6 ms·

They don't waive more than what was defined in the PREP Act[0], they're exempt because it's an emergency and all evidence points at the treatment being better t

by fer 5y ago

They don't waive more than what was defined in the PREP Act[0], they're exempt because it's an emergency and all evidence points at the treatment being better than the disease, and its production, distribution and administration is under government request. This was enacted in 2005, shortly after the original SARS, partially because pharma companies were reluctant to mass produce any novel vaccine/drug under government request only for it to possibly bite their asses. Another motivation for this was 2001, and the increasing potential threat of bioterrorism; companies lose any incentives to be responsive in the wake of such an attack. This is just actuarial science: a relatively rare but serious side effect (i.e. not found in trials), when put on a massive scale, becomes a big enough threat for the economic viability of the company. [0] https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx https://www.phe.gov/Preparedness/legal/prepact/Pages/default...

roenxi 5y ago
> they're exempt because it's an emergency and all evidence points at the treatment being better than the disease I know you don't write the law, so these questions are more in the vein of statements with questionmarks: * Why only consider evidence of cost vs. benefit in an emergency? * Why are vaccines suddenly safe in an emergency and not at other times? This pandemic proved that we can produce a "safe and effective" vaccine in 12 months. That is apparently a record. It shouldn't be - this signals that 75% of the wait time for new cures and vaccines is red tape.
- resonantjacket5 5y ago
  > This pandemic proved that we can produce a "safe and effective" vaccine in 12 months. That is apparently a record. It shouldn't be - this signals that 75% of the wait time for new cures and vaccines is red tape. It can be kinda hard to test vaccines quickly and ethically typically as subjecting people to a disease on purpose isn't really allowed and you have to wait for them to catch it naturally and compare. Fortunately (or unfortunately) during a pandemic it's pretty easy to test vaccines as one can quickly compare one's that got the vaccine and one's that didn't effectiveness.
- gretch 5y ago
  Consider that part of the expedition comes from “skipping the line”. Only 1 thing can skip the line at a time. If everything skips the line then nothing changes.
  - roenxi 5y ago
    What line? Can the regulators not consider two drugs in parallel? They should consider hiring a 2nd clerk to stamp the paperwork. Drug & vaccine testing should be highly parallelisable.
landemva 5y ago
'all evidence points at the treatment being better than the disease'. I had it and have Dr. letter that says so. I now have sterilizing immunity. The jab does not provide sterilizing immunity, so it is not better for me nor my family. I am not jabbed, and will not get jabbed. While I am just one, I invalidate your use of the word 'all'.
- fer 5y ago
  > I had it and have Dr. letter that says so. I now have sterilizing immunity. No, you don't, nobody has, 'sterilizing immunity' doesn't exist as you seem to think it does [0]. I seriously doubt a doctor would write 'sterilizing immunity' in such a letter, so I assume that's your reasoning. > so it is not better for me nor my family. It actually is [1]. Even if you had it, you're still better off having the jab. > I am not jabbed, and will not get jabbed. You just sound like someone that can't be convinced of things. Talk to your doctor. > While I am just one, I invalidate your use of the word 'all'. Yeah, like seatbelt doesn't save 100%. Luckily one data point doesn't count as evidence when we're talking about statistics. [0] https://www.theatlantic.com/science/archive/2021/09/sterilizing-immunity-myth-covid-19-vaccines/620023/ https://www.theatlantic.com/science/archive/2021/09/steriliz... [1] https://www.cdc.gov/media/releases/2021/s0806-vaccination-protection.html https://www.cdc.gov/media/releases/2021/s0806-vaccination-pr...
  - landemva 5y ago
    I have talked to my Dr. 'you're still better off having the jab.' You are not my Dr. Supposedly vaccine reporting of harm is about 1%, though it would seem to be difficult to verify if it is 1% or 3%. 52 dead infants have been reported. https://www.lifesitenews.com/news/baby-of-fully-vaccinated-mom-dies-after-being-born-bleeding-from-mouth-nose-vaers-report/?source=patrick.net https://www.lifesitenews.com/news/baby-of-fully-vaccinated-m... It is not better, and not for 'all'.
    - fer 5y ago
      > I have talked to my Dr. Then imagined things in your head. No doctor will write what you suggest. > You are not my Dr. Nobody said I am.
native_samples 5y ago
PREP Act is an American thing. Pharma requires liability waivers globally and changing laws to eliminate legal liability is a requirement of the contracts they sign with governments. Sometimes even that isn't enough. In some cases they demand collateral. They also demand immunity from criminal prosecution, even in cases where it's proven that people were injured through "negligence, fraud or malice": https://www.pharmaceutical-technology.com/news/company-news/pfizer-latin-american-vaccine/ https://www.pharmaceutical-technology.com/news/company-news/... "Government officials from Argentina and another Latin American country, which has signed a confidentiality agreement with Pfizer and so cannot be named, told the Bureau that Pfizer demanded additional indemnity against civil lawsuits citizens might file in relation to Pfizer’s Covid-19 vaccine. Pfizer reportedly asked governments in Argentina and Brazil to put up sovereign assets, including military bases and federal bank reserves, as collateral for potential future legal costs. According to government officials in Argentina and the unnamed country, Pfizer asked for liability protection not only against civil claims from citizens who suffer serious adverse events after being vaccinated, but also for cases brought due to Pfizer’s own negligence, fraud or malice. Documents from Brazil’s Ministry of Health suggest that Pfizer made similar demands of the Brazilian government."
- fer 5y ago
  Pfizer allocated doses for those countries (and more) at non-profit prices. Argentina pays $12 per dose[0]. The EU, who haggled a lot, and bought a lot more, is paying $15, and the US pays almost $20. If Pfizer agreed to be held liable at any level, they'd be literally be agreeing to losing money. These countries are free to pay the regular price other countries are, with the usual emergency levels of indemnity. I'm sure Pfizer won't mind. What Argentina and Braz^H^H^H^H the other country want is to have the cake and eat it too: "you manufacture it, you bring it, you earn nothing, yet you're held accountable if things go wrong". Personally I wouldn't go in, not sure about you. This is actuarial 101. [0] https://www.batimes.com.ar/news/argentina/argentina-has-paid-for-46-of-its-covid-vaccines-to-date.phtml https://www.batimes.com.ar/news/argentina/argentina-has-paid...

