Nowhere do I say that "the work they're doing is other than safety and efficacy work". — Fooloso4

At this point it is a matter of bureaucracy rather than safety or efficacy — Fooloso4

Are you unsure what 'rather than' means?

Are you deliberately trying to misconstrue what I've said? What was at issue in my initial comment to @180 Proof was the choose of getting the vaccine now or waiting for approval. Waiting at this point should not be about safety and efficacy, they have been established. The reason the FDA has not yet approved the vaccine is not that they have doubts about its safety and efficacy, it is, rather, about the workings of the agency. Its processes and procedures take time. That does not mean its workings are about something other than safety and efficacy. It means that the processes and procedures must be fully carried out for each product it approves. The delay in approval is at this point a bureaucratic problem rather than a problem with the safety and efficacy of the vaccine. That is why Marks and others are recommending getting the vaccine now rather than waiting for approval.

Nowhere do I say that "the work they're doing is other than safety and efficacy work". — Fooloso4

The delay in approval is at this point a bureaucratic problem rather than a problem with the safety and efficacy of the vaccine. — Fooloso4

Again we are back to your misunderstanding of the term bureaucracy and how this particular bureaucracy works. All of their work is to establish safety and efficacy. In this case we have a clear view of the safety and efficacy ahead of approval. Clear enough for Marks and other experts to recommend getting the vaccine, but they will not just approve it before they complete their work for approval. They must complete their review. As Marks said, they are working to streamline the review process.

So...safety and efficacy have already been established. The FDA is just making extra sure, even though we are already quite sure. We just gotta go through this beaurocratic process to make extra sure even though we are already quite sure.
Again, we are already quite sure. Therefore you should just get the vaccine now, even though we haven't got the extra bit of sureness from the FDA yet.
Is that basically what you were trying to say Fooloso?

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. — Isaac

I don't know what the BLA is or what it's approval entails. I do know fringe media outlets are profiteering off selling the conspiracy excitement of confirmation bias. I know vaccine hesitancy is a catalyst for unnecessary death and suffering that is happening in real time.

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. — Isaac

The vaccine you aren't taking now will be the vaccine I wager you won't take then. I thought about not enduring an immune system response. It sounded unpleasant. I believe this is the reason people want to have a reason not to take it.

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. — Isaac

According to your population data the choice to take it seems more like a matter of community solidarity. My population needs uptake to increase in order to curb an uptrend in suffering. If your community already has upwards of 90%, then whether you personally take it is disproportionally immaterial to vaccine hesitancy happening in other places. You are in a rare position to have only yourself to worry about for the most part. It is a unique experience. So, I would expect your position is being wrongly ascribed the negative responsibility for damage that exist elsewhere.

Again, we are already quite sure. Therefore you should just get the vaccine now, even though we haven't got the extra bit of sureness from the FDA yet.
Is that basically what you were trying to say Fooloso? — Yohan

No, sometimes scientific rigor is out paced by pragmatic urgency. In fact, they may be taking more time knowing it doesn't limit access.

At this point it is still up to you, but that might change.

It is not just me saying this. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration and many others are saying this. See the letter to the New York Times he wrote that I linked to above.

What some here do not seem to understand that it is not simply a matter of review and approval. Regulatory personnel from the participating companies meet with the FDA where questions are raised that must be answered and concerns must be addressed. In many cases approval comes with recommendations, requirements for packaging and labeling, and restrictions for certain groups.

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 — fishfry

I'm sorry to have to say it, but this is simplistic. Firstly the vaccinated are far less likely to spread infection, even though it is acknowledged to be possible. The vaccines are not perfect, and to say that because they are not perfect I won't be vaccinated is like saying I won't put locks on my doors because sometimes thieves can pick them. Simplistic thinking!

And secondly, the vaccinated are following the medical advice in doing what is judged to be best for society as a whole, whereas the deliberately unvaccinated are acting only out of self-interest and against what is best for all.

One aim among others of vaccination is to allow freedom of movement and opening of borders and businesses which is what is needed lest our economies crumble causing much more suffering, hardship and many more deaths.

