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WHO vaccine drive bedeviled by familiar question: Who pays if things go wrong?

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By Francesco Guarascio
The World Health Organization headquarters in Geneva Photo: Yann Forget / Wikimedia Commons

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© Thomson Reuters 2020.

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Except her statement much later behind closed doors reveals that they do not have safe monitoring systems she claimed:

Here are her statements at the 3 minute mark (for your convenience - BUT I know you'll write it off as no need to worry. These vaccines are in fact "SAFE")

She clamed vaccines are safe with good monitoring systems, that does not mean those systems are perfectly functional everywhere, specially in places where not even distribution is working appropriately, the contradiction is only on your mind, both declarations are complementary without any problem. The systems are a necessity to avoid problems and they should be implemented as an absolute requirement in those places where (apart from many other problems) they are not in place, because in that case vaccines could have troubles without authorities being able to notice on time and (as she is mentioning) vaccines could be still as safe as everywhere else but there would be no proof of it.

You talk as if the coronavirus vaccine will be the end to the pandemic. It will not.

No, I talk as if the coronavirus vaccine COULD be the end to the pandemic, that depends on efficacy and safety, As I already corrected you "it will not" is simply an empty declaration without any weight, because you don't have a crystal ball to divinate the future and know the data yet to be obtained from the Phase III trials.

That is what makes you wrong, trying to force an absolute conclusion on something you cannot even evaluate because it is still in the future.

The bar has already been set so low for approval:

ONLY reduces cough and headache IF YOU GET COVID-19

Of course not, once again you are trying to divinate the future without any basis, having low requirements to advance from the preliminary data do not mean that is the result the vaccines will have at the end of the clinical trials, it only means the priority is on safety first and then thousands of participants can be evaluated and the real efficacy can then be evaluated.

Your mistaken conclusion is like seeing in a language school that the requirement to pass from elementary level to medium is to be able to do a self introduction and then concluding by this that nobody graduating from the advanced course will be able to do more than that. Simply irrational.

Well, it's looking like it won't do that. If something changes I will monitoring those details but looks like the bar is already set very low PLUS if you're lucky you have a good chance of getting a wallop of negative side effects (fever over 100 for 5 or more hours, severe headache, expect to take a day off the next day, fainting -whose going to catch you). AND these are healthy volunteers above 18-65 (you said some people above that)

No it does not look like that, that is just where you failed to properly understand what are the steps for the trials and what is going to be evaluated in preliminary and final results.

And no, there is no "good chance" of important side effects, what are those chances? one in a thousand participants? in five thousands? that would be like saying you have a "good chance" of dying of COVID.

Specially because until the end the participants are also blinded and its completely possible that many of those side effects were suffered by people that did not even received the vaccine.

The real kicker? Who of those volunteers had the actual COVID-19 infection? 

A terribly easy question to answer once the data from the trials is taken, that is part of the purpose of doing it, to see who got it and what difference there are if they were vaccinated or not.

At least you finally accept you have no idea about the results, this is what makes your categorical predictions invalid, mistaken, false.

And from phase II & III seeing negative adverse events already and still you're pushing the "Hey...it happens all the time...it will all be fine" cause the 0.1%-0.5% death rate causes you grave concern.

Of course it happens all the time, so much that even people that did not received the vaccine also get them sometimes, unless you want to blame the vaccine for magically causing problems to people that do not get it that is enough to prove you wrong.

And yes, if up to one in 200 people die from the disease, while one in 2000 people vaccinated only get a few hours of fever and headaches that is a huge improvement. At least for people that like to be alive.

You think the side effects are more frequent? sure, put here the data you cannot have to prove it. Else you are just guessing again and pretending its a fact.

You don't look at age, you don't look at comorbidities you keep pushing the pharma agenda that "you never know...asymptomatic people are vulnerable too so you'd better get vaccinated with this new COVID-19 vaccine regardless.

Age and comorbidities are part of what the selection criteria for phase III includes for evaluation, just reading the trial description is enough to prove (again) you are wrong.

*Vaccines are designed to trigger the immune system into fighting off diseases. In rare instances, they can cause it to go into hyperdrive, resulting in severe allergic reactions and even paralysis. With potentially hundreds of millions of people getting vaccinated against one disease, *even a very small percentage can translate into a lot of injured people.

Doh! that is why the clinical trials are done, to prove that this "small percentage" is insignificant, and specially a much less number of people when compared with those that do get severe reactions from the natural infection (that is much more likely to produce it since it exposes the body to a million times or more of antigen even during an asymptomatic infection

Let me put a very basic example for you to understand this.

If a million people are vaccinated and 5 get an important negative reaction, that is unfortunate,

But if a million people get the natural infection and 500 get those negative reactions and 50 of them die it is obvious that being vaccinated is still much better.

