Showing posts with label Booster. Show all posts
Showing posts with label Booster. Show all posts

Dana Carvey's Fauci Impression Is Insane!

I miss Covid.  Booster just sounds better.  I am introducing a daily COVID shot. 

Sign Petition FDA To Investigate Pfizer's Clinical Trial Fraud

Sign Petition FDA Needs To Investigate Pfizer's Clinical Trial Fraud Allegations

Should the FDA investigate Pfizer's clinical trial fraud allegations? Or look the other way?

Sucharit Bhakdi, MD - Antibodies, Lymphocytes & Immune System


Why if you had an infection you have natural immunity and herd immunity is now present!!!  Professor Sucharit Bhakdi, MD - Proff that puts an end to the Sars COV-2 Narrative. 

Vaccines only present danger and have no benefit!  Why multiple boosters will turn your natural immune system to start killing you.  

This video is from July 2021. 

PROF SUCHARIT BHAKDI, M.D


Twitter Poll Shows The Tide Is Turning on Fake News & Boosters

Spike Protein Inside Nucleus Enhancing DNA Damage?


This video discusses a new surprise discovery (yet to be confirmed by other scientists) that SARS-CoV-2 full-length spike protein can enter human cell nuclei and interfere with the fixing of broken DNA damage. The authors of the study propose this might have been evolved in order to prevent genetic recombination required to produce antibody variety to successfully attack the virus. If true, and if this could have important implications for potential negative health outcomes and might require reconfiguration of vaccine design.

So apparently: the spike proteins enter the cell nucleus, destroy DNA, destroy the ability to fix DNA, a massive increase in cancer? the reason for endless booster shots?

Thank you for these notes made by a kind and awesome supporter:

00:00 Dr Mikolaj Raszek, Phd from Merogenomics 

00:09 The latest widest news in Molecular Microbiology

00:33 WHO? Swedish research shows spike protein enters nucleus in human cells (in vitro)

00:57 this is of course, biologically verboten (*German for STRICTLY FORBIDDEN) 

01:04 WHAT? *Discovery* Spike protein inhibits proper fixing of broken DNA

01:18 Specifics: double stranded breaks where both strands are broken

01:33 HOW? *Mechanism 1* suspected interference with BRCA1 gene product’s ability to repair DNA

01:48 Consequence: if BRCA1 is mutated though, then you have highest predisposition for Cancer development precisely because BRCA1 gene codes for proteins that fix DNA damage when sheared in half

02:14 Significance: Consequences are so great if true that it should be double checked, verified and reinvestigated

2:42 Call for a lot more studies: Revalidation

2:51 HOW? *Mechanism 2* Spike also interferes with mysterious nuclear protein 53BP1 which may serve to prevent DNA breaks from re-ligating to other DNA sources ensuring 2 chromosomes don’t link together that aren’t supposed to. 

4:21 HOW? *Mechanism 3* Perhaps spike in Nuclei interferes with Immune cells’ mechanisms (eg.BRCA1 and 53BP1) and diversity of response to infections. 

4:42 *TAKEAWAY* What if Spike protein evolved as a mutagen for DNA – what would implications be for a vaccine that’s primary focus was to produce Spike? 

5:32 CONTEXT: Recent discovery that Spikes may circulate for months on end in Exosomes to different parts of the body and in theory enter cells well after the point of vaccination as COVID-19 mRNA vaccines update 16 discussed

06:15 CONTEXT: DNA gets 70k lesions/day /cell! But only 25 are double stranded shearing damages

07:25 IMPLICATIONS: So within this context, what are the chances circulating spike proteins could enter and damage DNA and predispose to cancer? In cancer, it takes months for damage to accumulate and cause symptoms. Therefore…

7:45 IMPLICATION: *Vaccine Safety* Are vaccines “SAFE”? What is vaccine “Safety”? Only Time can/will tell.

8:07 IMPLICATION: Yes, Vaccines don’t produce dangerous clinical symptoms in the first few months BUT we don’t know what they do in very long-term basis so can we call them safe? 

8:34 HOW? *Mechanism 4*  Vaccines use FULL length of spike protein thus  produces whole protein in body.  Prior to vaccinations some scientists mentioned that FULL protein length of Spike protein was dangerous

9:16 IMPLICATION: *Antibody Dependent Enhancement or ADE* could occur with use of full length of Spike protein

10:27: AUTHORS’ RECOMMENDATION: Not to use full length of spike protein but only the Receptor Binding Domain or RBD portion for vaccines

10:41 Explanation: RBD 

11:29: *TAKE AWAY* *Vaccine Safety* This shows how Vaccines are still uncharacterized on what they might be doing at the molecular level once injected in us. 

