The safety and efficacy have been established. — Fooloso4

Long term safety certainly has not been established. That said, I have no doubt many therapeutics are approved prior to long term safety being established.In this case, since we are dealing with a virus that will evolve, long term efficacy cannot be established.

Long term safety certainly has not been established. That said, I have no doubt many therapeutics are approved prior to long term safety being established. — Janus

600,000 thousand and counting dead in the U.S. from the virus or complications. How many deaths from the vaccine? What long term deleterious effects are you rationally contemplating that could make the vaccine the less good choice?

I'm not saying the vaccine is the less good choice. I haven't seen any what I count as good reasons to think that there will be long term consequences, even dire ones, but some well-respected (or previously well-respected at least) medical experts apparently do:

https://sciencebasedmedicine.org/the-covid-19-vaccine-holocaust-the-latest-antivaccine-messaging/

It seems reasonable to think that just because someone is a well-respected Professor in the medical field, that doesn't preclude the possibility that they might lose the plot and start having and fueling paranoid delusions..Part of those what certainly seem to be delusions are driven by what @Isaac identified as a justifiable distrust of "Big Pharma".

On the other hand the possibility that experts are rejecting these kinds of possibilities out of hand on account of fearing criticism from their peers for not towing the official line, losing their positions or research funding and so on, should not be blithely dismissed either. There would seem to be some truth in that too.The complaint from the "anti" side is that there is no reasoned debate. But it is an emergency situation, and if these concerns are not merely dismissed out of hand, but publicly debated, the worry is that it would spook even more people increasing vaccine hesitancy thus undermining the response to the emergency.

It's a complex situation, but I'm certainly not convinced by what seem to be conspiracy theories and wild speculations that are abounding. But then I also realize I'm just a lay person and not really in a good position to judge what is correct and what is not, and so I, like most other people, are left with the decision as to whether to place trust in the official narrative, in regards to which it seems reasonable to think there are good reasons not to trust it entirely, or be left completely at sea with wacko conspiracy theories, or speculation involving possibilities which are dressed up as being likelihoods or even certainties, which it seems we have no reason at all to trust..

The choice seems clear;I'm going to go with the dominant, the official narrative, but not entirely without misgivings, which means I have some empathy for those who place themselves on the other side, and don't want to simply dismiss them, even though the emergency nature of the situation seems to call for that.

What long term deleterious effects are you rationally contemplating that could make the vaccine the less good choice? — prothero

From the petition sent to the FDA by (among others) Peter Doshi, Associate Professor, Pharmaceutical Health Services Research,University of Maryland School of Pharmacy (also Editor in Cheif of the British Medical Journal), Linda Wastila, BSPharm, MSPH, Professor, Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, and

Required studies must, at a minimum, address these concerns: i. Coagulopathy issues, including blood clots, hemorrhage, thrombocytopenia, heart attack, and strokes. According to the VAERS, as of May 21, 2021, there have been a total of 1,222 reports of thrombocytopenia/low platelets; and 6,494 (112 in 0-24 year-olds) reports of blood clots/strokes. ii. Reproductive issues, including menstrual irregularities, reduced fertility, miscarriages, and preterm births. According to VAERS, as of May 21, 2021, there were 511 reports of miscarriage and 522 reports of uterine hemorrhage (including 88 in women older than 50 years). The vaccines induce the generation of antibodies to attack spike protein, which are genetically similar to proteins produced by the placenta.30 To date, no vaccine sponsors have conducted immunologic studies of spike protein involvement with proteins involved in placental development. iii. Carcinogenesis. There is preliminary and theoretical evidence that the spike protein may promote cancer.31,32 Considering the potential for annual booster vaccinations, COVID-19 vaccines should be treated similarly to medication taken for chronic conditions on a long term basis. Carcinogenic potential is important to characterize. iv. Transmission of spike protein (or its fragments) from vaccinated individuals, such as through breast milk and associated risk in neonates and infants. According to the UK Medicines & Healthcare products Regulatory Agency, there are 921 reports of exposure via breast milk following AstraZeneca’s vaccine and 215 reports following Pfizer’s v.vi.vii.viii.Neurological disorders, including Guillain-Barré syndrome, acute disseminated encephalomyelitis, transverse myelitis, encephalitis, myelitis, encephalomyelitis, meningoencephalitis, meningitis, encephalopathy, demyelinating diseases, and multiple sclerosis. Cardiac issues, including myocardial infarction, myocarditis and pericarditis, among others. According to the VAERS, as of May 21, 2021, there have been a total of 1,598 reports of heart attacks (24 reported in 0-24 year-olds; 501 resulted in death). Autoimmune diseases, including thyroiditis and diabetes mellitus, immune thrombocytopenia, autoimmune hepatitis, primary biliary cholangitis, systemic sclerosis, autoimmune disease for skeletal muscles (myasthenia gravis, myositis such as polymyositis, dermatomyositis, or other inflammatory myopathies) Studies should be conducted in individuals of both sexes 33 and all ages. We cannot assume that the effects of spike protein are the same across populations of all ages, sex, and across pre-existing conditions.

