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Coronavirus in the United States - news and thoughts

Discussion in 'Too Hot for Swamp Gas' started by GatorNorth, Feb 25, 2020.

  1. gator95

    gator95 GC Hall of Fame

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    So we have Pfizer booster info. Someone needs to explain how when this is primarily needed for the elderly, that Pfizer in their infinite wisdom decided to enroll 12(yes, twelve) patients in their booster study for Phase 1. For the Phase 2/3 they enrolled no one over 55. Anyone think that's right? I mean, this isn't that hard. Go find thousands of people over 65 and test the booster. Report data to the FDA good or bad.

    https://www.fda.gov/media/152176/download
     
  2. Gatorrick22

    Gatorrick22 GC Hall of Fame

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    My children are adults. I refuse to further discus with you or anyone else here about a medical procedure that they might or might not have had.
     
  3. tilly

    tilly Superhero Mod. Fast witted. Bulletproof posts. Moderator VIP Member

    I'm several pages behind as this thread can really move along at times, but while I am all for all healthcare professionals being vaccinated or at least tested daily or similar, I will stop short of calling people who have risked their lives for 18 months "selfish".
     
  4. tilly

    tilly Superhero Mod. Fast witted. Bulletproof posts. Moderator VIP Member

    Probably right. It's probably higher.
     
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  5. dangolegators

    dangolegators GC Hall of Fame

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    You don't understand what a Phase 1 study is.
     
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  6. mdgator05

    mdgator05 GC Hall of Fame

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    There were 23 participants in Phase 1, which is entirely in-line with what Phase 1 is supposed to be, which is a very limited sample size to make sure that there is no severe, extremely common reaction before giving it to more people and to get some basic data on dosing.

    Step 3: Clinical Research
     
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  7. gator95

    gator95 GC Hall of Fame

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    Right. Who are the boosters targeted towards? So then lets test the booster on some 25 year olds. Yeah, that makes sense. And people wonder why some are wary of drug companies.
     
  8. gator95

    gator95 GC Hall of Fame

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    Yes, I get that. Why wasn't there a single person over 55 included in the study. Sounds like they are trying to make the booster look better than it is. Don't see another rational possible answer.
     
  9. mdgator05

    mdgator05 GC Hall of Fame

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    Well, first, there were people over 55 included in Phase 1. They explained their reasoning for only including 18-55 in phase 2/3.
     
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  10. lacuna

    lacuna The Conscience of Too Hot Moderator VIP Member

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    **
    Fair enough. It is certainly your right to refuse to answer or discuss the question. I asked because I recalled and copied something you posted several years ago. Doing so because I admit I doubted it at the time, having on occasion found reasons to doubt the veracity of a number of things you have posted from time to time on this forum.

    Do You remember this exchange with another poster on a thread about global warming back in the summer of 2018?

    S--b--Gator said:
    "Likewise, you enjoy the McDonald's hamburger and fries your cooking.... Pathetic that instead of people actually understanding an issue and ASKING if something can be done about it, small minds throw up red herrings like tax increases or kale jokes. Oh well, its only the planet God created and your kids will inherit. So F it up and joke about it, right!"
    _____________________________________________

    Gatorrick posted:
    "You're still relatively new around here, so I'll cut you some slack, but we've read hundreds of posts and read dozens of comprehensive articles about ice core samples dating back hundreds of thousands of years, over more than 10 years here, and found no causation between high CO2 levels in the past and Global Warming. So, you probably didn't know that about. And I we did beat this DEAD HORSE over an over again. So, next time you come here accusing people of not knowing what you think you and only you do know... please rethink before you post. And by the way, my son is a doctor and went to, and graduated from the University of Florida medical school.

    "And I am convinced that other nations might have something to do with the climate... deforestation is killing our world's ability to process the CO2 could cause weather patterns to change and become more unpredictable. Yes, man is somewhat effecting the weather patterns across the globe, but it's mankind in other nations that are most to blame. So... there is no need to invent a new tax on the American"

    _______________________________________________

    My memory is pretty good, and I recall you posting back in late '15 or early '16 during the primaries you would intentionally lie if it would help to further your intentions. If, as you claimed, your son is a physician educated at UF's medical school, I wonder what is his opinion towards vaccination.
     
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  11. gator95

    gator95 GC Hall of Fame

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    You talking about this explanation?

    "Safety data from 306 Phase 2/3 booster recipients do not show evidence of increased local or systemic reactogenicity relative to Dose 2. While evaluated in only 12 participants in the age cohort of 65 through 85 years, the booster dose was less reactogenic in this age cohort compared to younger adults 18 through 55 years of age. Most reactogenicity events after the booster dose were of mild to moderate severity and self-limited in duration."
     
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  12. NavyGator93

    NavyGator93 GC Hall of Fame

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    I would think so too.
     
  13. ncargat1

    ncargat1 VIP Member

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    It is interesting that initially they proposed Phase 2/3 in a large number across multiple countries, but in the end the FDA only required 306 people age 18-55. I would also be curious to know what led to the approved change. It seems like Pfizer was more than willing to "go big" to collect data and then something altered that plan.

    I also wonder if any of the real world data will be added to body of information reviewed by the FDA. Israel has now given nearly 2 million boosters, initially covering the oldest part of its society and saw a relatively quick plateau in new cases as they scrambled to figure out if one was related to the other.
     
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  14. mdgator05

    mdgator05 GC Hall of Fame

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    Amongst others. At different points in the research, they indicate that the reactions that they are testing are not age-dependent and that both Phase 1 and the initial trials indicate no need to include older people in a sample.
     
  15. ncargat1

    ncargat1 VIP Member

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    GP's are human beings driven by the own personal experiences, time limits and even prejudices just the same as anyone else. Further, most have a good general medical knowledge. However, I would not expect any GP to be an expert on vaccines and immunology. It is not the knock on GP's that you may be interpreting it as, it is an acknowledgement that they are very limited in the depth and breadth of their knowledge. To have a GP with the medical experience of the one who treated @jeffbrig is the exception, not the norm.
     
  16. ncargat1

    ncargat1 VIP Member

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    Lived in the Southwest. Hantavirus has a mortality rate north of 30% when untreated, however it would have been the crushing sensation of a truck parked on your chest and your inability to breath that would have been the dead give away.

    All kidding aside, sounds like a great doctor. Guessing you will really miss him as your primary in the coming years.
     
  17. gator95

    gator95 GC Hall of Fame

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    If there is no difference then they should have a proportional elderly population in the trial. This shouldn't be an argument. There isn't any reason to not have elderly subjects be tested as well. Any excuse as to why sounds like they might not like the results of what they might find in their trial.
     
  18. flgator2

    flgator2 GC Hall of Fame

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  19. OklahomaGator

    OklahomaGator Jedi Administrator Moderator VIP Member

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    How would they know the results before the trial?
     
  20. gator95

    gator95 GC Hall of Fame

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    I would like to know what "altered" their plan.

    I assume the FDA is seeing the Israeli data for sure. Still don't like what Pfizer is doing with their trial.