
Covid vaccine makers commit to not seek approval until complete Phase III trials - sethbannon
https://www.statnews.com/2020/09/08/pharma-pledge-reassure-covid-19-safety/
======
Animats
The New York Times has a chart, updated daily, of all the vaccines in
development.[1] This is worldwide, not US.

Phase I: 24

Phase 2: 14

Phase 3: 9

Limited approval: 3 (CanSinoBio, Gamaleya Research Institute (Russia),
Sinovac)

Full approval: 0

That's not even including the hundred or so still in lab or animal testing.
It's encouraging; _something_ is likely to work.

The real question is, how effective are the ones that make through the safety
tests? Nobody really knows yet. The FDA (pre-Trump push) announced that their
minimal effectiveness for approval was 50%, which is low for a vaccine.
Moderna is aiming for 60%. Effectiveness times fraction of population getting
it has to be > 70% or so to stop the epidemic with a vaccine alone. That's the
"herd immunity" fraction for a disease with a growth rate of 3.

Useful questions:

\- If a vaccine is only partially effective, will an antibody test tell if it
worked?

\- Will taking one vaccine limit the effectiveness of another vaccine taken
later? That's happened for a few vaccines.[2] It's usually more of a timing
thing; some vaccines should not be given within a few weeks of other
vaccines.[3]

\- Could widespread use of a moderately effective vaccine cause people to
abandon mask-type precautions and cause an epidemic spike in the unprotected
part of the population?

Is someone working those issues effectively?

[1]
[https://www.nytimes.com/interactive/2020/science/coronavirus...](https://www.nytimes.com/interactive/2020/science/coronavirus-
vaccine-tracker.html)

[2]
[https://www.tandfonline.com/doi/pdf/10.1080/21645515.2015.10...](https://www.tandfonline.com/doi/pdf/10.1080/21645515.2015.1091908)

[3]
[https://www.ok.gov/health2/documents/IMM_PRG_5-20_Intervals_...](https://www.ok.gov/health2/documents/IMM_PRG_5-20_Intervals_Live_Vaccines&Other_Rules.pdf)

~~~
cpeterso
If multiple vaccines are ready at the same time, who will decide which vaccine
is distributed to which people? Would it be regional? Random?

~~~
mc32
Some are easier to make, some are more stable, some require special handling,
some are more effective... it may mean different one are used according to
fit.

------
mchusma
I hope that the benchmark for approval is "for a given group, the risk of the
vaccine is lower than the risk of COVID".

This has some good commentary:
[https://marginalrevolution.com/marginalrevolution/2020/09/on...](https://marginalrevolution.com/marginalrevolution/2020/09/on-
vaccine-timing-from-the-comments.html) some thoughtful commentary.

I believe that for at risk populations it is very likely that taking a phase
III vaccine candidate is the safer option right now, let alone after another
month of data.

I think let anyone who wants to volunteer to take it make their own risk
assessment but be required to send data back. The only real arguments I have
seen against this are political or paternalistic. But I also think people
should be allowed to run human challenge studies on volunteers, which is also
an ethical no brainier. But that doesn't seem to be happening either.

It basically feel like the world in 2020 decided the answer to the "trolley
car problem"
[https://en.wikipedia.org/wiki/Trolley_problem](https://en.wikipedia.org/wiki/Trolley_problem).
2020 society's action seems to be: "inaction causing 5 deaths is better than
action causing 1 death".

~~~
outside1234
If the vaccine confers only limited immunity - but the users run off and act
like they are immune for life - we could pretty quickly end up in a situation
where giving a vaccine could result in 5 deaths where 1 only would have
happened without it because people would have been more careful.

This is why it is important to understand not only that it doesn't kill
people, but how much immunity it provides.

~~~
cultureulterior
That's what they said about masks, and that turned out to be wrong too.
Assuming that people are idiots never helps

~~~
meowface
But you have some broad idea if a mask is having some effect (e.g. if your
mouth and nose are tightly covered). With a vaccine, the protection or lack
thereof is invisible to you and others.

~~~
ballenf
Anyone who's been getting flu vaccines surely has a pretty good idea how
ineffective they can be.

~~~
tylerhou
Flu vaccines _are_ effective — but the government has to try to predict which
specific strains of flu will be active that season. If they mispredict, you
might get the flu despite having the vaccine since you got a different strain.

For COVID-19, there is a known set of strains that hopefully won't change. So
a vaccine targeted towards that set should work, at least temporarily.

The following is just me speculating: from what I have heard, coronaviruses
are called such because of distinctive proteins on the outside of the cell
that are hard for the virus to change. If a vaccine elicited an immune
response to target such a protein, then it should be effective for all the
strains.

