COVID-19

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Comments

  • brianlux
    brianlux Moving through All Kinds of Terrain. Posts: 43,662
    pjl44 said:
    I know there's a thread on AMT, but I think putting it in the forum for political discussion has brought out all the problems you might imagine.

    My hope is that this thread can be focused on discussion of vaccine and treatment progress, apolitical analysis of case/mortality trends, good faith discussions about difficult decisions like when to reopen schools, etc. If you want to bicker about red states and blue states, mask wearing, Governors, our President, etc., the thread in AMT would be more appropriate.

    My motivation to kick things off was a couple articles that caught my eye recently:

    Despite some anecdotes, it looks very unlikely for someone to get reinfected:
    https://www.nytimes.com/2020/07/22/health/covid-antibodies-herd-immunity.html#click=https://t.co/cTiRddiIZm

    It hasn't been published in a peer-reviewed journal yet, but these are potentially the best treatment results we've seen so far. A well-designed study, although I wonder if it's a large enough sample.
    https://www.bbc.co.uk/news/amp/health-53467022?__twitter_impression=true

    And hopefully many people have already seen the encouraging results from Oxford's Phase 1 studies published in The Lancet:
    https://www.nbcnews.com/health/health-news/oxford-coronavirus-vaccine-induces-strong-immune-response-early-trial-results-n1234191

    This is a great idea, pjl.  Everything is politicized these days and even though there are some political ramifications to how the pandemic is responded to, moving the COVID-19 discussion over to AET will help keep the focus on the medical aspects. 

    I'm not sure avoiding the topic of mask wearing here as it relates to the prevention of the spread of disease is necessary, but hopefully we can keep that sub-topic focused on the medical aspects, not the political.

    I feel fortunate to not have anyone close to me get the disease yet although I did hear recently of a close friend of a friend coming down with it- a very nice gentleman I met early this year before the disease went rampant.  He has it bad enough to be in the hospital.  I really hope he pulls through.




    "It's a sad and beautiful world"
    -Roberto Benigni

  • RogueStoner
    RogueStoner Sunny AZ Posts: 1,716
    My kids’ school just got delayed until mid-October and then they’ll reassess in-person attendance. This is causing so much anxiety but I keep reminding myself that it keeps others safe. Meanwhile, here I go again, screwing up basic math for them. :fearful:
  • deadendp
    deadendp Northeast Ohio Posts: 10,434
    RogueStoner said:
    My kids’ school just got delayed until mid-October and then they’ll reassess in-person attendance. This is causing so much anxiety but I keep reminding myself that it keeps others safe. Meanwhile, here I go again, screwing up basic math for them. :fearful:
    So in-person is delayed? Try Khan Academy, Brainly or quickmath.com . We have used all three. (Math is not my thing.)

    Quick Math actually shows step-by-step how to work through the problem. 

    Khan Academy covers several subjects. 
    2014: Cincinnati
    2016: Lexington and Wrigley 1
  • RogueStoner
    RogueStoner Sunny AZ Posts: 1,716
    deadendp said:
    RogueStoner said:
    My kids’ school just got delayed until mid-October and then they’ll reassess in-person attendance. This is causing so much anxiety but I keep reminding myself that it keeps others safe. Meanwhile, here I go again, screwing up basic math for them. :fearful:
    So in-person is delayed? Try Khan Academy, Brainly or quickmath.com . We have used all three. (Math is not my thing.)

    Quick Math actually shows step-by-step how to work through the problem. 

    Khan Academy covers several subjects. 
    Thank you. I will. Much appreciated. :smile:
  • oftenreading
    oftenreading Victoria, BC Posts: 12,856
    Two interesting articles on the issue of Covid and vaccines. 

    The first is from Scientific American and discussed why evidence of dropping antibodies after infection may not be as much of a problem as feared. 


    The second talks about several reasons why it’s not a good idea to rush to put out a vaccine without thorough testing. This is something I am personally concerned about and which may well lead me to delay getting a vaccine, should one be made available more quickly than I think is reasonable. 