Also there's

Paediatrics professor Ruediger von Kries, a member of Germany's advisory vaccine committee,

practically nothing is yet known over any long-term adverse effects in adolescents

also there's the issue of Myocarditis https://www.sciencedirect.com/science/article/pii/S0264410X21006824 in young people which significantly outweighs their risk from Covid-19.

Of the FDA's own Dr Philip Krause who explains

Very often, it's the fact that we have that placebo controlled follow-up over time, that gives us the ability to say that the vaccine didn't cause something at a longer period of time after vaccination Continuation of placebo controlled follow-up after EUA will be important and may actually be critical to ensure that additional safety and effectiveness data are accrued to support submission of a licensure application as soon as possible following an EUA. Once a decision is made to unblind an ongoing placebo controlled trial, that decision cannot be walked back. And that controlled follow-up is lost forever.

or Dr Stepen Baral Professor of epidemiology at Johns Hopkins

For adults, the benefits of COVID-19 vaccination are enormous, while for children, they are relatively minor. Rare side effects from adult COVID-19 vaccination are unlikely to lead to future vaccine hesitancy whose public health impact could be comparable to the benefits of the adult COVID-19 vaccination program itself. But accelerated mass child vaccination under EUA — perhaps even spurred by school mandates and “vaccine passports” — presents a different balance of risks and benefits. Rare adverse events really could prove to be the most durable public health legacy of an EUA for child COVID-19 vaccines.

also there's the issue of Myocarditis https://www.sciencedirect.com/science/article/pii/S0264410X21006824 in young people which significantly outweighs their risk from Covid-19. — Isaac

From the paper:

"Interpretation

Our report of myocarditis after BNT162b2 vaccination may be possibly considered as an adverse reaction following immunization. We believe our information should be interpreted with caution and further surveillance is warranted."

I think it's a bit of a leap from that to your conclusion that the risk of myocarditis from vaccination outweighs the risks from Covid.

I think it's a bit of a leap from that to your conclusion that the risk of myocarditis from vaccination outweighs the risks from Covid. — Janus

Yes, sorry. I missed out the important analysis of the statistics - here (see chart no 3) https://medium.com/@wpegden/weighing-myocarditis-cases-acip-failed-to-balance-the-harms-vs-benefits-of-2nd-doses-d7d6b3df7cfb . I was rushing, thanks for picking up on that.

I'm not sure who you're arguing against here. — Isaac

You are so busy arguing you can't keep track of what you are arguing for or against.

No one is denying it's safe and effective. — Isaac

Because it has been shown to be safe and effective.
— Fooloso4

That doesn't make sense. — Isaac

Still going?

How have you translated my saying that your argument doesn't make sense into me disagreeing with one of its propositions?

If I claimed trees were yellow because custard is yellow, and you said "that doesn't make sense", would I then be entitled to say "ah, so you think custard isn't yellow"?