11:52 Spike protein also uncharacterized post-infection (but learning lots now).

12:00 LIKE AND SUBSCRIBE and please *SHARE* 

Pfizer CEO Albert Bourla Lied & Pushed Misinformation Months Ago

Pfizer CEO is publically commenting about stopping the spread of vaccine misinformation.

The irony: months back Pfizer CEO touted their product had 84% efficacy at 6 months from the 2nd shot. This info was then echoed by the government to push mandates with the vaccine being so effective.

Israel and other countries do large-scale independent testing and find Pfizer to have 16%-20% efficacy at 6 months from the 2nd dose. It's the exact reason that Israel pushed for boosters asap.

Now the US government is pushing boosters and admitting the vaccine wains way quicker than initially thought.

Where did Pfizer get this info? It was clear misinformation was being pushed by the manufacturers to sell their product and they aren't being held accountable.

How many Americans got the Pfizer jab after reading these stats? Thinking it would be 2 jabs and they're good for well over 6 months. Now they are being told they will need boosters every 4-6 months.

Soon we will follow Israel's move and double jabbed Americans past 6 months won't even be counted as vaccinated.

Pfizer loves this. Every jab is money in their pockets.

Vaccine immunity “wanes after 2-3 months”


"Why do the protected need to be protected from the unprotected by forcing the unprotected to use the protection that didn't protect the protected in the first place?" - Unvaccinated 2021

"Isn't it a false medical claim when someone who is fully-vaccinated says their COVID-19 symptoms would be worse if they weren't vaccinated; considering there's absolutely no scientific way to prove that for an individual case?" - Unvaccinated 2021

Fake News Lies Showing Vaccine Efficacy Headlines Compilation


This is perhaps one of the best short video encapsulations of the COVID-19 efficacy narrative ever produced…

The video quickly walks through the past ten months of government and media claims surrounding vaccine efficacy.  It is an alarming point all by itself how quickly the arc of this vaccine narrative traveled from 100% effective to virtually zero effectiveness with multiple nations now stopping the vaccine program entirely.

This is a video against the interests of Big Pharma and the global governments that have been paid by Big Pharma to push the untested vaccine into their populations.  However, the effectiveness of this video is enhanced because the producer doesn’t use opinion to drive home the point. The central assertion of vaccines being ineffective is proven in their own words and media statements during the course of only ten months. 

Fauci pinocchio



Fully Vaccinated Are COVID ‘Super-Spreaders,’ Says Inventor of mRNA Technology

 
On the latest episode of “The Hidden Gateway” podcast, Dr. Robert Malone, recognized for his role in inventing mRNA vaccine technology, said, “The idea that if you have a workplace where everybody's vaccinated, you're not going to have virus spread is totally false. A total lie.”

On the latest episode of “The Hidden Gateway” podcast, host Justin Williams spoke to Dr. Robert Malone, an internationally recognized medical doctor and scientist who assisted with inventing mRNA vaccines.

The wide-ranging discussion covered:

The invention and early testing of mRNA technology, in which Malone was heavily involved.
How governments are employing different forms of coercion to drive vaccine uptake, policies Malone said he believes are illegal.

How public health authorities lack the normally required safety and efficacy information for a global vaccination campaign.

How governments and public health authorities are lying to the public “for their own good.”
Malone referenced two instances where citizens are being “enticed” to take what he refers to as the “experimental” vaccine.

“There was a period where West Virginia was trying to get people to get vaccinated,” Malone said. “And so they had a shotgun lottery. And in Canada, there was a policy of offering free ice cream to children to get them to take the jab even without their parents’ approval. So those are just two particularly clear examples of unfair coercion … It’s not actually legal.”

Malone likened what’s going on today with COVID vaccines to the illegal medical experiments conducted by Nazi Germany. “[During the Second World War], Jews and other ethnic groups were subjected to horrible experimental medical research,” Malone said. “And they justified it by saying it was for the common good.”

Malone said the Western World “agreed we weren’t going to do that anymore. Yet, from time to time we seem to forget, and of course, Tuskegee is one example, and frankly, this is another example.”

