Alarm as FDA willing to issue Covid-19 vaccine before stringent safety testing

https://mindhive.org/challenges/1273/overview/brief

by rabies94 • 6 years ago

40 106 6 years ago

swiley2• 6 years ago

This is why people are uncomfortable with mandatory vaccination orders. I’m pro vaccine and in general well tested vaccines are very important for eradicating some pretty awful diseases. I have all of mine and I’m thankful my parents were sane and paid attention to science.

Safe modern medicine involves care and testing, that’s the whole point of organizations like the FDA. If we just carelessly push stuff like this through we can end up with some pretty nasty stuff.

jtbayly2• 6 years ago

This might be one reason they are uncomfortable with mandatory vaccination orders, but there's also the fact that the government is putting a gun to your head and saying, "I'm from the government and I'm here to help. Now I'm going to stick this needle in you. Don't resist and nobody will get hurt."

logicchains6• 6 years ago

It's also a violation of the UN "right to be free from non-consensual medical treatment" (https://www.ohchr.org/Documents/Publications/Factsheet31.pdf)

hoseja• 6 years ago

It's called monopoly on violence and there are worse examples, but perhaps it doesn't even occur to you to imagine them.

cblconfederate2• 6 years ago

is it going to be mandatory?

emerged• 6 years ago

There's basically no chance a mandatory vaccine will happen in the US at least. If it somehow made it through the legal/political side of things, it wouldn't make it through the people side of things. Especially if it's being rushed, or could be perceived that way.

ghthor2• 6 years ago

The FDA is the leading example for how NOT to protect the public from the medical industry. See the documentary "The Bleeding Edge".

wegs6• 6 years ago

Well, it's being done for all the wrong reasons, but I'd gladly take a relaxing of safety measures to be done with COVID, depending on the vaccine and the risks.

The relatively known risks of some types of a vaccine seem a lot better than the unknown ones of COVID.

I would want to wait for full phase III before we had a mandatory vaccine, relied on this fully, or otherwise did too much with it. But we can't ramp up production that quickly regardless. A pilot with a few million volunteers seems as good as any phase III. And with the right few million, it could potentially really curb spread.

_-___________-_9• 6 years ago

Really? The risks of COVID are pretty well known at this point, and for the vast majority of people they seem quite low.

andybak7• 6 years ago

I still get the feeling there's still a lot to discover about this disease.

And some will quibble over the precise definitions of "vast" and "low" in that statement.

henrikschroder5• 6 years ago

I think the most important thing to remember is that the risk profile of covid-19 is vastly different for different people.

I'm sure as fuck not getting an untested vaccine, because I'm not in a risk group. If I catch the virus, my risk of death is in lightning strike territory.

For my 70+ dad, he's in a bunch of risk groups, which means the risk equation looks very different for him, and for him it might be worth the risk of an untested vaccine.

Everyone has to do the risk calculation for themselves, and everyone is going to come to different conclusions. That's how it's supposed to work, and that's how it works for pretty much every other non-childhood vaccine.

jonnypotty2• 6 years ago

Wow.

mantap• 6 years ago

If the risks are quite low for the vast majority of people, then how come COVID-19 can be seen "from space" i.e. as excess deaths in death statistics.

wegs6• 6 years ago

Okay, if they're known, describe them to me.

* What portion of the population will have reduced lung capacity post-COVID? How long will it last?

* What about other long-term effects, such as chronic fatigue? What puts me at risk? What causes it? How long does it last?

* What about other organ damage?

Please give me some semblance of an idea of what portion of the population will have long-term disability due to COVID?

boudin• 6 years ago

Without the time to properly test the vaccine, you're as much in the unknown as with COVID-19. Maybe even more. This is really high risk that can backfire a lot. If the vaccine is ineffective, or worse, cause health issues, how would you convince a population (with already a portion being anti-vaccine) to get vaccinated to the point it requires to stop the spread once a good vaccine is available? Taking this risk for a political campaign is insane...

wegs6• 6 years ago

I wouldn't. I would offer it to selectively to narrow segments of the population who have extremely high exposure to other people (for example, a huge number of NYC mass transit drivers came down with COVID19). That's where the risk-balance benefit swings.

derbOac• 6 years ago

I think you might have your knowns and unknowns backwards.

rsynnott3• 6 years ago

But we can't ramp up production that quickly regardless.

