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FDA approves drug to treat smallpoxJudy Stone MD at WebMD reported on the drug's approval on June 10th 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.
Bearing in mind the description above, some researchers believe that it's the small pox virus that is responsible for the plague outbreaks reported throughout history, such as the Black Death. From the article New Light on the Black Death: The Viral and Cosmic Connection by Dr Segura we read:No known virus existing today is responsible for the Black Death, although the symptoms resemble those of Ebola, Marburg and the viral hemorrhagic fevers - diseases caused by filoviruses. They have a high mortality rate and tend to occur in explosive epidemics driven by person-to-person transmission. Outbreaks occur unpredictably and, as of yet, no animal reservoir is known.
Similar plagues have been described in antiquity, i.e. the devastating epidemic that struck Athens in 430 BC and which Joseph and Wickramasinghe suggest the causative agent of which to be cometary as well.[9] As with the Black Death, the epidemic in Athens was localized geographically, it declined and disappeared as abruptly as it had started, and no known current disease fits its description by the historian Thucydides.
Where did these diseases go? Did the Black Death virus mutate, causing other fearsome diseases? What we do know is that a more virulent form of smallpox came to the fore in the 1630s and, just as the Black Death disappeared from the stage of history, smallpox took its place as the most feared of human diseases. We can only speculate. Smallpox virus, as opposed to the causative agent of the Black death, is very resistant to cold temperatures, making it a more viable virus. According to the data collected by Scott and Duncan which describe the disease process of the Black Death, hemorrhagic smallpox is almost virtually identical to the Black Death.
But were there cometary impacts at the time of the Black Death?
If you read the special feature of The Dot Connector Magazine issue 11, (see also The Golden Age, Psychopathy and the Sixth Extinction) you probably know the answer to be positive. Plague outbreaks often coincided against a background of food shortages, famines, flooding, peasant uprisings and religious wars. In certain countries, there were volcanic eruptions, earthquakes and famines. And not only did the plague outbreaks coincide with cometary impacts, but earthquakes themselves may well have been indications of cometary impacts. Dendrochronologist Mike Baillie of Queen's University, Belfast, Ireland makes this case in his book New Light on the Black Death: The Cosmic Connection. [10]
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.
So it's not proven to be effective or safe in humans. Much like the experimental coronavirus injections that were railroaded through using 'emergency' approval powers.
Safety information to support approval of Tembexa was derived from clinical trials of the drug for a non-smallpox indication, primarily from patients who received hematopoietic stem cell transplants. An increased risk of death was seen in another disease (Cytomegalovirus disease - a viral infection) when Tembexa was used for a longer-than-recommended duration (longer than once a week for two weeks on days 1 and 8). Tembexa is only approved for the treatment of smallpox.
The most common side effects when using Tembexa are diarrhea, nausea, vomiting, and abdominal pain.
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.
The FDA has approved a new drug to treat smallpox. Fearful of a possible bioweapon attack, the United States has been steadily preparing a defense through BARDA, the Biomedical Advanced Research and Development Authority.Considering the US' involvement in bioweapon research, and the well founded suspicions that the coronavirus actually escaped from its Fort Detrick's lab, as well as Bill Gates' & co's use of the current manufactured crisis to roll out the WEF's agenda of the 'Great Reset', one could be forgiven for thinking that any outbreak of smallpox will be equally leveraged for the benefit of the establishment and its nefarious schemes:
Tecovirimat was the first drug for smallpox, approved in 2018. The FDA granted the new drug, brincidofovir, or BCV, fast track status and orphan drug designations in 2018. The new approval came under the FDA's Animal Rule.
Drug testing usually goes through several phases prior to approval. First, there is preclinical testing in test tubes and animal models. Phase I is the "first in human" testing, looking primarily for safety and toxicity. Phase II is where researchers look for the best dose to treat a specific condition. The drug being tested is generally given to people who are relatively healthy otherwise.
Phase III broadens the population that receives the drug, including older people and those with underlying diseases (like diabetes or mild kidney disease). After this, the pharmaceutical company seeks FDA approval. Then phase IV, or post-marketing, studies are done, continuing to monitor for side effects. Rare side effects will often not appear until Phase IV, which is why drugs are sometimes recalled after initial approval.
But that's not how it worked for brincidofovir. The Animal Rule recognizes that some investigational treatments cannot be tested for a specific indication in people. This happens for infections where it is dangerous and unethical to expose people to an agent. Smallpox is one such infection; plague is another. Levaquin and Cipro, two quinolone antibiotics, are approved and often used for various infections but required this specific approval under the FDA's Animal Rule for use against plague.
BCV also received priority review, fast track, and orphan drug designations. The first two mean that the FDA believes the drug is likely to provide a significant advantage over current therapy. This speeds approval. An orphan drug designation is intended to support the development of drugs for rare diseases, but it has been abused by a number of pharmaceutical companies because the status is lucrative.
BCV is neither a new nor unknown drug. It is a version of a drug used to treat certain patients with AIDS.
Smallpox is a deadly disease that kills about 30% of those infected and maims many of its victims. Smallpox also used to be a leading cause of blindness, Gigi Kwik Gronvall, PhD, senior scholar atJohns Hopkins Center for Health Security, says. Natural smallpox was eliminated in the 1979, but both the United States and Russia (and perhaps other countries) have maintained stocks of the virus that could be used as bioterrorism.
Related to BCV's pre-approval studies, Gronvall says that "it was nice to see that some more naturally, relevant poxviruses were used as a standard instead" of using primates. The current studies used rabbitpox and mousepox (ectromelia virus) models, which have, she said, "a lot of relatedness to human smallpox" and are more like a natural infection.
The major defense against smallpox has been an old vaccine (ACAM2000) which has been stockpiled for emergency use. Routine administration of that vaccine was discontinued in the 1970s because it had so many side effects. There is a newer vaccine, modified vaccinia Ankara or MVA, which is less effective but safer.
That's one reason brincidofovir is important, Gronvall says. In the event of a smallpox attack, "if you are not able to give somebody a vaccine within a few days of exposure, they're not going to benefit from the vaccine. So, having a treatment is important."
Gronvall concluded: "It's another success for BARDA that, with not as much resources [due to COVID-19], they were able ... to get this approved. That should be something we think about more in the future, especially with new advances in vaccine technologies and how that could be applied to some of the bioterrorism agents."
In biodefense labs, she added, "There are populations of people who actually do work with some of these agents and some of these vaccines would be very helpful for them. And so maybe I'm hopeful that ... BARDA can take this up."
"I don't think parents should be telling schools what they should teach."In a CNN exit poll, more than half of voters said parents should have more say in what is taught in schools, indicating that core issue for Youngkin drove the voter turnout. Democrats also appear to have lost their majority in the Virginia House of Delegates with four races not yet officially called.
Comment: So much Modern Murica!