Before a vaccine is licensed by the Food and Drug Administration (FDA) for marketing and administration to the general public, the vaccine manufacturer needs to obtain regulatory approval by conducting testing.
The initial task is to perform preclinical testing (typically using human cell cultures or animal models) to determine both safety (i.e., non-toxicity) and efficacy (that it achieves a desirable immune response). If the pre-clinical testing is satisfactory, the vaccine can progress to clinical development.
Clinical development is supposed to be a three-phase process.
During Phase I, a small group (20-100) of healthy people receive low doses of the trial vaccine to verify that it isn’t toxic to humans and that it does indeed trigger the desired immune response. Phase I trials also determine what side effects are exhibited at which doses and the optimal dosage.
In Phase II, the clinical study is expanded to several hundred test subjects and the prevalence and severity of short-term side effects are noted, as well as the vaccine’s effect on the immune systems of the test subjects.
Phase III is the most rigorous. The vaccine is given to hundreds or thousands of people and tested for efficacy and safety. This phase typically involves double-blind testing using both the vaccine and a placebo, such that the health professionals administering the shots don’t know whether they are administering the vaccine or the placebo. The infection rates of the two groups are compared to determine whether the vaccine actually is efficacious. The severity and prevalence of side effects are also noted, to determine the safety of the vaccine.
If all these phases are successfully completed (a process that typically take at least a year, but usually several), the vaccine is licensed by FDA. At least, that’s how the process is SUPPOSED to work.
The fly in the ointment is The National Childhood Vaccine Injury Act (NCVIA) of 1986 (42 U.S.C. §§ 300aa-1 to 300aa-34), which was designed to eliminate the potential financial liability of vaccine manufacturers due to vaccine injury claims, in order to ensure a stable market supply of vaccines, and to provide cost-effective arbitration for vaccine injury claims.
Under NCVIA, vaccine manufacturers are shielded from civil liability for injuries cause by their vaccines unless they engage in fraud, intentional and wrongful withholding of information during testing, or other criminal behavior.
Sounds reasonable, right? Yes. Until you realize that the way vaccine managers elude these provisions by not specifically TESTING for safety, just noting what side effects are reported. They can’t withhold what they don’t have.
Now comes Da ‘Rona, which is entirely a political shitstorm and not a public health “crisis.” The Democrats know that they can’t win the upcoming elections on the merits, so they resorted to terrorizing gullible citizens and trashing their civil rights, triggering “lockdowns” (a prison term), and tanking the economy.
State governments (I’m looking at YOU, New York, New Jersey, and Pennsylvania!) that were underwater with their financial obligations to an elderly population found a handy way to reduce that population, and thus those obligations: put COVID-19 patients into nursing homes, instead of quarantining them in temporary hospitals set up expressly for that purpose. At the same time, these insolvent states received federal funding that helped them out of the budgetary holes they had dug for themselves.
(I’m not being cynical; I’m just reporting what happened. The cynical bastards are the governors who accomplished these results by putting sick people into nursing homes and not into quarantine and who then lied about the actual death tolls to maximize the federal payouts. That is some world-class cynicism on their parts right there.)
And, having failed to prevent the Democrats from carrying out their dastardly plan, what miracle solution has POTUS come up with to right the ship of state, re-open America, and restore the economy? A magic bullet: a vaccine. A VACCINE! We’re SAVED!
Nevermind the fact that SARS-CoV-2 is more like a bad flu and not the super-ninja killer bug the corrupt Democrats and their media mouthpieces have made it out to be.
Nevermind the fact that the annual flu vaccine is only 20-45% effective at preventing the flu.
Nevermind the fact that the first type of vaccine (attenuated virus) has proven not to work in clinical trials and the other type (Moderna‘s mRNA vaccine) has NEVER been approved as safe.
And nevermind the fact that it is being rushed through the regulatory approval process at dangerously fast speed. (Indeed, his program is literally entitled “Operation Warp Speed.”)
The potentially lethal fallacy in this approach is that speed is the most desirable factor when developing a new vaccine. In this case, speed may kill. Speed may maim. And, given the fact that this vaccine will, for the first time ever, inject viral genetic material into healthy people to “protect” them from a disease with a 99.98%+ survivability rate with absolutely ZERO knowledge of the long-term effects of doing so, speed may mutate.
The GOP rush to vaccinate in time to win the election is just as cynical as the Democrats ginning up false fear and unconstitutional, anti-Science, anti-medicine mask mandates in order to terrorize the public and crater the economy to win the election.
God help us all and save us from our “saviors” on both sides of the aisle.