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FDA greenlights updated Covid shots, making fall booster rollout imminent.
invite response
2023 Sep 12, 4:43am 649 views 15 comments
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2
RC2006
2023 Sep 12, 5:42am
RC2006
2023 Sep 12, 5:42am
Evil shit. At this point everyone has been exposed to covid and has a natural immunity turning this into a cold/flu if one gets it at all.
With covid all the common knowledge about dealing with a viruses is thrown out the window.
With covid all the common knowledge about dealing with a viruses is thrown out the window.
3
Bd6r
2023 Sep 12, 6:39am
Bd6r
2023 Sep 12, 6:39am
They should just go and fuck themselves. Before CCP flu, I would get flu shots almost every year because I am in contact with huge numbers of people in winter. I will not have a single flu shot ever again because they lost any vestiges of trust I had and I think they will start sneaking Covid death shots into regular season flu shots.
4
PeopleUnited
2023 Sep 12, 6:51am
PeopleUnited
2023 Sep 12, 6:51am
Bd6r says
Agreed. And wise choice my friend. I basically have decided not to see any doctor unless I’m bleeding, broken or need fluids because they as corrupt as the AMA and big pharma they ultimately work for.
More and more people are waking up to their hypocrisy, fear mongering and lies. For that I’m thankful but is it going to matter when our rights are being systematically removed by tyrants like the governor of New Mexico?
They should just go and fuck themselves. Before CCP flu, I would get flu shots almost every year because I am in contact with huge numbers of people in winter. I will not have a single flu shot ever again because they lost any vestiges of trust I had and I think they will start sneaking Covid death shots into regular season flu shots.
Agreed. And wise choice my friend. I basically have decided not to see any doctor unless I’m bleeding, broken or need fluids because they as corrupt as the AMA and big pharma they ultimately work for.
More and more people are waking up to their hypocrisy, fear mongering and lies. For that I’m thankful but is it going to matter when our rights are being systematically removed by tyrants like the governor of New Mexico?
5
Al_Sharpton_for_President
2023 Sep 12, 6:59am
Al_Sharpton_for_President
2023 Sep 12, 6:59am
Paraphrasing Dr. Peter Marks: "We don' need no stinking public health emergency to emergency use authorize mismatched boosters
Many of us knew this day would come, and now here it is. As of Monday, September 11, 2013, the FDA has provided “Emergency Use Authorization” for the SARS-CoV-2 mRNA vaccine boosters. But there is no public health emergency at this time. And the “boosters” being “Emergency Use Authorized” are designed to provide protection against the Omicron variant called “Kraken”. Which is on its way to becoming extinct, outcompeted by newer variants like Eris which have evolved even further to escape the antibody pressure elicited by the globally deployed leaky “vaccines”.
Prior versions of which boosters, by the way, have been shown to have been adulterated with high levels of plasmid DNA incorporating SV40 virus promoter/enhancer sequences. Which adulteration the FDA continues to ignore.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
But Biden, under congressional pressure, had decided and certified that the COVIDcrisis “national emergency” ended May 11, 2023, right? Sort of. The administrative class at the FDA decided that they have the authority to to interpret this in their own special way. Despite clear Congressional intent and the Presidential decision, the FDA responded with a series of delaying tactics. These are summarized in an “action notice” in the Federal Register titled “Guidance Documents Related to Coronavirus Disease 2019 (COVID-19), A Notice by the Food and Drug Administration on 03/13/2023”. At the time of the Presidential declaration, the FDA had 72 COVID-19-related guidance documents currently in effect. These are not law, they are administrative guidance, but often function and are enforced as if they are law. If you are seeking an example of administrative state overreach, this would be a good place to start. So, whats an agency to do? Issue an action notice in the federal register laying out new rules, functionally a guidance on guidances.
------------
What congressional law and language determines when FDA can issue EUAs?
From the FDA’s own website regarding Emergency Use Authorization-
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.
So, basically, the FDA administrative bureaucracy self-determined that they could continue to bypass their normal (already lax) procedures for evaluating vaccine purity, potency, safety and efficacy pretty much for as long as their hearts desire, at least until November 07, 2023. And that is the administrative basis used to enable the September 11, 2023 “Emergency Use Authorization” for the SARS-CoV-2 mRNA vaccine boosters.
Meanwhile, back at the capital dome, the leadership of the congressional gerontocracy continued to snooze, raise funds for the next election, and almost daily demonstrate to the world (during rare public appearances) their quite literal mental incompetency (in a strict medical sense of the term).
