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As Above So Below
WHO Behind FDA Scheme to Skip All Future Clinical Trials for COVID Vaccines
(Excerpts)
The U.S. Food and Drug Administration (FDA) tomorrow, June 28, will vote on the “Future Framework,” a scheme that would allow Pfizer and Moderna to “reformulate” COVID-19 mRNA vaccines in perpetuity, without conducting clinical trials on the new vaccines.
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Moderna, Pfizer and Novavax are all developing reformulated COVID-19 shots. But they know that the FDA is not going to look at health outcomes so they are going to great lengths to jack up the antibody response. Pfizer tested a double-strength dose (60 mcg of mRNA instead of 30 mcg) even though they had previously ruled out a higher dose because of safety concerns. So the antibody levels are through the roof.
But the VRBPAC admitted on April 6 that there are no known correlates of protection (meaning: antibody levels do not tell you who will be immune) so these antibody measures are medically meaningless. Sane people realize that if you turbo charge the immune response, you may also turbo charge adverse events. But the “Future Framework” allows pharmaceutical companies to skip clinical trials altogether.
.
(Excerpts)
The U.S. Food and Drug Administration (FDA) tomorrow, June 28, will vote on the “Future Framework,” a scheme that would allow Pfizer and Moderna to “reformulate” COVID-19 mRNA vaccines in perpetuity, without conducting clinical trials on the new vaccines.
_____________________________
Moderna, Pfizer and Novavax are all developing reformulated COVID-19 shots. But they know that the FDA is not going to look at health outcomes so they are going to great lengths to jack up the antibody response. Pfizer tested a double-strength dose (60 mcg of mRNA instead of 30 mcg) even though they had previously ruled out a higher dose because of safety concerns. So the antibody levels are through the roof.
But the VRBPAC admitted on April 6 that there are no known correlates of protection (meaning: antibody levels do not tell you who will be immune) so these antibody measures are medically meaningless. Sane people realize that if you turbo charge the immune response, you may also turbo charge adverse events. But the “Future Framework” allows pharmaceutical companies to skip clinical trials altogether.
.