[late]

I think a lot of people will take it, and yes, I agree, it will be interesting to see the results of this experiment.

Also, recall, China/Russia are always giving out vaccines too, would be interesting to see their results as well, though not sure how much they can be trusted.

If, perhaps I should say when, a vaccine gets pushed out prematurely; if there's a problem, a bunch of people will get harmed or dead before we can figure it out.

When you consider billions will likely take it, that could be a lot of people.

[Atlantis]

Ideally, you should be giving the vaccine to groups you know will likely be exposed to the disease: reckless party goers and prisoners living in tight quarters. But in the latter case, this would be politically incorrect because you would hear social justice warriors screaming about “black men used as guinea pigs in medical experiments.”

Autocrats like Putin don't have that problem. Instead of running a phase 3 test, the Russians decided to tell teachers and medical professionals to get vaccinated with the Russian Sputnik-V vaccine. So far it's not mandatory, but there is enough peer-pressure in most of these institutions to make employees get vaccinated.

[Drlee]

They get volunteers who allow themselves to take the vaccine and get injected with Covid.

No. No. No.

This is called "human challenge studies" and is neither called for not ethical. Not that this would deter Trump and his folks.

Now some of you who do not understand how vaccine studies work are going to google attenuated virus studies, misunderstand them, and post them as evidence here. I don't know why I waste my time.

Oh. and by the way. Human challenge studies do not answer critical questions that are an important part of human trials.

Here is what is going to happen. Around October first Trump is going to announce that "we have a vaccine, are ready to deploy "millions and millions of doses" and that the pandemic is over. This is going to happen.

Either the NHS and FDA back him on this or he will fire the leadership claiming that they are trying to tank his reelection. This is going to happen.

The leadership of the FDA and the NHS have already shown that they value their jobs more than the public health. This has already happened.

Trumps supporters, being almost universally very stupid people, will believe anything he says because they want to.

Now. I work in a clinic where I am in contact with people who have been exposed. Would I roll the dice and take a shot at a vaccine early on? You bet. Would I suggest to other seniors and health care workers that they might consider it a reasonable risk/reward ratio? You bet. Would I start sticking massive numbers of healthy people, including children, with a vaccine that has not been carefully tested. Not on a bet. But if Trump gets his way, we will.

This will make Sivad happy. Why? Because he will see thousands of doctors refusing to vaccinate their children.

[annatar1914]

No. No. No.

This is called "human challenge studies" and is neither called for not ethical. Not that this would deter Trump and his folks.

Now some of you who do not understand how vaccine studies work are going to google attenuated virus studies, misunderstand them, and post them as evidence here. I don't know why I waste my time.

Oh. and by the way. Human challenge studies do not answer critical questions that are an important part of human trials.

Here is what is going to happen. Around October first Trump is going to announce that "we have a vaccine, are ready to deploy "millions and millions of doses" and that the pandemic is over. This is going to happen.

Either the NHS and FDA back him on this or he will fire the leadership claiming that they are trying to tank his reelection. This is going to happen.

The leadership of the FDA and the NHS have already shown that they value their jobs more than the public health. This has already happened.

Trumps supporters, being almost universally very stupid people, will believe anything he says because they want to.

Now. I work in a clinic where I am in contact with people who have been exposed. Would I roll the dice and take a shot at a vaccine early on? You bet. Would I suggest to other seniors and health care workers that they might consider it a reasonable risk/reward ratio? You bet. Would I start sticking massive numbers of healthy people, including children, with a vaccine that has not been carefully tested. Not on a bet. But if Trump gets his way, we will.

This will make Sivad happy. Why? Because he will see thousands of doctors refusing to vaccinate their children.

Right on time, as expected, now the doom-mongering and doubting about a vaccine begins as I figured close to November 3rd. No time is a good time for a Vaccine if Trump is still President, his Liberal enemies figure, and of course a good thing (like a safe and effective vaccine) cannot possibly coincide with his re-election chances, that would be very unfair... In the meantime, people are dying and the economy hasn't truly opened back up fully, and people in many states are under restrictions, hoping for a vaccine so they can resume some kind of normal existence again.

