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Discussion in 'Politics' started by gwb-trading, Apr 24, 2020.

  1. UsualName

    UsualName

    Nah. Half of Europe thinks the AZ shot is unsafe, we don’t need that spilling into our vaccine pool. We are good to go with the mRNAs and J&J.

    Whether the problems with AZ are real or imagined, we don’t want those problems.

    Hesitancy is a real issue that has to be managed. In some ways not allowing the AZ shot in our pool could increase confidence in the shots we have.
     
    #831     Mar 23, 2021
  2. I see.

    Even if the problems turn out to be imagined, the AZ vaccine still must be suppressed.
     
    #832     Mar 23, 2021
  3. UsualName

    UsualName

    This goes back to the adage that a compass will tell you true north but it has no advice for the obstacles you’ll encounter along the way. If your goal is true north, in your pursuit it’s best not plunge head first into a chasm when you can avoid it.
     
    #833     Mar 23, 2021
  4. The request for more data and the objection raised came from the National Insitute of Healtht and Allergies. Also known as Fauci's organization.

    And Fauci has been very clear that Moderna is a great vaccine because it was developed in-house at his organizaition along wiith Moderna.

    Yeh. Swamp at work.
     
    #834     Mar 23, 2021
  5. UsualName

    UsualName

    Your argument doesn’t make any sense for a number of reasons. 1. We already widely use 2 other vax besides Moderna 2. Moderna is already ordered and we have enough vax in the pipeline to vaccinate the whole country 3. It won’t make a difference in the time table as we are about to have excess vaccines before AZ would be authorized anyway.
     
    #835     Mar 23, 2021
  6. Except Joe needs to do a political pay-off to Canada and Mexico so the AZ vaccine needs to be declared "unavailable" to Americans and for that status to not change.

    Look. I discussed this last Friday and this is what I said:

    "AstraZ is dead in the water. The administration has tilted against them. They will need to jump through some hoops real or perceived and the market timing is now against them.

    Moderna is Fauci's vaccine. Pfzier and Moderna and JandJ are now the favored ones - although it should be noted that they all had problems or negative press at various points, and Merk is producing for J and J now since it cancelled its own vaccine."



    Okay, so having covered that, I don't want to be drawn into a discussion of what the "perceived need" actually turns out to be. One is as good as another. I said that the swamp politics requires something so they produced something right on schedule, as predicted, just like clockwork.

    Have a nice day.
     
    #836     Mar 23, 2021
  7. gwb-trading

    gwb-trading

    More details are coming out...

    U.S. officials and an independent panel accused AstraZeneca of essentially cherry-picking trial data on the effectiveness of its vaccine.
    Tuesday, March 23, 2021 3:32 PM EST
    https://www.nytimes.com/2021/03/23/...it_na_20210323&instance_id=0&nl=breaking-news

    In a two-page letter to AstraZeneca and federal authorities, an independent panel of medical experts that was helping oversee the vaccine’s clinical trial in the United States said the company had essentially cherry-picked data that was “most favorable for the study as opposed to the most recent and most complete.”

    According to federal officials, an independent panel of medical experts said the promising results announced by the company on Monday may have relied on “outdated information.”

    Federal health officials and an independent oversight board accused AstraZeneca of presenting the world with potentially misleading information about the effectiveness of the company’s Covid-19 vaccine, an extraordinary blow to the credibility of a company whose product has been seen as critical to the global fight against the pandemic.

    In a two-page letter to AstraZeneca and federal authorities on Monday, an independent panel of medical experts that was helping oversee the vaccine’s clinical trial in the United States said the company had essentially cherry-picked data that was “most favorable for the study as opposed to the most recent and most complete.”

    Only hours earlier, AstraZeneca had issued a news release trumpeting the effectiveness and safety of its vaccine, whose low price has made it the leading vehicle to inoculate people worldwide. The company said that based on its U.S. trial, the vaccine appeared to be 79 percent effective at preventing Covid-19.

