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Well then, I'll give em a good dose of ghostly stink eye and haunt them! That'll teach em!
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I am sure it will be just fine |
We'll see what happens, of course.
To me it is helpful to remember that the companies that are working on this globally are indeed companies. So there's that. It is also helpful to remember that the Pandemic is global. And that things like Covax reinforce that: https://www.who.int/initiatives/act-accelerator/covax. And that some of the companies are or may conduct Phase 3's in areas of the world where there is more virus around. And that statistics are important, including patient demographics. And that, for example if a company like Pfizer applies for EAU or approval and get it, their study work won't stop of course. |
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If you are saying you have trepidation about mass distribution without further testing, I would tend to agree. I am assuming you mean blanket immunity from liability of unforeseen side effects, but I'm not 100% sure I am interpreting your meaning correctly. |
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Here is Pfizer announcing they are part of "Warp Speed" Quote:
https://www.facebook.com/Pfizer/photos/a.390855402242/10158440104377243/?type=3 |
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The critical question to me is how many of those took the vaccine. |
I think the OWS deal with Pfizer may have been primarily focused on "manufacturing at risk" and not much, if at all on financially supporting development and safety and efficacy evaluation. That may be a subtle distinction for some. For most it likely does not matter.
Folks wanting to learn more can start on the HHS web site. Here is a quote: "July 22: HHS announced up to $1.95 billion in funds to Pfizer for the large-scale manufacturing and nationwide distribution of 100 million doses of their vaccine candidate. The federal government will own the 100 million doses of vaccine initially produced as a result of this agreement, and Pfizer will deliver the doses in the United States if the product successfully receives FDA EUA or licensure, as outlined in FDA guidance, after completing demonstration of safety and efficacy in a large Phase 3 clinical trial, which began July 27th." Here is the web site: https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html |
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Normally I think you really want, nay, need the great majority to be vaccinated, but this situation might be different (?). |
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"I think they are trying to figure out if upon EUA they are obligated to immediately unblind the trial and vaccination everyone who got placebo. It sounds like they would like to keep the blinding until they reach the final stopping point of 164 events. Which should be in a little over a month. I suppose it won’t be too hard to finesse the dates to get to 164 while making diligent preparations to vaccinate the placebo arm. "
Not sure... my hypothesis is that something like what you describe is already baked into plans. What I meant by continue is ongoing surveillance. Not well understood by public, but I am sure that you understand. So the Phase 3 might or would end is some customary way, but activities related to customary surveillance would commence and/or be continued. My FDA experience is with devices and capital equipment (510k and PMA) not drugs. Sorry for any confusion caused by my improper terminology. I am not sure what happens to a company that gets OWS funds to manufacture at risk but whose vaccine fails go through. I wonder if that is in the financial disclosures of the companies. I suspect that you could not take a $1-2B order with contingencies and not disclose them. And I expect that there is a chain, for example a company with OWS funds for MFG at risk likely has other public companies like Emergent Biosolutions in the chain. I suspect we'll learn more in coming months. And I suspect some of what we learn will be a bit complex. |
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"If (a big if) these 1st gen vaccines do NOT prevent asymptomatic infection and subsequent transmission but DO protect the vaccinated from serious disease with high efficacy (Pfizer CEO just reiterated in interview that efficacy is “over 90%” and hinted that he doesn’t mean 90.1%), then after everyone who wants to be vaccinated has been, is there a compelling reason to devote too much effort to persuade vaccine refusers to get vaccinated? Should we simply say “whatever, take your chances”?
Normally I think you really want, nay, need the great majority to be vaccinated, but this situation might be different (?). " I think this might be formed into some excellent questions for Osterholm. I suspect he would give informed answers. His podcasts are usually on Thursdays. I have listened to some previous ones and found them quite informative. Previous podcasts are available on the CIDRAP web site. |
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