If people don't want to play their part then why should they enjoy what those who are playing their part do? And how much less so if they are also much more likely to become sick and burden the hospital system perhaps thereby denying a bed to someone else who needs it for some Covid unrelated emergency condition.

No one is saying that even the vaccinated will enjoy totally unrestricted freedom in any case. Mask-wearing and social distancing may become the norm, since the latest advice is that Covid is very unlikely to be totally eradicated and the vaccines are only around 70-90% efficacious in preventing symptomatic infection. None of them are sterilizing vaccines. A sterilizing vaccine would be ideal; but we don't have it.

How about this: if you want to remain unvaccinated would you agree to sign a waiver relinquishing your right to hospitalization if you became infected with Covid and sick enough to require it?

So confused.

All of their work is to establish safety and efficacy. — Fooloso4

In this case we have a clear view of the safety and efficacy ahead of approval. — Fooloso4

They must complete their review. — Fooloso4

...They must complete the thing they've actually already done - because all their work is about safety and efficacy which they've already established.

You've still not answered the very simple question I've asked three times now. What are the FDA doing, right now, and how is it that you know (when seemingly even experts in public health don't even know)?

Marks and other experts...recommend getting the vaccine — Fooloso4

I don't think you understand what a EUA is. It's when the FDA decide that the risks from a new medicine are outweighed by the risks from the emergency - meaning that they think people ought to take it. It would have been rather foolish of them to give it EUA and then not endorse taking it, wouldn't it? So obviously Marks is going to recommend getting it, the crisis whose risk outweighs the risk from the vaccine is still going on. None of this has any bearing on the lower threshold of risk the full approval requires.

I know vaccine hesitancy is a catalyst for unnecessary death and suffering that is happening in real time. — Cheshire

Interesting. How is it that you know this?

The vaccine you aren't taking now will be the vaccine I wager you won't take then. I thought about not enduring an immune system response. It sounded unpleasant. I believe this is the reason people want to have a reason not to take it. — Cheshire

What you believe is irrelevant. why would your guess as to the reasons of others have any bearing on the matter?

My population needs uptake to increase in order to curb an uptrend in suffering. — Cheshire

The people who believe that have already taken the vaccine. We're talking here about the people who don't believe that - what should they do? Are you suggesting that other people should act, not on what they believe is right, but on on you believe is right? How would you feel if it were the other way round?

Firstly the vaccinated are far less likely to spread infection, even though it is acknowledged to be possible. — Janus

Far less likely than whom? The unvaccinated? The unvaccinated but masked? The unvaccinated but healthy, the unvaccinated but rural dwelling, the unvaccinated but young, the unvaccinated but non-smoker...

Here is the PHE study showing reduced transmission in the vaccinated...you tell me.

the vaccinated are following the medical advice in doing what is judged to be best for society as a whole, whereas the deliberately unvaccinated are acting only out of self-interest and against what is best for all. — Janus

Where does medical advice suggest that getting vaccinated is best for society as a whole? Give me one single medical advisory that suggests I should get vaccinated, in my circumstances.

And how much less so if they are also much more likely to become sick and burden the hospital system perhaps thereby denying a bed to someone else who needs it for some Covid unrelated emergency condition. — Janus

Show me the evidence that I am much more likely to get sick enough to need a hospital bed if I don't take the vaccine. Any scrap of evidence at all will do.

if you want to remain unvaccinated would you agree to sign a waiver relinquishing your right to hospitalization if you became infected with Covid and sick enough to require it? — Janus

Would you advocate the same for smoking, drinking eating red meat, not exercising enough, practising sports, doing office work, foreign travel, insufficient handwashing...

The problem here seems to revolve around two things;

Firstly the confusion between medical advice as to the safety of the vaccine and ethical decisions as to what risk it is fair to take (for what gain).

Secondly, this new idea which has emerged that one must believe whatever the consensus, or majority or official, scientific opinion is, not simply that one ought to have their beliefs suitably supported by scientific opinion.

