9 ms·

Sounds like the 3 week delay was merited if Moderna originally had a mostly white study group and thus wasn't properly testing the effects on the entire populat

Sounds like the 3 week delay was merited if Moderna originally had a mostly white study group and thus wasn't properly testing the effects on the entire population. This is very important to do in medicine. And I wonder if that means that Pfizer did not use a broad sample set of the population and DHS was not there to keep them in line? Or maybe they did this correctly from the get-go and it was sheer luck that Moderna had the additional needed oversight?

Exmoor 6y ago
Pfizer trial demographics are on page 31 of this PDF: https://www.fda.gov/media/144246/download https://www.fda.gov/media/144246/download You can compare that with the demographic table of the US. Looks like they don't quite align, but are presumably within the guidelines. FWIW, all the comments I saw from people more familiar with medical data were pretty positive about the demographic spread. https://en.wikipedia.org/wiki/Race_and_ethnicity_in_the_United_States#Racial_categories https://en.wikipedia.org/wiki/Race_and_ethnicity_in_the_Unit...
- Herodotus38 6y ago
  Notably, specifically look at the phase 1 demographics. It was 100% white. I’m not saying anything for or against this, but I bet it was in the first phase where the concerns for equity were brought up. Edit: the difficulty becomes the argument between recruiting equitably vs recruiting quickly, both are going to have downsides. Ideally you would do both at once, the question becomes why is this so hard in the US, and there are lots of reasons.
  - KKKKkkkk1 6y ago
    Is that why African Americans don't trust the US medical establishment? Phase 1 is meant to select the safest dose. If Black people did not take part in Phase 1 and were only added in Phase 2, that means that folks in Phase 2 were exposed to unnecessary risk.
    - Herodotus38 6y ago
      I have no insight into how volunteers were recruited in the study but I would imagine that it is partially a cycle of African Americans being less likely to volunteer due to a history of mistreatment by medical community. A lot of studies also recruit people who have a connection to the study (maybe friends/family members, students at the local university, etc...). If there is less diversity in the company and people running the study, I think this would also lead to less diversity in the participants. Again, I have no knowledge of how this one was done.
    - rrrrrrrrrrrryan 6y ago
      It's still very difficult to convince black people to partake in medical trials, largely because their trust in the system was so thoroughly violated in the not-so-distant past: https://en.wikipedia.org/wiki/Tuskegee_Syphilis_Study https://en.wikipedia.org/wiki/Tuskegee_Syphilis_Study It's not hard to imagine a patient noping out of an experiment if he's the token black guy in a room full of white doctors poking and prodding at him. I work for a company that makes medical devices for people with diabetes, (a disease which disproportionately affects people of color), and we go out of our way to ensure that we have a diverse cast of people who interact with the patients in our studies.
      - spoopyskelly 6y ago
        Is diabetes racist?
      - runamok 6y ago
        I see the Tuskegee example trotted out pretty often and frankly I was ignorant of it. Is this a well known and discussed thing among black people or might it be more about a general distrust of the government, etc. and as you pointed out, being historically under represented in medicine. I am just guessing a fairly small people asked about Tuskegee would know what it is but maybe it's just me. I am just suggesting maybe asking black people why they don't want a covid vaccine for example and address those issues.
        6y ago
t3rabytes 6y ago
This is something that Pfizer got asked about during the hearings on Friday -- their execs stated that they tried to recruit minorities heavily in the beginning of the study and continued doing so in later recruiting rounds (I don't recall if they mentioned actual number though).
- Pfhreak 6y ago
  There's a lot of history there, unfortunately. The US medical establishment has a long track record of experimenting on Black people -- from performing experimental surgery (without anesthetic) on slaves to infecting Black US soldiers with syphilis to study how the disease progressed that continued until the 70s. All this to say nothing of how the medical establishment generally under serves minorities. There's quite a bit of writing on why it might be so hard for these major pharma corps to find volunteers from these communities.
  - rossdavidh 6y ago
    If I were a black man in America, and they wanted me as a volunteer in Phase 1, I have to say that the history there would be a pretty big negative factor in my mind. Volunteering for Phase 1 is an act of trust, because by definition there's not much data yet. If I were an African-American, I don't know that I would have that kind of trust in big corporations.