    I’m not even going to bother posting these in the AMT thread. Any actual info gets ignored as people argue back and forth about how much Trump and other officials are to blame for the current situation. 
    my small self... like a book amongst the many on a shelf
  • Jearlpam0925
    Jearlpam0925 Deep South Philly Posts: 17,530
    https://apple.news/AOTL9zyF8S8CX38-je6TOMA

    The second talks about several reasons why it’s not a good idea to rush to put out a vaccine without thorough testing. This is something I am personally concerned about and which may well lead me to delay getting a vaccine, should one be made available more quickly than I think is reasonable. 
    Paraphrasing things told to me by a buddy who is a doctor at a children's hospital and is working on covid research,a long with a vaccine at Penn:
    • They can accelerate some of the more challenging phases (higher bar to have necessary conditions to run the trial) by doing extra things like human challenge trials — which is a bioethics topic we could have an hours long discussion over
    • bottom line, if there is a vaccine — it will be safe
    • If anyone ever wants the science on how to counter vaccine hesitancy — happy to share the research papers. I'll follow up with him for this stuff.
  • oftenreading
    oftenreading Victoria, BC Posts: 12,856
    Jearlpam0925 said:
    https://apple.news/AOTL9zyF8S8CX38-je6TOMA

    The second talks about several reasons why it’s not a good idea to rush to put out a vaccine without thorough testing. This is something I am personally concerned about and which may well lead me to delay getting a vaccine, should one be made available more quickly than I think is reasonable. 
    Paraphrasing things told to me by a buddy who is a doctor at a children's hospital and is working on covid research,a long with a vaccine at Penn:
    • They can accelerate some of the more challenging phases (higher bar to have necessary conditions to run the trial) by doing extra things like human challenge trials — which is a bioethics topic we could have an hours long discussion over
    • bottom line, if there is a vaccine — it will be safe
    • If anyone ever wants the science on how to counter vaccine hesitancy — happy to share the research papers. I'll follow up with him for this stuff.
    I’m familiar with the science. I am generally very provaccine, but there is no denying that some information takes time to acquire, by its very nature. 
    my small self... like a book amongst the many on a shelf
  • Jearlpam0925
    Jearlpam0925 Deep South Philly Posts: 17,530
    oftenreading said:
    Jearlpam0925 said:
    https://apple.news/AOTL9zyF8S8CX38-je6TOMA

    The second talks about several reasons why it’s not a good idea to rush to put out a vaccine without thorough testing. This is something I am personally concerned about and which may well lead me to delay getting a vaccine, should one be made available more quickly than I think is reasonable. 
    Paraphrasing things told to me by a buddy who is a doctor at a children's hospital and is working on covid research,a long with a vaccine at Penn:
    • They can accelerate some of the more challenging phases (higher bar to have necessary conditions to run the trial) by doing extra things like human challenge trials — which is a bioethics topic we could have an hours long discussion over
    • bottom line, if there is a vaccine — it will be safe
    • If anyone ever wants the science on how to counter vaccine hesitancy — happy to share the research papers. I'll follow up with him for this stuff.
    I’m familiar with the science. I am generally very provaccine, but there is no denying that some information takes time to acquire, by its very nature. 
    Sure - my point is by the time it is available, even with accelerated testing, it will be safe.
  • Jearlpam0925
    Jearlpam0925 Deep South Philly Posts: 17,530
    Funny - he actually just texted me this article, which is relevant re: the topic of schooling being discussed:

    https://www.nejm.org/doi/full/10.1056/NEJMms2024920
  • oftenreading
    oftenreading Victoria, BC Posts: 12,856
    Jearlpam0925 said:
    oftenreading said:
    Jearlpam0925 said:
    https://apple.news/AOTL9zyF8S8CX38-je6TOMA

    The second talks about several reasons why it’s not a good idea to rush to put out a vaccine without thorough testing. This is something I am personally concerned about and which may well lead me to delay getting a vaccine, should one be made available more quickly than I think is reasonable. 
    Paraphrasing things told to me by a buddy who is a doctor at a children's hospital and is working on covid research,a long with a vaccine at Penn:
    • They can accelerate some of the more challenging phases (higher bar to have necessary conditions to run the trial) by doing extra things like human challenge trials — which is a bioethics topic we could have an hours long discussion over
    • bottom line, if there is a vaccine — it will be safe
    • If anyone ever wants the science on how to counter vaccine hesitancy — happy to share the research papers. I'll follow up with him for this stuff.
    I’m familiar with the science. I am generally very provaccine, but there is no denying that some information takes time to acquire, by its very nature. 
    Sure - my point is by the time it is available, even with accelerated testing, it will be safe.

