FDA to announce tougher standards for a coronavirus vaccine that make it unlikely one will be cleare

[demmiblue]

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 Trump’s repeated predictions of a coronavirus vaccine by Nov. 3, coupled with the administration’s 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]

1. Don't worry

they'll rescind these standards within the next several days, per order of Donny Dollhands himself

[iluvtennis]

11. You're probably right, but I hope that isn't the case.

[hatrack]

14. Days? It only took the CDC an hour or two to yank airborne infection info . . .

Maybe FDA isn't quite as captured by Trumpanzees (yet).

[brewens]

2. Is this a major pushback, showing they are not afraid of Trump. he is gonna shit over this one! n/t

[PSPS]

3. No he won't. His toady Hahn will "fix it."

[PSPS]

4. LOL. They're lying. Toady ring-kisser Hahn will do what he's told.

I'll wait for approval from a trusted non-US agency.

[Illumination]

5. Trump is going to pull a rabbit out of a hat! He might have better luck taking his show on the

road!...Then again, maybe not...

[SergeStorms]

6. FDA administrators to be clear cut in......

5......4.....3.....2....1

[durablend]

7. Which means it'll be ready by next week

[IcyPeas]

8. Why do we even need a vaccine?

According to Trump and kayleigh only 200,000 virtual people have died.

[raccoon]

9. At first I read this as, "FDR said...". Wishful thinking I suppose. Nt

[LiberalLovinLug]

10. 3....2....1.....

DEEP STATE DEMOCRATS!!!!WHAAAAAAAAAAAAAA!!!!

[Warpy]

12. As much as we are desperate for one, they won't let Dumdum pull a Putin

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]

13. Tough luck for the dotard

Most of us want a safe and effective vaccine.