~~~
ballenf
My point was not that Covid vaccines will be ineffective, just that people
have relatively little faith in flu vaccines right now (although I still get
one every year, because better than nothing).

And I think people will see a covid vaccine as more like a flu vaccine than an
MMR vaccine.

------
jwieczorek
Meanwhile, Russia just today announced it is starting the release of the first
batch of its own vaccine to the public.

[https://www.aljazeera.com/news/2020/08/sputnik-russia-
corona...](https://www.aljazeera.com/news/2020/08/sputnik-russia-coronavirus-
vaccine-200813070859021.html)

~~~
avaika
Well. As of now the Russian vaccine doesn't look like a trustworthy solution.
Recently Russians published article in The lancet [1], but scientists who read
this have a lot of questions. Especially on data consistency. They even
published open letter to head of vaccine research Denis Logunov with open
questions [2].

According to first reaction by Denis Logunov (don't have a link on this) the
open letter doesn't worth to answer. Unless The lancet asks to react.

imho: It actually shouldn't be a surprise that if the government is corrupted,
the other governmental institutions most likely do not function well either.
This research center is a governmental institution. And might be interested
and involved in some political games as well.

[1]:
[https://www.thelancet.com/journals/lancet/article/PIIS0140-6...](https://www.thelancet.com/journals/lancet/article/PIIS0140-6736\(20\)31866-3/fulltext)

[2]: [https://cattiviscienziati.com/2020/09/07/note-of-
concern/](https://cattiviscienziati.com/2020/09/07/note-of-concern/)

upd: formatting

~~~
crx07
This is nonsense -- I'm at high risk, and I'd take a flight to Russia right
now to get a dose of Sputnik V if I knew I wouldn't catch COVID-19 on the
trip.

Those grandstanding against these vaccines in the name of safety should know
that they're directly responsible for deaths, and what's about to happen is we
will just end up with a candidate from the least scrupulous manufacturer,
because data are easy to manipulate and there's a lot of money on the line.
I'd almost guarantee that this announcement means we've just traded a stable
delivery platform for one of the mRNA candidates with risks that may be
unknowable potentially for decades.

I'm a progressive and I get it that everything Trump does is necessarily
frustrating, but whoever politicized this in response to his November 1st
deadline should be ashamed, including whoever started the pledge that some of
these companies signed today.

~~~
elorant
And what will happen if you get the vaccine and it doesn't work, but you live
your life assuming that it did. You'll stop being as cautious as you are
today, and if by any chance you get infected you'll die. How on earth is that
a better solution?

~~~
crx07
I assume nothing.

I've left home exactly once since the second week of April, the next time I
leave will be to get vaccinated (whether next week or years from now), and the
very next time I leave after that will be to get my antibody levels checked.
If the level is satisfactory, I'll resume leaving with an N95 or KN95 mask at
all times until more is known.

------
warent
I've recently heard an argument that the probability of being injured/killed
by a vaccine (e.g. due to complications, allergies, etc.) is on average
greater than the probability of covid causing damage/fatality to an
individual, therefore if people are administered these vaccines then we'll
actually see an increase in mortality/illness.

Can anyone speak to this? I'm not sure how legitimate this is, but it sounds
somewhat convincing enough to be concerning.

EDIT: Downvoting someone for asking questions, even if based on a false
premise, is completely shameful, especially when there's no claim to fact and
it's clearly not made to be inflammatory. This community should encourage
asking questions. Think carefully before throwing around a downvote as a
marker of disagreement.

~~~
airza
I think ruling that out is the point of a phase 3 trial.

~~~
newacct583
Exactly. Realistically vaccines are very safe, very occasionally they aren't.
So you start small and increase the sample size gradually to manage that risk
until you have enough data to show both efficacy and safety.

To be fair: it's also a global pandemic, and one very poorly controlled in the
US. So there is real and quantifiable risk to being "too slow", also.
Balancing between the two extremes isn't well-served by a static protocol,
you'd do something different for a vaccine against ebola (where you want to
take your time because there are very few cases) than you would for covid
(more urgent, low thousands of people dying every day) than you would have in
the 50's for polio (an ongoing global catastrophe).

So... sure. It's not at all unreasonable that an "emergency" vaccine approval
might happen. Which is why it's such a disaster that the FDA has given the
appearance of being politicized (c.f. the plasma nonsense announcement, the
right wing journalist hired as a press manager by the white house and then
fired from within the bureaucracy). There is real concern that this
administration really would "cheat" with a vaccine announcement in a way
unsupported by the science.