*The potential volume of people affected “will be too much for some unfunded compensation program,”** said Topping, currently chief legal officer of CareSource Management Group Inc., a Dayton, Ohio-based non-profit that’s one of the nation’s largest Medicaid-managed health care plans."*

Or it could not, or funding can be allowed, once again, you are trying to predict the future and pretend its a fixed thing, surprise, it is not.

Billions have been paid for people that have no need to prove vaccines damaged them, only that this may have been the case. That for vaccines that do not have such a big impact on the lives of the population. It is very naive to think that at the same time the government will do things completely differently just this case, and push for the vaccine without providing a safety net for the patients to be able to claim damages as they want. Even if for any reason there is no compensation program that by definition would mean that vaccines would not be even recommended, the government do not have to absorb responsibility just because someone have a vaccine to sell, it can simply choose not to include any given vaccine to that program and there will be no compensation to be given from the government.

Once again....no long term studies in children, pregnant women, those who have more comorbidities, seniors 65 and above that this "liquid confidence" is supposed to protect. And now if they are injured they will not be compensated?

Yes, no long term studies on anybody, specially people infected with COVID-19, that are much more likely to have problems in the future just because they are exposed to viral proteins made specifically to mess with the immune system (and completely absent from every vaccine in phase III trials) in huge amounts.

The lack of long term studies is one of the most effective arguments FOR vaccination, this bad argument do not apply for a vaccine for a new disease, the only value it has is for diseases that already have those studies.

Looks like you're on your own so tread carefully and follow the reactions from each of the vaccine manufacturer trials (you could care less about them probably). It's not looking to be fine and dandy like you say it is.

How would you know? you have no idea about the data of the trials, it is not even collected yet, That is my point, that to sustain all your arguments you need that data that you don't have, so the only thing you have are beliefs that you try to disguise as facts, they are not, at the end is you trying to force products of your imagination.

You're almost oblivious to any adverse reactions those volunteers have. Which is troubling to see for a vaccine that only reduces cough and headache...with a bar set that doesn't prevent infection, transmission, hospitalization and death. Not a vaccine in my opinion. Just a shot that reduces cold symptoms but gives you a major blast of the flu symptoms for 1 or 2 days (from what I've seen so far).

Of course not, much less to the degree you are always oblivious the huge health problems and deaths caused by the pandemic, something that makes you so easily ignore them as non important (something morally unacceptable) You don't even know if the adverse reactions come from people actually vaccinated, you failed to prove that the vaccine only effect is reducing cough and headache (again your imagination)

Try reading with more time, you have troubles understanding almost every piece of information you bring, almost as if you were doing it on purpose. Like the antivaxxers that actively promote science denialism in order to benefit economically from selling antiscientific "cures" and "preventive measures" to all the people they mislead into doubting clear data.

9 ( +11 / -2 )

Please make your posts shorter.

What?!! I thought vaccines were safe and effective!

They are, in general and much more than the option, that in this case is the risk of an infection with serious complications and even death in the short term, and who knows what in the long term because every week or so a new consequence is found, even on people that were asymptomatic.

That is not the same as saying nothing could ever go wrong, that is just a pseudo-argument that people against science and public health like to use instead of the real one. Things can go wrong, even with the outmost care, and a precise system to deal with that possibility is necessary. Which is what the article talks about.

4 ( +8 / -4 )

Vaccines ARE safe and effective with VERY GOOD SAFETY MONITORING SYSTEMS according to W.H.O.'s chief scientist Dr. Soumya Swaminathan

What is wrong with that? it is obvious that effective monitoring systems are required to continuously corroborate safety and efficacy, It does prove that your false argument that vaccines have no liability whatsoever its nonsense (if it were true, what role would the monitoring systems have?). Emphasizing the importance of those systems is yet another way of preventing problems, so countries without them should prepare and implement them now, where there is still time to do it.

I know you really wish for this not to be said, so you could still say that nobody ever gives importance to keeping vaccinations in check, but fortunately that is not true, vigilance is a huge part of immunizations campaigns because nobody just assume vaccines are perfect (a favorite strawman of the antivaxxers).

You just had to add that last tidbit didn't you virusrex? It's just not safe out there....better get your injections today. Because, because "every week or so a new consequence is found".

Well it does not matter at all how much you dislike it, it is true. And no, vaccinations are not the sole way to protect you from those yet unknown risks, giving the proper importance to the COVID-19 allows people to protect themselves better with a huge lot of measures, from nutrition and exercise to better hygiene and opportune visits to the doctor.