The data clearly demonstrate that there is no longer a COVID public health emergency, and there are no human data demonstrating safety and effectiveness of these mismatched “vaccine booster” products.
------------
Hospitalized cases are up in the USA. But deaths are down. Not surprising, as the majority of currently circulating SARS-CoV-2 virus are more highly evolved Omicron variants. Typically more infectious, less pathogenic, and better adapted to evade the narrow antibody-based anti-Spike immune responses elicited by these leaky vaccines.
Who are the ones that are being hospitalized? More of them are the ones that have received a Moderna or Pfizer Emergency Use Authorized mRNA “vaccine” product than have not. That is a fact long known by the US Government, but hidden until internal government discussions about this were recently documented by FOIA request.
I infer that the real crisis here is that the data from all over the world are clearly demonstrating that some period of time after receiving a mRNA “Booster vaccine”, recipients are developing “negative effectiveness”.
What the heck is “negative effectiveness”, you may well ask? The term means that those who have received the product are more likely to develop COVID than those who have not been injected. And there are suggestions in the data that the period of time between injection and “negative effectiveness” is getting shorter.
Even if the “vaccine” products even have zero rather than negative effectiveness, they certainly have toxicity risks, so why would anyone be willing to receive these products if they knew this?
The “vaccinated” are at higher risk for developing COVID than the unvaccinated. So the “vaccinated” need more “vaccines”. So they can become at yet higher risk for COVID (and other infectious diseases)? Somehow the Joseph Heller WW-II book “Catch-22” comes to mind.
And why would the FDA provide “emergency use authorization” and the CDC recommend these clearly toxic products for children?
https://rwmalonemd.substack.com/p/fda-has-gone-rogue
Many of us knew this day would come, and now here it is. As of Monday, September 11, 2013, the FDA has provided “Emergency Use Authorization” for the SARS-CoV-2 mRNA vaccine boosters. But there is no public health emergency at this time. And the “boosters” being “Emergency Use Authorized” are designed to provide protection against the Omicron variant called “Kraken”. Which is on its way to becoming extinct, outcompeted by newer variants like Eris which have evolved even further to escape the antibody pressure elicited by the globally deployed leaky “vaccines”.
Prior versions of which boosters, by the way, have been shown to have been adulterated with high levels of plasmid DNA incorporating SV40 virus promoter/enhancer sequences. Which adulteration the FDA continues to ignore.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
But Biden, under congressional pressure, had decided and certified that the COVIDcrisis “national emergency” ended May 11, 2023, right? Sort of. The administrative class at the FDA decided that they have the authority to to interpret this in their own special way. Despite clear Congressional intent and the Presidential decision, the FDA responded with a series of delaying tactics. These are summarized in an “action notice” in the Federal Register titled “Guidance Documents Related to Coronavirus Disease 2019 (COVID-19), A Notice by the Food and Drug Administration on 03/13/2023”. At the time of the Presidential declaration, the FDA had 72 COVID-19-related guidance documents currently in effect. These are not law, they are administrative guidance, but often function and are enforced as if they are law. If you are seeking an example of administrative state overreach, this would be a good place to start. So, whats an agency to do? Issue an action notice in the federal register laying out new rules, functionally a guidance on guidances.
------------
What congressional law and language determines when FDA can issue EUAs?
From the FDA’s own website regarding Emergency Use Authorization-
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.
So, basically, the FDA administrative bureaucracy self-determined that they could continue to bypass their normal (already lax) procedures for evaluating vaccine purity, potency, safety and efficacy pretty much for as long as their hearts desire, at least until November 07, 2023. And that is the administrative basis used to enable the September 11, 2023 “Emergency Use Authorization” for the SARS-CoV-2 mRNA vaccine boosters.
Meanwhile, back at the capital dome, the leadership of the congressional gerontocracy continued to snooze, raise funds for the next election, and almost daily demonstrate to the world (during rare public appearances) their quite literal mental incompetency (in a strict medical sense of the term).
The data clearly demonstrate that there is no longer a COVID public health emergency, and there are no human data demonstrating safety and effectiveness of these mismatched “vaccine booster” products.
------------
Hospitalized cases are up in the USA. But deaths are down. Not surprising, as the majority of currently circulating SARS-CoV-2 virus are more highly evolved Omicron variants. Typically more infectious, less pathogenic, and better adapted to evade the narrow antibody-based anti-Spike immune responses elicited by these leaky vaccines.