In an attempt to clear up misinformation coming from the medical establishment, Malone said fully vaccinated individuals can spread COVID. “The idea that if you have a workplace where everybody’s vaccinated, you’re not going to have virus spread is totally false. A total lie,” Malone said.

The vaccinated are actually the “super-spreaders” that everyone was told about in the beginning of the pandemic, Malone argued.

He said:

“If you consider the scientific fact that vaccinated people have less symptoms than the unvaccinated, but can still easily spread disease, consider your fellow vaccinated worker, whose unvaccinated son brought the disease home and gave it to him … He might not have any symptoms … but he’ll definitely be producing the virus. And he’s going to say, hey, I can go to work today. But he’s going to be spreading the virus like crazy.”

Malone also touched on the idea of “the noble lie:”

“If the government isn’t going to disclose to you what the [vaccine] risks are, and they’re not going to disclose to you what’s really going on because they think that you can’t handle the news … this is called the noble lie.”

Malone denounced the “noble lie” as “paternalistic authoritarianism.” He said the idea of governance-by-lying goes back to Plato and Ancient Greek philosophy which argues that it’s  “okay for politicians and people in authority positions to lie to the general public because they have special knowledge and ability to understand things … and the general public can’t cope with that level of information. And so it’s okay to lie to them.”

“I really disagree with this line of thinking,” Malone said. “Yet it has been public policy in the United States and worldwide in public health for a very long time.”

Explanation on Why Natural Immunity is Vastly Superior

Here are highlights from this full article

There are a number of reasons why those who survive SARS-CoV-2 infection can expect to have longer-lasting immunity than those who have received vaccines, especially for the spike-protein-only vaccines. First, and most importantly, the spike protein has fewer immunogenic epitopes than the entire SARS-CoV-2 virus. These epitopes provide a diversity of nAbs and a diversity of memory B- and T-cells. Therefore, if immunity from infection conferred by the spike protein epitopes fails, those with prior infection will have redundant, back-up immunity. As I reported in April 2020, there were 54 immunogenic epitopes in the original SARS-CoV-2 proteome. That number has been expanded.

As evolutionary pressure against the spike protein pushes it away from being neutralized by vaccine induced antibodies, the virus cannot escape due to the other antibodies. The multiple components that contribute to fitness now make the adaptive landscape highly complex; from the virus’ evolutionary point of view, mutations that confer protection against nAbs that bind the spike protein do not also confer protection against nAbs that bind, for example, the M protein.

Similarly, mutations that confer protection to the virus from nAbs that bind the M protein do not also confer protection to the virus against nAbs that bind the SARS-CoV-2 endoRNAase.

Similarly, mutations that confer protection to the virus from nAbs that bind the endoRNAase do not also confer protein against nAbs that bind the SARS-CoV-2, helicase, leader protein, or matrix protein. This redundancy is really a numbers game: the probability that evolution will be able to co-localize all of the immune escape mutations into a single virion is exceedingly low, and decreases multiplicatively as the number of antigen sources are increased.

This Means Boosters with the Same Viral Protein Will be Ineffective and Massively Wasteful

The entire world seems focused on neutralizing antibodies. In a study of “waning immunity” following SARS-CoV-2 infection, the authors focused primarily on antibodies and suggested that re-infection or vaccination might be expected to produce prolonged immunity by keeping antibody levels up. They found that while nABs declined, that memory T- and B-cells increased and thus their estimate of the durability of immunity are likely conservative. However, the productions of neutralizing antibodies by itself is not a measure of immunity against an evolving virus: high nAbs are expected to be produced even in patients in whom first-round immunity has waned. See; "Prospects for durable immune control of SARS-CoV-2 and prevention of reinfection".

To boost the immune system to produce more antibodies that do not work is madness.

Those who are vaccinated will simply experience of boost in nAbs against the original SARS-CoV-2 type, not the more recent types like the Delta variant.

How Multiple Epitopes Should Prevent Viruses from Achieve Immune Escape

Imagine you’re a virus (actually a population of viruses), and you’re happily evolving toward an adaptive fitness peak. The close you get to the peak, the faster you evolve - runaway selection against viruses that are different from you die off due to the nasty neutralizing antibodies from a spike-protein-only antigen vaccine.

You can see the adaptive peak. Soon, you’ll be surrounding by viruses just like you, all capable of infecting every person you run into, vaccinated or not.

You’re just about there… but then you hit a roadblock. Your types start dying off. Other types are increasing, but they, too don’t seem to be able to get to the top of the fitness peak. What’s going on?

