Are the FDA just wasting time and money looking through data which cannot yield any useful information. — Isaac
Clinical trials don't just hand out the product and then stand back and wait to see if anyone calls them. — Isaac
'Safe and effective' is not a binomial status. Nothing is without risk. — Isaac
It's not the optimism I was questioning. It was the relegation of important investigations by dedicated scientists to 'bureaucracy'. — Isaac
There may be people who either should or are obliged to be armed most of the time. But for the rest of us, in my book, it takes a real pussy to wear, and to think he needs to wear, a gun beyond need. — tim wood
The point is that what the find will confirm that the vaccine is safe and effective. — Fooloso4
It is sometimes the case that a product is approved and then pulled from the market based on problems that are found only when they are used widely and they are called. — Fooloso4
Yes, they are relative terms, but they are the terms used by the FDA. — Fooloso4
It’s reasonable to believe that the product may be effective and that the known and potential benefit outweigh the known and potential risks.
most of that work is done by the pharmaceutical industry and academic institutions. The FDA's role is primarily to compile and evaluate data provided to it. — Fooloso4
So they are wasting their time then? If what they'll find is already known. — Isaac
It is, but that's not what a phase IV trial is, nor is it the type of data the FDA are looking at. — Isaac
A EUA's terms are that... — Isaac
And you think that role a trivial foregone conclusion? — Isaac
It still needs to be rigorously documented. — Fooloso4
Phase IV trials are for products that have been approved and are already on the market. Phase IV trails are not the only way that problems are reported. Do you have a point here? — Fooloso4
We are talking about approval. EUA was issued months ago. The question is whether the vaccine will be approved based on the evidence to date. — Fooloso4
What problems can you cite that will lead them to deny approval? — Fooloso4
efficacy and manufacturing data. Companies also submit at least six months of follow-up safety data from clinical trials
What source are you using for your assertion that the full approval process consists of only 'documenting' that which is already known. — Isaac
The point is simply that the absence of any negative reports is not the same thing as an investigation to determine safety. — Isaac
You said it had already been shown to be 'safe and effective' by the FDA. — Isaac
It's not that complicated, full approval checks... — Isaac
So the problems would be some limit to efficacy, a risk in the manufacturing process, or some methodological error in the follow up trials. — Isaac
That is your assertion not mine. — Fooloso4
what the find will confirm that the vaccine is safe and effective. — Fooloso4
There is a process in place that must be followed. It still needs to be rigorously documented. — Fooloso4
The investigation has been ongoing from the start. It include both positive and negative reports. — Fooloso4
I did not say that. I said it has been shown to be safe and effective, not that the FDA has shown it to be safe and effective. — Fooloso4
What problems can you cite that will lead them to deny approval? — Fooloso4
And where do you see evidence of such problems? — Fooloso4
But the idea that people shouldn't wear guns because other people with guns will protect them just seems like an admission of helplessness and dependency. — darthbarracuda
Again, seasonal recurrence of influenza demonstrates this. — 180 Proof
Unless we buy into a vast conspiracy, involving every medical journal, every major research university, every nation on the planet, and various independent research organizations, we have to conclude the vaccine works. — Hanover
The peer review team of every medical journal (which would publish on vaccine safety) - maybe ten key journals, lots of overlap in peer reviewers used, maybe 10-15 people, 30 at most — Isaac
Are you suggesting that it's completely beyond understanding that people might think the largest lobbying group in the world might have unduly influenced a few hundred people? — Isaac
This study had 3000 alone. https://www.cdc.gov/media/releases/2021/p0329-COVID-19-Vaccines.html
Show me why even in the studies you cited why the sample size was statistically invalid. — Hanover
Show me your study disproving the effectiveness of the vaccine. — Hanover
That you've arrived at a motive for why people might fabricate results does not prove they fabricated results. — Hanover
Proof would be showing the results invalid or in having a witness come forward, which apparently everyone from the lab to the boardroom has taken a vow of silence on. — Hanover
Instead of doubling down and fighting the obvious, how about just admit the best evidence is that the vaccines reduce your chance of getting the original strain of covid (>95%) and virtually eliminate your chance of getting seriously sick from the Delta strain. — Hanover
You are part of the problem. — Hanover
What, if not just documentation, do you think the FDA are doing in their full approval process? — Isaac
https://www.fda.gov/news-events/press-announcements/fda-brief-fda-provides-guidance-master-protocols-evaluating-prevention-treatment-options-covid-19#:~:text=%E2%80%9CDuring%20this%20global%20pandemic%2C%20the,a%20very%20time%2Dconsuming%20process.Conducting clinical trials to see if a drug is safe and effective can be a very time-consuming process. To meet the urgent demand for effective therapies, FDA has worked with clinical trial experts to rapidly advance best practices in the design and execution of clinical trials. Today, we’re providing industry guidance for creating master protocols (an overarching protocol designed to answer multiple questions) when evaluating drugs for the treatment or prevention of COVID-19.
