
Alarm as FDA willing to issue Covid-19 vaccine before stringent safety testing - rabies94
https://mindhive.org/challenges/1273/overview/brief
======
christophilus
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.

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aphextron
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.

~~~
waihtis
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.

~~~
jmeister
what’s wrong with profits?

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

~~~
waihtis
The argument is not against profits but rather there is a huge first-to-market
benefit here, which might have an impact on usual quality and safety measures.

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swiley
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.

~~~
jtbayly
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."

~~~
logicchains
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](https://www.ohchr.org/Documents/Publications/Factsheet31.pdf))

~~~
Galanwe
Apologies, but could you clarify "non-consensual" for non native English
speakers?

Does this mean "no consent given for the medication" or "medication that is
not part of an agreed consensus"?

If the former, then there are literally tons of occurrences of this
everywhere.

~~~
logicchains
It means the former. What are some examples of medication being given without
consent in developed countries?

~~~
LarvaFX
Tuberculosis

~~~
logicchains
In which countries? The Tuberculosis vaccine is generally not even given in
the US, let alone mandatory.

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libertine
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.

~~~
aphextron
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_gnurc
> 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.

~~~
aphextron
>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.

Those were totalitarian states. Authoritarian is general term which can be
used to describe any entity engaging in autocratic decision making.

~~~
gnusty_gnurc
At least in America, you don't have to be engaged in "political discussion"
once you're elected. Or even before for that matter.

You're responsible to the Constitution. Once you violate that you're arguably
authoritarian. Blind submission to power without regard for protections
against it...that's authoritarianism.

------
wittyreference
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...](https://www.theguardian.com/world/2020/aug/30/fda-
covid-19-vaccine-fast-track)

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

~~~
querez
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....](https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html)
, 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.

~~~
_-___________-_
Honestly, is it really worth throwing away the strict guidelines for this?

------
y04nn
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
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.

------
oxfordmale
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
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.

------
throwaway815190
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](https://t.co/W7Sxq4Pmos?amp=1)

~~~
nojs
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.

------
raverbashing
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.

------
hedgew
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".

~~~
emteycz
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.

~~~
ghthor
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.

~~~
emteycz
I am from a country that deems many of vaccines that are used in the US
unsafe. That might make a difference.

------
wegs
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.

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

~~~
mantap
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.

~~~
henrikschroder
There is excess death due to influenza _every_ year. The number of dead due to
covid-19 is not some kind of crazy anomaly that's going to stick out in the
statistics.

In no-good zombie-apocalypse Sweden, the total deaths/capita for 2020 is
probably going to be above the 5-year average, but below the 10-year average
and below the death rate of 2012.

Here's how the excess mortality of 2020 compares to the last 40 years of
mortality in Germany, Sweden, France, and Belgium:
[https://medium.com/@FrankfurtZack/unprecedented-overall-
mort...](https://medium.com/@FrankfurtZack/unprecedented-overall-mortality-in-
sweden-and-other-european-countries-cd8fcdd6174a)

If you didn't know about it, you wouldn't think anything special at all
happened in 2020, just by looking at the statistics.

~~~
WalterGR
_There is excess death due to influenza every year._

Right. And the flu deaths will be on top of the COVID deaths.

 _The number of dead due to covid-19 is not some kind of crazy anomaly that 's
going to stick out in the statistics._

Yes it is.

I don't know who @FrankfurtZack is beyond how he describes himself: "armchair
virologist. hobbyvirologe, hobbystaatsepidemiologe". He has one post on Medium
and that's it.

Here are some information sources that are more trustworthy.

[https://www.cdc.gov/nchs/nvss/vsrr/covid19/excess_deaths.htm](https://www.cdc.gov/nchs/nvss/vsrr/covid19/excess_deaths.htm)

[https://www.nytimes.com/interactive/2020/08/12/us/covid-
deat...](https://www.nytimes.com/interactive/2020/08/12/us/covid-deaths-
us.html)

[https://www.statnews.com/2020/08/03/measuring-excess-
mortali...](https://www.statnews.com/2020/08/03/measuring-excess-mortality-
gives-clearer-picture-pandemics-true-burden/) (Boston Globe)

[https://www.economist.com/graphic-
detail/2020/07/15/tracking...](https://www.economist.com/graphic-
detail/2020/07/15/tracking-covid-19-excess-deaths-across-countries)

The CDC link in particular is good because the first graph you come across
when you scroll down shows deaths going back to 2017, so you can compare COVID
excess deaths with H1N1 excess deaths.

~~~
_-___________-_
"going back to 2017" is a very short window. The European excess mortality
data I've seen does show COVID as a fairly significant spike in a 5-year
context, but even just "zooming out" to 10 years makes it fairly
insignificant.

~~~
WalterGR
Okay, but the above is US data. It’s a significant spike given the time window
shown.

Also, reputable link to the European data you refer to?

------
OneGuy123
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.

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

~~~
OneGuy123
Compared to an untested vaccine? You truly belive you can ensure the safety of
a vaccine without multiple years of trials?

~~~
andybak
> Compared to an untested vaccine?

I didn't say anything about comparisons. I was pointing out that you were
engaging in hyperbole.

~~~
OneGuy123
You did: COVID vs vaccine IS a comparison.

Since in the end it's RISK of covid vs RISK of vaccine.

~~~
andybak
I'm really struggling to follow your logic when I didn't mention vaccines at
all. You said "...children and adults are NOT at risk for COVID." and I am
claiming that this statement is obviously false.

If you'd said something more nuanced I wouldn't be having this conversation.