Who are the ones that are being hospitalized? More of them are the ones that have received a Moderna or Pfizer Emergency Use Authorized mRNA “vaccine” product than have not. That is a fact long known by the US Government, but hidden until internal government discussions about this were recently documented by FOIA request.
I infer that the real crisis here is that the data from all over the world are clearly demonstrating that some period of time after receiving a mRNA “Booster vaccine”, recipients are developing “negative effectiveness”.
What the heck is “negative effectiveness”, you may well ask? The term means that those who have received the product are more likely to develop COVID than those who have not been injected. And there are suggestions in the data that the period of time between injection and “negative effectiveness” is getting shorter.
Even if the “vaccine” products even have zero rather than negative effectiveness, they certainly have toxicity risks, so why would anyone be willing to receive these products if they knew this?
The “vaccinated” are at higher risk for developing COVID than the unvaccinated. So the “vaccinated” need more “vaccines”. So they can become at yet higher risk for COVID (and other infectious diseases)? Somehow the Joseph Heller WW-II book “Catch-22” comes to mind.
And why would the FDA provide “emergency use authorization” and the CDC recommend these clearly toxic products for children?
https://rwmalonemd.substack.com/p/fda-has-gone-rogue
6
NuttBoxer
2023 Sep 12, 7:10am
NuttBoxer
2023 Sep 12, 7:10am
Al_Sharpton_for_President says
If we aren't going to mask, or do any of the other bullshit anymore, why would we take the shots either? If you go by the official numbers, which I've given reasons why you shouldn't, even then almost no one took a third shot. Giant nothingburger..
FDA greenlights updated Covid shots, making fall booster rollout imminent.
If we aren't going to mask, or do any of the other bullshit anymore, why would we take the shots either? If you go by the official numbers, which I've given reasons why you shouldn't, even then almost no one took a third shot. Giant nothingburger..
7
PeopleUnited
2023 Sep 12, 7:12am
PeopleUnited
2023 Sep 12, 7:12am
Al_Sharpton_for_President says
$ and Molech.
And why would the FDA provide “emergency use authorization” and the CDC recommend these clearly toxic products for children?
$ and Molech.
8
Robert Sproul
2023 Sep 12, 7:13am
PeopleUnited says
An interesting development in ALB is the Sheriff of Bernalillo county has said he will NOT enforce this 'emergency' ruling. It is good to pay attention to who is getting elected to that office in your locale.
our rights are being systematically removed by tyrants like the governor of New Mexico?
An interesting development in ALB is the Sheriff of Bernalillo county has said he will NOT enforce this 'emergency' ruling. It is good to pay attention to who is getting elected to that office in your locale.
9
Robert Sproul
2023 Sep 12, 7:30am
NuttBoxer says
It seems that the 'promotion' of these injections by the government is its own entrenched administrative cesspool now. They will likely never quit peddling them no matter the outcomes. Unbelievably they are working on an mRNA 'vaccine' to address the opioid addiction that THEY largely created. There are not going to be many problems that they will not approach with this technology now that they have also changed the very definition of 'vaccine'. One prediction might be a 'vaccine' for "Extremist Mindset".
https://www.healthline.com/health/opioid-vaccine
If you go by the official numbers, which I've given reasons why you shouldn't, even then almost no one took a third shot. Giant nothingburger..
It seems that the 'promotion' of these injections by the government is its own entrenched administrative cesspool now. They will likely never quit peddling them no matter the outcomes. Unbelievably they are working on an mRNA 'vaccine' to address the opioid addiction that THEY largely created. There are not going to be many problems that they will not approach with this technology now that they have also changed the very definition of 'vaccine'. One prediction might be a 'vaccine' for "Extremist Mindset".
https://www.healthline.com/health/opioid-vaccine
10
NuttBoxer
2023 Sep 12, 7:04pm
NuttBoxer
2023 Sep 12, 7:04pm
bio-digital convergence my friend. Normalizing re-writing the human being is really their own potential win at this point.
11
clambo
2023 Sep 12, 9:00pm
They should not call new Wuhan shots boosters; they are a new recipe each time, like the flu shot each year.
12
zzyzzx
2023 Sep 13, 5:23am
zzyzzx
2023 Sep 13, 5:23am
https://finance.yahoo.com/video/fda-determines-popular-decongestant-doesnt-220412573.html
Another case where the FDA approved something that didn't work. I can personally vouch for it's ineffectiveness. The comments agree with me.