So now worry about blowback is forcing the pharma companies to, perhaps, err
in the opposite direction by ruling out an emergency approval. I'm not sure
that's right either.

(Or maybe they all know there's no way they'll have valid data before November
and are just trying to shut the debate down early.)

~~~
jdhbbbhb
> Realistically vaccines are very safe, very occasionally they aren't

Tell that to all the people bill gates fucked up with his third world vaccine
program

------
wearhere
What’s the timeline for Phase III trials? The article doesn’t seem to say. I
don’t feel reassured that those won’t be rushed.

~~~
shajznnckfke
The virus is pretty bad, right? Ought we be making a cost-benefit analysis
where we compare the risks of side effects from the vaccine to the risks of
the spread of the virus? In comparison to a vaccine like Gardisil, which
surely prevents far fewer deaths than a covid-19 vaccine will, wouldn’t such
an analysis actually indicate that the trials be rushed to some extent?

I’m feeling anxious that the current political milieu has a few factors
pushing against deployment of a vaccine:

1\. Republicans have been downplaying the virus the whole time, so they don’t
take the need for a vaccine seriously.

2\. Democrats are justifiably afraid of Trump pushing out a vaccine to get a
pre-election “win”.

What I’m worried about:

1\. Huge numbers of people dying every day from covid-19, with so many people
out of work and struggling, with no end in sight other than a vaccine.

What’s the worst-case scenario for undiscovered side-effects on a treatment
that has already been tested on thousands of people for months, and how
probable is that risk?

~~~
spamizbad
The 1976 swine flu outbreak is one example of what can go wrong if you rush a
vaccine:
[https://en.wikipedia.org/wiki/1976_swine_flu_outbreak](https://en.wikipedia.org/wiki/1976_swine_flu_outbreak)

It was rushed by the Ford administration for political reasons and got a lot
of people very sick.

~~~
BurningFrog
Let's quantify "a lot of people".

Out of 45 million vaccinated, 450 got Guillain-Barré Syndrome. I couldn't find
info on if any of them died.

That would have been acceptable if it had stopped a disaster, but as it turned
out the 1976 Swine Flu epidemic never really materialized as expected.

With Covid killing 1000 Americans per day, I think we should happily accept
those odds of side effects or worse.

~~~
ethanbond
Yeah, um, the point of trials is to find out _what those odds are._

They can easily be much, much, much worse.

~~~
shajznnckfke
There’s no hard line where we need to test for _t_ months, and then we will
find out if the vaccine is safe. There is no magic threshold where suddenly we
know the answer for sure. It’s more like: the size of the error bars on our
estimate of the harm _y_ in quality-adjusted-life-years (QALY) is constrained
by some function on the time _t_ , where there is diminishing returns as _t_
increases. It’s always going to be possible that there’s some side-effect that
doesn’t show up until _t+1_ months.

Further, we could build an expression of our estimate _z_ of the total harm
caused by the virus (including downstream harms like “deaths of despair” from
economic damage). By minimizing _y-z_ over _t_ , we can find out the best time
to release the vaccine (maybe to the most at-risk populations first).

I don’t think anyone at the FDA is doing this calculation. I think they are
just trying to get _y_ below some threshold, which is probably quite low
compared to _z_. My goal in this conversation is to advocate for the people
who will suffer and die because of that gap - and hope there is someone better
qualified than me that fills that role in the government helping decide what
to do. My fear is that the FDA is a highly conservative institution using
processes that aren’t well-adapted to the current epidemic.