    - pmiller2 6y ago
      Why would you trust big corporations as an American, period? History shows us that they will take every opportunity they are given to make or save a buck, from virtually enslaving people via company towns and company scrip, to killing people for unionizing, to polluting the places we live, to covering up evidence that their products do harm, and to suppressing evidence of the severity climate change for literal decades. These things are all so well known, it isn't even worth the effort to track down citations for them, and you still trust them?
      - 6y ago
Siira 6y ago
All the tests I have heard about have shown the new vaccines effective. The natural conclusion is that this whole test-first-use-later approach is stupid, and we should have given people the option to use the experimental vaccines without them having been proven effective. Then the pandemic would have been over by now. Of course, it’s even more obvious that delaying the tests for their whiteness has also been stupid. I am not white, and testing other populations matters, but delaying the tests needed for the authorization is just stupid. Humans aren’t that different.
- tertius 6y ago
  > Humans aren’t that different. This is true, except when it's not. Then it really matters. I do agree some in this thread are exaggerating a little.
dmurray 6y ago
A coronavirus vaccine that has only been demonstrated to work for white people would be great and well worth pumping billions of dollars into. Any drug company executive would agree. It's still reasonable that the federal government would be reluctant to fund such a vaccine, though.
- furyofantares 6y ago
  Your post is technically true and not at all relevant. You've gotta think about the context and not just post technically correct contrarian stuff. There's no excuse for bad testing demographics. If only whites are tested then we'd only find out in the wild if it works on non-whites or has adverse effects on non-whites, which is obviously hideous. We'd also flat out reject a vaccine that only works on non-whites because we'd never know it. It's fine to say that a vaccine that only works on some known part of the population is a good thing. It's better than no vaccine. But we have to know who it works on. That's what testing does, and that's what's being discussed.
  - IMTDb 6y ago
    > There's no excuse for bad testing demographics There never is a "bad testing demographic". The testing demographic can only be "good" or "bad" in relation to the population the vaccine is going to be certified for. > If only whites are tested then we'd only find out in the wild if it works on non-whites or has adverse effects on non-whites, which is obviously hideous. That's absolutely correct, if a vaccine is tested on a specific demographic, it should only be certified for that demographic, and only be given to other people after additional tests. In this context, if the FDA notices that there are not enough non-white people in the testing group, the FDA should not certify the vaccine for non-white people. White people can already start being vaccinated, and additional tests need to be performed on non-white groups. The role of the FDA is precisely to notice these stuff, react accordingly, and keep phrama companies in check. It's already what we are doing for people suffering for immunodeficiency. We develop a vaccine explicitly without including them in the trials - because it's harder to make a vaccine considering them. We certify the vaccine for the non immunodeficient people - as fast as possible. Then we will start looking for a vaccine for immunodeficient people at a later stage. First by testing the already developed vaccine - or by looking in another way if that does no work. What Pfizer exec decided to do, is put speed above all. And they were absolutely right to do so. They published they trial sampling details and it's up to the FDA to certify the vaccine for the part of the population the FDA think the sample was good enough for. And require additional tests for the others.
ChildOfChaos 6y ago
Well for example in the UK, we have rolled out the Pfizer vaccine and people started having a reaction to it, so now anyone with an allergy cannot have the vaccine and everyone has to be monitored for 15 minutes after taking it, something that should of been picked up during adequate testing.
- djxfade 6y ago
  Do you have a source for this? Never heard about it
  - krona 6y ago
    Section 2.4 of NHS standard operating procedure for COVID-19 local vaccination services deployment in community settings: https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/12/C0910-COVID-19-Vaccine-Deployment-in-Community-Settings-LVS-SOP-10-December-2020.pdf https://www.england.nhs.uk/coronavirus/wp-content/uploads/si... See also the press release from the regulatory agency specifically about anaphylaxis: https://www.gov.uk/government/news/confirmation-of-guidance-to-vaccination-centres-on-managing-allergic-reactions-following-covid-19-vaccination-with-the-pfizer-biontech-vaccine https://www.gov.uk/government/news/confirmation-of-guidance-...