Another case where the FDA approved something that didn't work. I can personally vouch for it's ineffectiveness. The comments agree with me.
13
RC2006
2023 Sep 13, 5:29am
RC2006
2023 Sep 13, 5:29am
Just watched the same BS propaganda on news. Saying booster helps to stop spread.
14
Al_Sharpton_for_President
2023 Sep 13, 5:43am
Al_Sharpton_for_President
2023 Sep 13, 5:43am
NuttBoxer says
We are in control of your immune system.
bio-digital convergence my friend. Normalizing re-writing the human being is really their own potential win at this point.
We are in control of your immune system.
15
stereotomy
2023 Sep 13, 6:17am
stereotomy
2023 Sep 13, 6:17am
Al_Sharpton_for_President says
We will adjust your IG4 levels
We will induce endothelial inflammation
We can, through "hot shot" or placebo, completely degrade your health, or leave you clear of spike protein.
For the rest of your life, your cells' gene expressions will be modified by foreign mRNA.
You are embarked on a great adventure, which reaches from pureblood to toxxine injured or dead.
Welcome to the Fauci Limits.
We are in control of your immune system.
We will adjust your IG4 levels
We will induce endothelial inflammation
We can, through "hot shot" or placebo, completely degrade your health, or leave you clear of spike protein.
For the rest of your life, your cells' gene expressions will be modified by foreign mRNA.
You are embarked on a great adventure, which reaches from pureblood to toxxine injured or dead.
Welcome to the Fauci Limits.
The CDC’s vaccine advisors are set to meet Tuesday, and they’re likely to recommend the updated boosters before CDC Director Mandy Cohen is expected to make the final decision on the rollout.
“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated,” CBER Director Peter Marks said in a statement.
The FDA’s announcement on Monday did not mention Novavax’s vaccine. In a statement issued shortly thereafter, Novavax said its shots were ready to ship, though did not explain why they were not included in the FDA’s action.
FDA’s vaccine advisors did not meet to discuss these specific vaccines, but in June, they unanimously recommended a monovalent vaccine for the fall targeting the XBB.1.5 lineage. The expectation is that the vaccines will be updated on an annual basis, barring the emergence of a completely new variant that requires a different approach.
Last week, Moderna published data suggesting that the updated booster is effective at boosting antibodies against the now-in-circulation BA.2.86 variant, also known as Pirola, which public health officials have warned could overcome immunity from prior vaccination or infection.
Pfizer and BioNTech’s updated booster is approved for those ages 12 and older, regardless of whether they previously received a Covid-19 vaccine. Their vaccine for people ages 6 months to 11 years was cleared through an emergency use authorization, which is a lower bar than approval.
Pfizer CEO Albert Bourla said the majority of Americans are eligible for the new vaccine, even if they haven’t previously received one amid rising Covid-19 cases.
“We expect this season’s vaccine to be available in the coming weeks, pending recommendation from public health authorities, so people can ask their doctor about receiving their Covid-19 vaccine during the same appointment as their annual flu shot, saving time now and helping to prevent severe disease later when respiratory viruses are at their peak,” Bourla said.
BioNTech CEO Uğur Şahin said in a statement that the updated shot addresses multiple Omicron XBB-lineages, which account for most cases globally.
“Studies about confirmed viral infections suggest that Covid-19 adopts a seasonal pattern with peaks in fall and winter, similar to other respiratory viruses,” Şahin said. “Our goal is to provide people worldwide with Covid-19 vaccines that are adapted to circulating virus variants or sublineages.”
With vaccines available for Covid-19, RSV and flu this upcoming season, public health officials now face the daunting task of encouraging people to take the updated shots. Despite officials’ efforts last fall to encourage Americans to get their Covid-19 and flu shots concurrently, uptake of the bivalent booster still severely lagged.
Jeffrey Henderson, a professor of medicine at Washington University in St. Louis, said the seasonal approach to updating the Covid vaccines marks a significant shift since the start of the pandemic when there was no widespread immunity to the virus.
“With time you would hope there’s some greater comfort level and time and experience with this vaccine type to convince more people to stay up to date with it,” he said. “Time will tell whether that’s the case.”
https://endpts.com/fda-greenlights-updated-covid-shots-making-fall-booster-rollout-imminent/