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.

[Freedom56v2]

Yes, I am well aware...I have been reading news for 15 years.

I just don’t trust much of what I read in 2021.

[JohnBovenmyer]

I doubt there is a commercial test available for smallpox immunity. No market for such. You’d need someone doing smallpox research. The second article mentioned at end of #54, if you can succeed in navigating to it, looked at vaccinia specific antibody tigers and found them well preserved, even into old age.

With no US cases since 1949 probably the only Americans getting repeat vaccinations the past 70 years were those traveling to where such was required until the general end in vaccination (1976?). US Military vaccination resumed for some and switched to the new vaccine when available, but I don’t know how widely that was done. Use of the new vaccine otherwise would be quite rare.

[FreedomPoster]

Who do I trust?

After the last year and a half, not the CDC. I am convinced they have been fully politically weaponized and are no longer in pursuit of their stated mission.

[EEGator]

I read this about smallpox...

[EEGator]

Creepy shit.

Why they’re messing with this crap is beyond me...

[familyop]

"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."

I was vaccinated by the Army for it--the same vaccine that I received as a child. It introduces cowpox--not smallpox. The cowpox is what vaccinates a person against smallpox.

The one blister caused by the vaccination is a cowpox blister. Then it usually leaves a tiny scar for a long time. The Army vaccination still worked fine.

[familyop]

I might have been incorrect about “cowpox,” having assumed that from school history as a child. There was the vaccination in the early 1960s (school) and 1989 (Army), though. The latter was similar to the first: a quick poke with a very short needle (no injection). The blister and tiny scar followed.

[redgolum]

Well, Yes.

Some of us hope to go out in style. Like turning into a werewolf and charging zombie Nazi hordes!

But small pox isn’t on my list.

[Oorang]

...rumors that smallpox victims were being disinterred in Oklahoma."

Really, I missed that one. Do you have any more details?

[the OlLine Rebel]

I think the cowpox was used by the first discoverer (forget name) in the 1700s to show smallpox could be innoculated against.

I don’t think continued using it in more advanced forms.

[Seruzawa]

I was thinking of the problem with the homeless who don’t finish their round of antibiotics. Much of the problem with drug resistance is people not finishing a course of antibiotics.

[Mears]

88 years old and fading fast.

.

[gleeaikin]

Given Russia’s harboring/encouraging? hackers that are making more and more serious attacks on our vital businesses, at some point we may feel forced to react strongly to Russia itself. Since they have supplies of smallpox and hostile attitudes and behavior toward us, it may be the thinking that we need to be prepared. Also, some hackers may be a lot less constrained in their behavior than Russia itself, and who knows how much it would cost to bribe a containment laboratory worker for access.

[null and void]

nully ~ ...rumors that smallpox victims were being disinterred in Oklahoma."

Oorang ~ Really, I missed that one. Do you have any more details?

There is a mass grave disinterment going on right now

They believe it is victims of the 1921 Tulsa massacre, the timing is purely coincidental (yeah, I bet it is!).

They allow there could be 1918-1919 Spanish Flu victims in the mix.

No mention of smallpox, that appears to be someone's speculation.

Thanks for asking, always good to do some followup!

[rxsid]

Thanks for the post about the book! I’ll add it to my list to read.

[rxsid]

Indeed, a contributing factor.

[EEGator]

Anytime. He also wrote Hot Zone too.

[Myrddin]

Cemeteries in Wales are full of TB victims. My great great grandfather died from it in 1844. His son, my great grandfather emigrated to the US in 1863.

[thecodont]

Pretty sure I had the old vaccine—not sure if I had repeat vaccinations—I only have one jab scar on my bicep. Given the political climate today, not sure I would want a new one...

I seem to recall "booster shots" from my childhood but right now I can't remember what they were for.

[greeneyes]

Nukes are expensive. Bio weapons are not nearly so expensive.
******************************************************************************
Your analysis is spot on. In addition, nukes can render a place uninhabitable etc. for many years. Bio weapons can just take out the pesky citizens and the enemy can then claim the land and do what they will.