To add more color, I think if the vaccine comes out with unexpected side-
effects, heads will roll at the FDA. But no heads will roll at the FDA over
the many thousands who could have been saved by releasing a vaccine sooner.

~~~
hilbertseries
I don’t think your fear is well founded. The fact that these vaccines are
already in phase 3 trials, despite being developed earlier this year, is a
testament to how much the FDA understands the current situation. Look up how
long it usually takes a vaccine to get from development to phase three trials,
I can guarantee you it’s not six months. People in this thread are quite
alarmist. Vaccine trials usually take a long time, because whatever is trying
to be cured isn’t a pandemic. In a pandemic you can run trials and get results
quickly in a large area. Any side effects of these vaccines are going to show
up quickly, it runs through your bloodstream and then your immune system takes
care of it. We’re running large phase three trials and we’ll have a sense of
effectiveness and general safety in a few months.

------
woke_neolib
They did not actually commit to finishing the clinical trials.

> The companies did not rule out seeking an emergency authorization of their
> vaccines, but promised that any potential coronavirus vaccine would be
> decided based on “large, high quality clinical trials” and that the
> companies would follow guidance from regulatory agencies like the Food and
> Drug Administration.

[https://www.nytimes.com/2020/09/08/world/covid-19-coronaviru...](https://www.nytimes.com/2020/09/08/world/covid-19-coronavirus.html#link-679303d7)

------
anonu
Does anyone know the dangers of a "bad batch" of vaccines, specifically with
Covid?

Here's a bit of digging on some of the dangers of smallpox[1]. Apparently, you
can get something called progressive vaccinia which eats away at your skin.[2]

[1] [https://www.cbsnews.com/news/the-most-dangerous-
vaccine/](https://www.cbsnews.com/news/the-most-dangerous-vaccine/)

[2]
[https://en.wikipedia.org/wiki/Progressive_vaccinia](https://en.wikipedia.org/wiki/Progressive_vaccinia)

~~~
nouveaux
"After the program began, the vaccine was associated with an increase in
reports of Guillain-Barré Syndrome, which can cause paralysis, respiratory
arrest, and death."

This vaccine was rushed which had deadly results.

[https://en.wikipedia.org/wiki/1976_swine_flu_outbreak](https://en.wikipedia.org/wiki/1976_swine_flu_outbreak)

~~~
hedgew
> "There is not even complete agreement about the causal relationship between
> the swine flu vaccine and Guillain-Barré syndrome"

> "Studies suggest that it is more likely that a person will get GBS after
> getting the flu than after vaccination"

In the worst case, about 450 people got Guillain-Barre due to the vaccine.
Counterfactually, some thousands or even a million Americans might have died
from the swine flu itself.

------
nfw2
The question of whether the virus or vaccine poses a greater risk seems like a
controversial one.

I (28, no health conditions) personally would be willing to take the vaccines
that have gone through stage 2 trials. I registered myself as a willing
volunteer but have not been selected.

It seems to me that there is a middle ground between approving and
recommending a vaccine to all Americans and completely blocking access to
vaccines that have been through some baseline safety testing.

What seems like a good solution to me is to have open phase 3 trials that
accept anyone willing to waive the risks. This would also accelerate us
towards to a point where we are ready to approve a vaccine for everyone.

~~~
afarrell
> have open phase 3 trials that accept anyone willing to waive the risks

If we can quickly train up musicians and waitresses to do the data collection,
sure.

------
credit_guy
The actual pledge is here [1].

There are 4 bullet points, 3 of them are quite generic; the one that made all
the waves is:

"[we pledge to] Only submit for approval or emergency use authorization after
demonstrating safety and efficacy through a Phase 3 clinical study that is
designed and conducted to meet requirements of expert regulatory authorities
such as FDA."

I feel there's some weasel wording going on here. They don't pledge to ask for
approval after the completion of Phase 3. Instead they use a very convoluted
phrasing, that's designed to make people think it's after Phase 3 is
completed, but if you read more closely says something quite different.

When is the Phase 3 for Moderna expected to be completed anyway? This is
readily available information at clinicaltrials.gov [2]. The estimated study
completion date is October 27, 2022. Is the CEO of Moderna saying he will not
seek approval prior to that date?

Pfizer's estimated study completion date is November 14, 2022 [3].

Two years from now doesn't sound quite "warp speed" to me. Did they take
billions of dollars of public money to deliver a vaccine in 2 years?

[1]
[https://www.businesswire.com/news/home/20200908005282/en/Bio...](https://www.businesswire.com/news/home/20200908005282/en/Biopharma-
Leaders-Unite-Stand-Science)

[2]
[https://clinicaltrials.gov/ct2/show/NCT04470427](https://clinicaltrials.gov/ct2/show/NCT04470427)

[3]
[https://clinicaltrials.gov/ct2/show/NCT04368728](https://clinicaltrials.gov/ct2/show/NCT04368728)

~~~
maxerickson
'after demonstrating safety and efficacy' is not weasel wording though, it's
just a different benchmark than 'completing the study'.

The headline is inaccurate, but that's on Statnews.

When studies go really well, doctors consider themselves ethically obligated
to end them early, so that the placebo group can receive the treatment. That
these studies have planned end dates well into the future doesn't mean that
they must run that long (or that it will take that long to collect sufficient
safety data).

~~~
credit_guy
Yes, but then the pledge is devoid of content. The act of seeking approval is
a submission of evidence that demonstrate safety and efficacy.