But no, ''Conservatives'' and ''Liberals'', Democrats and Republicans, have to play politics with this pandemic, as they have all along.

[JohnRawls]

Right on time, as expected, now the doom-mongering and doubting about a vaccine begins as I figured close to November 3rd. No time is a good time for a Vaccine if Trump is still President, his Liberal enemies figure, and of course a good thing (like a safe and effective vaccine) cannot possibly coincide with his re-election chances, that would be very unfair... In the meantime, people are dying and the economy hasn't truly opened back up fully, and people in many states are under restrictions, hoping for a vaccine so they can resume some kind of normal existence again.

But no, ''Conservatives'' and ''Liberals'', Democrats and Republicans, have to play politics with this pandemic, as they have all along.

Most Budem supporters on here are pro vaccine, it is the Trump funboys who are saying something is wrong.

@Drlee
Thanks for clarifying. There were news that thousands of not tens of thousands want to participate in that way. So this needs full special approval from the government?

[annatar1914]

@JohnRawls , you said;

Most Budem supporters on here are pro vaccine,

That is changing. If it comes out before November 3rd, it'll be labeled ''unsafe'', ''not truly tested well enough'', and ''an election year ploy'' by most Liberals. Who will still take the vaccine.

it is the Trump funboys who are saying something is wrong.

Libertarian-leaning Anti-Vaxxers, who often don't care for Trump either, seem to be of that persuasion.

I'll take the Vaccine, whether Trump or Biden is President. And I'll be happy to take it next month, especially if it saves more lives and ends this pandemic. I used to think everyone would want that too in the same way, but some people are just twisted by political hatred to not think pragmatically or rationally about this.

[Rancid]

Would announcing a vaccine in November actually have a significant impact on the elections though?

[annatar1914]

Would announcing a vaccine in November actually have a significant impact on the elections though?

I suspect some don't want to find that out. Certainly, there are those who don't want to give Trump any credit or anything to brag about, even if it costs lives.

Edit; here's a story I found on Kamala Harris for example, voicing concern about an early vaccine;

https://townhall.com/tipsheet/bethbauma ... e-n2575718

So clearly they are concerned about it's political effect on the election more than anything else I suspect.

[Drlee]

Right on time, as expected, now the doom-mongering and doubting about a vaccine begins as I figured close to November 3rd. No time is a good time for a Vaccine if Trump is still President, his Liberal enemies figure, and of course a good thing (like a safe and effective vaccine) cannot possibly coincide with his re-election chances, that would be very unfair... In the meantime, people are dying and the economy hasn't truly opened back up fully, and people in many states are under restrictions, hoping for a vaccine so they can resume some kind of normal existence again

Oh fuck off. Is there no end you will not go to to defend Trump?

You try watching people die everyday gasping for breath for a few months and then come back with your shit.

Fucking overseas trolls. There is no end to their nonsense.

[annatar1914]

Oh fuck off. Is there no end you will not go to to defend Trump?

You try watching people die everyday gasping for breath for a few months and then come back with your shit.

Fucking overseas trolls. There is no end to their nonsense.

@Drlee ;

People can be such unbearable fools when it comes to their ideological confirmation biases and basic worldview.

Not defending Trump, I'm going after people that would rather hold off on a safe and effective vaccine just in case it helps him win in November if it comes out before.

I worked hospice and home health for 20 years, so you can take your offensive language to the Devil where it belongs. But I forgive you, you really are emoting and don't know what you're saying and how it may effect people wrongly.

And I'm not an ''overseas troll''. You have been so obsessed with this man Trump that you're becoming paranoid and conspiracy theory minded. I'm an American. There was a time when differences in politics (and I'm far from being a Trump supporter even-being a Socialist!) didn't bring people to question one's identity or patriotism, I'm an American and proud of it, actually. We could do better, but we could be doing a hell of a lot worse.

You're just angry because what I say doesn't fit what you would like to hear.

[Drlee]

But I forgive you, you really are emoting and don't know what you're saying and how it may effect people wrongly

Nonsense. This is my field. Go play your condescending crap on someone else.

