The Smallpox Vaccine, Tembexa

A Few Facts and It's FDA Approved

Jun 16, 2022

Smallpox hasn't existed since 1980. But on June 4, 2021, the FDA approved a pharmaceutical to treat the disease which they fear might become a bioweapon.

And just like the COVID vaccine, the FDA fast tracked the drug with zero human trials conducted. To push it through, they exploited their July 1, 2002 Animal Rule directive. A rule designed to permit vaccines without proper human clinical research (Research 2021).

The directives

21 CFR 314.600-650 for drugs;
21 CFR 601.90-95 for biologics

These two options allow the FDA the ability to permit experimental drugs at will. All they need, data from animal trails which claim its safety. The reason, they consider human trials unethical (Research 2022).

Due to these regulations, Chimerix Inc. won approval for the use of Tembexa on U.S. citizens (Research 2021).

A Few Facts

In 1996, the FDA gave the green light for TEMBEXA with two assigned NDC’s (FDA, 2021, p. 17)

NDC 79622-010-04
NDC 79622-012-65

Because researchers only observed the effects in animals, human safety data doesn't exist. They never completed tests on human subjects with smallpox (FDA, 2021, p. 8).

The effectiveness of TEMBEXA for the treatment of smallpox disease has not been determined in humans because adequate and well-controlled field trials have not been feasible, and inducing smallpox disease in humans to study the drug’s efficacy is not ethical (FDA, 2021, p. 2)

The drug has many known severe side effects, and in some cases, it carries the death penalty. But this time around, if we learned anything from the COVID vaccines, do not trust these people. And if immune compromised, it’s not worth the risk. Studies show it might not offer any benefit (FDA, 2021, p. 19).

Adverse Reactions Include:

Inflammation (Hepatic Transaminases) in the liver (Hepatitis). Patients may experience abdominal pain and discomfort, dark urine and turn jaundice (FDA, 2021, p. 17).
Increases risk to those pregnant as it can cause defects in the fetus or death in the womb, Embryo-fetal Toxicity (FDA, 2021, p. 5). When on the drug, condoms need worn during and up to 4 months after the last dose (FDA, 2021, p. 18). In animal studies, the vaccine was present in the milk of animals. It’s not recommended to breastfeed while on brincidofovir FDA, 2021, p. 9).
The drug can cause tumors in the breast (Mammary adenocarcinomas). It also increases the chance of squamous cell carcinomas; cancer, Carcinogenicity. It’s known as a potential human carcinogen and FDA approved (FDA, 2021, p. 14).
Irreversible sterilization in males (FDA, 2021, p. 5). It causes depletion in sperm, which leads to infertility (FDA, 2021, p. 18).
Gastrointestinal adverse reactions such as diarrhea, nausea, vomiting and abdominal pain (FDA, 2021, p. 17).

Other ingredients used,