3 ms·

The FDA hasn't approved the vaccine yet. That says a lot.

SideburnsOfDoom 5y ago
It says less than nothing. The FDA is not usually fast at all, but Full FDA approval for Pfizer and Modena Vaccines is expected soon (i.e. in next 6 months or so) https://www.npr.org/sections/coronavirus-live-updates/2021/05/07/994839927/pfizer-seeks-full-fda-approval-for-covid-19-vaccine https://www.npr.org/sections/coronavirus-live-updates/2021/0... https://www.healthline.com/health-news/when-will-the-fda-give-full-approval-for-covid-19-vaccines https://www.healthline.com/health-news/when-will-the-fda-giv...
- nickthemagicman 5y ago
  Cancer can take years to develop. Hep C is an mRNA virus that causes liver cancer. Why aren't vaccine makers allowing themselves to be liable for the vaccine if they're so safe? Shouldn't be an issue right? https://www.cnbc.com/amp/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html https://www.cnbc.com/amp/2020/12/16/covid-vaccine-side-effec... If a bunch of people with the mRNA virus get malignent terminal cancer in a few years....the companies just throw up their hands and say "Our bad" and there's nothing you can do.
  - shadowgovt 5y ago
    It's not so much up to the vaccine manufacturers as the Secretary of HHS under a law dating back to 2005 (https://www.congress.gov/109/plaws/publ148/PLAW-109publ148.pdf#page=140 https://www.congress.gov/109/plaws/publ148/PLAW-109publ148.p...). And the incentives seem self-evident: given a global pandemic with a known high fatality and infectivity rate, Congress provided the power to "clear the runway" for potential mitigators to a pandemic by limiting civil liability. Lacking that power, there's a risk that manufacturers would decide the liability potential of administering a drug to >99% of the population (regardless of its efficacy) would be too high to justify being the ones to assume the risk, which could slow development or deployment of a preventative treatment during a crisis. If only 1 in 100,000 Americans suffered an adverse effect from a COVID-19 vaccine, that would stack up to a class-action lawsuit that could top a billion dollars. Injured parties (as per https://crsreports.congress.gov/product/pdf/LSB/LSB10443 https://crsreports.congress.gov/product/pdf/LSB/LSB10443) may still be eligible for direct compensation from the US federal government under https://www.hrsa.gov/cicp/ https://www.hrsa.gov/cicp/. No medical procedure is zero-risk. The relevant question is whether the risk of long-term complications from a COVID-19 vaccine is higher than risk from COVID-19 itself. Since the long-term complication of COVID-19 is "death," the risk-tradeoff curve for long-term consequences from a vaccine is pretty steep.
    - nickthemagicman 5y ago
      Doctors and lawyers have very steep tradeoff curves for their work. One lawsuit can ruin them. Yet they're still liable. Why should companies be any different? If the world was certain of the vaccine's safety then it should be no big deal for them to stand behind their product. It's crazy how people are just shrugging their shoulders at this.
      - shadowgovt 5y ago
        > Doctors and lawyers have very steep tradeoff curves for their work. One lawsuit can ruin them. Yet they're still liable. Why should companies be any different? If a few doctors decide the liability tradeoff doesn't work for them, a few patients that could have been saved might die. If Pfizer decides the liability tradeoff isn't worth developing a COVID-19 vaccine... Well, we're already past 600,000 dead in the US alone. > If the world was certain of the vaccine's safety Define "certain." The preponderance of evidence is that it's safer than catching COVID-19. Long-term effects are by definition unknown. The PREP act allows HHS to basically say to a private company "We will assume the unknown risk of long-term vaccine consequences by shielding your company from direct civil liability" (and Uncle Sam will foot the bill for treating long-term effects of the vaccine in the population). > It's crazy how people are just shrugging their shoulders at this I think few people who understand medical risk profiles are shrugging their shoulders at this (note: I don't consider most of the public to be in that category; this stuff requires college math to really grasp and the average American tops out around a 6th-grade level). The decisions government officials are making are literally life-or-death. But the regular risk / reward profile goes out the window during a pandemic and is replaced with "apparent best course of action" tradeoffs, because society lacks the luxury of doing nothing. Do nothing, and a lot of people definitely die (back-of-the-napkin math suggests the US would look down the barrel of 5.9 million dead at the end of the pandemic). Deploy a vaccine with possible (but low-probability) side-effects, and far fewer people die unless there's an extremely unlikely set of unknown-unknowns. To give a (bad) software development analogy: unit, integration, and functional tests are best practice. But at a startup company, there are occasional instances of "we need a demo by 6:30 tomorrow or the company will run out of money and die." In those circumstances, regular best practices go out the window because the company lacks the luxury of time. Project managers in such circumstances will declare that if the quick hacks result in pain down the road, they'll cover the team's ass (and devote resources later to fixing any pain caused by less-than-best practice). Pandemic time is risk tradeoff time.