You said "safe and effective". Care to tell me how that happens with incomplete testing? I already said I would try it and have no problem with high risk people taking a shot at it. But you seem to think it is fine, with very limited testing, to vaccinate millions of children and well adults. You are out of your fucking mind., You are not betting on science. You are betting on luck.


Besides. Learn rather than talk for a moment.

At this point in the pandemic we have a very effective way of handling this disease without putting people at risk using an incompletely tested vaccine. The problem is that Trump and the republicans don't want to do it because.....money and motivation from their herd of bovine like followers.

Tell you what Skippy. Get people to practice physical distancing, mask wearing and hand washing and then come tell me that a vaccine on the 15th of October is just a coincidence. Trump has been saying we are going to have one by that time since before there was even a vaccine in testing. So go fuck yourself and stop trying to kill people. If the scientific community, AMA, Cochran, et all say this is a good vaccine then I am you man. Line up outside our clinic and I will put you first in line. That is a highly unlikely scenario.

We are rushing to an emergency use authorization, which the folks at FDA will automatically give or Trump will fire them. I will take the vaccine if they offer it to me. I will not ask my much younger wife to take it. How about you. Should we line up the school kids and experiment on them?

[annatar1914]

@Drlee

Nonsense.

Of course

You don't like being called on anything, But I don't know too many people who enjoy being contradicted anyway. It is what it is, you going to work yourself into a lather over what some guy on the internet says about something? Get real.

This is my field.

So you say, a lot. As it is, in the anonymity of the internet, nobody knows anybody from Adam. I'm not saying you aren't educated or don't make good points from time to time, but you are extremely influenced by political fever, Doc. ''Physician heal thyself.''

Go play your condescending crap on someone else.

More projection, I don't do ''condescension'', I honestly forgive you for using vile language against me. External signs of inner realities, it's what comes out of a person that makes them sick in the worst way, not what goes in.

You said "safe and effective". Care to tell me how that happens with incomplete testing?

They'll rate it ''safe and effective, with complete enough testing'', but i'm certain that won't be enough for you politically speaking, which is what this is all about for some people, of course.

I already said I would try it and have no problem with high risk people taking a shot at it. But you seem to think it is fine, with very limited testing, to vaccinate millions of children and well adults.

Strawman, assuming ''limited testing'' to suit your criteria and assuming feelings which aren't rational topics of discussion.

You are out of your fucking mind., You are not betting on science. You are betting on luck.

Another strawman. If someone in charge of the roll out who has medical experience in his or her field signs off on it, good enough for me. Apparently because of Trump and company, it is you who are at risk of losing your mental health. None of these people are worth that, you have forgotten that.

Besides. Learn rather than talk for a moment.

More projection, and yet you have the gall to make the truly condescending comments?

At this point in the pandemic we have a very effective way of handling this disease without putting people at risk using an incompletely tested vaccine. The problem is that Trump and the republicans don't want to do it because.....money and motivation from their herd of bovine like followers.

''bovine like followers''?

What in the hell is wrong with you, seriously?

More dehumanization and demonization of others, that usually happens when people try to work themselves up (or others) into killing other people.

Tell you what Skippy. Get people to practice physical distancing, mask wearing and hand washing and then come tell me that a vaccine on the 15th of October is just a coincidence. Trump has been saying we are going to have one by that time since before there was even a vaccine in testing. So go fuck yourself and stop trying to kill people. If the scientific community, AMA, Cochran, et all say this is a good vaccine then I am you man. Line up outside our clinic and I will put you first in line. That is a highly unlikely scenario.

I'm on record as being in favor of physical distancing and mask wearing and hand washing of course, among other preventative measures from the beginning. I am a fairly Authoritarian Statist not a ''Conservative'' sort of person who is really a Libertarian Ideologue in disguise.

We are rushing to an emergency use authorization, which the folks at FDA will automatically give or Trump will fire them. I will take the vaccine if they offer it to me. I will not ask my much younger wife to take it. How about you. Should we line up the school kids and experiment on them?

''Rushing'' does not necessarily logically preclude ''safe'', and you know that.

[Drlee]

''Rushing'' does not necessarily logically preclude ''safe'', and you know that.

