5 ms·

Does this feel rushed to anyone? Why don’t they stagger the release? Why jump from initial trials involving thousands to widespread distribution involving milli

Does this feel rushed to anyone? Why don’t they stagger the release? Why jump from initial trials involving thousands to widespread distribution involving millions?

scrollaway 6y ago
Is your question whether the research and release of a vaccine nearly the entire world has been tirelessly either working on or waiting for "feels rushed"? I mean, what did you expect?
- DSingularity 6y ago
  I don’t know what I expected. I just feel that the timeline is unprecedented.
tssva 6y ago
Because there is an ongoing global pandemic killing people and economies.
ummonk 6y ago
Because delaying it would entail thousands of extra deaths.
Kye 6y ago
My understanding is they got a huge boost from a sudden flood of funding for mRNA research and the partially done testing for vaccines for related diseases that went away with containment measures.
nojito 6y ago
You can't rush Stage III of vaccine trials. 95% with a p of < .0001 is unheard of in Vaccines. This is an amazing feat for science.
- that_guy_iain 6y ago
  Sorry, but what does p stand for?
  - mynegation 6y ago
    https://en.m.wikipedia.org/wiki/P-value https://en.m.wikipedia.org/wiki/P-value In this context it means that the probability of getting the result they got, in the assumption that vaccine does not work, is less than 1 in 10000.
- klmadfejno 6y ago
  > 95% with a p of < .0001 is unheard of in Vaccines. That can't possibly be true. Not to diminish the accomplishment though.
  - nojito 6y ago
    How is it not true? Most are 85-90% but the jump from high 80s --> 95% is massive,
    - klmadfejno 6y ago
      Well a one second google search says chickenpox is 98% effective, so already that's not unheard of. I would think extremely low p values are not just normative, but required for a vaccine to reach public acceptance. This vaccine is noteworthy for the speed at which it was developed, but its not the first really good vaccine. edit: and because I'm getting a lot of downvotes for some reason, Anthrax, Measles, Rubella, and Polio also seem to have 90%+ effectiveness ratings. edit edit: and as a corollary, with equivalent n sizes for the trials and higher effect sizes, the p value is by necessity smaller, not that it matters below very small thresholds edit^3: high 80s to 95 isn't that noteworthy, and is likely within the margin of error of the clinical trials.
      - raven105x 6y ago
        > required for a vaccine to reach public acceptance. This leads to frightening considerations. The reason FDA testing is so stringent is that trying to explain statistics along with a myriad of other fields, that are at this point likely too complex and exhaustive for any one human to fully comprehend even if they spent their entire lifetime learning, to the "public" for them to truly make an informed decision is a futile effort. A vaccine is no doubt a great thing and much needed. Two things bother me very greatly about it: 1) A lot of testing was skipped. This will be injected into tens, possibly hundreds, of millions of people long before we even know the long term side effects. If by some very low chance this introduces an inheritable change, and if by an even lower chance that inheritable change leads to genetic collapse in 10-20 generations - just to be very clear, this is extremely unlikely - we have opened the window to humanity's end. 2) A far more realistic ethical concern is what happens to states (god forbid if the fed does it) who legally require this (unconstitutionally, of course, since most modern laws already are and nobody seems to have an issue with this) like New York who've already had a number of terrifying assembly bills for something similar, if this backfires and causes permanent harm to people? The human body is incredibly complex. A doctor's oath includes "above all, do no harm", and most of the people that will be vaccinated have a 90%+ survival chance. Granted, the above is a very myopic view that completely ignores large scale economics - so please bare with me and use your medicine/ethics hat for it. Is this the right thing to do in the long run? As a country, the US has proven track record of making stupid decisions in tough times (911 -> PATRIOT, etc).
