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.
a bioweapon, hmm
has fauci said whether or not he gonna fund that?
Could it coincide with the upcoming release of govt. info about UFO's?
“Those of us of a certain age who sport odd scars on our upper arms may be ok”
I wouldn’t count on that. We are protected because no one has it.
I seem to recall one booster had a big needle...Maybe DPT?
MMR did not exist. Polio was a sugar cube. From what I recall, only smallpox, polio, and DPT existed during my childhood.
Travelling in Mexico as a teen required some additional shots.
It is interesting that this is a drug for treatment—not prevention. You would think this vax-obsessed administration would be contracting for more of the traditional-type smallpox vaccines...
“...compared to the animals treated with placebo.”
I thought a placebo was the psychological component of a blind test. Why would animals need to play the mind game?
I thought a placebo was the psychological component of a blind test. Why would animals need to play the mind game?
===========================================================
Might be of interest...
What is a placebo?
Animals receiving inert treatments may show improvement due to causes other than direct placebo effects
https://www.veterinarypracticenews.com/what-is-a-placebo/
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.