That is, arguably, what makes this such a bonkers decision. Given that, around the world, production has started on phase 3 candidates, with no guarantee they'll ever be usable, skipping phase 3 doesn't really bring forward the time that a vaccine would see significant penetration. Doing so seems like a lot of risk for negligible benefit; it won't lead to saturation any quicker. And if anything goes wrong, the consequences, both immediate and in long-term damage to trust in the institutions, are potentially dramatic.

In fact, even if there are no negative medical effects, this could _still_ damage trust significantly. And raise significant ethical issues for medical professionals.

wittyreference• 6 years ago

Mods, can we replace the linked page here with a link to the guardian? The page here is just two paragraphs of no-content and a link to the guardian. This is its link: https://www.theguardian.com/world/2020/aug/30/fda-covid-19-v...

OneGuy1233• 6 years ago

No healthy child or adult (excluding the very old) should take this vaccine unless it's 500% safe because children and adults are NOT at risk for COVID.

Really it's only the old people that should be given any kind of a COVID vaccine.

andybak7• 6 years ago

"NOT at risk" is a bold overstatement. We can debate how much risk but it's dishonest to say "no risk"

OneGuy1233• 6 years ago

Compared to an untested vaccine? You truly belive you can ensure the safety of a vaccine without multiple years of trials?

Seb-C• 6 years ago

I know it is a voluntary exaggeration but well, if I saw a report seriously stating a 500% safety for a vaccine, I probably wouldn't take it.

hedgew• 6 years ago

Every day vaccines are delayed costs thousands of lives.

Bioethicists who have forbidden challenge trials in vaccine trials have firmly taken the no-action stance in the trolley problem.

A normal phase 3 trial gives the vaccine to volunteers and waits for them to get sick (or not). A challenge trial is the same, but infects the volunteers intentionally, which significantly speeds up the trial and reduces the sample size needed.

The trolley is running over thousands of people every day, and by flipping a switch you could reroute it to another rail where only a few people would be at risk. The modern bioethicist stance is that flipping this switch is unacceptable. Maybe waiting for people to randomly fall ill instead of acting is more holy and sacred — or perhaps "natural".

emteycz2• 6 years ago

The bioethicists argue that perhaps having people stay at home and wear a mask when going outside is absolutely required would be better than untested vaccines.

Can you imagine what happens if the antivax crowd gains actual arguments? I don't want to.

ghthor2• 6 years ago

The antivax group DOES have actual arguments. If you have kids and they have complications from the vaccines maybe you'll do the research needed to help them through their suffering like my wife and I had to do when our 5 year old started screaming, pissing herself and rocking uncontrollably.

cblconfederate2• 6 years ago

maybe because the legal stakes are much higher? It does seem that a lot of scientists will 'let nature take its course' to absolve their ingroup from responsibility. Which makes sense in a culture of outrage.

bryanrasmussen• 6 years ago

https://www.sciencemuseum.org.uk/objects-and-stories/medicin...

Thalidomide changed our relationship with new medicines for ever.

It took five years for the connection between thalidomide taken by pregnant women and the impact on their children to be made. Not only did thalidomide change people’s lives, but it resulted in tighter drug testing and reporting of side-effects.

perl4ever• 6 years ago

The trolley is running over thousands of people every day, and by flipping a switch you could reroute it to another rail where only a few people would be at risk.

The mathematical issue is that a vaccine is given to everybody, so even if it has a very small rate of harm, it can be greater than the illness it's meant to prevent, if the incidence of the illness is small enough.

I'm not against vaccines in general, but they have to be incredibly safe to be worthwhile, assuming all lives are equal. Much more so than regular medication that is only given to sick people. Inherently, there has to be a higher bar.

looperhacks• 6 years ago

I don't have much of an opinion here, but the situation is a bit different than the classic trolley problem. With the vaccines, you don't know how many people are on the rails. Yes, a not finished vaccine might safe thousands of people. But what if it causes other damage and the vaccinated people die a year later, even though the would've survived covid?

christophilus• 6 years ago

As someone who has hastily patched production systems without properly testing the fix, this may be just fine... Or, we may end up with two problems; COVID and ____. This seems like a bad idea.

nojs2• 6 years ago

How dangerous are untested vaccines and what would be the worst case scenario?