by fer 5y ago

roenxi 5y ago

> they're exempt because it's an emergency and all evidence points at the treatment being better than the disease I know you don't write the law, so these questions are more in the vein of statements with questionmarks: * Why only consider evidence of cost vs. benefit in an emergency? * Why are vaccines suddenly safe in an emergency and not at other times? This pandemic proved that we can produce a "safe and effective" vaccine in 12 months. That is apparently a record. It shouldn't be - this signals that 75% of the wait time for new cures and vaccines is red tape.

resonantjacket5 5y ago
> This pandemic proved that we can produce a "safe and effective" vaccine in 12 months. That is apparently a record. It shouldn't be - this signals that 75% of the wait time for new cures and vaccines is red tape. It can be kinda hard to test vaccines quickly and ethically typically as subjecting people to a disease on purpose isn't really allowed and you have to wait for them to catch it naturally and compare. Fortunately (or unfortunately) during a pandemic it's pretty easy to test vaccines as one can quickly compare one's that got the vaccine and one's that didn't effectiveness.
gretch 5y ago
Consider that part of the expedition comes from “skipping the line”. Only 1 thing can skip the line at a time. If everything skips the line then nothing changes.
- roenxi 5y ago
  What line? Can the regulators not consider two drugs in parallel? They should consider hiring a 2nd clerk to stamp the paperwork. Drug & vaccine testing should be highly parallelisable.

landemva 5y ago

'all evidence points at the treatment being better than the disease'. I had it and have Dr. letter that says so. I now have sterilizing immunity. The jab does not provide sterilizing immunity, so it is not better for me nor my family. I am not jabbed, and will not get jabbed. While I am just one, I invalidate your use of the word 'all'.