I know it completely destroys your endlessly repeated argument that any new vaccine will not have long term studies of safety (since the natural infection neither does, and have demonstrated much more risks on the short and medium term), but that is a very poor reason to try and live in denial of the hidden dangers of a disease. Knowledge allows for people to be careful instead of scared, as the antivaxxers would wish. Always with the appeal of the "possible" dangers that lurk over the next immunization and how people would likely die or be left invalid over something that has proved to be much safer than the diseases they prevent.

2 ( +6 / -4 )

As I see it the risk from adverse long term side effects of a notional Covid-19 vaccine are much less than the risks if no vaccine is administered. Without a vaccine we know millions of people will die from Covid-19. Likewise the WHO has good monitoring systems but not every small, economically undeveloped nation is implementing them and some may not be able to, without assistance from WHO. That is how I read it. She is trying to make her people aware that not every nation that may receive the vaccine has the means to monitor the aftereffects. Not a reflection on WHO so much as a measure of how undeveloped many nations are. They need to do some work in those nations. I guess that is a reason not to take the vaccine in the US where there are more than adequate monitoring systems? Strange way of thinking to me.

2 ( +3 / -1 )

The first reports of this death were not disputed but now they are saying the volunteer was given the placebo. The statement about the placebo does not appear to come from a 3rd Party however

There is a 50% chance of that, it is not so difficult to believe, if you make a random group of thousands of people and follow them for 6 months it is very likely at least a few will have heavy health problems and one dying, It is of course needed to investigate such events, but there should be no problem with checking the information as it is registered by several actors, including the government, to see how likely they are related to the vaccine.

There is a lot of, cough cough, "information" on the internet with variable degrees of veracity. Everyone has an axe to grind. Why do I believe anything you post?

My point is the opposite, you don't need to believe anything, you can go to the best source you can find and check anything I write because nothing depends on anything I have to vouch for.

1 ( +3 / -2 )

But we often hear of adverse effects occurring within minutes or hours after vaccination, not 6 months.

I never said that the people will have trouble at the end of the 6 months, simply that speaking from the point of view of a group of people the more people you include and the more time you are following the more likely it is to find all kinds of problems, from small aches to life threatening problems.

Since the vast majority of the adverse effects are pain and swelling in the site of injection it is obvious they will be presented in the first minutes and hours after the injection. But that also applies for people injected saline solution as a placebo.

If you follow an equivalent group of thousands of people for the same amount of time it is unbelievable that not a single one of them had any health problem during that time. That is why thinking it is weird that something was not related to the vaccine is invalid. It is perfectly possible.

And when considering vaccine safety, I suspect they only look at short term adverse effects; RFK jr talked about this.

If that were the case the vaccines would be ready for the population since the summer, Phase III is precisely done to look for a much longer time to every kind of problem any of the participants would present, because the people doing the immunizations as well as the ones examining the patients and the volunteers themselves all ignore who got what. RFK Jr is well known for repeating false statements that have been proved so, it has no credibility and has accepted to be deeply antiscientific, nobody interested on being rational would recommend to listening to him.

1 ( +2 / -1 )

@Takara

I am on your side on this one. Once I see for myself the vaccine is safe I will take it.

The trials as of now are not encouraging.

https://www.aljazeera.com/news/2020/10/21/brazilian-volunteer-in-astrazeneca-covid-19-vaccine-trial-dies

https://www.wsj.com/articles/volunteer-in-astrazeneca-oxford-coronavirus-vaccine-trial-dies-in-brazil-11603306508

The first reports of this death were not disputed but now they are saying the volunteer was given the placebo. The statement about the placebo does not appear to come from a 3rd Party however.

0 ( +3 / -3 )

Fact, that you won't get immune after having covid speaks against vaccine...When you look on effectivity and also the fact, that it will "protect" you for one year only than it will be similar to flu shots... I do ignore these too for similar reasons.

If Covid-19 protection only lasts a year or two ends up being part of the annual flu shot I'm fine with that.

0 ( +2 / -2 )

I mean, information is open for anybody that would want to research it, you can easily corroborate anything that you think it may not be true, I am completely irrelevant for anything written.

There is a lot of, cough cough, "information" on the internet with variable degrees of veracity. Everyone has an axe to grind. Why do I believe anything you post?

0 ( +2 / -2 )

There is a 50% chance of that, it is not so difficult to believe, if you make a random group of thousands of people and follow them for 6 months it is very likely at least a few will have heavy health problems and one dying

But we often hear of adverse effects occurring within minutes or hours after vaccination, not 6 months.

And when considering vaccine safety, I suspect they only look at short term adverse effects; RFK jr talked about this...

-4 ( +0 / -4 )

What?!! I thought vaccines were safe and effective!