    I think that's a fairly simplistic view of the situation. I work in health care, I prescribe medications, I'm familiar with the whole host of adverse and unintended effects that come even with medications and products generally viewed as "safe", i.e. those that have received regulatory approval. It isn't a binary issue, safe or not safe; it's a much more complex gradient of both potential short term and long term effects. At least one of the front-runner vaccine candidates is an RNA vaccine; however, there are, to date, no approved RNA or DNA vaccines for humans, so we do not even have a history of safety and efficacy in that modality to draw from. 

    Beyond the issue of safety there is efficacy, including the thorny issue of durability of immune response. This is impossible to determine without taking the time to measure it. 

    Thus, back to my original statement of my concern if a vaccine is made available more quickly than I think is reasonable. There is a massive push to have one or more vaccines developed in record time, with some people now estimating possibly by the end of 2020 or early 2021. In my opinion that's more quickly than is reasonable. 
    my small self... like a book amongst the many on a shelf
  • Jearlpam0925
    Jearlpam0925 Deep South Philly Posts: 17,530
    Well understood and I appreciate one's personal view of their own hesitancy. My point is, yes, basically it is that simple that when and if any vaccine is approved it will have gone through a thorough process. Is skepticism valid to an extent, sure. But my point of all this isn't for you individually. Any public messaging system/board is a place that amplifies a message. And the message that needs to be amplified is that when and if a vaccine is approved that it will be safe. Otherwise the more doubt that bleeds into the public discourse will lead to more negative effects for when and if distribution of the vaccine begins. 

    That's my greatest concern- by the time a vaccine is ready to roll out the herd immunity will never be effective because too many people will doubt its use.
  • pjl44
    pjl44 Posts: 10,529
    oftenreading said:
    Jearlpam0925 said:
    oftenreading said:
    Jearlpam0925 said:
    https://apple.news/AOTL9zyF8S8CX38-je6TOMA

    The second talks about several reasons why it’s not a good idea to rush to put out a vaccine without thorough testing. This is something I am personally concerned about and which may well lead me to delay getting a vaccine, should one be made available more quickly than I think is reasonable. 
    Paraphrasing things told to me by a buddy who is a doctor at a children's hospital and is working on covid research,a long with a vaccine at Penn:
    • They can accelerate some of the more challenging phases (higher bar to have necessary conditions to run the trial) by doing extra things like human challenge trials — which is a bioethics topic we could have an hours long discussion over
    • bottom line, if there is a vaccine — it will be safe
    • If anyone ever wants the science on how to counter vaccine hesitancy — happy to share the research papers. I'll follow up with him for this stuff.
    I’m familiar with the science. I am generally very provaccine, but there is no denying that some information takes time to acquire, by its very nature. 
    Sure - my point is by the time it is available, even with accelerated testing, it will be safe.

    I think that's a fairly simplistic view of the situation. I work in health care, I prescribe medications, I'm familiar with the whole host of adverse and unintended effects that come even with medications and products generally viewed as "safe", i.e. those that have received regulatory approval. It isn't a binary issue, safe or not safe; it's a much more complex gradient of both potential short term and long term effects. At least one of the front-runner vaccine candidates is an RNA vaccine; however, there are, to date, no approved RNA or DNA vaccines for humans, so we do not even have a history of safety and efficacy in that modality to draw from. 

    Beyond the issue of safety there is efficacy, including the thorny issue of durability of immune response. This is impossible to determine without taking the time to measure it. 