I'm not disagreeing with the proposition that the vaccine has been shown to be safe and effective. I'm disagreeing with the proposition that the FDA work does not relate to safety and efficacy. As I explained literally in the same post you cherry-picked that quote from.

The vaccine being safe and effective does not have any bearing whatsoever on whether someone can make it more safe by being even more certain, nor whether someone can find it the less safe by finding errors in the methods used to check its safety at first. In neither case need anyone conclude that the vaccine is not safe because it's possible for things that are safe to be more safe or less safe. Safe is not a binomial measure, it's not 1or 0, safe or unsafe - there's quite safe, averagely safe, very safe, extremely safe... all forms of safe.

The FDA are expecting to take a vaccine which is safe and make it more safe. There's a very small chance they might find it to be less safe, but even in this case it might still be safe, just less so than we thought.

I can't believe I'm having to explain how continuous variables work...

I'm disagreeing with the proposition that the FDA work does not relate to safety and efficacy. — Isaac

In that case once again you are disagreeing with a claim of your own making. I said nothing of the sort. What I said is:

The role of the FDA is to verify that products are safe and effective. — Fooloso4

The problem begins with your lack of understanding of the term bureaucracy:

I don't see the justification for saying that the additional work of exactly the same form to meet the higher threshold is 'just bureaucracy'. — Isaac

From there you raised additional claims about wasting time and money, paper pushing, trivial conclusions, and the FDA delaying approval so they can do work which has no bearing on either safety nor efficacy, only to then argue against these claims as if someone other than you made them.

After all this, you seem to have come around to the position I started with:

The FDA will approve the vaccine. At this point it is a matter of bureaucracy rather than safety or efficacy, which have been amply demonstrated. — Fooloso4

You do not dispute that is is safe and effective:

No one is denying it's safe and effective. — Isaac

Despite your wild claims that you attempted to attribute to me, you also seem to be aware that the process take time.

Now unless you have some other claims you want to make up in order to argue against them I think we are done.

Why have you started from the middle of our conversation?

You said

At this point it is a matter of bureaucracy rather than safety or efficacy, which have been amply demonstrated. — Fooloso4

That is wrong. That's all I've been arguing. Your own later comment says as much. It is logically incoherent to claim that

The role of the FDA is to verify that products are safe and effective. — Fooloso4

And then claim that their main job is some other work rather than safety and efficacy work.

I'm not disagreeing with the proposition that the vaccine has been shown to be safe and effective. I'm disagreeing with the proposition that the FDA work does not relate to safety and efficacy. — Isaac

You are arguing for marginal safety on principle. That's like proving that time passes.

You are arguing for marginal safety on principle. — Cheshire

It's a blessing just to hear from someone who actually understands at least the structure of the argument I'm making... at least I'm not having to explain how continuous variables work...

However, if you want to argue that it's marginal then I expect to see some evidence to that effect. It really shouldn't be too much to ask.

No problem. It's good to see someone who's open enough to change their mind when it's warranted. :up:

And then claim that their main job is some other work rather than safety and efficacy work. — Isaac

Once again making claims and then attributing them to me.

What I said was:

At this point it is a matter of bureaucracy rather than safety or efficacy, which have been amply demonstrated. — Fooloso4

Note the bolding: AT THIS POINT. Is that not clear enough? That is not to deny the purpose and function of the FDA. It is a matter of where they are in the process of approval. The problem with the length of time it takes to approve a product is well known. They have taken measures to reduce the amount of time but it still takes time to complete that process.

Let's turn thins around. As you admit the vaccine has been shown to be safe and effective, so why hasn't it been approved yet?

Last night's Media Watch program - a TV program that monitors reporting and media across Australia - noted that there's been a 180 degree turnaround in vaccine messaging on News Ltd (read: Murdoch) press in Australia. A month back there were routine headlines in the leading tabloid rags questioning the efficacy of the COVID vaccine. But last month a well-known loudmouthed radio bigot rubbished vaccines in an interview with an anti-vax politician, which lead to Sky News being banned from Youtube for seven days for spreading disinformation. Added to that, there were two deaths of young, healthy persons from the Delta variant within a week, and a lot of people have been thrown out of work by lockdowns. So suddenly the tide has turned, the main daily paper, The Daily Terror, has started urging its readership to turn out for vaccines, and the rates are skyrocketing.