It says less than nothing. The FDA is not usually fast at all, but Full FDA approval for Pfizer and Modena Vaccines is expected soon (i.e. in next 6 months or so) https://www.npr.org/sections/coronavirus-live-updates/2021/05/07/994839927/pfizer-seeks-full-fda-approval-for-covid-19-vaccine https://www.npr.org/sections/coronavirus-live-updates/2021/0... https://www.healthline.com/health-news/when-will-the-fda-give-full-approval-for-covid-19-vaccines https://www.healthline.com/health-news/when-will-the-fda-giv...

nickthemagicman 5y ago
Cancer can take years to develop. Hep C is an mRNA virus that causes liver cancer. Why aren't vaccine makers allowing themselves to be liable for the vaccine if they're so safe? Shouldn't be an issue right? https://www.cnbc.com/amp/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html https://www.cnbc.com/amp/2020/12/16/covid-vaccine-side-effec... If a bunch of people with the mRNA virus get malignent terminal cancer in a few years....the companies just throw up their hands and say "Our bad" and there's nothing you can do.
- shadowgovt 5y ago
  It's not so much up to the vaccine manufacturers as the Secretary of HHS under a law dating back to 2005 (https://www.congress.gov/109/plaws/publ148/PLAW-109publ148.pdf#page=140 https://www.congress.gov/109/plaws/publ148/PLAW-109publ148.p...). And the incentives seem self-evident: given a global pandemic with a known high fatality and infectivity rate, Congress provided the power to "clear the runway" for potential mitigators to a pandemic by limiting civil liability. Lacking that power, there's a risk that manufacturers would decide the liability potential of administering a drug to >99% of the population (regardless of its efficacy) would be too high to justify being the ones to assume the risk, which could slow development or deployment of a preventative treatment during a crisis. If only 1 in 100,000 Americans suffered an adverse effect from a COVID-19 vaccine, that would stack up to a class-action lawsuit that could top a billion dollars. Injured parties (as per https://crsreports.congress.gov/product/pdf/LSB/LSB10443 https://crsreports.congress.gov/product/pdf/LSB/LSB10443) may still be eligible for direct compensation from the US federal government under https://www.hrsa.gov/cicp/ https://www.hrsa.gov/cicp/. No medical procedure is zero-risk. The relevant question is whether the risk of long-term complications from a COVID-19 vaccine is higher than risk from COVID-19 itself. Since the long-term complication of COVID-19 is "death," the risk-tradeoff curve for long-term consequences from a vaccine is pretty steep.
  - nickthemagicman 5y ago
    Doctors and lawyers have very steep tradeoff curves for their work. One lawsuit can ruin them. Yet they're still liable. Why should companies be any different? If the world was certain of the vaccine's safety then it should be no big deal for them to stand behind their product. It's crazy how people are just shrugging their shoulders at this.
    - shadowgovt 5y ago
      > Doctors and lawyers have very steep tradeoff curves for their work. One lawsuit can ruin them. Yet they're still liable. Why should companies be any different? If a few doctors decide the liability tradeoff doesn't work for them, a few patients that could have been saved might die. If Pfizer decides the liability tradeoff isn't worth developing a COVID-19 vaccine... Well, we're already past 600,000 dead in the US alone. > If the world was certain of the vaccine's safety Define "certain." The preponderance of evidence is that it's safer than catching COVID-19. Long-term effects are by definition unknown. The PREP act allows HHS to basically say to a private company "We will assume the unknown risk of long-term vaccine consequences by shielding your company from direct civil liability" (and Uncle Sam will foot the bill for treating long-term effects of the vaccine in the population). > It's crazy how people are just shrugging their shoulders at this I think few people who understand medical risk profiles are shrugging their shoulders at this (note: I don't consider most of the public to be in that category; this stuff requires college math to really grasp and the average American tops out around a 6th-grade level). The decisions government officials are making are literally life-or-death. But the regular risk / reward profile goes out the window during a pandemic and is replaced with "apparent best course of action" tradeoffs, because society lacks the luxury of doing nothing. Do nothing, and a lot of people definitely die (back-of-the-napkin math suggests the US would look down the barrel of 5.9 million dead at the end of the pandemic). Deploy a vaccine with possible (but low-probability) side-effects, and far fewer people die unless there's an extremely unlikely set of unknown-unknowns. To give a (bad) software development analogy: unit, integration, and functional tests are best practice. But at a startup company, there are occasional instances of "we need a demo by 6:30 tomorrow or the company will run out of money and die." In those circumstances, regular best practices go out the window because the company lacks the luxury of time. Project managers in such circumstances will declare that if the quick hacks result in pain down the road, they'll cover the team's ass (and devote resources later to fixing any pain caused by less-than-best practice). Pandemic time is risk tradeoff time.