The FDA's main job is not to conduct clinical trials but to review and either approves or rejects the products based on their evaluation of the trial results. — Fooloso4
I'm not sure what it is about my responses that's given you the impression I'm unaware of what the FDA's role is since I cited their own lawyer explaining it, but I appreciate the effort nonetheless. — Isaac
It was the relegation of important investigations by dedicated scientists to 'bureaucracy'. — Isaac
1. The FDA have yet to perform some of these checks which may lead to them rejecting the product on the basis of their evaluation of the trial results. — Isaac
2. The FDA have no more checks to do that could lead to them them rejecting the product on the basis of their evaluation of the trial results. They're just wasting time doing paperwork which cannot possibly make any difference to the decision. — Isaac
It was the relegation of important investigations by dedicated scientists to 'bureaucracy'. — Isaac
I think the problem may be your lack of understanding of what a bureaucracy is. The FDA's function is bureaucratic. — Fooloso4
At this point it is no longer just trial results. Millions of doses of the vaccine have been administered. The protocol for a trial is very different from actual use. The main difference is that no one is receiving a placebo. The FDA is no longer looking at just trial results. — Fooloso4
It is a bureaucratic process. It takes time. I don't know what you think "paperwork" means as part of this process. — Fooloso4
That relegates the work the FDA are doing to work that is of no consequence to the safety of the public. — Isaac
The matter at hand is whether the remaining work the FDA has to do prior to approval has any impact on reducing the risks faced by the public with regards to the vaccine. — Isaac
Again, the terms we use are irrelevant. — Isaac
Do you think the FDA are carrying out any work at all which reduces the risk to the public from the vaccines? — Isaac
This is your misunderstanding that you attribute to me. — Fooloso4
The FDA will approve the vaccine. At this point it is a matter of bureaucracy rather than safety or efficacy — Fooloso4
The only way it would reduce the risk is if something previously unknown or undisclosed were to come to light in the next few weeks. It is unreasonable to assume that the FDA is hiding things from us, allowing vaccination to continue for the next few weeks only to deny approval. — Fooloso4
And yet you took exception to the use of the term bureaucratic — Fooloso4
The FDA will approve the vaccine. At this point it is a matter of bureaucracy rather than safety or efficacy — Fooloso4
Again, your accusation. — Fooloso4
The FDA will approve the vaccine. At this point it is a matter of bureaucracy rather than safety or efficacy — Fooloso4
most of the work has already been done, but they must be thorough and complete the job. — Fooloso4
I am suspicious of the logic one has to employee to come to this conclusion. A vaccine is the opposite of a money maker; because it is a preventive. It's like claiming dental floss is a trick by the dental cabal. There is no logical connection. A single/double dose per person versus a bottle of pills sold every month for a lifetime. It's not rocket surgery. It eats up there production capacity to produce drugs that aren't price negotiated with the government. They had to use a wartime production act in order to get more made.What about the notion that the vaccine is a tool for extracting money from the population? How suspicious are you? — frank
You have not given a single reason why you think it will not be approved. — Fooloso4
I'll suppose your correct and percent of preventive protection is lower than reported. — Cheshire
Not taking a poorly working vaccine would make an unfavorable situation worse. — Cheshire
I don't see how the speculation improves an anti-vax position. — Cheshire
It's not like people are suddenly going to rush out and get it upon finalized approval. — Cheshire
three in ten unvaccinated adults, rising to about half of those in the “wait and see” group, say they would be more likely to get vaccinated if one of the vaccines currently authorized for emergency use were to receive full approval from the FDA. — https://www.kff.org/coronavirus-covid-19/poll-finding/kff-covid-19-vaccine-monitor-june-2021/
If everyone gets a virus before a vaccine can be approved then what was the point of the approval process. It's a simple risk/reward analysis — Cheshire
it has to be made from the point of view of a population. Looking at it on an individual level is misleading. — Cheshire
The consensus may be an excuse. They can't find another excuse? There is a mutli-billion dollar industry built on products that aren't FDA approved for medical treatment. But, are consumed without hesistation.The general consensus is that they would. — Isaac
Rather, I was acknowledging the intuitive rationality behind hesitation. If I perceive a vaccine risk higher than my perceived virus threat then the decision is do not take. If every decision is made from this subjective view then no one takes a vaccine that might have worked. It's a rational strategy for an individual to optimize that is detrimental to a group outcome. "every individual" is a bit of an empty term in a medical context beyond we all need air.Yes. Basically the whole of the point I've been making recently. That a policy is a good public health initiative is not the same as it being necessary or even appropriate for every individual. — Isaac
I have a family. Are they safer if I have and wear guns to protect them, or if I do not have guns. Safer? Not safer? — tim wood
It's a simple risk/reward analysis, but it has to be made from the point of view of a population. Looking at it on an individual level is misleading. — Cheshire
The consensus may be an excuse. They can't find another excuse? — Cheshire
If I perceive a vaccine risk higher than my perceived virus threat then the decision is do not take. If every decision is made from this subjective view then no one takes a vaccine that might have worked. — Cheshire
It's a rational strategy for an individual to optimize that is detrimental to a group outcome. — Cheshire
I wear a mask and stand 6 feet away from you, and you wear a mask and stand 6 feet away from me, the chances that I'm going to get the virus from you or you from me is about zero. — Dr Paul Offit - CDC vaccine and immunology advisor
Consider the harm of vaccinated 1 too few versus 1 too many. — Cheshire
What’s the difference between full approval and an EUA?
It’s one of scale. FDA will review much more data, covering a longer period of time, before granting full approval. “It’s not a huge difference, but it is a real difference,” Goodman* says. The agency will analyze additional clinical trial data and consider real-world data on effectiveness and safety. It will inspect manufacturing facilities and make sure quality control is very strict. “It’s an exhaustive review,” Goodman says.
On Wednesday, President Joe Biden told CNN's Don Lemon during a CNN Townhall that he expects Covid-19 vaccines could get full approval "quickly."
"They're not promising me any specific date, but my expectation, talking to the group of scientists we put together... plus others in the field, is that sometime, maybe in the beginning of the school year, at the end of August, beginning September, October, they'll get a final approval," Biden said.
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