The "pledge" is essentially just saying "we'll do everything as we always
planned to do it".

Why make this pledge then? What's the value added?

There is value added indeed. In today's climate of general mistrust, simply
stating that you will not cut corners (even if there was never any possibility
of cutting corners) can allay some fears. But then, who is stoking these
fears? Should they know better than doing that?

------
ars
"82% of Democrats and 72% of Republicans expressed concern that the Covid-19
vaccine approval process would be driven more by politics than by science.

More than 80% of independents, Republicans, and Democrats said they would
worry about the safety of a vaccine that was approved quickly."

Wow.

And lest you think this is a Trump thing, the figures are similar in European
countries.

A bad COVID vaccine (one that doesn't work), or heaven help us, one that
causes harm, could set public healthcare back decades.

~~~
treeman79
It is a political decision. The kind leaders are supposed to make, the kind
they don’t like making.

A leader has to decide on either pushing early and either saving/condemning
hundreds of thousand of lives.

Or playing it safe and condemning/saving hundreds of thousands to death while
we complete years worth of trials.

Oh because that’s not enough pressure the economy is burning, which will cost
many lives as well.

It’s a horrible decision to make anyway you slice it.

Politician is going to be hated no matter what.

If it works, they are bad for taking so long, taking risk. If it goes south...

~~~
gilbetron
"political decision" in this context is making a decision to approve something
to increase the odds of one candidate winning. It is not "a decision by a
politician" but rather "a decision with the primary motivation being political
gains only".

~~~
CodesInChaos
Are you sure the polled people interpreted it like that?

I for one read it as politicians pushing for a quick release because the
effects of the pandemic are so bad while the risk of side-effects is difficult
to predict.

------
nfw2
After hearing Fauci's recent comments on the matter, my understanding is that
the phase III trials can be considered for approval once there are enough
infections in the control group to do a comparative analysis.

Since the events now needed to confirm the vaccine are in the control group,
not the experimental group, it seems that the blocker for approval now isn't
SAFETY, as it has been continually suggested, but EFFICACY.

If that is indeed the case, what makes the most sense to me would be to allow
an early approval of any vaccine that meets reasonable safety requirement
(some x months in stage 3 trial), but the patient must sign a waiver saying
that they understand there may be rare side effects and there is no guaranteed
immunity.

~~~
mumblemumble
It's both. The purpose of phase II trials is merely to demonstrate that the
new drug is safe enough to proceed to phase III trials. That's typically a
much lower bar to clear than demonstrating that it's safe enough to release
onto the market.

With (typically) no more than a few hundred participants, phase II trials
don't really have the statistical power to detect anything but the most
serious of safety problems.

~~~
nfw2
Yes, but figuring out whether something is safe is different than figuring out
whether is something is effective.

To answer the efficacy question you would look at the infection and mortality
rate of the experimental group and compare it to the rates of the control
group. There is a minimum number of infection events needed in the control
group for the comparison to be statistically significant, hence the long trial
periods.

To answer the safety question I assumed you would wait some X period of time
and evaluate the incidence of severe side effects that may have been caused by
the vaccine. This analysis wouldn't be dependent on results to the control
group. I assume this analysis can be sufficiently done with the current phase
3 trial data we have based on Fauci saying the only thing we are waiting for
is events in the control group.

I didn't consider the potential safety issue that the vaccine could
potentially make the vaccine worse. This safety analysis would also be
dependent on control group events.

~~~
mumblemumble
Establishing safety also involves a comparison with the control group.
Otherwise you can't tell if the outcome in question is significantly more or
less likely in the treatment population than in control.

------
bglusman
So, correct me if I'm wrong, but

a) current hypothesis is people with prior exposure to common-cold non-
COVID-19 coronaviruses are by and large either asymptomatic or have milder
symptoms than those without such exposure

b) presumably it should be possible to test people for these antibodies much
as we can test people for COVID antibodies

If people would volunteer for the b) anti-body test in reasonable numbers, and
a subset of them who have them would volunteer for a modified trial, we could
possibly do a double-blind intentional-exposure test on people to confirm that
the vaccine confers BETTER immunity than the existing similar antibodies do,
right? Would it be possible to ethically and realistically use that strategy
to accelerate effectiveness testing (if not safety testing) of any vaccine
candidates? or would the smaller scale of that have only made sense for
something more like Phase 2 trials?

