FDA to announce tougher standards for a coronavirus vaccine that make it unlikely one will be cleare
Source: WaPo
The Food and Drug Administration is expected to spell out a tough, new standard for an emergency authorization of a coronavirus vaccine as soon as this week that will make it exceedingly difficult for any vaccine to be cleared before Election Day.
The agency is issuing the guidance to boost transparency and public trust as it approaches the momentous decision of whether a prospective vaccine is safe and effective. Public health experts are increasingly worried that President Trumps repeated predictions of a coronavirus vaccine by Nov. 3, coupled with the administrations interference in federal science agencies, may prompt Americans to reject any vaccine as rushed and potentially tainted.
The stakes are high: polls show the relentless politicization of the race to develop a vaccine is taking its toll. Pew Research Center recently reported that the percentage of people who said they would get the vaccine if it were available today has dropped to just over 50 percent from 72 percent in May.
The guidance, which is far more rigorous than what was used for emergency clearance of hydroxychloroquine or convalescent plasma, is an effort to shore up confidence in an agency that has made missteps during the pandemic. With the vaccines, the FDA is expected to ask manufacturers seeking an emergency authorization a far quicker process than a formal approval to follow participants in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot, according to two individuals familiar with the situation who spoke on the condition of anonymity to discuss information before it is made public.
Read more: https://www.washingtonpost.com/health/2020/09/22/fda-covid-vaccine-approval-standard/
NewJeffCT
(56,829 posts)they'll rescind these standards within the next several days, per order of Donny Dollhands himself
iluvtennis
(19,882 posts)hatrack
(59,594 posts)Maybe FDA isn't quite as captured by Trumpanzees (yet).
brewens
(13,631 posts)PSPS
(13,621 posts)PSPS
(13,621 posts)I'll wait for approval from a trusted non-US agency.
Illumination
(2,458 posts)road!...Then again, maybe not...
SergeStorms
(19,204 posts)5......4.....3.....2....1
durablend
(7,465 posts)IcyPeas
(21,916 posts)According to Trump and kayleigh only 200,000 virtual people have died.
raccoon
(31,127 posts)LiberalLovinLug
(14,178 posts)DEEP STATE DEMOCRATS!!!!WHAAAAAAAAAAAAAA!!!!
Warpy
(111,383 posts)and try to rush one out before it has been thoroughly tested. Putin might get lucky. Then again, there is at least an equal chance that he will not. The same is true here.
Yo_Mama_Been_Loggin
(108,304 posts)Most of us want a safe and effective vaccine.