    But the independent oversight board said in its letter that the vaccine’s efficacy may have been between 69 percent and 74 percent. The letter reprimanded AstraZeneca for an overly rosy description of the trial data.

    “Decisions like this are what erode public trust in the scientific process,” the board wrote.

    The letter prompted the National Institute of Allergy and Infectious Diseases to issue a sharply worded statement shortly after midnight on Tuesday, making public the panel’s concerns.

    The public airing of a conflict between a pharmaceutical company and a board overseeing a clinical trial is highly unusual. It is almost certain to trigger extra scrutiny of the vaccine by the Food and Drug Administration and other regulators if AstraZeneca seeks emergency authorization of its vaccine in the United States in the coming weeks, as expected.

    “Any type of thing like this could unfortunately contribute to a lack of confidence in the process,” said Dr. Anthony S. Fauci, the nation’s leading infectious disease expert.

    The dispute centered on how AstraZeneca was determining whether participants in the clinical trial had possible or actual cases of Covid-19, according to people familiar with the situation. The board twice pushed AstraZeneca representatives to take a more rigorous approach, telling them they had sufficient information to determine how many volunteers had the disease.

    But AstraZeneca unveiled its interim results on Monday without the full analysis the board requested, possibly casting its vaccine in an overly favorable light.

    AstraZeneca defended the data it released on Monday, which it said showed the vaccine was 79 percent effective at preventing Covid-19. The company said on Tuesday that the interim results appeared to be “consistent” with more recent data collected during the trial. AstraZeneca said it would immediately share its latest efficacy data with the monitoring board. The company said it would reissue fuller results within 48 hours.

    The results that AstraZeneca announced on Monday were a badly needed dose of good news, especially because they came at a moment when concerns about the vaccine’s safety had led more than a dozen countries, mostly in Europe, to temporarily suspend the shot’s use over concerns about possible rare side effects. The results not only affirmed the vaccine’s safety, but also made the vaccine look more effective than it appeared in earlier trials.

    The news sent AstraZeneca shares up about 4 percent on Monday.

    But members of the independent monitoring board were surprised by the company’s announcement. “They got concerned and wrote a rather harsh note to them and with a copy to me, saying that in fact they felt that the data that was in the press release were somewhat outdated and might in fact be misleading a bit and wanted them to straighten it out,” said Dr. Fauci, who runs the National Institute of Allergy and Infectious Diseases, on ABC’s “Good Morning America.”

    That prompted the overnight statement from the infectious-disease institute, which is part of the National Institutes of Health.

    AstraZeneca’s stock fell more than 3.5 percent in early trading on Tuesday.

    Companies sponsoring drug or vaccine trials typically wait for the monitoring board to review analyses and conclude that the study has yielded an answer before they announce trial results.

    Company executives do not see the results of the study until the monitoring board reports their study data back to the company. The monitoring board ultimately conveyed the results of the study to AstraZeneca in a meeting over the weekend, leading to the company’s announcement Monday morning.

    The monitoring board’s slow progress fueled concerns among federal officials that AstraZeneca may have been sitting on the data or that the monitoring board had concerns about the way the data it was reviewing had been presented.

    An AstraZeneca spokeswoman, whom the company declined to name, said on Friday that it was “completely incorrect” that the trial data had formatting problems or had not been submitted to the monitoring board in a clean fashion.

    “As is often the case,” the spokeswoman said, monitoring boards “can request new or clarifying analyses of data from the trial. This would enable them to ensure the robustness of their determinations.”

    The national institute’s statement, issued shortly after midnight, stunned experts. Dr. Eric Topol, a clinical trials expert at Scripps Research in San Diego, said it was “highly irregular” to see such a public display of friction between a monitoring board and a study sponsor, which are typically in close concordance.

    “I’ve never seen anything like this,” he said. “It’s so, so troubling.”

    AstraZeneca’s relationship with the U.S. authorities has been fraught since last year, when senior health officials believed the company was not being forthright about the design of its clinical trials, its results and safety issues. That skepticism carried over to last week, when senior officials at a number of federal health agencies grew suspicious about why AstraZeneca had not announced data from its U.S. study.