The first case is simple to lay out. Let's say that the FDA, or equivalent body, are such experts on vaccines with such a wealth of data that they are 100% right all the time. Say we can measure safety on a scale of 1 to 10. Using their data and 100% accurate analytical skills they determine that the vaccine is exactly 9.675 safe. Now...where, in all their expertise, did they learn that 9.675 is the level of safety at which we ought to take a new medicine? How has their expertise in vaccines conferred upon them an ability to judge ethics?

The second I've no idea on. Even two years ago it wasn't the case. I've presented a post full of actual qualified experts who think there are problems with the vaccine that the FDA are not addressing, but for some reason, in this new world, that's insufficient to justify forming a view based on their expert opinion. Not just insufficient, but "acting only out of self-interest and against what is best for all". You'll have to tell me what you think the advantage to society is in stifling proper scientific differences of opinion.

Far less likely than whom? The unvaccinated? The unvaccinated but masked? The unvaccinated but healthy, the unvaccinated but rural dwelling, the unvaccinated but young, the unvaccinated but non-smoker... — Isaac

If vaccination is roughly 90% efficacious at preventing hospitalization compared to lack of vaccination then it would be far less likely for the unvaccinated compared to the vaccinated in all of those categories, most likely.

I haven't seen the latest figure but here in NSW a week or so ago all bar one out of the 150 people in hospital with covid were unvaccinated. The other one had had one shot, so was not fully vaccinated.

Where does medical advice suggest that getting vaccinated is best for society as a whole? Give me one single medical advisory that suggests I should get vaccinated, in my circumstances. — Isaac

In general if it is true that vaccination greatly reduces transmission of the virus then it is obviously in society's best interest that as many people as possible be vaccinated. I don't know your circumstances, so I can;t comment about that.

Would you advocate the same for smoking, drinking eating red meat, not exercising enough, practising sports, doing office work, foreign travel, insufficient handwashing... — Isaac

Those activities do not enjoy pandemic status and are unlikely to overwhelm hospitals, so probably no.

If vaccination is roughly 90% efficacious at preventing hospitalization compared to lack of vaccination then it would be far less likely for the unvaccinated compared to the vaccinated in all of those categories, most likely. — Janus

I don't follow you. Why, if it's on average 90% efficacious would it be less likely in all categories? If, on average drunk people are more likely to have a car accident, does that mean drunk people are more likely to have a car accident even among those who don't drive? Averages don't apply to all groups unless the criteria are random, which, with susceptibility to hospitalisation with covid-19, we know they're not.

But that's an aside because I asked about transmission, not hospitalisation. The same applies here though. The fact that on average, transmission is halved for those who are vaccinated it doesn't mean that transmission would be halved in the subset, say, of those who live in rural areas, or those who wash their hands frequently, or those who are better at any of the non-pharmaceutical measures. The reason I posted the study is to show that the study did not account for these factors.

It is simply false to say that vaccines reduce transmission of the virus in all cases. They have been shown, by one study, to reduce transmission, on average, in a limited number of cases, for a specific cohort.

To have a moral case that someone ought to take the vaccine to protect others you'd have to show that the vaccine was more capable of protecting others than other methods that that person might be willing to adopt. There is no evidence of this capability to date, and so absolutely no moral case that anyone ought to take the vaccine to protect others.

Nor is there a moral case that anyone ought to take the vaccine to help eradicate the virus. As Prof Pollard told the All Party Parliamentary Group only yesterday

Herd immunity is 'not a possibility' with the current Delta variant.
He referred to the idea as 'mythical' and warned that a vaccine programme should not be built around the idea of achieving it.
He predicted that the next thing may be 'a variant which is perhaps even better at transmitting in vaccinated populations', adding that that was 'even more of a reason not to be making a vaccine programme around herd immunity'. — APPG - coronavirus

So with no moral case for protecting others and no moral case for eradication - what is the moral case that any individual ought to take the vaccine?

In general if it is true that vaccination greatly reduces transmission of the virus then it is obviously in society's best interest that as many people as possible be vaccinated. — Janus

I don't disagree with that. I think vaccination is an excellent public policy response in general.

I don't know your circumstances, so I can;t comment about that. — Janus

Exactly. And yet...

the deliberately unvaccinated are acting only out of self-interest — Janus

...is commenting on individuals, isn't it? Do you know their circumstances?

