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About markeb

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    Cool Cruiser

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    Northern Virginia
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    Watches, Pens, Travel
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  1. Thank you. I completely missed this a year ago and was completely shocked a few months ago to discover she was gone. She was one of the great contributors to this site and her absence leaves a big hole. RIP.
  2. It depends on the limitations of the EUA. I think some of us discussed that a couple of pages up. The FDA could expand the EUA once granted, and I’m pretty sure it will be granted. Or it could expedite the Biological License Application or BLA to full licensure. The BLA would require a complete data package. No universal answer.
  3. More research, or ultimately you'll be able to infer it from epidemiology; if vaccine rates approach the 60-70% of the population that would stop sustained transmission, and the vaccines stop individuals from transmitting, you'll see decreases in the PCR and serological positive population overall, and obviously the disease prevalence, including in the unvaccinated. That's long term, unfortunately. I'll say again that in pretty much every other case I can think of, you would have had years of basic and applied research on the virus and the disease before ever starting serious vacci
  4. Why couldn’t I have written that? That’s a perfect summary.
  5. Typing at the same time... Yeah. Same destination, different routes! 😀
  6. I'll try... Once upon a time, most vaccines used either a killed whole pathogen (virus or bacteria), or a live but modified whole pathogen that no longer caused disease. Those worked well for a lot of pathogens, but they tended to cause more significant reactions (especially for killed pathogens) or posed at least a theoretical risk of returning to virulence (able to cause disease). Most work over the last few decades has revolved around subunit vaccines. Those produce one or more specific proteins, or more typically parts of a protein, by fermentation in another organi
  7. I’d like some data on this, but it’s possible they’re getting an anti-vector response at the higher dose and that’s curtailing their immune response on the second dose. That would make some sense, but it could be something completely different. The reviewers may want to look at that phenomenon, so hopefully AZ and Oxford are trying to understand it. It could impact booster schedules, for instance. But generally good news, I think.
  8. It depends. I haven’t read Pfizer’s request. The could ask for a limited population. The FDA could grant the EUA for a limited population. That could be age limited, risk limited, or almost anything. It probably won’t be for everyone, but it could be. The FDA could expand the EUA as more data comes in, or it could move to act on the BLA for full licensure. There will likely be significant post-marketing requirements, and the licensure could still limit use pending more data and an amended BLA. Lots of possibilities at this point.
  9. I'm not sure I'd want to be working data review at CBER right now... I haven't done this, but I'm assuming something like this, especially with two coming in almost at the same time, will pretty much be all hands on deck? As someone with a lot of familiarity, but always outside this process, this seems almost like they've got a near complete BLA to review for the EUA (other than the longer term safety data they've talked about). And they're coming close to reviewing it like it was a BLA!
  10. Just guessing here, but even with rolling data submission, there are probably thousands of pages of data to review before the actual meeting. That takes time. I’m amazed they’re meeting that early...
  11. The "Most Americans were not born then" statement was bolded in the reply. I assumed that's what the explain comment referenced. Could be wrong.
  12. The current US population (as of 2019) is around 328M. Of that, 23M were born before the end of WWII, 72M are boomers, born before 1964, and 65M are Gen X born before 1980. Even if I assign ALL of Gen X to 1980, that's 160M born since 1980, I get (328-160)/328=.49. Since probably at least half of those 65M were born within that last 47 years, then those born within the last 47 years would exceed 50%; if it's as much as 1/2, it's 60%. Which again, has nothing to do with COVID in Europe...
  13. November 21st is the "Reviewed by" date; the most recent actual change to the CDC page is still dated October 30th. Someone at CDC looked at it today and updated it as still current. That's all. Someone at Reuters is subscribed to all updates and didn't bother to read to see if anything had changed.
  14. It would be the ultimate irony to go from nothing to having discussions of one of the FDA's most obscure terms: noninferiority... It wouldn't surprise me if one or more of the vaccines performs differently in different age groups, and it wouldn't surprise me if they don't. But there could be a perception that a 90% effective vaccine, for example, is inferior to a 95% effective vaccine, and that could be meaningless in the real world, and might be judged noninferior by the different regulatory authorities around the world. I'm going to go with the glass being mostly full
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