: rxsid

Uh...

Crap

This isn’t even tin foilstuff.


42 posted on 06/10/2021 6:07:37 PM PDT by redgolum (If this is civilization, I will be the barbarian. )
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To: rxsid
Although naturally occurring smallpox no longer exists, 

Except in bat caves in China. Every disease known to man lives there.

43 posted on 06/10/2021 6:09:34 PM PDT by KarlInOhio (Police should refuse duty at NBA venues. Let them wallow in their desired chaos without police.)
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To: rxsid

Almost everyone over 50 is vaccinated, as well as certain portions of the military (I hope it’s the most lethal guys and not paper pushers in the Pentagon) as well as many lab workers in high level research labs.

Releasing smallpox would be a super stupid act that would result in severe global backlash to the miscreants responsible. Smallpox has a 50-80% fatality rate in children (the younger the child the higher the rate).

I don’t think anyone can count on the military or law enforcement to follow their orders when their children are dying of the disease they released. There would be a coup and summary executions.


44 posted on 06/10/2021 6:25:46 PM PDT by Valpal1
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To: the OlLine Rebel

That was measles.


45 posted on 06/10/2021 6:28:37 PM PDT by Valpal1
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To: rxsid; LucyT

funny how suddenly there are treatments and maybe cures coming along, huh???


46 posted on 06/10/2021 7:16:43 PM PDT by bitt ( A murderer is less to fear. The traitor is the plague.)
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To: EEGator
"I thought smallpox was eradicated completely?..."

"Naturally" occurring, it was. The last known case occurring in Somalia in 1977.

Some interesting history:

The origin of smallpox is unknown. The finding of smallpox-like rashes on Egyptian mummies suggests that smallpox has existed for at least 3,000 years. The earliest written description of a disease like smallpox appeared in China in the 4th century CE (Common Era). Early written descriptions also appeared in India in the 7th century and in Asia Minor in the 10th century.

...

By the time the Intensified Eradication Program began in 1967, smallpox was already eliminated in North America (1952) and Europe (1953). Cases were still occurring in South America, Asia, and Africa (smallpox was never widespread in Australia). The Program made steady progress toward ridding the world of this disease, and by 1971 smallpox was eradicated from South America, followed by Asia (1975), and finally Africa (1977).

https://www.cdc.gov/smallpox/history/history.html
47 posted on 06/10/2021 7:20:17 PM PDT by rxsid (HOW CAN A NATURAL BORN CITIZEN'S STATUS BE "GOVERNED" BY GREAT BRITAIN? - Leo Donofrio (2009))
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To: hanamizu
"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."

Surprised me as well.

Why a new drug approval for smallpox...now? And, why was it fast-tracked for approval? What's the hurry?

There has to be much more to this story.

48 posted on 06/10/2021 7:22:20 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: Valpal1

I think you are right. Thanks!


49 posted on 06/10/2021 7:25:51 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: Seruzawa
"Drug resistant TB. Brought to you by the homeless. Thanks libs."

Immigration, both legal and illegal should be at the top of the list for reasons why there are so many cases of multi drug resistant TB in the U.S.

Keshavjee shared 2008 data from WHO indicating that among 27 high-burden countries, China, India, and Russia have the highest numbers of MDR TB patients. It is estimated that 50 percent of MDR TB cases worldwide occur in China and India. Other countries with large numbers of MDR TB cases include Bangladesh, Indonesia, Myanmar, Nigeria, Pakistan, the Philippines, and South Africa.

https://www.ncbi.nlm.nih.gov/books/NBK62452/
50 posted on 06/10/2021 7:26:36 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: DAC21
"I think a Civil War is inevitable to clean up Science, Government, politicians, big business. I hope I’m wrong."

I hope your wrong too.

But I'm coming around to that conclusion as well.

"Drain the swamp" sounded great initially, but there are just far too many dwelling there and are entrenched for life. Especially, if there is only a small handful of those in power who were trying to do the draining.
Uphill battle with both legs and arms tied behind their backs while blindfolded.

