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Thread: FDA rejects Pfizer Booster approval

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    Default FDA rejects Pfizer Booster approval

    An influential federal advisory panel has soundly rejected a plan to offer Pfizer booster shots against COVID-19 to most Americans.

    The vote Friday, 16-2, was a blow to the Biden administration’s effort to shore up people’s protection against the virus amid the highly contagious delta variant.

    Over several hours of discussion, members of the Food and Drug Administration panel of outside experts voiced frustration that Pfizer had provided little data on safety of extra doses.

    And they complained that data provided by Israeli researchers about their booster campaign might not be suitable for predicting the U.S. experience.

    THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below.

    WASHINGTON (AP) — The Biden administration’s embattled plan to dispense COVID-19 booster shots to most Americans faced its first major hurdle Friday as a government advisory panel vigorously debated whether to endorse extra doses of the Pfizer vaccine.

    Scientists inside and outside the government have been divided in recent days over the need for boosters and who should get them, and the World Health Organization has strongly objected to rich nations giving a third round of shots when poor countries don’t have enough vaccine for their first.

    The panel, made up of outside experts who advise the Food and Drug Administration, weighed a less than clear-cut case: While research suggests immunity levels in those who have been vaccinated wane over time and boosters can reverse that, the Pfizer vaccine is still highly protective against severe illness and death, even amid the spread of the highly contagious delta variant.
    https://www.yahoo.com/news/fda-panel...132533880.html

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    no booster. IMPROVE YOUR IMMUNE SYSTEM is the answer for delta. always has been

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    Except the main reason for not doing it has been so that other nations can get doses. The reasons given here read as excuses.
    This illegal illegitimate regime that runs America is at fault...not me.... they do not represent me and I have long objected to their crimes against humanity.

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    Counterpoint:

    These days, extremely weird things are going on within the Biden administration. Even though his approval ratings are sinking, the president has to pretend that he has all the answers, that the science behind his mandates and virus war is universally settled, that anyone who disagrees with him is really just a political enemy. He has gone so far as to denounce, demonize, and legally threaten red-state governors who disagree with him.

    This is a deep problem for actual scientists working within the bureaucracy because they know for sure that all of this is a pretense and that the government cannot win this war on the virus. They simply cannot preside over more false promises, especially when the whole of their professional training is about assessing the safety and effectiveness of vaccines.

    So what can they do? In this case, it appears they had to get away before they dropped a bombshell.

    The bombshell is called “Considerations in boosting COVID-19 vaccine immune responses.” It appears in the prestigious British medical journal The Lancet. The two top officials are among the authors. The article recommends against the Covid booster shot that the Biden administration, following Fauci’s advice, is suggesting as the key to making the vaccines work better and finally fulfill their promise.

    Fauci and company are pushing boosters because they know what is coming. Essentially we are going the way of Israel: most everyone is vaccinated but the virus itself is not being controlled. More and more among those hospitalized and dying are vaccinated. This same trend is coming to the US. The boosters are a means by which government can save face, or so many believe.

    The trouble now is that the top scientists at the FDA disagree. Further, they think that the push for boosters is courting problems. They think the current regime of one or two shots is working as well as one can expect. Nothing is gained on net from a booster, they say. There just isn’t enough evidence to take the risk of another booster, and another and another.

    The authors knew this article was appearing. They knew that signing it under the FDA affiliation would lead to a push for their resignations. Life would get very difficult for both of them. They got ahead of the messaging and resigned before it came out. Very smart.

    The signed article goes even further to warn of possible downsides. They point out that boosters might seem necessary because “variants expressing new antigens have evolved to the point at which immune responses to the original vaccine antigens no longer protect adequately against currently circulating viruses.” At the same time, there are possible side effects that could discredit all vaccines for a generation or more. “There could be risks,” they write, “if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side-effects (such as myocarditis, which is more common after the second dose of some mRNA vaccines, or Guillain-Barre syndrome, which has been associated with adenovirus-vectored COVID-19 vaccines.”)

    Bringing up such side effects is essentially a taboo topic. That this was written by two top FDA officials is nothing short of remarkable, especially because it comes at a time when the Biden administration is going all in on vaccine mandates. Meanwhile, studies are showing that for teenage boys, the vaccine poses a greater risk to them than Covid itself. “For boys 16-17 without medical comorbidities, the rate of CAE is currently 2.1 to 3.5 times higher than their 120-day COVID-19 hospitalization risk, and 1.5 to 2.5 times higher at times of high weekly COVID-19 hospitalization.”

    From the beginning of these lockdowns – along with all the masks, restrictions, bogus health advice from plexiglass to sanitizer to universal vaccine mandates and so on – it was clear that there would someday be hell to pay. They wrecked rights and liberties, crashed economies, traumatized a whole generation of children and other students, ran roughshod over religious freedom, and for what? There is zero evidence that any of this has made any difference. We are surrounded by the carnage they created.