    Thus, back to my original statement of my concern if a vaccine is made available more quickly than I think is reasonable. There is a massive push to have one or more vaccines developed in record time, with some people now estimating possibly by the end of 2020 or early 2021. In my opinion that's more quickly than is reasonable. 
    It sounds like they're planning to review data around the 4 month mark. Do you think that's too soon? Does that go for all endpoints or just particular ones?
  • oftenreading
    oftenreading Victoria, BC Posts: 12,856
    pjl44 said:
    oftenreading said:
    Jearlpam0925 said:
    oftenreading said:
    Jearlpam0925 said:
    https://apple.news/AOTL9zyF8S8CX38-je6TOMA

    The second talks about several reasons why it’s not a good idea to rush to put out a vaccine without thorough testing. This is something I am personally concerned about and which may well lead me to delay getting a vaccine, should one be made available more quickly than I think is reasonable. 
    Paraphrasing things told to me by a buddy who is a doctor at a children's hospital and is working on covid research,a long with a vaccine at Penn:
    • They can accelerate some of the more challenging phases (higher bar to have necessary conditions to run the trial) by doing extra things like human challenge trials — which is a bioethics topic we could have an hours long discussion over
    • bottom line, if there is a vaccine — it will be safe
    • If anyone ever wants the science on how to counter vaccine hesitancy — happy to share the research papers. I'll follow up with him for this stuff.
    I’m familiar with the science. I am generally very provaccine, but there is no denying that some information takes time to acquire, by its very nature. 
    Sure - my point is by the time it is available, even with accelerated testing, it will be safe.

    I think that's a fairly simplistic view of the situation. I work in health care, I prescribe medications, I'm familiar with the whole host of adverse and unintended effects that come even with medications and products generally viewed as "safe", i.e. those that have received regulatory approval. It isn't a binary issue, safe or not safe; it's a much more complex gradient of both potential short term and long term effects. At least one of the front-runner vaccine candidates is an RNA vaccine; however, there are, to date, no approved RNA or DNA vaccines for humans, so we do not even have a history of safety and efficacy in that modality to draw from. 

    Beyond the issue of safety there is efficacy, including the thorny issue of durability of immune response. This is impossible to determine without taking the time to measure it. 

    Thus, back to my original statement of my concern if a vaccine is made available more quickly than I think is reasonable. There is a massive push to have one or more vaccines developed in record time, with some people now estimating possibly by the end of 2020 or early 2021. In my opinion that's more quickly than is reasonable. 
    It sounds like they're planning to review data around the 4 month mark. Do you think that's too soon? Does that go for all endpoints or just particular ones?

    By "too soon", are you referring to safety or efficacy data?

    If you mean efficacy, I think that is too soon to come to any definitive answer, unless they go ahead with challenge trials. Certainly too soon if we're just talking about people being out and about in the world

    If you mean safety, 4 month data would capture immediate/short term adverse effects but not long term, of course.

    I have read that Fauci has stated that they would consider dropping the requirement for Phase 3 studies and giving emergency release to a promising vaccine after Phase 2 trials. That, to my mind, is way too soon and I'd be pretty cautious about a vaccine without robust Phase 3 data.
    my small self... like a book amongst the many on a shelf
  • dankind
    dankind Posts: 20,841
    New cases in Mass are heading in the wrong direction. Fuck a duck!
    I SAW PEARL JAM
  • oftenreading
    oftenreading Victoria, BC Posts: 12,856
    pjl44 said:
    oftenreading said:
    Jearlpam0925 said:
    oftenreading said:
    Jearlpam0925 said:
    https://apple.news/AOTL9zyF8S8CX38-je6TOMA

    The second talks about several reasons why it’s not a good idea to rush to put out a vaccine without thorough testing. This is something I am personally concerned about and which may well lead me to delay getting a vaccine, should one be made available more quickly than I think is reasonable. 
    Paraphrasing things told to me by a buddy who is a doctor at a children's hospital and is working on covid research,a long with a vaccine at Penn:
    • They can accelerate some of the more challenging phases (higher bar to have necessary conditions to run the trial) by doing extra things like human challenge trials — which is a bioethics topic we could have an hours long discussion over
    • bottom line, if there is a vaccine — it will be safe
    • If anyone ever wants the science on how to counter vaccine hesitancy — happy to share the research papers. I'll follow up with him for this stuff.
    I’m familiar with the science. I am generally very provaccine, but there is no denying that some information takes time to acquire, by its very nature. 
    Sure - my point is by the time it is available, even with accelerated testing, it will be safe.