Would you advocate the same for smoking, drinking eating red meat, not exercising enough, practising sports, doing office work, foreign travel, insufficient handwashing... — Isaac


Those activities do not enjoy pandemic status and are unlikely to overwhelm hospitals, so probably no. — Janus

Beds occupied by Covid-19 patients currently stand at about 2,500 out of 115,000 beds (source https://www.england.nhs.uk/statistics/statistical-work-areas/covid-19-hospital-activity/), about 2% of activity. About 20% of those 115,000 beds are occupied by those with avoidable illness (source https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/causesofdeath/bulletins/avoidablemortalityinenglandandwales/latest). Over a the short period of time the pandemic will run for, making vaccination mandatory would, at best relieve just under 2% of the pressure on health services for a few years. Making the lifestyle choices that cause avoidable illness prohibited would relieve nearly ten times that. Hospital admissions for Myocardial Infarction alone are at about 280 a day (source https://www.bhf.org.uk/-/media/files/research/heart-statistics/bhf-cvd-statistics-uk-factsheet.pdf) - every day, every year crisis or no crisis.

So it's simply false to say that lifestyle choices which lead to avoidable illnesses don't put the same pressure on health services that Covid-19 hospitalisations do. One of the main reasons why hospitals can't cope with Covid-19 is that they're overwhelmed by those other cases caused by avoidable lifestyle choices.

Not to mention the fact that the vast majority of severe hospitalisations with Covid-19 are the result of underlying commorbidities such as obesity and diabetes, caused by the very lifestyle choices you're relegating the harm of.

Interesting. How is it that you know this? — Isaac

Empirical observations from local nurses.

What you believe is irrelevant. why would your guess as to the reasons of others have any bearing on the matter? — Isaac

Human nature is fairly consistent when it comes to avoiding discomfort. I demonstrated this on this thread when 180 reversed his position.

The people who believe that have already taken the vaccine. We're talking here about the people who don't believe that - what should they do? Are you suggesting that other people should act, not on what they believe is right, but on on you believe is right? How would you feel if it were the other way round? — Isaac

I would probably be annoyed. But, if harm to my community was the issue I would listen.

Your position remains tied to your population. But, your argument generalizes to others. What good is localized data for speaking to an international matter? I agree, in your particular case, the decision is largely moot. Others have already shouldered the necessary risk to arrive at projected herd immunity requirements. It is a specific context from which to argue. It is not the case elsewhere is the point. Who these other people you think you speak for are; confuses the matter. Their communities have not arrived at herd immunity and their decisions carry more impact to those around them. Some things aren't best left to taste or preference. If I could take a vaccine for someone else I would, but I can't.

My county reissued a mask mandate to the public during this discussion. Is yours having emergency meetings? It's like arguing against taking shelter because there's no tornado near my house. It doesn't translate to places with tornados.

So confused. — Isaac

Indeed you are! You are confusing authorization with the widespread professional opinion backed by substantial evidence that the vaccine is safe and effective. This does not mean that they are without risk. Even with approval there will be individual cases where there are problems.

It's when the FDA decide that the risks from a new medicine are outweighed by the risks from the emergency - meaning that they think people ought to take it. It would have been rather foolish of them to give it EUA and then not endorse taking it, wouldn't it? /quote]

Wrong. The FDA issued EUA for hydroxychloroquine, but did not think people ought to take it. The EUA allowed its use, but they then revoked the EUA when the determined it was unlikely to be effective. The same happened with Bamlanivimab.
— Isaac

Marks and other experts...recommend getting the vaccine
— Fooloso4

I don't think you understand what a EUA is. — Isaac

It is, rather, you who does not understand. An EUA is not a recommendation for use. It allows the product to be used. In the case of the vaccine the EUA provided through the use of the vaccine for sufficient evidence of it safety and effectiveness that Marks and others recommend getting it. It is not regarded as safe and effective because of the EUA, it is regarded as safe and effective because of the evidence, including the evidence of millions of shots that were made possible by the EUA.