Arguably, as long as safety is near perfect, we should be willing to tolerate
only moderate (say, 90%) effectiveness (and I'd read one of the vaccines took
two doses to get 100% effectiveness but was 90% after a single dose), but I
don't know how safety is evaluated and obviously long-term safety and short-
term safety are pretty different/I imagine a lot of people will be more
concerned about long term safety and I don't know how you can reassure them on
that on any kind of accelerated schedule.

~~~
DavidSJ
What’s your source for (a)? I think virtually every human being on the planet
has been infected with some coronavirus common cold strain in the past.

~~~
411111111111111
It would also be inversely correlated with age, as the likelihood of having
contracted the common cold increases with the amount spend interacting with
people throughout your life.

This doesn't reflect reality, as its correlation isnt inverted.

~~~
nomel
> inversely correlated with age

To some degree. Immunity fades, which is the whole concept of booster shots.

------
Invictus0
Without fast track approval, in the best case scenario, approximately how long
would it take for any of these vaccine candidates to go through phase 3
trials?

------
rsynnott
Timely: [https://www.statnews.com/2020/09/08/astrazeneca-
covid-19-vac...](https://www.statnews.com/2020/09/08/astrazeneca-
covid-19-vaccine-study-put-on-hold-due-to-suspected-adverse-reaction-in-
participant-in-the-u-k/)

(This may be nothing, of course, but it's a decent illustration that some
caution is warranted)

------
GavinB
Given that a vaccine may not provide total protection, they should consider
how to sell a potential early, safe but only moderately effective vaccination.
For instance, calling it a "COVID-19 Immune Booster Shot," and be very
transparent that it reduces your protection against the virus but is not total
immunity. Then the world won't lose faith in science and medicine when folks
who had the shot are testing positive and even dying.

Hopefully either way the amount of news coverage will be enough that most
people will get informed about it, in a way that they don't for most issues.

------
mola
What exactly is this news source doing here? Just repackaging a press release?
There are very important questions being asked here about the wording.
Journalists should be the one thinking up these questions and asking them.
They shouldn't publish these kinds of statements without doing this. Otherwise
they are no more than propaganda machines.

Fake news is not only out-right lying, it's journalists not doing their jobs
of asking the hard questions.

------
jrochkind1
Sure, who even needs a regulator if pharmaceutical companies will just promise
not to bring products to market unless they are "safe and effective".

~~~
ISL
Looming in the background are torts. If vaccine makers are forced to race
ahead of safety in order to get to market and one turns out to be
insufficiently safe, the manufacturer may get sued into the ground.

By agreeing not to jump the safety protocol, they are continuing to both limit
their liability directly (by ensuring a safer product) and adhere to best-
practices (which might help in a future court case).

~~~
ralph84
It's been decades since vaccine makers had any liability for their products in
the US. That hasn't changed with COVID-19.

[https://en.wikipedia.org/wiki/National_Childhood_Vaccine_Inj...](https://en.wikipedia.org/wiki/National_Childhood_Vaccine_Injury_Act)

~~~
ISL
I signed a waiver for a non-approved yellow-fever vaccine in the US recently
(supply of the approved vaccine is either non-existent or very limited); there
must be some level of testing/certification required before reaching that
threshold?

------
BurningFrog
There are 170+ covid vaccines being developed, 7 of which are in stage 3
trials: [https://www.washingtonpost.com/graphics/2020/health/covid-
va...](https://www.washingtonpost.com/graphics/2020/health/covid-vaccine-
update-coronavirus/)

So it's a bit misleading to talk about "the vaccine".

------
mensetmanusman
We should have had a serious national discussion about letting low risk
volunteers be exposed to the virus to rapidly progress through Phase 3, right?

[https://www.nature.com/articles/d41586-020-01179-x](https://www.nature.com/articles/d41586-020-01179-x)

------
blumomo
Here in Europe they are freed from legal consequences should the vaccine harm
someone. Instead our countries are to pay any occurring damaging. So I don’t
quiet get what motivated the vaccine makers to await the approval given that
they are practically free from prosecution anyway.

~~~
eCa
It should be in everyone's (and certainly the manufacturers') interest that
the vaccines actually are safe.

~~~
blumomo
Past has shown that it wasn’t. See swine flu vaccinations.

~~~
refurb
No vaccine is 100% safe. That doesn't exist.

The real question is the risk/benefit profile. Does the benefit of the vaccine
outweigh the risks. That was a "no" for the swine flu vaccine since the
outbreak fizzled out quickly.

If tens of thousands were dying every month from the swine flu, then the
vaccine may have still be worth it even with the GBS side effect.

------
mumblemumble
Meta observation: The sheer volume of downvoting of reasonable comments in
here really speaks volumes about the extent to which the SARS-CoV-2 pandemic
is at least as much a political subject as it is a scientific one.

