Well the FDA is going to approve the vaccine.
Dr. Anthony Fauci said over the weekend that he hopes the vaccines will be fully approved by federal drug regulators in “the next few weeks,” noting in another interview that he believes a “flood” of vaccine mandates will be handed down after that.
So this is assuming that Fauci gets what he wants? Nope. To be approved, the drug has a rigorous procedure that it has to go through. BUT recently they approved a drug where they changed the rules.
note the part -
for new drugs to be approved under the normal process, they must show efficacy. Efficacy is typically defined as a drug treatment group significantly outperforming a placebo group for the registered outcome. In both of the Phase 3 clinical trials, this was not the case.
However, a secondary analysis (an unplanned analysis) showed that at a high dose of Aduhelm there was some (weak) evidence of benefit for the drug group over the placebo.
Nonetheless, in this case the FDA changed to a different criterion from the one that their advisory group was told to consider during their evaluation of the request to approve the drug. FDA changed to a criterion allowed for accelerated approval.
So when the system does not work to their liking, they change the rules. Same will apply here.
Im so glad I dont have to worry about my employer mandating a vaccine.
Dr. Anthony Fauci said over the weekend that he hopes the vaccines will be fully approved by federal drug regulators in “the next few weeks,” noting in another interview that he believes a “flood” of vaccine mandates will be handed down after that.
So this is assuming that Fauci gets what he wants? Nope. To be approved, the drug has a rigorous procedure that it has to go through. BUT recently they approved a drug where they changed the rules.
Unpacking the controversy over Aduhelm, newest approved Alzheimer's disease drug
The FDA changed to a different criterion from the one that their advisory group was told to consider during the evaluation to approve the drug.
www.tallahassee.com
note the part -
for new drugs to be approved under the normal process, they must show efficacy. Efficacy is typically defined as a drug treatment group significantly outperforming a placebo group for the registered outcome. In both of the Phase 3 clinical trials, this was not the case.
However, a secondary analysis (an unplanned analysis) showed that at a high dose of Aduhelm there was some (weak) evidence of benefit for the drug group over the placebo.
Nonetheless, in this case the FDA changed to a different criterion from the one that their advisory group was told to consider during their evaluation of the request to approve the drug. FDA changed to a criterion allowed for accelerated approval.
So when the system does not work to their liking, they change the rules. Same will apply here.
Im so glad I dont have to worry about my employer mandating a vaccine.