justforfunhere 6y ago
I guess, from a business perspective, a vaccine manufacturer would seldom get a chance or a time like this. We are seeing history in making. Literally the whole world is holding its breath for a vaccine to arrive.
- bamboozled 6y ago
  Too bad if we ever have a pandemic where developing a vaccine takes years. If this works out, we will be far less prepared for the next one because, why bother ?
- reverend_gonzo 6y ago
  To be fair, every day is history in the making.
  - bluGill 6y ago
    Most days nothing happens that will be in the history books. Richard III https://en.wikipedia.org/wiki/Richard_III_of_England https://en.wikipedia.org/wiki/Richard_III_of_England was born on October 2, 1452. Most days in 1452 nothing happened that was important enough to go into any history books.
ISL 6y ago
It is rushed, hence the emergency-use authorization. In settings like nursing homes, with a 16% case-fatality rate, a vaccine with no reported safety concerns at the 0.003% level or better sounds real good.
deugtniet 6y ago
They do stagger the release, these people do not have a billion doses available right away. The next step is a limited global release. Stage 4 of the medication begins, and the safety is tracked in the global release. Later in the year, there will be more doses available, and everyone will be able to get vaccinated. Furthermore, these are considered normal trial sizes it's been tested on tens of thousand of individuals. Every test subject remains tracked. Up to now, there are no permanent adverse effects found in the population that was tested.
qwerty456127 6y ago
Despite being extremely pro-vac I'm going to postpone getting vaccinated with this for as long as possible (at least a couple of years hopefully). Even if they would disallow me to travel abroad I would rather stay in my home country. I've heard about a guy who volunteered to try the Russian vaccine - he got extremely sick and almost died from inflammatory cardiomyopathy as the result. So I want to see thousands of people who to get vaccinated and keep fine for some long time after that.
- baybal2 6y ago
  And what so? Sputnik 5 is a live virus vaccine, Moderna and Fizer are RNA vaccines with, hopefully, no live viral material as such.
  - DiogenesKynikos 6y ago
    It's not really a "live" virus - it's an adenovirus (actually, two types of adenovirus) that's been modified so that it can't replicate. The adenoviruses have also been modified to carry the SARS-CoV-2 spike protein.
    - baybal2 6y ago
      Not really, it's not an inactivated adenovirus, just a strain that is much less strong in humans.
      - DiogenesKynikos 6y ago
        They apparently use what are called "replication-incompetent" or "replication-deficient" vectors: adenoviruses that have been genetically modified to be incapable of (or not very good at - I'm not sure) replicating. Importantly, the vaccine does not use SARS-CoV-2, even in a weakened form. It just presents a SARS-CoV-2 spike protein.
- chadash 6y ago
  I heard about several guys who died or were seriously injured by Covid. I know a few of them personally. Pick your poison.
pritovido 6y ago
For me the testing process feels painful and slow. I believe the best way to know the illness is through controlled infection of volunteers. I would have volunteered myself. I have been around people risking their lives in B.A.S.E jumps, scuba diving or aircraft acrobatics. If people can risk their own lives for the adrenaline rush, I don't know why they can't risk their lives for the improvement of all humanity.
- kube-system 6y ago
  There are plenty of people who are willing to risk their own life for controlled infection trials. The issue is finding professionals and professional institutions willing to risk the lives of others to administer those trials.
- usrusr 6y ago
