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.
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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.
I am surprised you were not vaccinated! I think it was available at the time!
Re “small” pox. Named for the scars (‘pocks’ or ‘pox’) it left rather than active skin lesions. In its early days syphilis was known, amongst many names, as the great pox. Early on that was visually more impressive than most modern cases, which tend to scar less than 600 years ago. I don’t know what pre-Columbian (syphilis likely was introduced to Europe by Columbus’s crew) “poxes” were thought of as bigger than smallpox scars.
I’ve seen different theories about the source of the name for “chicken” pox, the disease historically most often confused with smallpox. My favorite theory is that it was named not for poultry, but for chickpeas as thats skin lesions are similar in size. Many old names of skin diseases were botanical metaphors.
Last fatal case of smallpox was in London in a secretary working at a lab there doing smallpox. Her mom caught a mild case from her and survived so was the last actual case. Just how it got to the secretary was never proven, but the lab director suicided over the incident. There’d been multiple earlier lab releases so this London case convinced authorities to restrict it to one lab each in US and Russia. We know from defectors the Soviets weaponized smallpox (prior to final London accident) and had lab accidents with it. We don’t know whether to believe their claims they completely destroyed those stocks and hadn’t given any to Norks, Saddam, or other friends. Reconstruction of the virus from frozen bodies or published DNA sequences, or from working with its non-extinct cousins, of which monkeypox is the worst remaining, albeit seldom fatal, are also concerns.
Release of smallpox into a population in which none are immune is the most efficient way in history to kill millions. The Soviet defectors’ news scared the US into developing contingency countermeasures for an “extinct” disease last seen here in 1949. A brand new smallpox vaccine was developed, stockpiled, and given to some. Antiviral drugs though to be useful in it were developed and also stockpiled. I don’t think this is the only one.
so... a release of smallpox is next?
Smallpox no longer exists in the general population. We eliminated it via vaccines. There is absolutely no need for a drug to treat smallpox with this one exception.
Smallpox is alive and well in biological warfare labs in North Korea, China, and probably Russia and perhaps a few other nations but that is not certain. The first two are certain.
Funny story. Circa 1972 I was flying from Ecuador to Columbia. My smallpox vaccination was not current. Smallpox then was a disease that still existed in the world. The most polite medical officials took me aside and gave me the inoculation and wished me on my way and welcome to Columbia. It took less than five minutes.
Depends on if you have the old weakened virus vaccine or the newer modern one using a different virus from the same family.
Mine is old school.
Researchers obviously couldn’t prove immunity by exposing folks to it. But they did scour the old literature and tested blood in previously vaccinated folks to provide as good a guess as ethics allowed. IIRC their conclusion was that distant vaccination wasn’t likely to prevent you from getting smallpox, but it might significantly reduce the risk of death from it. Which makes sense. Surviving smallpox is a race between the virus and your immune system. To the extent any useful memory B or T cells survive the latter can accelerate quicker, even though their initial quantities may not prevent an early viral lead.
You should have actually read the study in your second link. It supports permanent immunity and criticizes the the CDC policy/statement of 3-5 years.
Well, I figured out the more to the story... The smallpox genome was sequenced and published on the internet.
And can be synthesized by any competent genetics lab.
Amazing how smart people can be so blazingly stupid.
I ‘fear’ smallpox is in labs in North .Korea, China, etc. but I am NOT certain it is. Officially it is only at CDC in Atlanta and one lab in Russia. At the time Soviets weaponized it they were on poor terms with China and probably wouldn’t have shared it. Scenarios with them sharing with Saddam or North Korea were more plausible. From where it may been subsequently been shared further. Any certainty of current existence beyond the official two sites would have to come from well classified intelligence. I’m not aware of any public releases on that front although I certainly hope we’re trying to know. Meanwhile having robust countermeasures on paper keeps potential bad actors concerned any release may fizzle resulting in intact, righteously p*shed Americans.
The future of mankind is a sick, delirious patient soon to die on a filthy litter.
We’re all gonna f***ing die.
Sorry, I did not fully research as it was not my question...I was trying to provide a quick answer. As I said consider the sources...(CDC? & others)
Frankly, I wouldn’t count being immune from the vaccine—tho given the current climate, I would be hesitant to get an experimental one...As I posted, I wondered if there is actually a test available to determine immunity. From what I read, it is possible, but not sure if readily available.
