Are the FDA just wasting time and money looking through data which cannot yield any useful information. — Isaac

The point is that what the find will confirm that the vaccine is safe and effective.

Clinical trials don't just hand out the product and then stand back and wait to see if anyone calls them. — Isaac

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.

'Safe and effective' is not a binomial status. Nothing is without risk. — Isaac

Yes, they are relative terms, but they are the terms used by the FDA.

It's not the optimism I was questioning. It was the relegation of important investigations by dedicated scientists to 'bureaucracy'. — Isaac

First, although research is ongoing, at this point approval is based on work that has already been done. Second, 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.

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

Wearing a gun can be a totum that represents someone's desire to be self-sufficient and prepared to defend themselves. Obviously it can be a danger to other people, since having a gun doesn't mean you know how to use it. And the sheer killing capacity of a gun (compared with a sword or a knife) may overshadow its symbolic role. 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.

The point is that what the find will confirm that the vaccine is safe and effective. — Fooloso4

So they are wasting their time then? If what they'll find is already known.

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

It is, but that's not what a phase IV trial is, nor is it the type of data the FDA are looking at.

Yes, they are relative terms, but they are the terms used by the FDA. — Fooloso4

I've provided a direct quote from the FDA's lawyer on the other thread. A EUA's terms are that...

It’s reasonable to believe that the product may be effective and that the known and potential benefit outweigh the known and potential risks.

Doesn't evenue mention 'safe', no binomial interpretation at all. If you've got some information to the contrary then it's customary to cite it, rather than just make the unsupported claim.

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

And you think that role a trivial foregone conclusion? The fact that 'most of that work is done by the pharmaceutical industry and academic institutions' is the very reason why the FDA are checking it.

So they are wasting their time then? If what they'll find is already known. — Isaac

There is a process in place that must be followed. It still needs to be rigorously documented. That is not a waste of time. That it is is your assumption.

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

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?

A EUA's terms are that... — Isaac

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.

And you think that role a trivial foregone conclusion? — Isaac

It is not a trivial conclusion. Again that it is trivial is your conclusion. What problems can you cite that will lead them to deny approval?

It still needs to be rigorously documented. — Fooloso4

What source are you using for your assertion that the full approval process consists of only 'documenting' that which is already known. You've yet to provide a single citation to back up anything you're saying. I don't see why you'd expect anyone to just take your word for it. Unless you're perhaps an expert in this and I'm just unaware of that.

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

The point is simply that the absence of any negative reports is not the same thing as an investigation to determine safety.

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

You said it had already been shown to be 'safe and effective' by the FDA. The FDA have currently given it EUA status, which does not even mention 'safe' and measures 'effectiveness' relative to the emergency, not in general.

What problems can you cite that will lead them to deny approval? — Fooloso4

It's not that complicated, full approval checks...

efficacy and manufacturing data. Companies also submit at least six months of follow-up safety data from clinical trials

So the problems would be some limit to efficacy, a risk in the manufacturing process, or some methodological error in the follow up trials.

What source are you using for your assertion that the full approval process consists of only 'documenting' that which is already known. — Isaac

That is your assertion not mine.

The point is simply that the absence of any negative reports is not the same thing as an investigation to determine safety. — Isaac

The investigation has been ongoing from the start. It include both positive and negative reports.

You said it had already been shown to be 'safe and effective' by the FDA. — Isaac

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.

It's not that complicated, full approval checks... — Isaac

That does not address my question: What problems can you cite that will lead them to deny approval?

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

And where do you see evidence of such problems?

I beg to differ. And I didn't choose "just masks" but the suite of public health behaviors vs the uncertainty of vaccine's adverse side-effects. By March it was reported that the 2020-2021 flu season was one of the mildest on record. Why? Because of very high usage of masking, social distancing, hand washing, disinfectants, etc. Slowing transmissibility is the key, which vaccines do not do and, even if +80% of the population were vaccinated, without continuiing public health measures to slow transmission we would not reach herd immunity. Again, seasonal recurrence of influenza demonstrates this.