    That U.S. trial, which involved more than 32,000 participants, was the largest test of its kind for the shot. The results AstraZeneca released on Monday were from an interim look at the data after 141 Covid-19 cases had turned up among volunteers.

    The company had not disclosed until Tuesday how up-to-date those data were. That information is important, because sometimes a more current look at clinical trial results can present a different effectiveness and safety.

    If the analysis was conducted on data from a month or two ago, it is possible that a more current look would present a different picture of the vaccine’s effectiveness and safety. The company has said it will provide the F.D.A. with a more comprehensive, recent set of data than what it disclosed on Monday. Although no clinical trial is large enough to rule out extremely rare side effects, AstraZeneca reported that its study turned up no serious safety issues.

    The fresh data may have arrived too late to make much difference in the United States, where the vaccine is not yet authorized and is unlikely to become available before May. By then, federal officials predict, there will be enough vaccine doses for all of the nation’s adults from the three vaccines that have already been authorized: Pfizer-BioNTech, Moderna and Johnson & Johnson.

    Even so, the better-than-expected results were seen as a heartening turn for AstraZeneca’s shot, whose low cost and simple storage requirements have made it a vital piece of the drive to vaccinate the world.

    The results were also thought to ease concerns about the AstraZeneca vaccine in Europe. Regulators there said last week that the shot was “safe and effective,” having conducted a review after a small number of people who had recently been inoculated developed blood clots and abnormal bleeding. The U.S. trial did not turn up any sign of such problems, although some safety issues can only be detected in the real world, once a drug or vaccine has been widely used.

    Many millions of people have received the AstraZeneca shot worldwide, including more than 17 million in Britain and the European Union, almost all without serious side effects. In an effort to increase public confidence, many European political leaders have gotten the injections in recent days. The AstraZeneca vaccine has also been administered in the past week to leaders in South Korea, Taiwan and Thailand.

    AstraZeneca said on Monday that it would continue to analyze the new data and prepare to apply in the coming weeks for emergency authorization in the United States. The vaccine has already been approved in more than 70 countries, but clearance from American regulators would bolster its global reputation.

    The statement from the infectious disease institute comes after a series of miscues and communication blunders by AstraZeneca dating to last year that have eroded American officials’ trust in the company.

    Last summer, at least some top F.D.A. officials learned only from news reports that AstraZeneca had paused its Phase 2/3 vaccine trial in Britain after a participant developed neurological symptoms. Then in September, after another participant in the British study fell ill with similar symptoms, AstraZeneca halted its trials globally but failed to promptly notify the U.S. authorities.

    The U.S. study was ultimately paused for seven weeks last fall, in part because AstraZeneca was slow to provide the F.D.A. with evidence that the vaccine had not caused the neurological symptoms. Investigators ultimately concluded that the illnesses could not be linked to the vaccine. Still, the delay was a key reason that AstraZeneca fell so far behind the three other manufacturers whose vaccines have been granted emergency authorization in the United States.
     
    #837     Mar 23, 2021
  8. As discussed, this whole thing is orchestrated like an Esther Williams water ballet now.

    U.S allegedly does not want AZ vaccine.

    Rob Ford said he was willing to drive down in his pick-up truck and get them.

    Additional nails put in AZ coffin today.

    Canada says, "not to worry. we are still good to go."


    Canada recommends AstraZeneca vaccine despite U.S. criticism of trial data
    https://www.ctvnews.ca/health/coron...despite-u-s-criticism-of-trial-data-1.5358898

     
    #838     Mar 23, 2021
  9. Cuddles

    Cuddles

    Odds of JJ, Moderna, or Pfeizer holdovers in the FDA scuttling a competitor? We know how Donnie rolled and dems aren't that much better at taking money from big pharma. Hell isn't even Fauci a little dirty over AIDS treatments decades ago?[​IMG]
     
    Last edited: Mar 23, 2021
    #839     Mar 23, 2021
  10. gwb-trading

    gwb-trading

    #840     Mar 23, 2021