    I think that's a fairly simplistic view of the situation. I work in health care, I prescribe medications, I'm familiar with the whole host of adverse and unintended effects that come even with medications and products generally viewed as "safe", i.e. those that have received regulatory approval. It isn't a binary issue, safe or not safe; it's a much more complex gradient of both potential short term and long term effects. At least one of the front-runner vaccine candidates is an RNA vaccine; however, there are, to date, no approved RNA or DNA vaccines for humans, so we do not even have a history of safety and efficacy in that modality to draw from. 

    Beyond the issue of safety there is efficacy, including the thorny issue of durability of immune response. This is impossible to determine without taking the time to measure it. 

    Thus, back to my original statement of my concern if a vaccine is made available more quickly than I think is reasonable. There is a massive push to have one or more vaccines developed in record time, with some people now estimating possibly by the end of 2020 or early 2021. In my opinion that's more quickly than is reasonable. 
    It sounds like they're planning to review data around the 4 month mark. Do you think that's too soon? Does that go for all endpoints or just particular ones?
    Adding to my earlier answer, it would be really interesting to see if the data separates at 2 months, 4 months, 6 months. 
    my small self... like a book amongst the many on a shelf
  • Poncier
    Poncier Posts: 17,889
    dankind said:
    New cases in Mass are heading in the wrong direction. Fuck a duck!
    Partly blamed on one of the hospital groups with a reporting data dump of tests inflating the overall total.
    The positivity rate has jumped a tick, from about 1.7% to about 2.0% the last week,
    Number still not bad, Covid hospitilazations today hit their lowest number since things ramped up in March. (347, down from a high of about 4,000).
    So if folks smarten up with the parties in Chatham and 33% capacity booze cruises that are more likely 133% capacity (they've been shut down), we'll be OK.
    This weekend we rock Portland
  • pjl44
    pjl44 Posts: 10,529
    oftenreading said:
    pjl44 said:
    oftenreading said:
    Jearlpam0925 said:
    oftenreading said:
    Jearlpam0925 said:
    https://apple.news/AOTL9zyF8S8CX38-je6TOMA

    The second talks about several reasons why it’s not a good idea to rush to put out a vaccine without thorough testing. This is something I am personally concerned about and which may well lead me to delay getting a vaccine, should one be made available more quickly than I think is reasonable. 
    Paraphrasing things told to me by a buddy who is a doctor at a children's hospital and is working on covid research,a long with a vaccine at Penn:
    • They can accelerate some of the more challenging phases (higher bar to have necessary conditions to run the trial) by doing extra things like human challenge trials — which is a bioethics topic we could have an hours long discussion over
    • bottom line, if there is a vaccine — it will be safe
    • If anyone ever wants the science on how to counter vaccine hesitancy — happy to share the research papers. I'll follow up with him for this stuff.
    I’m familiar with the science. I am generally very provaccine, but there is no denying that some information takes time to acquire, by its very nature. 
    Sure - my point is by the time it is available, even with accelerated testing, it will be safe.

    I think that's a fairly simplistic view of the situation. I work in health care, I prescribe medications, I'm familiar with the whole host of adverse and unintended effects that come even with medications and products generally viewed as "safe", i.e. those that have received regulatory approval. It isn't a binary issue, safe or not safe; it's a much more complex gradient of both potential short term and long term effects. At least one of the front-runner vaccine candidates is an RNA vaccine; however, there are, to date, no approved RNA or DNA vaccines for humans, so we do not even have a history of safety and efficacy in that modality to draw from. 

    Beyond the issue of safety there is efficacy, including the thorny issue of durability of immune response. This is impossible to determine without taking the time to measure it. 

    Thus, back to my original statement of my concern if a vaccine is made available more quickly than I think is reasonable. There is a massive push to have one or more vaccines developed in record time, with some people now estimating possibly by the end of 2020 or early 2021. In my opinion that's more quickly than is reasonable. 
    It sounds like they're planning to review data around the 4 month mark. Do you think that's too soon? Does that go for all endpoints or just particular ones?

    By "too soon", are you referring to safety or efficacy data?

    If you mean efficacy, I think that is too soon to come to any definitive answer, unless they go ahead with challenge trials. Certainly too soon if we're just talking about people being out and about in the world

    If you mean safety, 4 month data would capture immediate/short term adverse effects but not long term, of course.