~~~
trhway
"El sueño de la razón produce monstruos" (The Sleep of Reason Produces
Monsters).

------
astrophysician
Question: is it not a standard procedure to stop a Phase III trial early when
the statistics warrant it? Isn't this a pretty cut-and-dried statistical
question? Naively I would think that there's nothing controversial about
ending a trial early, isn't that the ethical thing to do?

I guess the political maneuvering angle before the election complicates all of
that, but if the Trump administration is really willing to actually fabricate
Phase III trial data, then why trust anything regardless of whether or not the
Phase III trial "completes" or not?

~~~
snowwrestler
The statement does not actually commit these companies to completing the
entire Phase III trials regardless of outcome. The relevant paragraph from
this article (with quote) is:

> In a statement, the companies pledged to “make the safety and well-being of
> vaccinated individuals our top priority.” The vaccine developers said they
> would continue to impose high ethical and scientific standards on the
> vaccine-testing process, and apply for government authorizations only “after
> demonstrating safety and efficacy through a Phase 3 clinical study.”

"Through" in that last quote is being taken to mean "at the completion of".
But it can also mean "through the use of."

I disagree with the headline that _Stat_ put on their article. To me it seems
clear that the commitment from these companies is to the quality of the
process, not a particular rigid timetable.

Edit - here is the full statement for those who want to read it.

[https://investors.modernatx.com/news-releases/news-
release-d...](https://investors.modernatx.com/news-releases/news-release-
details/biopharma-leaders-unite-stand-science)

~~~
astrophysician
Ah I gotcha yea, I just misread the article. That makes more sense and seems
much more reasonable.

------
chrisco255
The vaccine hail Mary is weird to me. We've seen that herd immunity can be
achieved (see Sweden). People under 65 with sufficient levels of vitamin D
have extremely low odds of dying from this disease, less than even the flu.
The CDC reported that less than 10% of deaths reported were from Covid alone.
We're probably already near herd immunity with hospitalizations plummeting
everywhere. Why are we still pinning everything on hopes for a vaccine?

~~~
whyleyc
Not sure where to start with these statements, but they aren't helpful.

    
    
        "We've seen that herd immunity can be achieved (see Sweden)."
    

No it can't. By the end of July 2020 only 6% of the population was known to
have antibodies, according to the Swedish Public Health Agency[1]. It is
estimated that 70% to 90% of a population needs such antibodies to achieve
herd immunity[2]

    
    
        "People under 65 with sufficient levels of vitamin D have extremely low odds of dying from this disease."
    

Vitamin D has not been scientifically proven as a preventative treatment for
COVID-19. The UK National Institute for Health and Care Excellence published a
report summarising the research studies on Vitamin D for COVID-19 and found
that 'no causal relationship between vitamin D status and COVID‑19 was found
after adjustment for confounders such as comorbidity, socio-demographics,
ethnicity, BMI and other baseline factors.' [3]

    
    
        "We're probably already near herd immunity"
    

If you are referring to the USA here this is likely not true. No one knows the
"true" infection rate, but even if you use the upper estimates of Imperial
College modelling[4] this figure is 72 million, or 22% of the population.

    
    
        "... less than even the flu"
    

Again not true. Every age group has worse outcomes from COVID-19 than the flu.
If you are 50-64 you are almost 5 times as likely to die[5]

    
    
        "... hospitalizations plummeting everywhere"
    

The hospitalisation rate is down, but not "plummeting". There are still 32,000
people hopsitalised in the U.S. [6] and a number of forecasters predicting a
rise over the next 4 weeks[7].

[1] [https://bbc.co.uk/news/world-
europe-53498133](https://bbc.co.uk/news/world-europe-53498133)

[2] [https://www.jhsph.edu/covid-19/articles/achieving-herd-
immun...](https://www.jhsph.edu/covid-19/articles/achieving-herd-immunity-
with-covid19.html)

[3] [https://www.nice.org.uk/advice/es28/chapter/Factors-for-
deci...](https://www.nice.org.uk/advice/es28/chapter/Factors-for-decision-
making)

[4] [https://ourworldindata.org/covid-
models](https://ourworldindata.org/covid-models)

[5] businessinsider.com/coronavirus-death-rate-us-compared-to-flu-by-
age-2020-6?r=US&IR=T

[6]
[https://covidtracking.com/data/national/hospitalization](https://covidtracking.com/data/national/hospitalization)

[7] [https://www.cdc.gov/coronavirus/2019-ncov/cases-
updates/hosp...](https://www.cdc.gov/coronavirus/2019-ncov/cases-
updates/hospitalizations-forecasts.html)

~~~
chrisco255
Then why are new hospitalizations and new cases nearly non-existent in Sweden?
There's only 13 people in serious or critical condition in the entire country,
according to:
[https://www.worldometers.info/coronavirus/country/sweden/](https://www.worldometers.info/coronavirus/country/sweden/)
No mask orders or shutdowns of schools or shelter in place ever occurred in
Sweden. They achieved comparable results to other European countries like
France, Spain, UK as well as the US with no lockdowns whatsoever.