When I made my decision over four months I did so on these bases and the course of the pandemic since, despite mass vaccinations, is consistent with my assessment. That said, last week I'd convinced my 79 year old, exceptionally healthy mother, who's a retired nurse of a half century and living in the Portland, Oregon metro area, to take the Pfizer vaccine which she received her first dose today. I might not wait much longer after all.

That is your assertion not mine. — Fooloso4

You said...

what the find will confirm that the vaccine is safe and effective. — Fooloso4

I asked if the exercise was then a waste of time, your conclusion was...

There is a process in place that must be followed. It still needs to be rigorously documented. — Fooloso4

But if I've misunderstood, then we can easily clear the matter up. What, if not just documentation, do you think the FDA are doing in their full approval process?

The investigation has been ongoing from the start. It include both positive and negative reports. — Fooloso4

Fine. A mixture of both positive and negative reports is still not a clinical trial.

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

I see. Then again, I'd ask what you think the FDA are doing. If third party research concluding it is safe and effective is sufficient for the FDA to find it so also, then they don't seem to have a role to play. Other, of course, than the 'documentation' you wish to distance yourself from.

What problems can you cite that will lead them to deny approval? — Fooloso4

I wrote the answer directly below the sentence you cited.

And where do you see evidence of such problems? — Fooloso4

Why would I see evidence of such problems? I'm neither privy to the research methodology, nor the manufacturing process.

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

Is this how you understand community and mature responsible membership in that community? And in terms of "protection," how many of those supposedly protected by privately-owned weapons have been injured or killed by those same weapons? Or in simpler terms, 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?

Again, seasonal recurrence of influenza demonstrates this. — 180 Proof

This isn't science. It's a theory. You'd have to prove it experimentally. You've got thousands of variables you have to control in order to correlate flu reduction to mask use and even if you could correlate it, you'd have to prove an equality between the flu and covid.

Meanwhile they've shown the vaccine works.

I never said anything about the efficacy of any vaccine. Not worth arguing about facts. Believe whatever you like. I'll be vaccinated soon enough.

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

Since you're not keen of the line of questioning regarding what 'works' means, perhaps this might be more interesting - how many people, in actual numbers, do you think this group consists of?

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.

Research institutions working directly on vaccine safety - the WHO lists 42, each with maybe 2-5 qualified lead staff (not including lab technicians and support staff), 120 or so.

Every nation on the planet - would get their data from the previous two.

Various independent research institutions - not sure what this is supposed to refer to.

I can't bring the list to much above about 200 people the majority of whom are working directly (or directly funded by) the pharmaceutical industry. Is that 'vast' to you? The June 2021 petition to the FDA to request that they not prematurely grant full approval is signed by 24 doctors and research scientists, including the Editor in Chief of the British Medical Journal, so if we expand the network to include people peripherally involved you lose the apparent consensus you're claiming.

I struggle to see how it is so hard to understand people who think that a couple of hundred individuals (most of whom work for the pharmaceutical companies) have been unduly influenced by those companies - the single largest industry in the world, the single largest lobbying budget of any industry in the world and one which spends more than four times the budget on lobbying than even it's next biggest in rank.

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?

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

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.

Show me your study disproving the effectiveness of the vaccine.

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

I'm suggesting I'm not interested in conspiracy theories. That you've arrived at a motive for why people might fabricate results does not prove they fabricated results. 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. It's preposterous and based upon groundless speculation, like all conspiracy theories. 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. That is, the vaccines "work." The hospitals and morgues are filled with the unvaccinated.

Whether it's PC to say the anti-vaxxers here are stupid is another question, but, suffice it to say, they are wrong, harmful, and their arguments depend upon creative writing conspiracy theories that they mindlessly spout.

You are part of the problem. That you don't like hearing it isn't part of the problem. The solution is to go get vaccinated.

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

I'm not talking about sample size. Your claim was that it would invoice a 'vast' conspiracy if claims about the vaccine's safety and efficacy were compromised. I asked you how many people you thought would be involved in such a conspiracy. The participants in a trial are not responsible for interpreting the results of it. You know what a peer review team is, yes?

Show me your study disproving the effectiveness of the vaccine. — Hanover

1. You've still not confirmed - effectiveness at doing what?

2. Medicines are required to prove their own effectiveness. It's not for others to prove ineffectiveness. The problems that have been highlighted are oversights, omissions and flaws with the studies proving efficacy, they're not studies proving ineffectiveness.