Something's gotta give.

51 posted on 06/10/2021 7:32:09 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: DAC21

Chances that a civil war will birth a country even nearly as free as the USA once was are probably nil.


52 posted on 06/10/2021 7:34:56 PM PDT by PghBaldy (12/14 - 930am -rampage begins... 12/15 - 1030am - Obama's advance team scouts photo-op locations.)
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To: Seruzawa
Unfortunately, that doesn't sound outlandish...especially after what's gone on (is going on) in this country from stolen national elections, to instituting actual racism in many/most sectors against "white" people, to opening our borders to invading foreign nationals and on and on.

There are a LOT of very evil people out there. They have the money, the power and now what they believe is, the momentum.

53 posted on 06/10/2021 7:36:42 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: Valpal1

Almost everyone over 50 is vaccinated, as well as certain portions of the military (I hope it’s the most lethal guys and not paper pushers in the Pentagon) as well as many lab workers in high level research labs.

Releasing smallpox would be a super stupid act that would result in severe global backlash to the miscreants responsible. Smallpox has a 50-80% fatality rate in children (the younger the child the higher the rate).

I don’t think anyone can count on the military or law enforcement to follow their orders when their children are dying of the disease they released. There would be a coup and summary executions.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Hate to rain on your parade, but I am not certain the vaccine is lifelong...Eh have to consider the sources...

Smallpox vaccination can protect you from smallpox for about 3 to 5 years. After that time, its ability to protect you decreases. If you need long-term protection, you may need to get a booster vaccination.

www.cdc.gov › smallpox › vaccine-basics

XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

Given that the majority of Americans under the age of 35 years have never been vaccinated against smallpox and the great majority of those over 35 have not received booster vaccinations since the early 1970s, immunity to smallpox is considered to be low to nonexistent in today’s population.

Immunity from Smallpox Vaccine Persists for Decades - NCBI - NIHwww.ncbi.nlm.nih.gov › pmc › articles › PMC2610468


54 posted on 06/10/2021 7:38:04 PM PDT by Freedom56v2 (If I wanted to live in China, I would move there!)
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To: GreyFriar

It has not come back! It was eradicated, except for samples the US & USSR (and ?) have.


55 posted on 06/10/2021 7:38:10 PM PDT by PghBaldy (12/14 - 930am -rampage begins... 12/15 - 1030am - Obama's advance team scouts photo-op locations.)
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To: rxsid

Why would you be surprised with the TON of illegals being set loose in the country!!


56 posted on 06/10/2021 7:47:15 PM PDT by Trump Girl Kit Cat (Yosemite Sam raising hell)
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To: hanamizu; EEGator; rxsid; All

I too have a nickle sized scar on my thigh from 82 years ago. I wonder if I still have any immunity after all these years.

Apparently all “wild” smallpox has been eliminated. However, man has decided to cage the beast in laboratories so we still have something to worry about.


57 posted on 06/10/2021 7:49:00 PM PDT by gleeaikin
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To: Trump Girl Kit Cat
"Why would you be surprised with the TON of illegals being set loose in the country!!"

Not at all surprised about MDR TB poring into our country. I see it in the medical field in increasing numbers.

However...smallpox?

Yup, that the FDA basically rushed an emergency approval for a smallpox medication IS surprising since there are zero publicly known cases...anywhere in the world.

Much more to this story.

58 posted on 06/10/2021 7:53:56 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: gleeaikin

See my post #54...No you likely don’t have immunity.


59 posted on 06/10/2021 8:01:27 PM PDT by Freedom56v2 (If I wanted to live in China, I would move there!)
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To: Freedom56v2; gleeaikin

Eh but as I noted, consider the source.
Wonder if can get some sort of test to find out if have immunity...


60 posted on 06/10/2021 8:02:31 PM PDT by Freedom56v2 (If I wanted to live in China, I would move there!)
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