disgruntledphd2• 6 years ago

Billions of people getting whatever the hell the post-Covid fatigue thing is.

rsynnott3• 6 years ago

This was probably the worst so far: https://en.wikipedia.org/wiki/Dengvaxia_controversy

Note that the worst long-term outcome of this was probably decline in trust of vaccines. Government regulators are in a position of significant trust on this stuff, and the consequences if that was damaged would be disastrous.

querez2• 6 years ago

Unlikely worst case: there are rare side-effects that get only discovered very late. For example: 70% of those who get the vaccine develops liver complications within 3 years and 60% die a horrible death with no way to cure. Or every women who gets the vaccine becomes infertile within a decade. This is super unlikely, and moreover could only partially detected in a Phase 3. But the longer you give people to look for such complications, the more likely that they're discovered before mass-application.

Realistic worst case: there are some minor complications, and some people will get hurt. This has happened before: https://www.cdc.gov/vaccinesafety/concerns/concerns-history.... , which is why we have such strict guidelines for vaccine development today.

Realistic bad case: the vaccine is not at all effective and does absolutely not protect from (re-)infection, but gives everyone post-covid19-fatigue. It will also be giving anti-vaxxers actual arguments and getting Trump re-elected.

_-___________-_9• 6 years ago

Honestly, is it really worth throwing away the strict guidelines for this?

daurnimator• 6 years ago

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2928990/

nearly 400,000 children had been inoculated with Cutter polio vaccine and 250 cases of atypical paralytic polio occurred. There were also reports of the Wyeth pharmaceutical company polio vaccine causing paralysis and death in several children in the northeastern United States. 19 , 21
It was soon discovered that some lots of Cutter and Wyeth polio vaccine were insufficiently inactivated with formalin leading to live polio virus in more than 100,000 doses. In fact, 16 lots of Cutter polio vaccine were retested and the first six lots produced were positive for live polio virus. These incidents demonstrated the lack of oversight and safeguards put into place before the vaccine was made so widely available.

rasz• 6 years ago

zombies

oxfordmale• 6 years ago

As highlight by many scientists, a badly working vaccine is much worse than no vaccine at all. There are two serious risks, the vaccine can have serious side affects for certain genetic population groups, or the vaccine doesn't provide the protection it claims it does. Both will be taken advantage of by anti vaxers.

n0rbwah• 6 years ago

Bah, even if the vaccine was 100% safe and 100% effective antivaxers would claim that it's a death shot that does nothing for your immunity.

But yes, we should definitely be as sure as possible that the vaccine is reasonably safe and effective before getting into large scale vaccination campaigns.

Not because of the antivaxers though. Because it would be incredibly irresponsible not to do so and it could hurt many people.

aphextron3• 6 years ago

I'm signing up for the Pfizer phase 3 trial today. I have every confidence in the world that the researchers involved know what they are doing and would never push something like this if it weren't safe. If I don't get the placebo (fingers crossed), I will be one of the first people in the world with an immunity against SARS-CoV-2. That's worth a slight risk in my opinion. I honestly don't think they can do this fast enough. The difference of having this vaccine by the end of the year versus waiting until next spring could mean hundreds of thousands of lives.

waihtis2• 6 years ago

Good luck, but you should consider that this isn’t a ”researcher is good/bad” issue, this is a ”global pharma race for billions in profits” issue with all kinds of interference from management, finance, etc.

yread• 6 years ago

More like "this stuff is super difficult/they have validated it on very small samples so only do it if you're feeling lucky"

jmeister• 6 years ago

what’s wrong with profits?

As long as they lead to delivering to the public/govt. what is needed?

raverbashing2• 6 years ago

Thank you for volunteering

rbinv• 6 years ago

I will be one of the first people in the world with an immunity against SARS-CoV-2

More like, one of the first vaccine-induced immunities. Regular survivors develop an immunity, after all.

disgu• 6 years ago

I'm not trying to be a negative nancy here but from what you write you really don't seem to understand the potential risks of medical trials or how they work. I'm not saying you should not participate but you seem a bit misinformed.

the researchers involved know what they are doing and would never push something like this if it weren't safe

No, they do all the time. They do not know if it's safe. They don't have enough indication that it's unsafe. There's a huuuge difference. That's what the trials are for: To find out if they're safe and work. Both assertions can only be made after the trials.

I will be one of the first people in the world with an immunity against SARS-CoV-2

Millions already are.