- tomatocracy 6y ago
  I don't think this is really a UK-specific issue - it presumably would have come out in this way whoever approved it first (if it was actually a vaccine reaction). It's also rather surprising to me (as a relative layman) that this wasn't picked up during safety trials. I get anaphylactic reactions to some food and medicines and carry an EpiPen. There are a few vaccines which have been counterindicated for me due to this so I have always thought it's a relatively well-known potential side effect from at least some vaccines (and other medicines of course). As such I would have expected it to be looked/checked for during safety trials.
- Rapzid 6y ago
  > anyone with an allergy cannot have the vaccine Or "anyone with a history of anaphylaxis to a medicine or food should not get"? Do you have a source for anyone with any allergy being denied the vaccine?
mensetmanusman 6y ago
Isn’t 3 weeks about 21k deaths?
- adventured 6y ago
  If we had used a challenge approach we could have saved hundreds of thousands of lives globally. Most of the time it took to develop the vaccines was government red tape (only some of which is reasonable at all). You won't find very many people that want to have that conversation however, they just stick their head in the sand and hide from it. It's morally revolting and evil that the US didn't utilize a challenge trial and move far faster on the vaccines. They talk about how fast this vaccine was delivered. We could have done it a lot faster. An incredible number of lives and livelihoods could have been saved. Take 1,000 diverse volunteers from the US military, start an isolated challenge trial (if something very unexpected happens, they're contained). Then expand it after those first thousand show success. Done in half the time that this took. We'll send those soldiers to die in pointless foreign wars, and then we won't do something so obvious as this to actually save American lives. The US would have had as many volunteers as you could handle for a challenge trial, hundreds of thousands of volunteers would have been trivial to get.
- CydeWeys 6y ago
  We're gated on production capacity, not approval speed. A 3 week delay in the Moderna vaccine's approval doesn't remotely cause anything close to 21k deaths. But the risks of incorrectly approving a vaccine that does turn out to be harmful in unexpected ways to certain groups of people are much worse -- that would permanently damage the public trust in coronavirus vaccines and would contribute to more than 21k deaths in the long run.
mchusma 6y ago
A three week delay is not "merited". If you want to require resources for people to determine if their subgroup (race, preexisting conditions, weight, gender, etc) then just set up a website for people to understand what the more personalized risk assessments are. Many subgroups will not be well represented even in large trials, but we can use techniques to show people relative risks. Which in vaccines cases, are basically always very low. The FDA is supposed to issue EUA if the "benefits likely outweigh the risks". That bar was crossed after phase I trials, frankly, definitely after phase II, and is 1000x safer after a phase III trial (even if you don't love everything about it). The FDA is clearly not abiding to this standard, and is instead going with "almost no conceivable downside" standard. That has cost many lives.
LatteLazy 6y ago
Or just release it for the group(s) you have tests as and when they're done?
- CyberDildonics 6y ago
  What makes you think the way people are being grouped together due to being visually different are the same factors that dictate the largest differences in efficacy between people?
  - tw1f8b850fe3d8 6y ago
    It's what the U.S. Department of Health and Human Services thought [1], and it's clear from the thread that the comment to which you responded was predicated on that. There's no need to imply it's the GP's own opinion, and sotto voce that the GP is a racist. [1] https://news.ycombinator.com/item?id=25408088 https://news.ycombinator.com/item?id=25408088
    - CyberDildonics 6y ago
      Those two things are not the same. Increasing the diversity of a study is not the same as thinking that the differences are so great between different ethnic groups and not so great between any other distinctions that it would make sense to test and roll out to them in isolation. No one implied anyone was racist, you might want to sotto voce reread the definition of that word.
  - LatteLazy 6y ago
    I actually don't think that, I'm just pointing out there are options for those who do...
CyanLite2 6y ago
The 3 week delay was most likely because this was Moderna's first Phase 3 ever. They didn't even know what forms to fill out and needed FDA guidance the whole way. Pfizer on the other hand has the former head of FDA on their board and hundreds of other trials conducted successfully.
- brailsafe 6y ago
  > Pfizer on the other hand has the former head of FDA on their board That's a bit sus

