The Food and Drug Administration is attempting to tighten the standards for a COVID-19 vaccine, but the plan appears to have run into a political blockade at the White House.
This is a smart move by FDA to cover their ass
. Set up reasonable standards for a vaccine that ideally would go to 80+% of the population, then leak them before approval
. WH disapproves rule and a weakerâor noârule issues.
. WH forces an early EUA for a vaccine
. NO ONE takes the vaccine.
One of the more immediate questions a trial needs to answer is whether a vaccine prevents infection. If someone takes this vaccine, are they far less likely to become infected with the virus? These trials all clearly focus on eliminating symptoms of Covid-19, and not infections themselves. Asymptomatic infection is listed as a secondary objective in these trials when they should be of critical importance.
It appears that all the pharmaceutical companies assume that the vaccine will never prevent infection. Their criteria for approval is the difference in symptoms between an infected control group and an infected vaccine group. They do not measure the difference between infection and noninfection as a primary motivation.
Even scarier from the same article: well fewer than 200 âcasesâ needed for an EUA
A careful reading reveals that the minimum qualification for a case of Covid-19 is a positive PCR test and one or two mild symptoms. These include headache, fever, cough, or mild nausea. This is far from adequate. These vaccine trials are testing to prevent common cold symptoms.
These trials certainly do not give assurance that the vaccine will protect from the serious consequences of Covid-19. Johnson & Johnson is the only trial that requires the inclusion of severe Covid-19 cases, at least 5 for the 75 participant interim analysis.
Why do we need a vaccine against a hoax - or something that hardly affects anybody? Those sound like situations where the FDA should take its time⌠[sarcasm]
Let us face the emergent reality. Trump and his cabal in our government are doing everything they can to destroy our country, and if that fails politically, they seem prepared to preside over the deaths of millions of Americans and others.
Whoa, whoa, whoa -the point of a vaccine is to prevent the disease. This is a therapeutic. Trump is such a corrupt influence on everything. Billions of tax dollars were given for this research and it was supposed to be a vaccine.
I want very much to assume that Biden will win - and that the obstruction of the transition is quelled swiftly as Trumpâs power drains precipitously in a matter of days -
âŚor is simply hauled out of the WH in a body-bag
in any event ⌠there will be massive amounts of professionalism to re-install in so many places - and it will require great diligence. Trump has disgustingly embedded trolls, Luddites, anti-science disturbed individuals ⌠what has been highly visible has gone on in areas where the work is visible and is intended to be a help to the general public ⌠Lord knows what sort of sabotage has been orchestrated in the less visible (but highly critical) areas ⌠imagine the fun these destructive rodents would have reducing safety standard for nuclear power plants ⌠or bridge & highway safety.
He tried to get Pharma to do this as a piece of his âdealâ to lower prescription drug prices but it fell apart. So now he just does it anyway because he is currently losing the 65+ vote.
Thanks for sharing that. Yikes! I mean I wasnât going to get a Trump vaccine, but this implies that these vaccine trials wonât be good for much even after January