  > I have been around people risking their lives in B.A.S.E jumps, scuba diving or aircraft acrobatics. Those are more risks of a quick end doing something you love, which is much more attractive than a risk of ruining a long life ever after, which being on the wrong end of a failed medical experiment very much is. If we somehow had cultural conventions and processes about controlled opt-out from life then this might be different, but we don't. I don't know how those cultural mechanisms would look and I don't know if they would even be possible without doing more harm than good, but I do know that we clearly don't have them. But the real issue with challenge trials is that they just don't tell you that much as the trial group would undoubtedly be extremely biased. Basic validation can be done in a dish, in programmerese that's the suite of unit tests, and it can be done well enough to skip from safety tests (that don't involve the virus) right to observed staged deployment. The main thing challenge tests would add is that they would be a big lure for reckless people who try to be faster by skimping on the initial dish tests that are the majority of development (the equivalent of skipping unit tests).
usrusr 6y ago
Basically because the mechanisms this generation of vaccine consist of are much less complex than any before. Historically, vaccines were huge biological black boxes with all kinds of biomachinery inside that weren't understood at all, that weren't even known. Vaccines were routinely developed, purely by clever trial and error search strategies long before any of their actual mechanisms were understood. In particular this meant that most of the molecular machinery included weren't even needed for the effect. You want a lipstick so you steal cars until you find one that contains a lipstick. Who knows what else you acquired. This generation of vaccines is the opposite, they know exactly what molecules they want, where, for what reason. And it's basically one molecule. One molecule you'd be exposed to, in much larger dosage, anyways one day if the vaccines are unsuccessful (the virus is well past flash-in-the-pan now, it will become endemic unless perhaps vaccination also prevents spread and not only illness, which isn't clear at all). The only uncertainty was the question of whether the immune system will react to the sound protein if it comes without a virus attached and wether an immune system that was already acquainted with that molecule will actually work better against the actual virus, not worse (some viruses are even worse if the immune system thinks it already has a defense and focuses on that but the defense is only partial). Both are easily checked in trials if you don't skip them (we didn't). The black box full of surprises of historic vaccines, the trunk of the car that you stole to find lipstick, it's just not there.
- DSingularity 6y ago
  Thank you! Did not know that this vaccine was simpler than past vaccines.
  - losvedir 6y ago
    I wouldn't call it "simpler", exactly. Yes, it's just getting the immune system to react to a single protein (albeit by injecting genetic material rather than the protein itself) rather than sending in a whole modified virus, but it's based on a fancy new vaccine technology that hadn't been successfully developed and deployed yet, I believe. Anyway, this[0] is a great rundown of the kinds of vaccines out there and in development. Both this one (Pfizer/BioNTech) and the other one that released data recently (Moderna) are mRNA vaccines. [0] https://blogs.sciencemag.org/pipeline/archives/2020/04/15/coronavirus-vaccine-prospects https://blogs.sciencemag.org/pipeline/archives/2020/04/15/co...
dgacmu 6y ago
A pandemic is a good time to do vaccine trials. They signed up 44,000 volunteers and got 170 cases unbelievably quickly. People were highly motivated to volunteer, making the enrollment faster, and the very high case rates in the US meant there for to their target very quickly. Also, 170 cases is a _lot_ in terms of phase III studies. Other than that, the vaccine is following basically the normal course. It won't get final approval until there is more time to monitor, but the EUA will be based upon saving lives now. For more, see: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4944327/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4944327/