Here is a randomized clinical trial on Vitamin D, released a few days ago:

Effect of Calcifediol Treatment and best Available Therapy versus best
Available Therapy on Intensive Care Unit Admission and Mortality Among
Patients Hospitalized for COVID-19: A Pilot Randomized Clinical study

"Our pilot study demonstrated that administration of a high dose of
Calcifediol or 25-hydroxyvitamin D, a main metabolite of vitamin D endocrine
system, significantly reduced the need for ICU treatment of patients requiring
hospitalization due to proven COVID-19. Calcifediol seems to be able to reduce
severity of the disease, but larger trials with groups properly matched will
be required to show a definitive answer."

[https://www.sciencedirect.com/science/article/pii/S096007602...](https://www.sciencedirect.com/science/article/pii/S0960076020302764)

EDIT:

Also, take a look at the Excess Deaths chart:
[https://www.cdc.gov/nchs/nvss/vsrr/covid19/excess_deaths.htm](https://www.cdc.gov/nchs/nvss/vsrr/covid19/excess_deaths.htm)
We are already back to average levels or somewhere near a bad flu season as
is. We only had a substantially higher excess death count for 6-8 weeks there,
and only by a few thousand. The data is certainly not matching up with the
extraordinary disruption of people's lives. It's time to move on.

------
garmaine
WTF. This is going to kill people. A lot of people.

Look, the _usual_ situation with vaccines is that we are weighing (1) the
danger posed to the few people who get sick while the trials are going on; vs.
(2) the risks taken on by _everybody_ who gets the vaccine. The vaccine might
have a small likelihood of triggering reactions or otherwise having adverse
effects, and spread over the entire population these edge cases can add up to
do more damage than the disease itself.

Again, that is for typical vaccine situations. A pandemic is totally different
--the number of cases is exponentially increasing and ripping through the
entire population. So our options are:

1\. Wait the additional 6-12 months it would take (even accounting for the
immense investments that have been made) to get a vaccine to go through all
the normal regulatory hoops we would demand of vaccine development outside of
a pandemic. During which time COVID-19 rips through the population leaving
potentially millions dead and hundreds of millions of recovered with disease-
related tissue damage.

2\. Wait, but stay in lockdown to keep the disease at bay, but in the process
massively drive up suicide, domestic violence, and divorce rates, wreck the
economy, and force people to spend their savings and/or trigger massive
inflation through pandemic relief.

3\. Some horrible compromise between the above two extremes.

4\. Roll out the vaccines as quickly as they can be manufactured, starting
now. Don't wait for Phase III results.

The Phase I and Phase II trials tell us that the vaccine successfully
generates antibodies. The group sizes so far have been large enough to know
that the risk of fatal interactions is less than the risk of dying from
COVID-19 itself--indeed, for the most part there haven't been ANY severe
reactions, at least in the major vaccines.

This "wait until the vaccine is proven safe!" is politically generated
nonsense. There is no data-driven argument supporting it. Ideologues on the
left assume that Trump wants a vaccine ASAP to win reelection, don't trust is
understanding of the science, and therefore assume that early administration
of a vaccine would be some sort of unsafe political compromise. Ideologues on
the right believe COVID-19 is a hoax anyway. But even a broken clock is right
twice a day, and the fact that Trump wants a quick vaccine approval has no
bearing on whether it is a good idea or not; and in this case it very clearly
IS beneficial to distribute a vaccine as quickly as it can be manufactured.

------
kippinitreal
Seems like a smart decision by those businesses to team up (collude?) here
both for business and public health reasons. If they all agree to wait post
election there will be a higher rate of vaccinations which will benefit
everyone (sales and progress towards herd immunity). I'm not sure if this
would put them into any odd legal situations for playing politics.

~~~
creaghpatr
There's no collusion or team up here, the pledge in question carries no
obligations and is not legally binding. So this is more of a PR play. Possibly
in response to politicians sowing doubt on the efficacy of a vaccine.