That you've arrived at a motive for why people might fabricate results does not prove they fabricated results. — Hanover

I never once mentioned fabricating results.

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

Really. So you'd stand by the claim that no qualified academic has come forward to raise concerns about the covid vaccine's trial methodology, safety and efficacy?

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

I haven't disputed that claim, so I haven't a clue why you would think I'm 'fighting the obvious'.

You are part of the problem. — Hanover

Explain how. You're here making a accusation that I'm actually part of the devastating crisis that is the covid pandemic, I think I at least deserve an explanation. How is what I do exacerbating that problem?

What, if not just documentation, do you think the FDA are doing in their full approval process? — Isaac

Perhaps this might help

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.

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.

The clinical trial experts are from the pharmaceutical industry and academia, not the FDA. 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.

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.

So, the undelined is the issue at stake. Only two possible states;

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.

Or

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.

Which do you think is happening and what evidence are you using to support your conclusion?

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

I am not going to chase down what you quoted in another thread.

You said earlier in this thread:

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.

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

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.

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 is a bureaucratic process. It takes time. I don't know what you think "paperwork" means as part of this process.

If there are serious problems or even suspected problems with either safety or efficacy that have come to light, the FDA and/or the vaccine manufacturers would already have stopped using the vaccine, at least temporarily. It is highly unlikely that anything yet unknown will come to light in the next few weeks before approval.

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

You missed the use of the word 'relegation'. It's the evident lack of utility you ascribe to it, quibbling over semantics is irrelevant when we have your assertion that there is no difference in risk between taking the vaccine now and taking it after approval. That relegates the work the FDA are doing to work that is of no consequence to the safety of the public. What we choose to call it is immaterial.

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

You keep adding these additional details about how the FDA carry out their checks as if a) I didn't know, and b) it impacts the discussion in some way. 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. I don't see how the fact that the work consists of more than just trial data has anything to do with that.

It is a bureaucratic process. It takes time. I don't know what you think "paperwork" means as part of this process. — Fooloso4

Again, the terms we use are irrelevant. It's the 'wasting time' that matters. You have just avoided the main question with all this fluff.

Do you think the FDA are carrying out any work at all which reduces the risk to the public from the vaccines? It would help move us on if you could just answer that question, in preference to acting as if you were playing the FDA round in a general knowledge quiz or arguing over the definition of 'paperwork'.

That relegates the work the FDA are doing to work that is of no consequence to the safety of the public. — Isaac

This is your misunderstanding that you attribute to me.

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

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.

Again, the terms we use are irrelevant. — Isaac

And yet you took exception to the use of the term bureaucratic. It is your "quibbling over semantics" that started this discussion.

quote="Isaac;576757"]It's the 'wasting time' that matters.[/quote]

Again, your accusation.

Do you think the FDA are carrying out any work at all which reduces the risk to the public from the vaccines? — Isaac

As I have said, most of the work has already been done, but they must be thorough and complete the job.

This is your misunderstanding that you attribute to me. — Fooloso4

You said...

The FDA will approve the vaccine. At this point it is a matter of bureaucracy rather than safety or efficacy — Fooloso4

How can we interpret that in a way that means the FDA are doing something that is of consequence to the safety of the public? You've directly said that the work does not relate to safety and efficacy.

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

Why would they be 'hiding' something? The work is not yet finished. What's at issue is facts they've yet to discover. They're not sitting on all the data they need twiddling their thumbs for a few weeks.

And yet you took exception to the use of the term bureaucratic — Fooloso4

I took exception to the context in which bureaucratic work was treated as being of little consequence. Again...

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

Again...

The FDA will approve the vaccine. At this point it is a matter of bureaucracy rather than safety or efficacy — Fooloso4

With the pharmaceuticals, government departments, universities and doctors clamouring for full approval you're accusing the FDA of delaying such important approval so they can do work which has no bearing on either safety nor efficacy. On what do you think the work they're doing does bear?

most of the work has already been done, but they must be thorough and complete the job. — Fooloso4

As above. What is it you think this remaining work consists of, and on what grounds?