fer 5y ago
> I had it and have Dr. letter that says so. I now have sterilizing immunity. No, you don't, nobody has, 'sterilizing immunity' doesn't exist as you seem to think it does [0]. I seriously doubt a doctor would write 'sterilizing immunity' in such a letter, so I assume that's your reasoning. > so it is not better for me nor my family. It actually is [1]. Even if you had it, you're still better off having the jab. > I am not jabbed, and will not get jabbed. You just sound like someone that can't be convinced of things. Talk to your doctor. > While I am just one, I invalidate your use of the word 'all'. Yeah, like seatbelt doesn't save 100%. Luckily one data point doesn't count as evidence when we're talking about statistics. [0] https://www.theatlantic.com/science/archive/2021/09/sterilizing-immunity-myth-covid-19-vaccines/620023/ https://www.theatlantic.com/science/archive/2021/09/steriliz... [1] https://www.cdc.gov/media/releases/2021/s0806-vaccination-protection.html https://www.cdc.gov/media/releases/2021/s0806-vaccination-pr...
- landemva 5y ago
  I have talked to my Dr. 'you're still better off having the jab.' You are not my Dr. Supposedly vaccine reporting of harm is about 1%, though it would seem to be difficult to verify if it is 1% or 3%. 52 dead infants have been reported. https://www.lifesitenews.com/news/baby-of-fully-vaccinated-mom-dies-after-being-born-bleeding-from-mouth-nose-vaers-report/?source=patrick.net https://www.lifesitenews.com/news/baby-of-fully-vaccinated-m... It is not better, and not for 'all'.
  - fer 5y ago
    > I have talked to my Dr. Then imagined things in your head. No doctor will write what you suggest. > You are not my Dr. Nobody said I am.

native_samples 5y ago

PREP Act is an American thing. Pharma requires liability waivers globally and changing laws to eliminate legal liability is a requirement of the contracts they sign with governments. Sometimes even that isn't enough. In some cases they demand collateral. They also demand immunity from criminal prosecution, even in cases where it's proven that people were injured through "negligence, fraud or malice": https://www.pharmaceutical-technology.com/news/company-news/pfizer-latin-american-vaccine/ https://www.pharmaceutical-technology.com/news/company-news/... "Government officials from Argentina and another Latin American country, which has signed a confidentiality agreement with Pfizer and so cannot be named, told the Bureau that Pfizer demanded additional indemnity against civil lawsuits citizens might file in relation to Pfizer’s Covid-19 vaccine. Pfizer reportedly asked governments in Argentina and Brazil to put up sovereign assets, including military bases and federal bank reserves, as collateral for potential future legal costs. According to government officials in Argentina and the unnamed country, Pfizer asked for liability protection not only against civil claims from citizens who suffer serious adverse events after being vaccinated, but also for cases brought due to Pfizer’s own negligence, fraud or malice. Documents from Brazil’s Ministry of Health suggest that Pfizer made similar demands of the Brazilian government."

fer 5y ago
Pfizer allocated doses for those countries (and more) at non-profit prices. Argentina pays $12 per dose[0]. The EU, who haggled a lot, and bought a lot more, is paying $15, and the US pays almost $20. If Pfizer agreed to be held liable at any level, they'd be literally be agreeing to losing money. These countries are free to pay the regular price other countries are, with the usual emergency levels of indemnity. I'm sure Pfizer won't mind. What Argentina and Braz^H^H^H^H the other country want is to have the cake and eat it too: "you manufacture it, you bring it, you earn nothing, yet you're held accountable if things go wrong". Personally I wouldn't go in, not sure about you. This is actuarial 101. [0] https://www.batimes.com.ar/news/argentina/argentina-has-paid-for-46-of-its-covid-vaccines-to-date.phtml https://www.batimes.com.ar/news/argentina/argentina-has-paid...