Actually it does. Two answers:

Snarky answer: There is always luck. We could luck into a harmless and effective vaccine.

Scientific answer: "Logically?" How about this. Time is what these studies are all about. Sometimes issues show up years later. Now years will not work in this case. But. It is unlikely that the efficacy results will be very accurate. Nor will the side effects profile. It is possible to get a strong immune response and poor protection.

And it is not a "strawman" to bring up children. What are you thinking?

[annatar1914]

Actually it does. Two answers:

Snarky answer: There is always luck. We could luck into a harmless and effective vaccine.

Scientific answer: "Logically?" How about this. Time is what these studies are all about. Sometimes issues show up years later. Now years will not work in this case. But. It is unlikely that the efficacy results will be very accurate. Nor will the side effects profile. It is possible to get a strong immune response and poor protection.

And it is not a "strawman" to bring up children. What are you thinking?

The ''strawman'' was in the assumption that a vaccine rolled out would likely be unsafe for younger people, by your inference. You are perhaps knowledgeable in your field, but logically speculation is still speculation, assumptions are still assumptions. Let's leave the politics out of it, especially since I imagine you too are like me, more of a Statist than say, Donald Trump. I'd have done things differently had I been in charge.

As you said; ''years will not work in this case''. But also, if we're going to make assumptions, we could assume that the scientists will indeed do the very best with a good vaccine in record time. But that's not really what I'm talking about.

What I'm talking about is a calculated rejection of an early vaccine before November 3rd, not because of safety concerns but really about political concerns on the part of some that it might unfairly help President Trump win re-election. To me, Biden and Trump are almost the same, so my concern really is with an early end to the Pandemic, as early as possible in order to save lives and civilization itself.

I'm no hypocrite on this. I support masks, I support use of hydroxychloroquine as a porphylactic. I would have banned the Strugis rally and other superspreader events, by force if need be, but that also includes all the protests and rioting.

[ThirdTerm]

Russia's Gamaleya vaccine's phase 1/2 results have been published in The Lancet (Lugunov et al. 2020). The study enrolled healthy adult volunteers (men and women) aged 18–60 years. All side effects were mostly mild: hyperthermia (37–38°C), headache, asthenia, and muscle and joint pain. When healthy adults are vaccinated, they are unlikely to develop serious issues, while we need to be careful with vaccinating children and pregnant women, who have not been tested in vaccine trials. Especially, schoolchildren should not be lined up to be vaccinated en masse.


Neutralising antibody response to rAd26 and rAd5 vectors after immunisation

Discussion
These findings of two open, phase 1/2 non-randomised studies of a heterologous prime-boost COVID-19 vaccine based on recombinant adenoviral vectors rAd26-S and rAd5-S show that the vaccine is safe, well tolerated, and induces strong humoral and cellular immune responses in 100% of healthy participants.

All reported adverse events were mostly mild. The most common systemic and local reactions were pain at the injection site, hyperthermia (body temperature 37–38°C), headache, asthenia, and muscle and joint pain, which are typical for vaccines based on recombinant viral vectors. No serious adverse events were reported during the study. In general, the adverse event profile did not differ from those reported in published work for other vector-based vaccines.25, 28, 29, 30 The incidence of adverse events in our studies was slightly lower than in other work; a comparative clinical study with other vaccines is needed to confirm these findings.

In preclinical studies of the vaccine (unpublished data), robust humoral and cellular immune responses were elicited in non-human primates, providing protection from SARS-CoV-2 infection. The vaccine showed 100% protectivity in a lethal model of SARS-CoV-2 challenge in immunosuppressed hamsters. No antibody-dependent enhancement of infection was seen in vaccinated and SARS-CoV-2-challenged animals.