Pursuant to all of this, there are also moves towards mandatory vaccination. The State and Federal Governments, both Liberal, say they would never make vaccination compulsory as a matter of principle, but in practice it's beginning to happen, in that workers who live in a designated area might be obliged to produce proof of vaccination if they want to work in another area. So to all intents that is a form of compulsion. It's a delicate question - I can see why a person is soveriegn over their own body and should have the right to refuse vaccines. But then, the person that might end up paying the price for that might be someone they infect. So perhaps the compromise is, anyone has a right to refuse to be vaccinated, but by so doing they forfeit the right to move freely in society.

But then, the person that might end up paying the price for that might be someone they infect. So perhaps the compromise is, anyone has a right to refuse to be vaccinated, but by so doing they forfeit the right to move freely in society. — Wayfarer

Excellent point. And by the same token, I assume you favor restrictions on the free movement of the vaccinated, since they too may infect others.

Vaccinated People May Spread the Virus, Though Rarely, C.D.C. Reports

You agree? If not, why not? If perhaps you're going to invoke the word "rarely," what's your standard for restricting free movement? Have you hard data on how many people are being infected by the unvaccinated? Is that rare, or common? What are the actual numbers? What is the science? I think people on all sides of these issues would like to see the data. Why is the Biden administration itself growing frustrated with the lack of CDC transparency?

From that latter article: "Public Health England published data collected through the end of July showing that vaccinated people are less likely than the unvaccinated to become infected with Delta, but once infected, they may be equally contagious."

I guess we SHOULD restrict the vaccinated individuals' freedom to move through society after all. If you have hard data on any of this I think we'd all be grateful, particularly the Biden administration. Of course you don't have data, because the CDC won't release it.

So perhaps the compromise is, anyone has a right to refuse to be vaccinated, but by so doing they forfeit the right to move freely in society.

What if they do not have the virus and present no risk to anyone?

The ethical implications of quarantining Typhoid Mary are one thing—her activities infected others—but removing the right for the healthy to move freely in society, where no one is at risk for interacting with them, could never be more than a policy premised on the ignorance and fear of those in power. In short, you would be discriminating against the wrong people.

Besides, it’s far better to protect oneself than expect everyone else to protect you. That way lies tyranny.

'Vaccinated People May Spread the Virus, Though Rarely.'

Perhaps their freedom of movement may also be curtailed, though less so. Perhaps 'social distancing', the wearing of masks, and other hygeine measures, will henceforth remain as part of civil society.

I get a lot if insights from your posts on maths. — Wayfarer

LOL. Can you comment on my point here? You said the unvaccinated should have their freedom of movement restricted because they may spread covid. I linked an article showing that the vaccinated spread covid at the same rate as the unvaccinated. In view of that, shouldn't the vaccinated be prohibited from free movement as well?

Have you a response?

It's deduced from the argument structure. Safety in regards to the threshold for public disbursement was met; safety beyond this threshold is literally increased incrementally following further results, studies, aggregate data expositions, etc. If argued in principle, then the principle defines the matter as a marginal increase. And thanks.

It is a matter of where they are in the process of approval. — Fooloso4

Firstly, where they are is right in the middle of their main job - full approval of a BLA for a new medicine.

Secondly, you've still not given any detail on exactly what it is you think the FDA are doing over the next stage in their work (this mysterious 'bureaucracy' which is apparently unrelated to either safety or efficacy). Nor, more importantly, provided a shred of evidence to support whatever that belief might be.

I think you really ought to share your evidence about what the FDA is doing. I mean even Leana Wen, Public Health Professor at George Washington University doesn't know, nor do any of her colleagues so the fact that you do is pretty big news...