That said, I have looked into it more fully.
My second link, the NCBI states:
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.
As link showed, they have a paper of a study with a seemingly small number of patients—but very long-term time period indicating lifetime:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2610468/
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CDC pulls up: How long does a smallpox vaccination last? Past experience indicates that the first dose of the vaccine offers protection from smallpox for 3 to 5 years, with decreasing immunity thereafter. If a person is vaccinated again later, immunity lasts longer.
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Here is another study saying MAY last a lifetime: (I know nothing about New Scientist)
https://www.newscientist.com/article/dn4064-smallpox-immunity-may-last-a-lifetime/
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NY Health Dept...(same as CDC) How long does a smallpox vaccination last? Past experience indicates that the first dose of the vaccine offers protection from smallpox for 3 to 5 years, with decreasing immunity thereafter. If a person is vaccinated again later, immunity lasts longer.
Smallpox Questions and Answers: The Disease and the Vaccinewww.health.ny.gov › publications
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Here is a website that has study says some lifetime: (Some debate)
https://www.cidrap.umn.edu/news-perspective/2003/09/researcher-defends-view-smallpox-shot-may-give-lasting-protection
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This article provides an interesting chart of various vaccine effectiveness timelines:
https://www.sciencemag.org/news/2019/04/how-long-do-vaccines-last-surprising-answers-may-help-protect-people-longer
So CDC has one opinion, NCBI states same but has studies contrary and there are studies questioning the CDC guidance...Sounds vaguely familiar. Who do you trust?
BTW, interesting, there have been vaccines being developed over the past decade at least—and there have been a few lab outbreaks...Hmm
Also interesting, there have been lab outbreaks—in 2017, 5 workers in China; and in 2018, one worker in San Diego...
...You are welcome.
Thank you for the information.
I put together some links in #72.
Your comment:
“The old vaccine was known not to provide Full lifelong immunity. When the disease was circulating folks got periodic repeat vaccinations.”
Seems to be debate in the literature I found and on this thread as to the length of immunity.
I would be very interested to see if anyone has information about getting a reliable test done to determine individual immunity.
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...
It hasn’t been seen anywhere in the world since then, except in a small number of labs (I believe 3?) where it is strictly controlled (frozen solid in containment units).
I have no idea where people are getting the idea that smallpox is making a comeback, but it isn’t. No known cases exist anywhere on Earth. None have for decades. The biggest risk would be someone recreating it and weaponizing it from previous research materials. Certainly the technology to synthesize it has grown increasingly cheap and readily available. Most of what would be missing at this point is knowledge. I wouldn’t be shocked if Iran could pull it off.
Wouldn’t help most people alive today anyway. Routine vaccinations for smallpox stopped in the US in 1972. Most people under 50 never got a smallpox shot.
Not sure what to make of these lab outbreaks...And they are developing a vaccine to prevent them...
Similar to smallpox;
In San Diego:
https://www.livescience.com/vaccinia-virus-infection-fingertip.html
Similar to smallpox;
In San Diego:
https://www.livescience.com/vaccinia-virus-infection-fingertip.html
Bookmark
Agreed. However, those individuals who were vaccinated previously—over 50 or perhaps medical/military personnel may have immunity, so they won’t need to rush to get a fast-tracked vaccine.
I also found it interesting that it received priority review and orphan drug designations.
The strategic countermeasures program began 15 years ago in order to anticipate, assess, prepare, and respond to emerging biological threats. The threat of weaponized smallpox release has been front and center since the Bush administration began understanding how terrorist organizations think and operate. One guy who infects himself and goes on a stroll through an international airport could bring about a million cases in a week. Smallpox already spreads well. If you tweaked it to have the infectivity of chickenpox or measles, that would be an absolute nightmare. That’s what keeps people up at night whose job it is to protect the American people: a guy in an airport with a weaponized pathogen filling the air around him.
I’m not at all surprised to see this get priority review. That just cuts the bureaucratic red tape a bit so that they target a 6 month response to the approval application. Further, I wouldn’t be at all surprised if the Federal government bought up 500 million doses of this stuff and stockpiled it around the country. Look at what COVID-19 has done to this country with an R0 of 2.5 (April 2020 variant) and an Infection Fatality Rate of 0.65% - 1%. Then imagine what this country would look like with something that has an R0 of 18 and an IFR of 50%. Scary stuff. They take it extremely seriously.
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