In conclusion, these data collectively show that the heterologous vaccine based on rAd26-S and rAd5-S is safe, well tolerated, and does not cause serious adverse events in healthy adult volunteers. The vaccine is highly immunogenic and induces strong humoral and cellular immune responses in 100% of healthy adult volunteers, with antibody titres in vaccinated participants higher than those in convalescent plasma. Unprecedented measures have been taken to develop a COVID-19 vaccine in Russia. Based on our own experience in developing vaccines against Ebola virus disease and MERS, the COVID-19 vaccine has been developed in a short time. Preclinical and clinical studies have been done, which has made it possible to provisionally approve the vaccine under the current Decree of the Government of the Russian Federation of April 3, 2020, no 441 on Aug 11, 2020 (registration no LP-006395 [Gam-COVID-Vac]) and on Aug 26, 2020 (registration no LP-006423 [Gam-COVID-Vac-Lyo]). Provisional licensure requires a large-scale study, allows vaccination in a consented general population in the context of a phase 3 trial, allows the vaccine to be brought into use in a population under strict pharmacovigilance, and to provide vaccination of risk groups.

The phase 3 clinical trial was approved by the appropriate national and local competent authorities, including the regulator (Department of State Regulation for Medicine Distribution) and the ethics committee of the Ministry of Health of the Russian Federation, on Aug 26, 2020 (approval 450). The phase 3 clinical trial is planned with involvement of 40 000 volunteers from different age and risk groups. The phase 3 clinical trial will be undertaken with constant monitoring of the condition of volunteers through an online application, and each dose of vaccine will have its own QR code, which will be assigned to the volunteer.

Published:September 04, 2020

DOI:https://doi.org/10.1016/S0140-6736(20)31866-3

[Drlee]

The ''strawman'' was in the assumption that a vaccine rolled out would likely be unsafe for younger people, by your inference.

No. That is not my assumption. What we know is that it will not have been tested in large numbers of children, if any at all. If you look at the excellent post @ThirdTerm made about the Russian preliminary results, it was confined to adults 18-60. While one can presume that older adults will benefit they may not develop sufficient immune response. (As we see in Influenza and precipitating a "geezer flu" vaccine.) Or maybe they will. We don't know yet. Then there are children. We do not know and will not know anytime soon.

You are perhaps knowledgeable in your field, but logically speculation is still speculation, assumptions are still assumptions.

That is precisely my point. The announcement of a vaccine in less than 30 days from now will be all about assumptions and limited scientific results. One of the results that will be missing will be actual experiential evidence of protection in the general population. As I said. I would (personally) roll the dice.

Let's leave the politics out of it, especially since I imagine you too are like me, more of a Statist than say, Donald Trump. I'd have done things differently had I been in charge.

I would have done a great deal more and with greater force to compel compliance.

As you said; ''years will not work in this case''. But also, if we're going to make assumptions, we could assume that the scientists will indeed do the very best with a good vaccine in record time. But that's not really what I'm talking about.

No argument here.

What I'm talking about is a calculated rejection of an early vaccine before November 3rd, not because of safety concerns but really about political concerns on the part of some that it might unfairly help President Trump win re-election.

It indeed might sway some people. That is why many in the scientific community fully expect Trump to announce success whether the vaccine (or should I say any vaccine) has been properly vetted. You chose to see politics on the Biden side and others on the Trump side. The correct answer is probably both. But. Where the difference lies is that there will be an empirical data available. One side (Biden) will be asking for that. The other side, (Trump) will likely not want that at all.

To me, Biden and Trump are almost the same, so my concern really is with an early end to the Pandemic, as early as possible in order to save lives and civilization itself.

Well I will avoid saying 'that would have been January if we had adult leadership" and rather assert that I am fine with throwing a vaccine at people like me. We are likely more likely to be harmed by the disease than the vaccine.

I'm no hypocrite on this. I support masks, I support use of hydroxychloroquine as a porphylactic. I would have banned the Strugis rally and other superspreader events, by force if need be, but that also includes all the protests and rioting.

The Sturges event was criminal negligence and heads should roll for it. It was disgusting and will kill thousands. IT has already started to kill them. Candor requires me to point out that the Sturgis group is hardly a Biden friendly bunch.
Hydrochloraquine does not work. It is not prophylactic. The risk reward ratio with it is unconvincing. I could get it just for the asking. I will not take the risk.

