Vaccine Trial in Florida Stopped: FDA Thinks European Trial May Be Good Enough

[Amethyst]

"After much fanfare about its launch, the vaccine trial for COVID-19 in Palm Beach County is on pause because of “political pressure,” its principal investigator says.

"Researchers said at a news conference Aug. 17 that they had received the vaccine and were ready to administer it to the first 10 test subjects.

"But the chief investigator for the vaccine trial confirmed to The Palm Beach Post on Thursday that the trial is on pause because of a question by the U.S. Food and Drug Administration on whether a European trial is good enough to start manufacturing and distributing the vaccine."


https://palmbeachpost-fl.newsmemory...aa7cbc53e12_5f49160e_d68e216&selDate=20200828

 

[JoeWras]

I keep seeing a lot of comments saying Europe is doing everything better. If so, they should be willing to accept the European trial, no?

 

[GravitySucks]

Hate to say it, but I'd trust a European trial more than a US trial in an election year.

 

[Out-to-Lunch]

I keep seeing a lot of comments saying Europe is doing everything better. If so, they should be willing to accept the European trial, no?

I don't know who "they" are in your post, but no one in a position to apply political pressure to a healthcare decision has been saying that Europe has done anything better.

 

[Popeye]

Maybe the chief investigator is xenophobic! Lol!

 

[Gumby]

I don't know who "they" are in your post, but no one in a position to apply political pressure to a healthcare decision has been saying that Europe has done anything better.

Maybe the chief investigator is xenophobic! Lol!

My impression, from reading the article, is that "they" is the FDA.

Dr. Larry Bush, the vaccine trial’s primary principal investigator, said the FDA is looking at whether the trial can be bypassed altogether and the vaccine approved using “emergency utilization access.”

and that Dr. Bush wants to do his trial

He said that if [the] FDA does approve emergency access utilization for the vaccine, then the true effectiveness of it may never be known and a bad precedent will be set for vaccine trials going forward.

I see nothing to indicate xenophobia.

 

[RunningBum]

I keep seeing a lot of comments saying Europe is doing everything better. If so, they should be willing to accept the European trial, no?

My impression has been that what people think Europe is doing better is to reduce the spreading of the virus--isolation, distancing, mask wearing, etc. That doesn't necessarily mean that anything and everything related to the virus must be better if it came from Europe, since a vaccine is far different than the methods of reducing virus spreading.

 

[Midpack]

My impression has been that what people think Europe is doing better is to reduce the spreading of the virus--isolation, distancing, mask wearing, etc. That doesn't necessarily mean that anything and everything related to the virus must be better if it came from Europe, since a vaccine is far different than the methods of reducing virus spreading.

+1, well said. The USA response has been horrible, but that doesn’t mean the first/best vaccine can’t come from the USA, Moderna or someone else. If the first/best vaccine is outside the USA, we won’t be first in line unless you’re a very wealthy or celeb American...

 

[explanade]

Supposedly they want to approve the Oxford/Astra Zeneca vaccine based on a 10,000 persons study in the UK, rather than proceed with the 30,000 persons study for Phase 3.

The Moderna and Pfizer vaccines are enrolling people for 30,000 persons each.

If they don't do the 30000 persons Oxford trial, they could give it EUA in October, well before the election.

 

[retire-early]

I am more willing to trust European trials to be more "unbiased" than a FDA and CDC that are apparently influenced by political pressure.

I actually may even trust Taiwan or New Zealand trials more than European trials.

.

 

[HI Bill]

I just received an invitation from Kaiser Permanente to participate in a COVID-19 trial. I think I'll pass....

 

[RAE]

The political influence in all of this is one big reason why I will not be getting a COVID-19 vaccine anytime soon. No matter what they say, this vaccine is being rushed to market FAR faster than any other vaccine in history. I'll let a couple hundred thousand other people give it a try first, if they choose to........I'll wait until I'm convinced it is safe (and effective).

 

[Popeye]

Supposedly they want to approve the Oxford/Astra Zeneca vaccine based on a 10,000 persons study in the UK, rather than proceed with the 30,000 persons study for Phase 3.

The Moderna and Pfizer vaccines are enrolling people for 30,000 persons each.

If they don't do the 30000 persons Oxford trial, they could give it EUA in October, well before the election.

I saw somewhere there was an additional 5000 subject study in Brazil. Is 30,000 the typical level in the US?

 

[explanade]

I saw somewhere there was an additional 5000 subject study in Brazil. Is 30,000 the typical level in the US?

Not sure.

But vaccines typically take years before they get approved.

Doesn't mean they don't deploy it until FDA approval but they take years and years.

 

[Midpack]

The political influence in all of this is one big reason why I will not be getting a COVID-19 vaccine anytime soon. No matter what they say, this vaccine is being rushed to market FAR faster than any other vaccine in history. I'll let a couple hundred thousand other people give it a try first, if they choose to........I'll wait until I'm convinced it is safe (and effective).

Don’t worry, a couple hundred thousand other people will get the vaccine before you and the rest of us even if we want it. Just like all the celebs, wealthy folks and health care workers (justified) had/have access to more and better testing than you and the rest of us now. It’s going to be a long, long time before a vaccine is widely available even if they’re proven by early 2021.

 

[donheff]

Don’t worry, a couple hundred thousand other people will get the vaccine before you and the rest of us even if we want it. Just like all the celebs, wealthy folks and health care workers (justified) had/have access to more and better testing than you and the rest of us now. It’s going to be a long, long time before a vaccine is widely available even if they’re proven by early 2021.

+1. Rather than push a poorly tested vaccine into the medical community they should have considered challenge trials on volunteers.

 

[Gumby]

I don't know if we can conclude that because vaccine development has always taken years it must always take years. I'm willing to be cautiously optimistic that with enough incentive (desperation plus wads of money) we may be able to improve on our prior performance.

 

[Ronstar]

Don’t worry, a couple hundred thousand other people will get the vaccine before you and the rest of us even if we want it. Just like all the celebs, wealthy folks and health care workers (justified) had/have access to more and better testing than you and the rest of us now. It’s going to be a long, long time before a vaccine is widely available even if they’re proven by early 2021.

But if the vaccine works, we laggards still benefit because the elite will be treated and there will be less folks transmitting the virus.

 

[easysurfer]

I keep seeing a lot of comments saying Europe is doing everything better. If so, they should be willing to accept the European trial, no?

In grade school, isn't that called borrowing the test answer from the smart student sitting next to you?

 

[Navigator]

I read today a poll that said a third of people in the US would refuse to get a Covid-19 vaccine if one were available. Normally I would say anti-vaxxers are crazy, but the politicalization of the FDA and the vaccine approval process has sown legitimate doubt about whether such a vaccine would be safe.