    I have read that Fauci has stated that they would consider dropping the requirement for Phase 3 studies and giving emergency release to a promising vaccine after Phase 2 trials. That, to my mind, is way too soon and I'd be pretty cautious about a vaccine without robust Phase 3 data.
    I was asking about both. Aren't challenge trials a little ethically dicey in this case? If they show 90% protection at 4 months, is your concern that they need longer exposure?

    One thing that isn't clear to me in what I've read about the primary endpoints: Are they just straight measuring infections in the vaccine group? Or is it relative risk vs. the placebo group?
  • oftenreading
    oftenreading Victoria, BC Posts: 12,856
    pjl44 said:
    oftenreading said:
    pjl44 said:
    oftenreading said:
    Jearlpam0925 said:
    oftenreading said:
    Jearlpam0925 said:
    https://apple.news/AOTL9zyF8S8CX38-je6TOMA

    The second talks about several reasons why it’s not a good idea to rush to put out a vaccine without thorough testing. This is something I am personally concerned about and which may well lead me to delay getting a vaccine, should one be made available more quickly than I think is reasonable. 
    Paraphrasing things told to me by a buddy who is a doctor at a children's hospital and is working on covid research,a long with a vaccine at Penn:
    • They can accelerate some of the more challenging phases (higher bar to have necessary conditions to run the trial) by doing extra things like human challenge trials — which is a bioethics topic we could have an hours long discussion over
    • bottom line, if there is a vaccine — it will be safe
    • If anyone ever wants the science on how to counter vaccine hesitancy — happy to share the research papers. I'll follow up with him for this stuff.
    I’m familiar with the science. I am generally very provaccine, but there is no denying that some information takes time to acquire, by its very nature. 
    Sure - my point is by the time it is available, even with accelerated testing, it will be safe.

    I think that's a fairly simplistic view of the situation. I work in health care, I prescribe medications, I'm familiar with the whole host of adverse and unintended effects that come even with medications and products generally viewed as "safe", i.e. those that have received regulatory approval. It isn't a binary issue, safe or not safe; it's a much more complex gradient of both potential short term and long term effects. At least one of the front-runner vaccine candidates is an RNA vaccine; however, there are, to date, no approved RNA or DNA vaccines for humans, so we do not even have a history of safety and efficacy in that modality to draw from. 

    Beyond the issue of safety there is efficacy, including the thorny issue of durability of immune response. This is impossible to determine without taking the time to measure it. 

    Thus, back to my original statement of my concern if a vaccine is made available more quickly than I think is reasonable. There is a massive push to have one or more vaccines developed in record time, with some people now estimating possibly by the end of 2020 or early 2021. In my opinion that's more quickly than is reasonable. 
    It sounds like they're planning to review data around the 4 month mark. Do you think that's too soon? Does that go for all endpoints or just particular ones?

    By "too soon", are you referring to safety or efficacy data?

    If you mean efficacy, I think that is too soon to come to any definitive answer, unless they go ahead with challenge trials. Certainly too soon if we're just talking about people being out and about in the world

    If you mean safety, 4 month data would capture immediate/short term adverse effects but not long term, of course.

    I have read that Fauci has stated that they would consider dropping the requirement for Phase 3 studies and giving emergency release to a promising vaccine after Phase 2 trials. That, to my mind, is way too soon and I'd be pretty cautious about a vaccine without robust Phase 3 data.
    I was asking about both. Aren't challenge trials a little ethically dicey in this case? If they show 90% protection at 4 months, is your concern that they need longer exposure?

    One thing that isn't clear to me in what I've read about the primary endpoints: Are they just straight measuring infections in the vaccine group? Or is it relative risk vs. the placebo group?
    Absolutely ethically dicey, given the potential seriousness of an infection and the fact that there is no really good treatment for those that develop a serious infection. I’m not advocating for that. Usually only done when there is an effective treatment, like for malaria. 

    If challenge trials aren’t going to be done, then four months doesn’t seem long enough if we are just hoping for community exposure. Would also be very interested to know the duration of protection. For instance, what if there are substantially fewer infections in the vaccine  at four months but not at six or eight? 