I understand that the regulatory process is complicated, but right now, it feels like a black box. And I think this is what I and other public health experts are calling for the FDA to not make this process so opaque. I mean, it would be really important, I think, for public credibility and understanding for them to say, for example, here are the 50 steps that we need in order for full approval to occur. We already have these 30 taken care of, 10 are in process, 10 are still to be determined. — Leana Wen, Public Health Professor at George Washington University

As you admit the vaccine has been shown to be safe and effective, so why hasn't it been approved yet? — Fooloso4

Because it has not yet been shown to be safe enough. As has been explained in the three quotes cited directly from FDA staff, the full approval is a more thorough process looking at trial methodology of longer-term data sets and manufacturing processes.

The EUA checks to see if the medicine is safe enough to balance the risks from the emergency in question, the full approval checks to see if it's safe enough to use even without that risk (and without specific usage guidance). Two levels of safety, for two different purposes, one higher than the other.

I'm not just going to re cite all the evidence I've already provided for this. At this point I give up. If you think the FDA are doing something other than I describe simply cite your evidence supporting that assertion, I'm not going to respond to unsupported claims anymore.

Safety in regards to the threshold for public disbursement was met; safety beyond this threshold is literally increased incrementally following further results, studies, aggregate data expositions, etc. — Cheshire

I think this only holds if you can somehow quantify each of the safety levels (unless I've misunderstood what you mean by 'marginal', I took it to mean 'small'). The EUA threshold is one level of safety, the BLA approval is another, higher, level. To know that the difference between the two is 'marginal' we'd need some way of quantifying each. I don't think such a way exists, which is why - going right back to the beginning of this whole shambles of an argument - which was...

I am surprised to hear that you are waiting. The FDA will approve the vaccine. At this point it is a matter of bureaucracy rather than safety or efficacy, which have been amply demonstrated. — Fooloso4

... I think it's not 'surprising' at all. Only each individual can determine for themselves whether the difference in safety between EUA and BLA approval is significant for them because we each only know our own risk profile (in consultation, hopefully, with health experts - our doctor, the ample research available online...). As such only the individual can make an assessment of whether they personally need that extra margin or not.

In view of that, shouldn't the vaccinated be prohibited from free movement as well? — fishfry

Whether or not they are as contagious once infected, they are infected at lesser rates. As continual testing of everyone is impractical, they therefore present less danger to the public than the unvaccinated.

The unvaccinated are making this choice to (in their mind) improve their well being, at the expense of the public well being. It is therefore rational public policy to restrict their freedom of movement, to both protect the public well being, and to discourage this selfish choice.

The situation is rather similar to driving. Everyone on the road presents some danger. But drunk drivers, as a result of their selfish decision to be drunk drivers, present a greater danger. Therefore their freedom of movement is restricted, to protect the public and to discourage drunk driving.

I think this only holds if you can somehow quantify each of the safety levels (unless I've misunderstood what you mean by 'marginal', I took it to mean 'small'). The EUA threshold is one level of safety, the BLA approval is another, higher, level. To know that the difference between the two is 'marginal' we'd need some way of quantifying each. I don't think such a way exists, which is why - going right back to the beginning of this whole shambles of an argument - which was... — Isaac

The rate of increase in marginal safety between approved/unapproved for public disbursement seems fairly exponential; increases following that I assume approach a limit on a logistical curve. Increases along a logistical curve are increasingly less significant. Speculating, I would suppose you are waiting for reductions of uncertainty concerning the last 5% which simply comes with time. In 10,000 years you can be certain the safety of the vaccine can not be reasonably increased. How long do you suppose your "behavioral vaccine" will remain uncompromised? The safety of a vaccine should be considered relative to the threat of serious infection?

You repeatedly conflate the question of whether the vaccine has been shown to be safe and effective enough to get vaccinated now with the issue of full approval.

Here is a letter in the NYT from July 9th by Peter Marks: https://www.nytimes.com/2021/07/09/opinion/letters/fda-covid-vaccines.html

It ends:

If we truly want our lives to return to normal, the fastest way to do so is simple — get vaccinated right now.