On your march to the peak, other neutralizing antibodies attack you, keeping you from taking the hill.

You and those like you cannot surpass the immunity escape threshold.

The population in which you and your kind are circulating have already had SARS-CoV-2 infections, and they have multiple B- and T-cell epitopes that keep you from surpassing the immune escape threshold.

This is reality, not fantasy.

In a study of immune response to other epitopes across the SARS-CoV-2 proteome, researchers found strong humoral responses to many epitopes SARS-CoV-2 proteins, notable strong in M, S and N proteins as well ORF3 protein (See: “The landscape of antibody binding in SARS-CoV-2 infection”. The paper is a good read, solid data, and has citations from 2004 and 2006 on synergistic immunogenicity from epitopes found among various proteins in SARS.

From an evolutionary standpoint, durable immunity to SARS-CoV-2 is expected to be more resilient and far, far more effective - and last decade - when dozens of types of memory B- and T-cells have been generated, preventing the emergence of types that can surpass the immune escape threshold. Multifactorial approaches to control viremia are also available - and will help reduce viremia in every patient, instead of forcing them to sit at home and incubate new variants (See: Who Are the World's Leading Authorities in COVID-19 Treatments?)

Thank you, Dr. Wright.


Natural Antibodies Are Better Says 3 Pfizer Scientists

Project Veritas released the fourth video of its COVID vaccine investigative series today, which exposes three Pfizer officials saying that antibodies lead to equal if not better protection against the virus compared to the vaccine.

Nick Karl, a scientist who is directly involved in the production of Pfizer’s COVID vaccine, said that natural immunity is more effective than the very own product he works on.

Here are some of the highlights from today’s video:

Nick Karl, Pfizer Scientist: “When somebody is naturally immune -- like they got COVID -- they probably have more antibodies against the virus…When you actually get the virus, you’re going to start producing antibodies against multiple pieces of the virus…So, your antibodies are probably better at that point than the [COVID] vaccination.”

Chris Croce, Pfizer Senior Associate Scientist: “You’re protected for longer” if you have natural COVID antibodies compared to the COVID vaccine.

Croce: “I work for an evil corporation…Our organization is run on COVID money.”

Rahul Khandke, Pfizer Scientist: “If you have [COVID] antibodies built up, you should be able to prove that you have those built up.”

If Data On The Duration Of The Pfizer Vaccine Is “Not Yet Available,” Then How Can The CDC Recommend A Booster After 8 Months?

Vaccine Duration: They Are Hiding Something
Vaccine Duration: CDC Is Hiding Something

Flying under the radar is an admission made by the FDA regarding the durability of the one COVID-19 vaccine – the Pfizer vaccine (under the name COMIRNATY) –  that was officially “approved”: “data is not yet available to inform about the duration of protection that the vaccine will provide.”

This stands in contrast to CDC admissions, in support of their push for a booster shot, that “vaccine effectiveness against COVID-19 infections is decreasing over time.”

Anyway, what a statement in light of the history of the Pfizer vaccine - and the publicly available data.

For background, let’s review some history. The Pfizer vaccine’s IND (New Drug Application) was filed in April 2020, after which it was granted its Fast Track Designation in July 2020. On December 11, 2020, the FDA issued an Emergency Use Authorization (EUA) for the Pfizer vaccine for persons age 16 and up. The Pfizer vaccine (COMIRNATY) was “approved” by the FDA on August 23, 2021.

Since the summer of 2020, Pfizer has been studying its vaccine on tens of thousands of individuals. The reliability of these studies was diminished greatly in December 2020, when the Pfizer study participants were “unblinded” and offered the Pfizer vaccine if they initially received the placebo.

From the time of the Pfizer vaccine EUA until the FDA gave its “approval” of the Pfizer vaccine, hundreds of millions of Pfizer vaccines had been administered. As of September 26, 2021, approximately 223 million people had received the Pfizer vaccine.

And as we previously discussed, the FDA’s approval of COMIRNATY was suspicious for a number of reasons, including because the COMIRNATY fact sheet admits “The duration of protection against COVID-19 is currently unknown.”

We had doubts about the truthfulness of that statement back in August, noting that Pfizer was relying on data “through March 13, 2021.” We observed that the data was five months old, asked if the FDA was using outdated information to support its COMIRNATY approval, and noted that more recent evidence pointed to vaccine effectiveness diminishing over time.