Firstly the confusion between medical advice as to the safety of the vaccine and ethical decisions as to what risk it is fair to take (for what gain). — Isaac

The medical advice was vaccinate a minimum of 70% of the population for the population to gain protection from the virus. The ethical matter is whether excluding yourself from the 70% is fair to the others in the population making the same choice. Is another's safety less valuable than yours without any known reason for qualification other than your willingness to doubt it? No authorities approval will predict a single outcome perfectly.

Secondly, this new idea which has emerged that one must believe whatever the consensus, or majority or official, scientific opinion is, not simply that one ought to have their beliefs suitably supported by scientific opinion. — Isaac

No it is an old idea; that when a group is asked to function together for a common end then a consensus is the best it can rely on.

It is a case where being wrong negatively effects others; made worse by distribution to others that might have otherwise decided correctly. There aren't resources available to soothe every possible apprehension one chooses to imagine. You've ignored the difference in population arguments 3 times by now; if hasn't been addressed at this reading. I consider my view valid and dismissed.

Empirical observations from local nurses. — Cheshire

What good is localized data for speaking to an international matter. — Cheshire

...?

Human nature is fairly consistent when it comes to avoiding discomfort. — Cheshire

Maybe, but if I disagree with you about the causes, then the consistency of human nature doesn't help arbitrate between our positions does it?

Your position remains tied to your population. But, your argument generalizes to others. — Cheshire

It's funny how important it seems to be that everyone gets vaccinated in whatever country you're in. Apparently, completely healthy people are either selfish, or scared, or deluded, for not getting a vaccine in one country regardless of the rest of the world. The myopia is shocking.

You're at about 50% and rising still. You'll be fine. You can stop wringing your soft first-world hands about it.

You're also at 14% of your stock...which constitutes most of the world's stock. If you were truly worried about people's health, you'd be preserving stock for those who need it most around the world, most third world countries are barely at 10%. But no, much more productive to wag a disapproving finger at your co-nationals...the ones who could still infect you.

It is not regarded as safe and effective because of the EUA, it is regarded as safe and effective because of the evidence, including the evidence of millions of shots that were made possible by the EUA. — Fooloso4

None of that has any bearing on the matter of whether it will be rendered more safe by the work being done to complete the BLA approval. It's just a load of bizarre psychologising about the motives for advocacy without, again, a shred of evidence.

Fourth time...

What are the FDA doing, right now, and how is it that you know (when seemingly even experts in public health don't even know)? — Isaac

You're at about 50% and rising still. You'll be fine. You can stop wringing your soft first-world hands about it. — Isaac

The chance to be "fine" evaporated a long time ago. There are 600K dead. As a former machinist I take offense to your characterization of "soft first-world hands".

It's funny how important it seems to be that everyone gets vaccinated in whatever country you're in. Apparently, completely healthy people are either selfish, or scared, or deluded, for not getting a vaccine in one country regardless of the rest of the world. The myopia is shocking. — Isaac

It isn't funny. It is the entire basis for the argument I've made; which you choose to ignore. What part of 'group project' is unclear. The myopia is what preserves your position in your own mind. You in the first quote pretend my circumstances are yours; then extrapolate from yours onto mine. What is a polite word for asinine?

The ethical matter is whether excluding yourself from the 70% is fair to the others in the population making the same choice. — Cheshire

Yes, that's what I said.

Is another's safety less valuable than yours without any known reason for qualification other than your willingness to doubt it? — Cheshire

No, that's not the choice is it. If I said to you "wearing a hat will kill you", you're not then deciding whether your fashion choice is more important than your life. You're deciding whether your belief that wearing a hat is fine outweighs my assertion that it isn't. If you're referring to people who completely believe the FDA and the pharmaceutical companies, but still don't get vaccinated then yeah, fuck 'em. But I don't know anyone in that position, so it's simply not a part if any ethical dilemma.

when a group is asked to function together for a common end then a consensus is the best it can rely on. — Cheshire

Is it? On what grounds?