Does this feel rushed to anyone? Why don’t they stagger the release? Why jump from initial trials involving thousands to widespread distribution involving millions?

scrollaway 6y ago

Is your question whether the research and release of a vaccine nearly the entire world has been tirelessly either working on or waiting for "feels rushed"? I mean, what did you expect?

DSingularity 6y ago
I don’t know what I expected. I just feel that the timeline is unprecedented.

tssva 6y ago

Because there is an ongoing global pandemic killing people and economies.

ummonk 6y ago

Because delaying it would entail thousands of extra deaths.

Kye 6y ago

My understanding is they got a huge boost from a sudden flood of funding for mRNA research and the partially done testing for vaccines for related diseases that went away with containment measures.

nojito 6y ago

You can't rush Stage III of vaccine trials. 95% with a p of < .0001 is unheard of in Vaccines. This is an amazing feat for science.

that_guy_iain 6y ago
Sorry, but what does p stand for?
- mynegation 6y ago
  https://en.m.wikipedia.org/wiki/P-value https://en.m.wikipedia.org/wiki/P-value In this context it means that the probability of getting the result they got, in the assumption that vaccine does not work, is less than 1 in 10000.
klmadfejno 6y ago
> 95% with a p of < .0001 is unheard of in Vaccines. That can't possibly be true. Not to diminish the accomplishment though.
- nojito 6y ago
  How is it not true? Most are 85-90% but the jump from high 80s --> 95% is massive,
  - klmadfejno 6y ago
    Well a one second google search says chickenpox is 98% effective, so already that's not unheard of. I would think extremely low p values are not just normative, but required for a vaccine to reach public acceptance. This vaccine is noteworthy for the speed at which it was developed, but its not the first really good vaccine. edit: and because I'm getting a lot of downvotes for some reason, Anthrax, Measles, Rubella, and Polio also seem to have 90%+ effectiveness ratings. edit edit: and as a corollary, with equivalent n sizes for the trials and higher effect sizes, the p value is by necessity smaller, not that it matters below very small thresholds edit^3: high 80s to 95 isn't that noteworthy, and is likely within the margin of error of the clinical trials.
    - raven105x 6y ago
      > required for a vaccine to reach public acceptance. This leads to frightening considerations. The reason FDA testing is so stringent is that trying to explain statistics along with a myriad of other fields, that are at this point likely too complex and exhaustive for any one human to fully comprehend even if they spent their entire lifetime learning, to the "public" for them to truly make an informed decision is a futile effort. A vaccine is no doubt a great thing and much needed. Two things bother me very greatly about it: 1) A lot of testing was skipped. This will be injected into tens, possibly hundreds, of millions of people long before we even know the long term side effects. If by some very low chance this introduces an inheritable change, and if by an even lower chance that inheritable change leads to genetic collapse in 10-20 generations - just to be very clear, this is extremely unlikely - we have opened the window to humanity's end. 2) A far more realistic ethical concern is what happens to states (god forbid if the fed does it) who legally require this (unconstitutionally, of course, since most modern laws already are and nobody seems to have an issue with this) like New York who've already had a number of terrifying assembly bills for something similar, if this backfires and causes permanent harm to people? The human body is incredibly complex. A doctor's oath includes "above all, do no harm", and most of the people that will be vaccinated have a 90%+ survival chance. Granted, the above is a very myopic view that completely ignores large scale economics - so please bare with me and use your medicine/ethics hat for it. Is this the right thing to do in the long run? As a country, the US has proven track record of making stupid decisions in tough times (911 -> PATRIOT, etc).

justforfunhere 6y ago

I guess, from a business perspective, a vaccine manufacturer would seldom get a chance or a time like this. We are seeing history in making. Literally the whole world is holding its breath for a vaccine to arrive.

bamboozled 6y ago
Too bad if we ever have a pandemic where developing a vaccine takes years. If this works out, we will be far less prepared for the next one because, why bother ?
reverend_gonzo 6y ago
To be fair, every day is history in the making.
- bluGill 6y ago
  Most days nothing happens that will be in the history books. Richard III https://en.wikipedia.org/wiki/Richard_III_of_England https://en.wikipedia.org/wiki/Richard_III_of_England was born on October 2, 1452. Most days in 1452 nothing happened that was important enough to go into any history books.

ISL 6y ago

It is rushed, hence the emergency-use authorization. In settings like nursing homes, with a 16% case-fatality rate, a vaccine with no reported safety concerns at the 0.003% level or better sounds real good.

deugtniet 6y ago

They do stagger the release, these people do not have a billion doses available right away. The next step is a limited global release. Stage 4 of the medication begins, and the safety is tracked in the global release. Later in the year, there will be more doses available, and everyone will be able to get vaccinated. Furthermore, these are considered normal trial sizes it's been tested on tens of thousand of individuals. Every test subject remains tracked. Up to now, there are no permanent adverse effects found in the population that was tested.

qwerty456127 6y ago

Despite being extremely pro-vac I'm going to postpone getting vaccinated with this for as long as possible (at least a couple of years hopefully). Even if they would disallow me to travel abroad I would rather stay in my home country. I've heard about a guy who volunteered to try the Russian vaccine - he got extremely sick and almost died from inflammatory cardiomyopathy as the result. So I want to see thousands of people who to get vaccinated and keep fine for some long time after that.

baybal2 6y ago
And what so? Sputnik 5 is a live virus vaccine, Moderna and Fizer are RNA vaccines with, hopefully, no live viral material as such.
- DiogenesKynikos 6y ago
  It's not really a "live" virus - it's an adenovirus (actually, two types of adenovirus) that's been modified so that it can't replicate. The adenoviruses have also been modified to carry the SARS-CoV-2 spike protein.
  - baybal2 6y ago
    Not really, it's not an inactivated adenovirus, just a strain that is much less strong in humans.
    - DiogenesKynikos 6y ago
      They apparently use what are called "replication-incompetent" or "replication-deficient" vectors: adenoviruses that have been genetically modified to be incapable of (or not very good at - I'm not sure) replicating. Importantly, the vaccine does not use SARS-CoV-2, even in a weakened form. It just presents a SARS-CoV-2 spike protein.
chadash 6y ago
I heard about several guys who died or were seriously injured by Covid. I know a few of them personally. Pick your poison.