On that point, with studies that have been ongoing since the summer of 2020, and hundreds of millions of vaccines being administered, and the CDC concessions of duration issues, how is it possible for the FDA to conclude “data is not yet available to inform about the duration of protection that the vaccine will provide”?

If it sounds like they’re hiding something – it’s because they are.

The CDC has issued a press release (attributable to CDC Director Dr. Rochelle Walensky, NIH Director Francis Collins, and Dr. Anthony Fauci, among others) “based on a thorough review of the evidence” that:

“We are prepared to offer booster shots [Pfizer and Moderna] for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose.”

This leads us to an important question:

If the data on the duration of the Pfizer vaccine is “not yet available,” then how can the CDC and Dr. Collins and Dr. Fauci recommend the Pfizer booster shot after 8 months?

While the CDC has provided some information on the topic, there is certainly more they aren’t telling us.

Protests Have Finally Erupted in Israel Against Vaxx Passports

Watch: Israelis Rise-Up Against Vaxx Passports After Being Told More Shots Needed To Be Considered "Fully Vaccinated"

Protests have finally erupted in Israel as it has slowly dawned on people there that the goalposts for vaccine passports keep being shifted by the government.

It is now expected to be announced that at least FOUR vaccinations will be needed to be considered ‘fully vaccinated’ and able to engage in society.

Over the weekend marches took place in the streets of Tel Aviv against the so-called ‘Green Pass’:

Protests have finally erupted in Israel as it has slowly dawned on people there that the goalposts for vaccine passports keep being shifted by the government.

Kim Iversen Unpacks Israel's Alarming Vaccination Data

Israel vs Sweden vax data

Political Commentator Kim Iversen Unpacks ‘Alarming and Shocking’ COVID Data From Israel.

Political talk show host Kim Iversen, who has been closely following COVID vaccine data in multiple countries, walks viewers through the data from Israel suggesting the vaccines are failing.

Political talk show host Kim Iversen, on a segment of the Kim Iversen Show Wednesday, called the latest COVID data coming out of Israel “alarming and shocking.”

Iversen reminded viewers that Israel was nearly fully vaccinated by February, after striking a deal with Pfizer to make its citizens “essentially … a giant study group.”

“They have very high vaccination rates in the country,” Iversen said. “Kids are still not vaccinated. There are some super ultra-Orthodox holdouts, but otherwise everybody in Israel banded together and they took the Pfizer vaccine — two doses.”

But by summer, Iversen said, Israel health officials determined the vaccine had worn off. “They saw skyrocketing numbers of cases, even after they’d hit this so-called herd immunity threshold of 70%.”

At first, Iversen said, it looked as though the vaccines might at least be protecting against more severe symptoms, because for the most part, only the unvaccinated were having to be hospitalized.

“But then as time went on … the hospitals started to fill up with fully vaccinated people,” Iversen said, “and they saw more and more cases among the fully vaccinated, and more and more of them becoming very severe to the point where the majority of their cases in the hospitals and in the ICU and those dying were fully vaccinated people.”

Iversen has been tracking data in multiple countries besides Israel, including Iceland, Chile, Seychelles, Uruguay and others.

“I have a whole list of countries that I’ve been monitoring on this,” she said. “And it was really clear early on that the vaccine was not stopping the spread, but it did seem to keep people out of the hospital for a period of time.”

But then Israel found the vaccine was wearing off — so they told everybody they would need a third, booster shot, “in order to participate in society,” Iversen said.

That seemed to work for awhile — but now cases are rising again.

“I don’t know what to make of that, “Iversen said. “And I’m not going to speculate. I’m just going to share the data and I’m going to keep watching that data. And we’re going to see what happens. I mean, at this point, that’s all we can do. All we can do is see what happens now.”

Biden NIH Director Gets Grilled Over Booster Shot Program


It was not a fantastic weekend for members of the Joe Biden administration as they traversed the talk show circuit and were hit with some tough questions.

Fox News Sunday host Chris Wallace took on NIH director Francis Collins and laced into him about Biden’s plan for vaccine boosters after it was shot down by the FDA.

“Do you now agree with them on this limited booster program over what the president was proposing last month, the general population getting boosters, which he said was based on advice from his medical experts, including you?” Wallace said, but Collins fought back.

“You know, Chris, I think there’s less difference between where we were in the middle of August and what the advisory committee said this past Friday. They did encourage and vote for the administration of boosters to people over 65 and those at high risk of exposure,” the director said.