[Rugoz]

AstraZeneca pauses coronavirus vaccine trial after unexplained illness in volunteer
https://edition.cnn.com/2020/09/08/heal ... index.html

Phase 3 trials, hence one of thousands. But if you vaccinate millions, it's important to get it safe.

[annatar1914]

@Drlee

No. That is not my assumption. What we know is that it will not have been tested in large numbers of children, if any at all. If you look at the excellent post @ThirdTerm made about the Russian preliminary results, it was confined to adults 18-60. While one can presume that older adults will benefit they may not develop sufficient immune response. (As we see in Influenza and precipitating a "geezer flu" vaccine.) Or maybe they will. We don't know yet. Then there are children. We do not know and will not know anytime soon.

The ''not know anytime soon'' may well be an assumption

That is precisely my point. The announcement of a vaccine in less than 30 days from now will be all about assumptions and limited scientific results. One of the results that will be missing will be actual experiential evidence of protection in the general population. As I said. I would (personally) roll the dice.

Not sure anyone is calling for it that early.

I would have done a great deal more and with greater force to compel compliance.

And in other cases, you'd probably go softer on some things, while with me it might be vice versa. Everyone here is something of a monday morning quarterback unfortunately.

Concerning the timing and the November Presidential Election;

It indeed might sway some people. That is why many in the scientific community fully expect Trump to announce success whether the vaccine (or should I say any vaccine) has been properly vetted. You chose to see politics on the Biden side and others on the Trump side. The correct answer is probably both. But. Where the difference lies is that there will be an empirical data available. One side (Biden) will be asking for that. The other side, (Trump) will likely not want that at all.

But that call might well be perceptual in itself.

Well I will avoid saying 'that would have been January if we had adult leadership" and rather assert that I am fine with throwing a vaccine at people like me. We are likely more likely to be harmed by the disease than the vaccine.

Precisely.

The Sturges event was criminal negligence and heads should roll for it. It was disgusting and will kill thousands. IT has already started to kill them. Candor requires me to point out that the Sturgis group is hardly a Biden friendly bunch.

Aside from the particulars of that one event, and people still argue back and forth about that as with other things, you'd have to admit then if you're right that the protests and the rioting are also ''criminally negligent'' and might kill ''thousands if they haven't already'', in order to be logically consistent, right?

Hydrochloraquine does not work. It is not prophylactic. The risk reward ratio with it is unconvincing. I could get it just for the asking. I will not take the risk.

There are those who disagree, I believe there's evidence for it. And it's use or non-use have been politicized in the US because President Trump supported it's use, so naturally those who hate him had to pull against it. It's the same with Conservatives not wanting to socially distance or wear masks or keep a somewhat longer lock down, which I support also.

[Drlee]

@annatar1914 The ''not know anytime soon'' may well be an assumption

No. It is not an assumption. It is a fact. There are no trials that have been made public involving the safety of these vaccines in children. So if we are to try to use it with children we will need lengthy trials.

I said: The announcement of a vaccine in less than 30 days from now will be all about assumptions and limited scientific results.

@annatar1914 said: Not sure anyone is calling for it that early.

Well that is the whole argument you are making. That about whether or not Trump will benefit from the announcement of a vaccine. The election is in what 57 days? And to have any effect on the election the announcement would have to come in time for it to influence mail-in ballots. That is about 30 days from now.

Come on Annatatr...just admit it. We are too soon. We are pushing too hard.

Now. If the FDA wanted to make any of these vaccines available on a compassionate use waiver I could see that. If someone like me decides to take the risk and grows a horn, oh well.

But here is the thing. There is another aspect to this. How do I behave if I get a compassionate dose of a vaccine tomorrow? What does it change? How does it affect my behavior? The wise answer is, "not at all". Though the vaccine might well save my life it is almost certain that we will never know. Short of my wife being diagnosed with the virus, there is little upon which to claim any efficacy at all. The evidence comes in large numbers of participants, dosed and undosed, over a relatively long period of time.

Consider. If I get my flu shot tomorrow and do not get the flu, can we be certain that the flu shot is why? Not on an individual level. Right? And if I get the shot and still get the flu can we be certain that my shot failed? Not without a great deal of reconstruction and probably not even then.