What about the notion that the vaccine is a tool for extracting money from the population? How suspicious are you? — frank

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.

The ones profiting are the ones profiting off the fiction. People eat up controversy and so the internet profiteers keep cooking it.

You have not given a single reason why you think it will not be approved.

Rather than repeat myself I will leave it there.

What's even in the logic for highlighting doubt in efficacy. I'll suppose your correct and percent of preventive protection is lower than reported. The counter balance is higher uptake. Not taking a poorly working vaccine would make an unfavorable situation worse. I don't see how the speculation improves an anti-vax position.

It's not like people are suddenly going to rush out and get it upon finalized approval. It's not rocket surgery to imagine the effect of with holding a vaccine could be worse in some cases. 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, but it has to be made from the point of view of a population. Looking at it on an individual level is misleading.

You have not given a single reason why you think it will not be approved. — Fooloso4

I didn't say that I think it won't be approved. I said that the risk to the public is higher prior to them completing their checks than it is after they have done so. My reason is that the FDA are still checking it. If it was already ready to approve they would approve it. What else do you think they are going to be doing over the coming months?

I'll suppose your correct and percent of preventive protection is lower than reported. — Cheshire

Not sure why you'd suppose that since I've not claimed anything even close to such a proposition.

Not taking a poorly working vaccine would make an unfavorable situation worse. — Cheshire

It depends entirely on how poorly working it is and what the alternatives are.

I don't see how the speculation improves an anti-vax position. — Cheshire

What's the anti-VAX position got to do with anything I've said. Generally I'm staunchly pro-vaccination.

It's not like people are suddenly going to rush out and get it upon finalized approval. — Cheshire

The general consensus is that they would.

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/

Honestly, this information is not hard to find...

Plus it would make mandates easier to enforce.

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

Indeed. The entire purpose of EUAs.

it has to be made from the point of view of a population. Looking at it on an individual level is misleading. — Cheshire

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.

The general consensus is that they would. — Isaac

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.

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

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.

Consider the harm of vaccinated 1 too few versus 1 too many. Over-shooting is the reasonable target.

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

Safer if you, and they, know how, and are willing, to use said weapons to defend themselves.

If they are unable or unwilling, then they are not safer, you have provided a weapon to someone who is able and willing to use it.

Now how does this apply to the vaccine issue?

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

But why? The population will not feel any side effects of the vaccination, but the individual will, therefore it is an individual decision.

The "better for the population long term" argument should also support non-intervention for anyone that is suicidal as less individuals would mean more resources for others, less environmental damage, more job availability, etc. And yet, we are not advocating suicide, despite being able to spin the positive effects for society.

The consensus may be an excuse. They can't find another excuse? — Cheshire

Strange how the supply of evidence vacillates between being a marker of one's sanity to being entirely optional depending on which side of the debate one is on.

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

Why would no one take a vaccine under these terms. Are vaccines so badly presented that literary everyone is going to perceive the risk from taking it to he higher than the risk of the disease. Is that the view you generally hear in public forums?

It's a rational strategy for an individual to optimize that is detrimental to a group outcome. — Cheshire

Only if the resultant group exceeds the inverse of the proportion required for herd immunity. If not, it really doesn't matter at all. If they adopt other strategies to minimize transmission it also doesn't matter one jot. If I'm healthy, live alone, remain masked in my occasional public visits, sanitise my hands regularly and remain a few feet apart from anyone I meet, explain to me how I'm going to have a higher probability of passing on a virus than if I did none of those things but took a vaccine at 70% symptomatic effectiveness... and yes, I will expect you to cite sources, not just make it up.

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

...in case you're wondering what citing sources looks like.

Consider the harm of vaccinated 1 too few versus 1 too many. — Cheshire

Depends entirely on the circumstances, the method by which you achieve the target, the alternatives available, the status of the virus concerned and the status of the one too few/many. It's not a simple metric.

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.

* Jesse Goodman, a former chief scientist at FDA who’s now at Georgetown University.
https://www.sciencemag.org/news/2021/07/when-will-covid-19-vaccines-be-fully-approved-and-does-it-matter-if-they-are

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.

https://www.cnn.com/2021/07/22/health/covid-19-vaccine-approval-when/index.html