Just read the papers you'll sign carefully so you don't go into all of this while not being 100% informed.

actsasbuffoon• 6 years ago

I will be one of the first people in the world with an immunity

You might become one of the first. Not all people gain immunity from vaccines. That's one of the things that the phase 3 trial is designed to measure.

Good luck, though. We really need a working vaccine, pronto. Thank you for participating.

Fjolsvith• 6 years ago

Actually, you would be one of first people to have an immunity to SARS-Cov-2 that hasn't already been infected by it.

raverbashing2• 6 years ago

Sounds like a cheap shot at politics and manipulating the narrative

If it works, praise the POTUS for being "brave", if it fails, blame the company.

Sure, the vaccine looks safe, and we might discuss if the protocol of Phase 3 testing can be modified and/or what are the reasons for it, but ignoring testing is stupid (and it's not only a matter of safe/not safe, but of dosage, booster shots required, etc)

Wear a mask and protect yourself while the vaccine gets ready, it's not hard. Or not, if you believe the recent misinformation news about "only 6% of healthy people die" then please join the queue for your Darwin Award.

libertine• 6 years ago

I'm so sick of politics... I know it's a byproduct of democracy, but this behavior becoming widespread - or at least more noticeable/transparent/obvious.

Even in a crises where scientist should be the shot callers, and regulators should be on their best game... no...

They became tools of politicians.

It's not only in the US. It's not just another "Trump thing". It's a worldwide phenomena. Every matter goes through the lens of politicians to get a refraction, or a twist.

Doesn't matter if it's a technical issue, or a scientific issue, that would required technical or scientific solutions - it all dilutes into politics.

The majority seems to be trying to leverage this pandemic for their political gains, even if that means cutting corners, hide or manipulate information. It's disgusting.

aphextron3• 6 years ago

And now you understand that everything is politics. There is no avoiding it. The moment you begin to make any form of decision that affects more than yourself, you are engaging in a political act. Ignoring this fact and doing things without political discussion is what we call authoritarianism.

gnusty_gnurc2• 6 years ago

Ignoring this fact and doing things without political discussion is what we call authoritarianism.

This is a broad statement and makes me think of how readily people talk about "fascism" and "neo-nazis" nowadays with little regard to whether the people they're describing bear any relation to Mussolini or Hitler.

rsynnott3• 6 years ago

It's not only in the US. It's not just another "Trump thing".

Eh, at least on vaccine approval, it... kind of is? The only cases I'm aware of are this one and the Russian one, and the Russian one was really more of a publicity exercise (they're 'approving' it, but only for very limited distribution, making it rather similar to a normal phase 3 in practice).

I think part of this is how the US govt is structured, rather than politics per se. It's particularly easy in the US for the executive to lean on government agencies; if nothing else it can get rid of heads of agencies without much fuss, whereas this would be anything from a major political scandal to just outright impossible in many developed countries. Also, of course, the executive is one person; in a parliamentary system this sort of leaning would require multiple people to make decisions that were, as Yes Minister put it, 'brave' (ie potentially career-ending).

y04nn• 6 years ago

If we discover any issue with this vaccine in the future, this will be a total disaster, not only because of possible complications that vaccinated people may develop in the long term but more importantly because of the anti-vax and the fear of any vaccine people will have for the next pandemic.

dariusj18• 6 years ago

I worry more that the people who are politically or economically invested in the vaccine's success will hide facts and/or lie about it's effectiveness. It is a common thing to worry about, however I feel there is a much greater chance of happening now, with certain leadership and their addled fans.

throwaway815190• 6 years ago

The narrative about COVID is starting to fall apart and these cynical people want to make as much money as they can before it falls apart completely.

CDC admits only 6% of reported COVID-19 deaths were actually caused by COVID.[0]

[0] https://t.co/W7Sxq4Pmos?amp=1

nojs2• 6 years ago

You probably know this, but that’s not what that table means.

Table 3 shows the types of health conditions and contributing causes mentioned in conjunction with deaths involving coronavirus disease 2019 (COVID-19). For 6% of the deaths, COVID-19 was the only cause mentioned. For deaths with conditions or causes in addition to COVID-19, on average, there were 2.6 additional conditions or causes per death.

Alarm as FDA willing to issue Covid-19 vaccine before stringent safety testing

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