Exmoor 6y ago

Pfizer trial demographics are on page 31 of this PDF: https://www.fda.gov/media/144246/download https://www.fda.gov/media/144246/download You can compare that with the demographic table of the US. Looks like they don't quite align, but are presumably within the guidelines. FWIW, all the comments I saw from people more familiar with medical data were pretty positive about the demographic spread. https://en.wikipedia.org/wiki/Race_and_ethnicity_in_the_United_States#Racial_categories https://en.wikipedia.org/wiki/Race_and_ethnicity_in_the_Unit...

Herodotus38 6y ago
Notably, specifically look at the phase 1 demographics. It was 100% white. I’m not saying anything for or against this, but I bet it was in the first phase where the concerns for equity were brought up. Edit: the difficulty becomes the argument between recruiting equitably vs recruiting quickly, both are going to have downsides. Ideally you would do both at once, the question becomes why is this so hard in the US, and there are lots of reasons.
- KKKKkkkk1 6y ago
  Is that why African Americans don't trust the US medical establishment? Phase 1 is meant to select the safest dose. If Black people did not take part in Phase 1 and were only added in Phase 2, that means that folks in Phase 2 were exposed to unnecessary risk.
  - Herodotus38 6y ago
    I have no insight into how volunteers were recruited in the study but I would imagine that it is partially a cycle of African Americans being less likely to volunteer due to a history of mistreatment by medical community. A lot of studies also recruit people who have a connection to the study (maybe friends/family members, students at the local university, etc...). If there is less diversity in the company and people running the study, I think this would also lead to less diversity in the participants. Again, I have no knowledge of how this one was done.
  - rrrrrrrrrrrryan 6y ago
    It's still very difficult to convince black people to partake in medical trials, largely because their trust in the system was so thoroughly violated in the not-so-distant past: https://en.wikipedia.org/wiki/Tuskegee_Syphilis_Study https://en.wikipedia.org/wiki/Tuskegee_Syphilis_Study It's not hard to imagine a patient noping out of an experiment if he's the token black guy in a room full of white doctors poking and prodding at him. I work for a company that makes medical devices for people with diabetes, (a disease which disproportionately affects people of color), and we go out of our way to ensure that we have a diverse cast of people who interact with the patients in our studies.
    - spoopyskelly 6y ago
      Is diabetes racist?
    - runamok 6y ago
      I see the Tuskegee example trotted out pretty often and frankly I was ignorant of it. Is this a well known and discussed thing among black people or might it be more about a general distrust of the government, etc. and as you pointed out, being historically under represented in medicine. I am just guessing a fairly small people asked about Tuskegee would know what it is but maybe it's just me. I am just suggesting maybe asking black people why they don't want a covid vaccine for example and address those issues.
      - 6y ago

t3rabytes 6y ago

This is something that Pfizer got asked about during the hearings on Friday -- their execs stated that they tried to recruit minorities heavily in the beginning of the study and continued doing so in later recruiting rounds (I don't recall if they mentioned actual number though).

Pfhreak 6y ago
There's a lot of history there, unfortunately. The US medical establishment has a long track record of experimenting on Black people -- from performing experimental surgery (without anesthetic) on slaves to infecting Black US soldiers with syphilis to study how the disease progressed that continued until the 70s. All this to say nothing of how the medical establishment generally under serves minorities. There's quite a bit of writing on why it might be so hard for these major pharma corps to find volunteers from these communities.
- rossdavidh 6y ago
  If I were a black man in America, and they wanted me as a volunteer in Phase 1, I have to say that the history there would be a pretty big negative factor in my mind. Volunteering for Phase 1 is an act of trust, because by definition there's not much data yet. If I were an African-American, I don't know that I would have that kind of trust in big corporations.
  - pmiller2 6y ago
    Why would you trust big corporations as an American, period? History shows us that they will take every opportunity they are given to make or save a buck, from virtually enslaving people via company towns and company scrip, to killing people for unionizing, to polluting the places we live, to covering up evidence that their products do harm, and to suppressing evidence of the severity climate change for literal decades. These things are all so well known, it isn't even worth the effort to track down citations for them, and you still trust them?
    - 6y ago

