General Question

crazyguy's avatar

How long will the FDA take with Pfizer's EUA application?

Asked by crazyguy (1441points) 6 days ago

The Phase 3 trial conducted by Pfizer and their German partner has shown their vaccine candidate to be more efficacious than expected by most people, including Dr Fauci. I would readily admit to some misgivings about how the efficacy is calculated. Basically efficacy was calculated as the percentage of infections in the study population of those receiving placebo versus those receiving the vaccine.

The total study population was 44,000. Half of the study population was injected with a placebo (probably glucose). The other half received the vaccine. Out of the 44,000 total participants,170 contracted covid-19. 162 of the infections occurred in the placebo group. And only 8 in the group that received the vaccine. Therefore, efficacy was calculated as 162/170 = 95%.

No attempt was made in the study to evaluate the behavior of the volunteers. Was one group more prone to taking chances of catching the disease? Given the large numbers, differences in behavior should average out. It is to be noted, that, unlike the early thinking (for instance, see https://jamanetwork.com/journals/jama/fullarticle/2767024), no test volunteer was deliberately exposed to the virus. That is the reason the studies took so long to complete. The endpoint was predetermined to be x naturally occurring positive results.

The FDA knows all this. Therefore, my question is, how much more time will the FDA take?

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16 Answers

crazyguy's avatar

I just saw a news item flash by on the screen that the FDA advisory committee will consider the application on Dec 10. However, I have been unable to confirm this online. If it is true can anybody tell me why it takes so long to consider something which has been well-known for months?

elbanditoroso's avatar

Why don’t you tell us, oh wise seer, who knows all, and wants to tell us all that he knows all?

As I understand the process, the FDA – for every drug – not just this one – goes through their own independent analysis. Basically they don’t take the word of the drug company, they analyze for themselves.

See “this”: https://www.fdareview.org/issues/the-drug-development-and-approval-process/

I’m not an expert on drug analysis, and I’ll bet you aren’t either. But when you consider that this process normally runs in time frames of a multiple years, I’d say that a couple months is pretty fast.

The last thing they want to do is approve a drug that kills people.

Consider their approval of
– thalidomide in 1956
– swine flu vaccine in 1976 (and Guillain-Barré Syndrome)

Given the political pressure and the appearance of presidential influence, you can be pretty sure that they will be deliberately conservative in their analysis.

si3tech's avatar

@elbanditoroso I remember the thalidomide. They can only do what they can do carefully.

crazyguy's avatar

@si3tech How about saccharin? This is a truly mind-boggling example. According to wikipedia:

“In 1911, Food Inspection Decision 135 stated that foods containing saccharin were adulterated.[26] However, in 1912, Food Inspection Decision 142 stated that saccharin was not harmful.[27]”

So the newly formed FDA did not approve saccharin in modern terms. However, they did bless it as “not harmful”.

In the 1970s studies on rats found that saccharin can be cancerous. In 1977, the FDA tried to ban saccharin. Instead it just added the following language to the label:
“Use of this product may be hazardous to your health. This product contains saccharin which has been determined to cause cancer in laboratory animals”.

The language was dropped in 2000 on the basis of “new research that concluded humans reacted differently than rats and were not at risk of cancer at typical intake levels.[28]”

So, as you can see, there is no way to prove a vaccine is safe over the long term without doing studies for a long term. Do we want that for the cvid vaccine?

zenvelo's avatar

Moderna also plans to ask for expedited approval.

The Moderna vaccine is equally effective but does not require the unusually low temperature storage. The Pfizer vaccine can’t be widely distributed because there aren’t storage facilities.

crazyguy's avatar

@KNOWITALL That, my friend, is an incredible bit of research. And a great find on your part. With a vaccine to prevent most infections and therapies to treat the few that escape the vaccine, we would appear to be on the path to recovery.

crazyguy's avatar

@zenvelo Moderna’s vaccine EUA application will, I believe, be submitted next week. They are one week behind Pfizer. Hopefully, much of the background work necessary to approve the Pfizer EUA will be useful for the Moderna EUA as well.

Dutchess_III's avatar

Except the news source is St.Jude. Of course they’re going to toot their own horn whether it’s valid or not.

crazyguy's avatar

@Dutchess_III Except, the premise of the science makes _so much sense)! Of course, I expect that you have at least made an attempt at reading and understanding the article?

Caravanfan's avatar

@Dutchess_III The anti-vax covidiots are going to ruin it for all of us.
@KNOWITALL Sadly, no. It won’t work.

crazyguy's avatar

@Caravanfan If you know of a scientific reason why the therapeutic described in the St Jude paper won’t work, please share.

KNOWITALL's avatar

@Caravan That science is way over my head. Who are you betting on?

Caravanfan's avatar

@KNOWITALL Since the American public are unbelievably stupid and refuse to wear universal masks, I’m all in on one of the vaccines. No other therapy has been shown to work.

crazyguy's avatar

@Caravanfan You said about the St Jude therapeutic: ” Sadly, no. It won’t work.” To which I had the rather obvious request: “If you know of a scientific reason why the therapeutic described in the St Jude paper won’t work, please share.” I am just a layman but do not see an answer to my request in your latest post.

Caravanfan's avatar

@crazyguy It’s because I didn’t answer you. After your insult to @Dutchess_III which you never apologized for I have decided not to answer any of your responses.

But in this case I will answer for @KNOWITALL, not you. To fully understand this you have to understand the immunology and cytokine response. It is nothing new that Covid-19 activates cytokine storm, in fact there have been a couple of therapies based upon the cytokine storm theory that have been shown in clinical trials not to work. This study St. Jude is referring to is done in mice only. The field it littered with drugs that have been shown, after further data to be useless. Physiologically it makes no sense that once you have alveolar damage, flooding, and hypoxia, adding a monoclonal antibody will magically reverse it.

Going to say this a final time. The only thing that has been proven to work is universal masking and staying the hell away from people. Don’t get sick in the first place is your best bet.

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