Marks is recommending being vaccinated now.

Secondly, you've still not given any detail on exactly what it is you think the FDA are doing over the next stage in their work (this mysterious 'bureaucracy' which is apparently unrelated to either safety or efficacy). — Isaac

What they are doing is exactly what I said they are doing, reviewing and evaluating the data. Which is exactly what Marks said in his letter. In the meantime Marks is recommending getting vaccinated now.

Speculating, I would suppose you are waiting for reductions of uncertainty concerning the last 5% which simply comes with time. — Cheshire

We can all speculate, that's the point of each individual being left to decide for themselves (on proper scientific advice, of course).

You repeatedly conflate the question of whether the vaccine has been shown to be safe and effective enough to get vaccinated now with the issue of full approval. — Fooloso4

Safe and effective enough is an individual judgement. Do you expect the government to tell you if you'll personally find riding a motorbike to be safe enough? It's safe enough for some people, too unsafe for others. Safe enough is a personal judgement and can only be made by the individual taking the risk.

The FDA are not even in the businesses of telling people what risks they should and should not take, their job is to determine if a medicine is safe enough according to strick legal definitions. They determined it was safe enough to be given a EUA. Marks also thinks it's safe enough for him to advise it. None of which has any bearing on what my, or anyone else's, personal threshold of risk happens to be, or should be.

Marks is an expert on vaccines, this doesn't confer him with any expertise at all on what level of risk any individual should be willing to take.

None of which had any bearing on the actual point at issue, of course, which remains...

What they are doing is exactly what I said they are doing, reviewing and evaluating the data. — Fooloso4

...data relating to safety and efficacy, hence you are wrong to say the the work they're doing is other than safety and efficacy work, which is the sole point of disagreement.

Speculating, I would suppose you are waiting for reductions of uncertainty concerning the last 5% which simply comes with time.
— Cheshire

We can all speculate, that's the point of each individual being left to decide for themselves (on proper scientific advice, of course). — Isaac

By the same logic we can all doubt. Proving the capacity for inquiry doesn't speak to the state of affairs. Because I was speculating I selected the number that errored against my position. The assumption of a .05 Alpha isn't exactly what I would call grabbing numbers out of the sky.

Proving the capacity for inquiry doesn't speak to the state of affairs. Because I was speculating I selected the number that errored against my position. The assumption of a .05 Alpha isn't exactly what I would call grabbing numbers out of the sky. — Cheshire

Indeed. And you'd have a perfectly reasonable and well-evidenced support for your position if you were to believe that.

The point is that there are other positions. Also well-supported by expert opinion and good evidence. As I've clearly shown, a substantial number of experts in vaccines, epidemiology and immunology do not think the FDA should approve the vaccine at this current level of evidence. They believe that more data is required before it can meet the higher threshold of safety the BLA approval confers.

So you have a good, well-supported view that the safety of the vaccine is, currently, near sufficient for BLA approval, and so little will be gained on meeting that threshold.

I have a good, well-supported view that the safety of the vaccine is, not currently, near sufficient for BLA approval, and so much could be gained on meeting that threshold.

What we used to do is maintain a difference of opinion without assuming our opponents were lunatics, sociopaths or liars. That seems too much to ask these days.

...data relating to safety and efficacy, hence you are wrong to say the the work they're doing is other than safety and efficacy work, which is the sole point of disagreement. — Isaac

Nowhere do I say that "the work they're doing is other than safety and efficacy work". Of course the data is related to safety and efficacy, that is what the FDA does. You are simply making up claims, attributing them to me, and then arguing against those claims. Read my early posts including this:

The role of the FDA is to verify that products are safe and effective. There is ample evidence that the vaccine is safe and effective. They are still required to do a thorough review of the data ... — Fooloso4

The evidence of safety and efficacy is sufficient to lead Marks and many other experts to recommend vaccination now even though the approval process is not complete.