Siira 6y ago

All the tests I have heard about have shown the new vaccines effective. The natural conclusion is that this whole test-first-use-later approach is stupid, and we should have given people the option to use the experimental vaccines without them having been proven effective. Then the pandemic would have been over by now. Of course, it’s even more obvious that delaying the tests for their whiteness has also been stupid. I am not white, and testing other populations matters, but delaying the tests needed for the authorization is just stupid. Humans aren’t that different.

tertius 6y ago
> Humans aren’t that different. This is true, except when it's not. Then it really matters. I do agree some in this thread are exaggerating a little.

dmurray 6y ago

A coronavirus vaccine that has only been demonstrated to work for white people would be great and well worth pumping billions of dollars into. Any drug company executive would agree. It's still reasonable that the federal government would be reluctant to fund such a vaccine, though.

furyofantares 6y ago
Your post is technically true and not at all relevant. You've gotta think about the context and not just post technically correct contrarian stuff. There's no excuse for bad testing demographics. If only whites are tested then we'd only find out in the wild if it works on non-whites or has adverse effects on non-whites, which is obviously hideous. We'd also flat out reject a vaccine that only works on non-whites because we'd never know it. It's fine to say that a vaccine that only works on some known part of the population is a good thing. It's better than no vaccine. But we have to know who it works on. That's what testing does, and that's what's being discussed.
- IMTDb 6y ago
  > There's no excuse for bad testing demographics There never is a "bad testing demographic". The testing demographic can only be "good" or "bad" in relation to the population the vaccine is going to be certified for. > If only whites are tested then we'd only find out in the wild if it works on non-whites or has adverse effects on non-whites, which is obviously hideous. That's absolutely correct, if a vaccine is tested on a specific demographic, it should only be certified for that demographic, and only be given to other people after additional tests. In this context, if the FDA notices that there are not enough non-white people in the testing group, the FDA should not certify the vaccine for non-white people. White people can already start being vaccinated, and additional tests need to be performed on non-white groups. The role of the FDA is precisely to notice these stuff, react accordingly, and keep phrama companies in check. It's already what we are doing for people suffering for immunodeficiency. We develop a vaccine explicitly without including them in the trials - because it's harder to make a vaccine considering them. We certify the vaccine for the non immunodeficient people - as fast as possible. Then we will start looking for a vaccine for immunodeficient people at a later stage. First by testing the already developed vaccine - or by looking in another way if that does no work. What Pfizer exec decided to do, is put speed above all. And they were absolutely right to do so. They published they trial sampling details and it's up to the FDA to certify the vaccine for the part of the population the FDA think the sample was good enough for. And require additional tests for the others.

ChildOfChaos 6y ago

Well for example in the UK, we have rolled out the Pfizer vaccine and people started having a reaction to it, so now anyone with an allergy cannot have the vaccine and everyone has to be monitored for 15 minutes after taking it, something that should of been picked up during adequate testing.

djxfade 6y ago
Do you have a source for this? Never heard about it
- krona 6y ago
  Section 2.4 of NHS standard operating procedure for COVID-19 local vaccination services deployment in community settings: https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/12/C0910-COVID-19-Vaccine-Deployment-in-Community-Settings-LVS-SOP-10-December-2020.pdf https://www.england.nhs.uk/coronavirus/wp-content/uploads/si... See also the press release from the regulatory agency specifically about anaphylaxis: https://www.gov.uk/government/news/confirmation-of-guidance-to-vaccination-centres-on-managing-allergic-reactions-following-covid-19-vaccination-with-the-pfizer-biontech-vaccine https://www.gov.uk/government/news/confirmation-of-guidance-...
tomatocracy 6y ago
I don't think this is really a UK-specific issue - it presumably would have come out in this way whoever approved it first (if it was actually a vaccine reaction). It's also rather surprising to me (as a relative layman) that this wasn't picked up during safety trials. I get anaphylactic reactions to some food and medicines and carry an EpiPen. There are a few vaccines which have been counterindicated for me due to this so I have always thought it's a relatively well-known potential side effect from at least some vaccines (and other medicines of course). As such I would have expected it to be looked/checked for during safety trials.
Rapzid 6y ago
> anyone with an allergy cannot have the vaccine Or "anyone with a history of anaphylaxis to a medicine or food should not get"? Do you have a source for anyone with any allergy being denied the vaccine?