    The appearance of The Lancet article by two top FDA vaccine scientists is truly devastating and revealing because it undermines the last plausible tool to save the whole machinery of government disease management that has been deployed at such enormous social, cultural, and economic cost for 19 months. Not in our lifetimes has a policy failed so badly. The intellectual and political implications here are monumental. It means that the real Covid crisis – the task of assigning responsibility for all the collateral damage – has just begun.

    In 2006, during the early years of the birth of lockdown ideology, the great epidemiologist Donald Henderson warned that if any of these restrictive measures were deployed for a pandemic, the result would be a “loss of trust in government” and “a manageable epidemic could move toward catastrophe.” Catastrophe is exactly what has happened. The current regime wants to point the finger toward the noncompliant. That is no longer believable. They cannot delay the inevitable for much longer: responsibility for this catastrophe belongs to those who embarked on this political experiment in the first place.
    https://brownstone.org/articles/the-...-resignations/
    This illegal illegitimate regime that runs America is at fault...not me.... they do not represent me and I have long objected to their crimes against humanity.

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    This illegal illegitimate regime that runs America is at fault...not me.... they do not represent me and I have long objected to their crimes against humanity.

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    Bret and Heather talk about this routinely:

    This illegal illegitimate regime that runs America is at fault...not me.... they do not represent me and I have long objected to their crimes against humanity.

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    Walgreens called us and said my wife and i qualified for the booster and we went and got it. That was about 2 weeks ago.

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    I know two people that have conditions and the doctor told them to take the booster, both have and both were in the hospital for two weeks. They are in their 70s and one of them is all fucked up. no booster for me

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    Quote Originally Posted by dukkha View Post
    An influential federal advisory panel has soundly rejected a plan to offer Pfizer booster shots against COVID-19 to most Americans.

    The vote Friday, 16-2, was a blow to the Biden administration’s effort to shore up people’s protection against the virus amid the highly contagious delta variant.

    Over several hours of discussion, members of the Food and Drug Administration panel of outside experts voiced frustration that Pfizer had provided little data on safety of extra doses.

    And they complained that data provided by Israeli researchers about their booster campaign might not be suitable for predicting the U.S. experience.

    THIS IS A BREAKING NEWS UPDATE. AP’s earlier story follows below.

    WASHINGTON (AP) — The Biden administration’s embattled plan to dispense COVID-19 booster shots to most Americans faced its first major hurdle Friday as a government advisory panel vigorously debated whether to endorse extra doses of the Pfizer vaccine.

    Scientists inside and outside the government have been divided in recent days over the need for boosters and who should get them, and the World Health Organization has strongly objected to rich nations giving a third round of shots when poor countries don’t have enough vaccine for their first.

    The panel, made up of outside experts who advise the Food and Drug Administration, weighed a less than clear-cut case: While research suggests immunity levels in those who have been vaccinated wane over time and boosters can reverse that, the Pfizer vaccine is still highly protective against severe illness and death, even amid the spread of the highly contagious delta variant.
    https://www.yahoo.com/news/fda-panel...132533880.html
    Are you ever going to stop beating the dead horse SIR?

    You may as well just beat on those 461,000,000 people that have died of this virus!

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    Quote Originally Posted by dukkha View Post
    no booster. IMPROVE YOUR IMMUNE SYSTEM is the answer for delta. always has been
    The FDA didn't say "improve your immune system," rather, that at this time, they needed further study to determine if the booster is necessary for those under sixty five. They approved it for those over sixty five, and some day down the road, may do the same for everyone over sixteen

    Why is it anytime there is a news event the right has to reframe facts to convey the picture they want to sell?

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    Quote Originally Posted by MAGA View Post
    I know two people that have conditions and the doctor told them to take the booster, both have and both were in the hospital for two weeks. They are in their 70s and one of them is all fucked up. no booster for me
    There are close to fifty million Americans over the age of sixty five and cause this poster knows two of those fifty million who had bad experiences, so, he ain't getting no booster.

    Why are those on the right so influenced by minuscular anecdotal narratives?

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    Quote Originally Posted by archives View Post
    There are close to fifty million Americans over the age of sixty five and cause this poster knows two of those fifty million who had bad experiences, so, he ain't getting no booster.

    Why are those on the right so influenced by minuscular anecdotal narratives?
    actually we are close to 7000 deaths after the second shot before the booster. Being in the hospital for two weeks and the expense is not worth chancing the booster when the reward is unknown. FDA did not approve the booster you know

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    Quote Originally Posted by MAGA View Post
    actually we are close to 7000 deaths after the second shot before the booster. Being in the hospital for two weeks and the expense is not worth chancing the booster when the reward is unknown. FDA did not approve the booster you know
    Amazing, like the fifth time in the same thread, just to inform of the facts, the FDA did approve the booster for those over sixty five, and said they want further study before issuing a recommendation of booster for everyone

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    Quote Originally Posted by archives View Post
    Amazing, like the fifth time in the same thread, just to inform of the facts, the FDA did approve the booster for those over sixty five, and said they want further study before issuing a recommendation of booster for everyone
    for the fifth time that is not full approval

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