It is a case where being wrong negatively effects others; made worse by distribution to others that might have otherwise decided correctly. — Cheshire

Evidence. Honestly, we can't have a proper discussion if you're just going to make shit up. I could just say "the vaccine is poisonous anyway so no one should take it". His does that constitute an argument. Cite your fucking sources! It's like arguing with children.

If every vaccine required each citizen to undertake and interpret a research project they wouldn't be very effective. Do you research the blueprints of every building before walking in? No. Go take a vaccine and come back arguing this position and I'll listen.

It is the entire basis for the argument I've made — Cheshire

Your argument is that everyone in America should get vaccinated even if they live rurally, are healthy, socially distance etc. Thus using up precious stocks, taking them away from those that really need them in other countries.

Forget 70%. Forget anyone who isn't vulnerable. Forget the mad anti-vax brigade who'll never take them anyway. Forget mandates. Forget the doubters. They're an irrelevance compared the truly needy whose doses they'll be using up just to save you from having to do so much non-pharmaceutical intervention.

Your argument is that everyone in America should get vaccinated even if they live rurally, are healthy, socially distance etc. Thus using up precious sticks, taking them away from those that really need them in other countries. — Isaac

Bit of a pivot. Let me think about it.

Evidence. Honestly, we can't have a proper discussion if you're just going to make shit up. I could just say "the vaccine is poisonous anyway so no one should take it". His does that constitute an argument. Cite your fucking sources! It's like arguing with children. — Isaac

There was an antivax movement that lead to a measles outbreak on the island of Samoa that would serve as evidence if the casual implications aren't obvious enough for your tastes. As a follow up, try and guess how many covid cases they have today.

https://www.worldometers.info/coronavirus/country/samoa/

None of that has any bearing on the matter of whether it will be rendered more safe by the work being done to complete the BLA approval. — Isaac

It may be rendered more safe if the FDA makes recommendations for changes with regard to labelling, packaging, identification of groups for whom the vaccine has greater risk because of age or health conditions or other things, but without making changes approving it does not render it more safe. It simply confirms that it is safe and effective.

It's just a load of bizarre psychologising about the motives for advocacy without, again, a shred of evidence. — Isaac

Evidence of what? The motives of experts who advocate getting the vaccine? I am not "psychologising" the motives of Marks and other experts. I assume their concern is for people's health and safety. Do you find that bizarre? The only thing that is bizarre here is your incessant need for disputation.

What are the FDA doing, right now, and how is it that you know (when seemingly even experts in public health don't even know)? — Isaac

Why would you think that I know what is going on right now at the FDA? Do you think that they are the only ones doing work on the safety and efficacy of the vaccine? Are you unaware of the CDC, the NIH, the WHO, and other regulatory agencies?

If there's anything bad about anti-vaxxers it's that they fail to recognize vaccines are the most natural way to immunize people against disease. They more or less go through the proper channels - stimulating our in-built immune system by inducing a milder, sometimes totally asymptomatic, infection so that when the real bug find its way into our body, we're ready to fend it off. Given current science & medicine, you won't find anything better in the market.

What's good about anti-vaxxers is they give a clear signal to the medical & scientific establishment that people won't tolerate substandard work/products. Vaccines, as they rightly complain, do have side-effects ranging from life-threatening anaphylaxis to long-term neurological complications. These are rare of course, so rare in fact that they the benefits overshadow the risks therein. However, such adverse outcomes of vaccinations indicate there's plenty of room for improvement. It appears the medical, pharmacological and scientific communities were caught with their pants down, they were resting on their laurels and didn't even notice the chink in our armor against bugs viz. we don't have effective treatment modalities against viruses.

What's good about anti-vaxxers is they give a clear signal to the medical & scientific establishment that people won't tolerate substandard work/products. — TheMadFool

Rigorous industry standards have nothing to do with anti-vaxxers. Vaccines are only one class of regulated pharmaceutical products.

we don't have effective treatment modalities against viruses. — TheMadFool

Shingrix and Gardasil are effective viral vaccines. But you are right, more work products need to be brought to market.

Are you unsure what 'rather than' means? — Isaac

You could replace every post you've made with a single one that simply says "I'd rather not". And I would respect that more; than the reaching, wandering, and misdirection by authoritarian demand. Why?