mensetmanusman 6y ago

Isn’t 3 weeks about 21k deaths?

adventured 6y ago
If we had used a challenge approach we could have saved hundreds of thousands of lives globally. Most of the time it took to develop the vaccines was government red tape (only some of which is reasonable at all). You won't find very many people that want to have that conversation however, they just stick their head in the sand and hide from it. It's morally revolting and evil that the US didn't utilize a challenge trial and move far faster on the vaccines. They talk about how fast this vaccine was delivered. We could have done it a lot faster. An incredible number of lives and livelihoods could have been saved. Take 1,000 diverse volunteers from the US military, start an isolated challenge trial (if something very unexpected happens, they're contained). Then expand it after those first thousand show success. Done in half the time that this took. We'll send those soldiers to die in pointless foreign wars, and then we won't do something so obvious as this to actually save American lives. The US would have had as many volunteers as you could handle for a challenge trial, hundreds of thousands of volunteers would have been trivial to get.
CydeWeys 6y ago
We're gated on production capacity, not approval speed. A 3 week delay in the Moderna vaccine's approval doesn't remotely cause anything close to 21k deaths. But the risks of incorrectly approving a vaccine that does turn out to be harmful in unexpected ways to certain groups of people are much worse -- that would permanently damage the public trust in coronavirus vaccines and would contribute to more than 21k deaths in the long run.

mchusma 6y ago

A three week delay is not "merited". If you want to require resources for people to determine if their subgroup (race, preexisting conditions, weight, gender, etc) then just set up a website for people to understand what the more personalized risk assessments are. Many subgroups will not be well represented even in large trials, but we can use techniques to show people relative risks. Which in vaccines cases, are basically always very low. The FDA is supposed to issue EUA if the "benefits likely outweigh the risks". That bar was crossed after phase I trials, frankly, definitely after phase II, and is 1000x safer after a phase III trial (even if you don't love everything about it). The FDA is clearly not abiding to this standard, and is instead going with "almost no conceivable downside" standard. That has cost many lives.

LatteLazy 6y ago

Or just release it for the group(s) you have tests as and when they're done?

CyberDildonics 6y ago
What makes you think the way people are being grouped together due to being visually different are the same factors that dictate the largest differences in efficacy between people?
- tw1f8b850fe3d8 6y ago
  It's what the U.S. Department of Health and Human Services thought [1], and it's clear from the thread that the comment to which you responded was predicated on that. There's no need to imply it's the GP's own opinion, and sotto voce that the GP is a racist. [1] https://news.ycombinator.com/item?id=25408088 https://news.ycombinator.com/item?id=25408088
  - CyberDildonics 6y ago
    Those two things are not the same. Increasing the diversity of a study is not the same as thinking that the differences are so great between different ethnic groups and not so great between any other distinctions that it would make sense to test and roll out to them in isolation. No one implied anyone was racist, you might want to sotto voce reread the definition of that word.
- LatteLazy 6y ago
  I actually don't think that, I'm just pointing out there are options for those who do...

CyanLite2 6y ago

The 3 week delay was most likely because this was Moderna's first Phase 3 ever. They didn't even know what forms to fill out and needed FDA guidance the whole way. Pfizer on the other hand has the former head of FDA on their board and hundreds of other trials conducted successfully.

brailsafe 6y ago
> Pfizer on the other hand has the former head of FDA on their board That's a bit sus