FDA approves drug to treat smallpox

www.fda.gov ^ | 06.04.2021 | FDA

[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.

[SeeSharp]

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

No. Not smallpox. You'd know if there was an outbreak of that. The variola virus is only known to exist in four high security research facilities.

[jz638]

There was a worry that the Iraqis had smallpox as part of a bioweapons program. They started trying to vaccinate soldiers but the vaccines were so old and differently formulated from modern vaccines that the rumor was they were nearly as likely to give you smallpox as they were to innoculate you. The plan died out rather quickly, not sure if anyone actually ever got a vaccine.

[Mears]

My father died of TB at age 32,way back in the 1930s.

Since I was exposed I still test positive when given the tine test.

.

[GreyFriar]

I figure that WHO hadn’t checked EVERYWHERE to see if it was TOTALLY gone, otherwise we would not see it coming back.

[entropy12]

So sorry to hear your father died at such young age from TB.

[phoneman08]

Seems like a proactive measure now that it’s clear that COVID was a bioweapon that was released “accidentally”.

[ransomnote]

I have seen rumors that small pox was the next plandemic. This time they have a toxic pill instead of a toxic ‘vaccine’ to herd the public into taking. :(

[Secret Agent Man]

Da phuck if i am taking anything from the government.

We havent even had heads roll for the ongoing murder of citizens by experimentsl treatment yet.

[null and void]

This following hard on the heels of rumors that smallpox victims were being disinterred in Oklahoma...

Make of that what you will!

Bring Out Your Dead

Post to me or FReep mail to be on/off the Bring Out Your Dead ping list.

The purpose of the “Bring Out Your Dead” ping list (formerly the “Ebola” ping list) is very early warning of emerging pandemics, as such it has a high false positive rate.

The false positive rate was 100%.

At some point we may well have a high mortality pandemic, and likely as not the “Bring Out Your Dead” threads will miss the beginning entirely.

*sigh* Such is life, and death...

Yearning to breathe free!

[Bonemaker]

It was...decades ago. Democrats are preparing cures for their soon to be released next pandemic.

[EEGator]

If smallpox goes global, that would be far, far worse than covid.

I think it only “survives” in Fort Meade and a lab in Russia.

[null and void]

The Aztecs wondered if this was smallpox what was the greatpox like???

[Bonemaker]

And Wuhan.😎

[E. Pluribus Unum]

Fauci must have funded gain-of-function research for the smallpox virus.

[EEGator]

Well, that’s okay since the Chinese are trustworthy...

[Old Yeller]

My father died of TB at age 32,way back in the 1930s.

If you don’t mind my asking, how old are you? Because your father would be about 120 now, if he were alive.

[Nuc 1.1]

So why don’t we get vaccinated like we used to?

[Nuc 1.1]

Nope it is in labs and graves around the world. Only a matter of time before it gets out.

[Nuc 1.1]

Not a word to disagree with.

[heartwood]

I thought this had to be a Babylon Bee article...

But the FDA is actually trying to get ahead of the game...