    Will have to get back to you on the rest - got dinner guests arriving soon. 
    my small self... like a book amongst the many on a shelf
  • PureandEasy
    PureandEasy Posts: 5,818

    I won’t go into detail about my organization and our involvement in this crisis.   As far as sending your kids to school, not in America.  Not now.  Until there is a true reliable vaccine that has been through all required stages, not rushed, not pushed through, but through all scientific vaccine approval requirements.  There is no science currently that gives you immunity.  Having positive antibody tests do not protect you from re-infection.  If you’ve been diagnosed or tested positive for the virus, there is no science that says you cannot contract the virus again and spread the virus to others.

    The science is not there as far as post-infection.  Hell, we’re still trying to deal with current infection.   This is not something to take lightly, to rush to "fix"  it will take time to develop.  Best we accept that folks.  Wear your masks and limit your exposure to others.

     


    Don't come closer or I'll have to go
  • oftenreading
    oftenreading Victoria, BC Posts: 12,856
    pjl44 said:
    oftenreading said:
    pjl44 said:
    oftenreading said:
    Jearlpam0925 said:
    oftenreading said:
    Jearlpam0925 said:
    https://apple.news/AOTL9zyF8S8CX38-je6TOMA

    The second talks about several reasons why it’s not a good idea to rush to put out a vaccine without thorough testing. This is something I am personally concerned about and which may well lead me to delay getting a vaccine, should one be made available more quickly than I think is reasonable. 
    Paraphrasing things told to me by a buddy who is a doctor at a children's hospital and is working on covid research,a long with a vaccine at Penn:
    • They can accelerate some of the more challenging phases (higher bar to have necessary conditions to run the trial) by doing extra things like human challenge trials — which is a bioethics topic we could have an hours long discussion over
    • bottom line, if there is a vaccine — it will be safe
    • If anyone ever wants the science on how to counter vaccine hesitancy — happy to share the research papers. I'll follow up with him for this stuff.
    I’m familiar with the science. I am generally very provaccine, but there is no denying that some information takes time to acquire, by its very nature. 
    Sure - my point is by the time it is available, even with accelerated testing, it will be safe.

    I think that's a fairly simplistic view of the situation. I work in health care, I prescribe medications, I'm familiar with the whole host of adverse and unintended effects that come even with medications and products generally viewed as "safe", i.e. those that have received regulatory approval. It isn't a binary issue, safe or not safe; it's a much more complex gradient of both potential short term and long term effects. At least one of the front-runner vaccine candidates is an RNA vaccine; however, there are, to date, no approved RNA or DNA vaccines for humans, so we do not even have a history of safety and efficacy in that modality to draw from. 

    Beyond the issue of safety there is efficacy, including the thorny issue of durability of immune response. This is impossible to determine without taking the time to measure it. 

    Thus, back to my original statement of my concern if a vaccine is made available more quickly than I think is reasonable. There is a massive push to have one or more vaccines developed in record time, with some people now estimating possibly by the end of 2020 or early 2021. In my opinion that's more quickly than is reasonable. 
    It sounds like they're planning to review data around the 4 month mark. Do you think that's too soon? Does that go for all endpoints or just particular ones?

    By "too soon", are you referring to safety or efficacy data?

    If you mean efficacy, I think that is too soon to come to any definitive answer, unless they go ahead with challenge trials. Certainly too soon if we're just talking about people being out and about in the world

    If you mean safety, 4 month data would capture immediate/short term adverse effects but not long term, of course.

    I have read that Fauci has stated that they would consider dropping the requirement for Phase 3 studies and giving emergency release to a promising vaccine after Phase 2 trials. That, to my mind, is way too soon and I'd be pretty cautious about a vaccine without robust Phase 3 data.
    I was asking about both. Aren't challenge trials a little ethically dicey in this case? If they show 90% protection at 4 months, is your concern that they need longer exposure?

    One thing that isn't clear to me in what I've read about the primary endpoints: Are they just straight measuring infections in the vaccine group? Or is it relative risk vs. the placebo group?
    Here’s an article that describes the format of the Phase 3 studies, including primary and secondary endpoints. Placebo controlled or active comparator.  

     https://www.raps.org/news-and-articles/news-articles/2020/7/icmra-outlines-shape-of-phase-3-covid-19-vaccine-t
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