pritovido 6y ago

For me the testing process feels painful and slow. I believe the best way to know the illness is through controlled infection of volunteers. I would have volunteered myself. I have been around people risking their lives in B.A.S.E jumps, scuba diving or aircraft acrobatics. If people can risk their own lives for the adrenaline rush, I don't know why they can't risk their lives for the improvement of all humanity.

kube-system 6y ago
There are plenty of people who are willing to risk their own life for controlled infection trials. The issue is finding professionals and professional institutions willing to risk the lives of others to administer those trials.
usrusr 6y ago
> I have been around people risking their lives in B.A.S.E jumps, scuba diving or aircraft acrobatics. Those are more risks of a quick end doing something you love, which is much more attractive than a risk of ruining a long life ever after, which being on the wrong end of a failed medical experiment very much is. If we somehow had cultural conventions and processes about controlled opt-out from life then this might be different, but we don't. I don't know how those cultural mechanisms would look and I don't know if they would even be possible without doing more harm than good, but I do know that we clearly don't have them. But the real issue with challenge trials is that they just don't tell you that much as the trial group would undoubtedly be extremely biased. Basic validation can be done in a dish, in programmerese that's the suite of unit tests, and it can be done well enough to skip from safety tests (that don't involve the virus) right to observed staged deployment. The main thing challenge tests would add is that they would be a big lure for reckless people who try to be faster by skimping on the initial dish tests that are the majority of development (the equivalent of skipping unit tests).

usrusr 6y ago

Basically because the mechanisms this generation of vaccine consist of are much less complex than any before. Historically, vaccines were huge biological black boxes with all kinds of biomachinery inside that weren't understood at all, that weren't even known. Vaccines were routinely developed, purely by clever trial and error search strategies long before any of their actual mechanisms were understood. In particular this meant that most of the molecular machinery included weren't even needed for the effect. You want a lipstick so you steal cars until you find one that contains a lipstick. Who knows what else you acquired. This generation of vaccines is the opposite, they know exactly what molecules they want, where, for what reason. And it's basically one molecule. One molecule you'd be exposed to, in much larger dosage, anyways one day if the vaccines are unsuccessful (the virus is well past flash-in-the-pan now, it will become endemic unless perhaps vaccination also prevents spread and not only illness, which isn't clear at all). The only uncertainty was the question of whether the immune system will react to the sound protein if it comes without a virus attached and wether an immune system that was already acquainted with that molecule will actually work better against the actual virus, not worse (some viruses are even worse if the immune system thinks it already has a defense and focuses on that but the defense is only partial). Both are easily checked in trials if you don't skip them (we didn't). The black box full of surprises of historic vaccines, the trunk of the car that you stole to find lipstick, it's just not there.

DSingularity 6y ago
Thank you! Did not know that this vaccine was simpler than past vaccines.
- losvedir 6y ago
  I wouldn't call it "simpler", exactly. Yes, it's just getting the immune system to react to a single protein (albeit by injecting genetic material rather than the protein itself) rather than sending in a whole modified virus, but it's based on a fancy new vaccine technology that hadn't been successfully developed and deployed yet, I believe. Anyway, this[0] is a great rundown of the kinds of vaccines out there and in development. Both this one (Pfizer/BioNTech) and the other one that released data recently (Moderna) are mRNA vaccines. [0] https://blogs.sciencemag.org/pipeline/archives/2020/04/15/coronavirus-vaccine-prospects https://blogs.sciencemag.org/pipeline/archives/2020/04/15/co...

dgacmu 6y ago

A pandemic is a good time to do vaccine trials. They signed up 44,000 volunteers and got 170 cases unbelievably quickly. People were highly motivated to volunteer, making the enrollment faster, and the very high case rates in the US meant there for to their target very quickly. Also, 170 cases is a _lot_ in terms of phase III studies. Other than that, the vaccine is following basically the normal course. It won't get final approval until there is more time to monitor, but the EUA will be based upon saving lives now. For more, see: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4944327/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4944327/