Vaccines ARE safe and effective with VERY GOOD SAFETY MONITORING SYSTEMS according to W.H.O.'s chief scientist Dr. Soumya Swaminathan

"Vaccines are safe. That's why they have vaccine safety systems. Robust vaccine safety systems. WHO works with countries to ensure vaccines do what they do best: Prevent disease without risks"

1 week later after that statement...behind closed doors at W.H.O. Global Vaccine Safety Summit Meeting December 2019 she says:

"I think we cannot overemphasize the fact that we really don't have very good safety monitoring systems in many countries, and this adds to the miscommunication and the misapprehensions because we're not able to give clear cut answers when people ask questions about the deaths that have occurred due to a particular vaccine, and this always gets blown up in the media"

because every week or so a new consequence is found, even on people that were asymptomatic.

You just had to add that last tidbit didn't you virusrex? It's just not safe out there....better get your injections today. Because, because "every week or so a new consequence is found".

-5 ( +2 / -7 )

What is wrong with that? it is obvious that effective monitoring systems are required to continuously corroborate safety and efficacy, 

Except her statement much later behind closed doors reveals that they do not have safe monitoring systems she claimed:

"I think we cannot overemphasize the fact that we really don't have very good safety monitoring systems in many countries, and this adds to the miscommunication and the misapprehensions because we're not able to give clear cut answers when people ask questions about the deaths that have occurred due to a particular vaccine, and this always gets blown up in the media"

Here are her statements at the 3 minute mark (for your convenience - BUT I know you'll write it off as no need to worry. These vaccines are in fact "SAFE")

https://www.youtube.com/watch?time_continue=180&v=FIGjQMlLFj8

I know it completely destroys your endlessly repeated argument that any new vaccine will not have long term studies of safety (since the natural infection neither does, and have demonstrated much more risks on the short and medium term), but that is a very poor reason to try and live in denial of the hidden dangers of a disease. Knowledge allows for people to be careful instead of scared, as the antivaxxers would wish. Always with the appeal of the "possible" dangers that lurk over the next immunization and how people would likely die or be left invalid over something that has proved to be much safer than the diseases they prevent.

You talk as if the coronavirus vaccine will be the end to the pandemic. It will not.

The bar has already been set so low for approval:

ONLY reduces cough and headache IF YOU GET COVID-19

What is the goal of a safe vaccine? Prevent infection and transmission (to prevent death) right?!

Well, it's looking like it won't do that. If something changes I will monitoring those details but looks like the bar is already set very low PLUS if you're lucky you have a good chance of getting a wallop of negative side effects (fever over 100 for 5 or more hours, severe headache, expect to take a day off the next day, fainting -whose going to catch you). AND these are healthy volunteers above 18-65 (you said some people above that)

The real kicker? Who of those volunteers had the actual COVID-19 infection? And from phase II & III seeing negative adverse events already and still you're pushing the "Hey...it happens all the time...it will all be fine" cause the 0.1%-0.5% death rate causes you grave concern. You don't look at age, you don't look at comorbidities you keep pushing the pharma agenda that "you never know...asymptomatic people are vulnerable too so you'd better get vaccinated with this new COVID-19 vaccine regardless.

*"*Potential Injuries

*Vaccines are designed to trigger the immune system into fighting off diseases. In rare instances, they can cause it to go into hyperdrive, resulting in severe allergic reactions and even paralysis. With potentially hundreds of millions of people getting vaccinated against one disease, *even a very small percentage can translate into a lot of injured people.

*The potential volume of people affected “will be too much for some unfunded compensation program,”** said Topping, currently chief legal officer of CareSource Management Group Inc., a Dayton, Ohio-based non-profit that’s one of the nation’s largest Medicaid-managed health care plans."*

Once again....no long term studies in children, pregnant women, those who have more comorbidities, seniors 65 and above that this "liquid confidence" is supposed to protect. And now if they are injured they will not be compensated?

Looks like you're on your own so tread carefully and follow the reactions from each of the vaccine manufacturer trials (you could care less about them probably). It's not looking to be fine and dandy like you say it is. You're almost oblivious to any adverse reactions those volunteers have. Which is troubling to see for a vaccine that only reduces cough and headache...with a bar set that doesn't prevent infection, transmission, hospitalization and death. Not a vaccine in my opinion. Just a shot that reduces cold symptoms but gives you a major blast of the flu symptoms for 1 or 2 days (from what I've seen so far).

-5 ( +2 / -7 )

Who foots the bill if people in poor countries fall sick with unexpected side-effects from coronavirus vaccines?

What?!! I thought vaccines were safe and effective!

-7 ( +2 / -9 )

Who pays if things go wrong?

That's easy. We the taxpaying suckers. We'll be indemnifying any payouts one way or another.

-7 ( +1 / -8 )

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