Tembexa Is Approved by the FDA to Fight the Weaponized Smallpox Virus, Despite Concerns About COVID Lab Origins
Smallpox is a disease that was once common in humans but was eradicated in 1980. The World Health Organization (WHO) has long been concerned that the variola virus, which causes smallpox, could be used as a bioweapon if it fell into the wrong hands.
The variola virus is still retained in two labs, one in Atlanta, Georgia, and the other in Russia, despite the fact that the disease has been eradicated.
The medicine Tembexa was approved by the US Food and Drug Administration (FDA) on Friday to treat smallpox, a contagious condition that can be lethal.
Fears of the COVID-19 coronavirus, which originated in a science facility, have heightened concerns about the variola virus.
“Despite the fact that naturally occurring smallpox no longer exists, worries about the variola virus’s potential use as a bioweapon has made smallpox medication development an important component of the United States’ medical countermeasures response,” the FDA said on Friday.
Smallpox, like the flu and COVID-19, was spread by intimate human contact until it was eradicated 41 years ago. Symptoms of smallpox typically appeared 10-14 days after infection. Fever, headache, backache, and tiredness are all symptoms of smallpox. Infected people frequently developed a rash with little pink bumps that evolved to pus-filled ulcers that eventually sealed over and became scars.
Brain damage (encephalitis), open sores on the clear, open area of the eye, blindness, and death are all possible complications of smallpox.
Tembexa has been designated as a priority review, fast track, and orphan drug by the FDA. This resulted in a six-month application assessment, as compared to the customary ten months or more. Because of the seriousness of the sickness, it was given a head start in testing and was declared an orphan medicine because of the disease’s rarity.
Tembexa was tested on animals infected with viruses that are extremely similar to the variola virus. Tembexa was given to one group and a placebo to the other. The drug’s effectiveness was determined by the fact that individuals who received Tembexa had a better survival rate than those who did not.
The FDA used the “animal rule” for testing since human clinical trials were not “feasible or ethical.”
“Tembexa was authorized by the FDA under the Animal Rule, which enables data from adequate and well-controlled animal effectiveness studies. This is a condensed version of the information.