Coronavirus vaccine could get emergency approval before critical testing is complete, FDA says

Jul 27, 2020
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One is compelled to wonder how many Pharm companies are going to submit for vaccine approval before their Phase III trials are complete and fully evaluated.

Is the government going to inoculate them from the massive lawsuits likely to arise if there are nasty results? And could that inoculation itself go through all the phases of court appeals for years afterwards? To be sure, most vaccines take years to develop and market based on safety and efficacy. Short-circuiting the process with less than Phase III results and their evaluation seems a bit too soon, with the potential dangers lurking.

These vaccines might cause antibody dependent enhancement in some people, or other nasty surprises waiting to be determined after an EUA and prior to the extensive evaluation of Phase III results.

Quoting from the article:

"To me, it's absolutely paramount that you definitively show that a vaccine is safe and effective, both," Fauci told Reuters. "We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective."

end quote

(Dr. Anthony Fauci, one of the world's top experts, is the director of the National Institute of Allergy and Infectious Diseases.)

This whole notion of an accelerated vaccine EUA could be a "floater", to find out how people react. It is likely the reaction from the pros will be as extremely negative as Dr. Fauci's, or more.

Time will tell.
 
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