“Those are the people who would be most likely to reach that eight-month period, because that’s how we prioritized initial immunizations back in January. So, I don’t think there’s huge differences here. I think the big news is that they actually did approve the initiation of boosters, and remember, they are taking a snapshot of right now.

“We’re going to see what happens in the coming weeks. It would surprise me if it does not become clear over the next few weeks that that administration of boosters may need to be enlarged. Based upon the data that was already seen both in the U.S. and in Israel, it’s clear the waning of the effectiveness of those vaccines is a reality, and we need to respond to it, but they looked at where we were on Friday and said here’s where the data is convincing to start now and we’ll see what CDC says later this week,” he said.

Wallace asked the director if he does “still think we are going to near booster program for everyone?

“I’m not sure about absolutely everyone. We’ll have to see what they say ultimately about the youngest individuals because of concerns about benefits and risks, but I will be surprised if boosters are not recommended for people under 65 going forward in the next few weeks, but we’ll wait and see. You know, Chris, what you’re seeing here is science playing out in a very transparent way. This is the way it ought to be. I’m a little troubled that people are complaining that the process isn’t working for them. The process is to look at the data, have the experts consider it and then make their best judgments — at that point, recognizing that the judgments may change. If people want an absolutely authoritative statement about here’s the right answer — well, that’s not what our country is all about. Move to China, you’ll get it there,” he said.

But Wallace pressed on, using Biden’s own words against him.

“Back during the campaign, he talked a lot about ‘follow the science,’” he said. “Isn’t announcing a specific date, and a specific plan, for the general population before any of the regulators — the FDA, the CDC — have approved it, isn’t that the exact opposite of ‘follow the science?’”

Dr. Fauci Flips On Booster Shots Non-Approval Being A 'Mistake'

Dr. Anthony Fauci said days ago that he believed not approving a booster shot would be a mistake.
Fauci flips on booster

Dr. Fauci on Natural Immunity on CNN "I don’t have a really firm answer for you on that"

Fauci on Natural Immunity on CNN
 
Dr. Fauci on why Americans who’ve previously been infected should get vaccinated despite studies showing it’s unnecessary: “I don’t have a really firm answer for you on that”  How do you make the case for people who have already been infected by COVID?  What is the durability of natural immunity?  It is an issue and could be an argument.  We are not clear.  

Dr. Fauci’s real response—well how do you expect us to make any money if I answer that question?

Why is he acting like vaccines DO protect you indefinitely and natural immunity doesn't?

How in the world doesn’t he already know the answer to this? He’s talking about sitting down to discuss natural immunity and we’re 18 months into this thing. Those studies should’ve happened long ago.

This past month I saw an increasing number of people finally start questioning him & his whole gong show.   Glad others are noticing.

Vaccination after acquiring natural immunity is actually counter-productive.  It's all about vaccination, not immunization.

This is what happens when a scientist becomes a bureaucrat but still pretends to be a scientist decades later.

Natural immunity looks better and better. The vaccine is proven they don’t last with all the booster here and booster there crap

What's the estimate on # of Americans who have contracted COVID and survived and have not been vaccinated since they had it?.

Nice to see them being honest for a change. Fauci is asking whether the vaccine alone is as durable as natural immunity. Israel has made it abundantly clear as they move towards the 4th booster shot, it's not doing what they said it would for their people.

FDA Advisory Panel Votes 16-2 For No Booster Shots

Eighteen FDA Senior Officials Say NO Evidence Fully Vaccinated Americans Need Booster Shots 

An influential federal advisory panel rejected a plan to offer Pfizer booster shots against COVID-19 to most Americans. The 16-2 vote was a blow to the Biden administration’s effort to increase virus protections amid the contagious delta variant.

A report authored by 18 FDA officials comes out against COVID-19 vaccine boosters as current vaccines are still effective against severe illness

Officials write that taking vaccines when the shots are not necessary could cause people to suffer from dangerous side effects for no reason  

Instead, they write, vaccines should be donated across the world in order to prevent more loss of life and stop more variants from forming 

Dr Marion Gruber and Dr Philip Krause are among the 18, and both have already announced their plans to resign in protest of the decision 

A group of senior U.S. Food and Drug Administration (FDA) officials - including two who announced they will soon resign - have authored a report disagreeing with the White House's plan to roll out COVID-19 vaccine boosters next week.

In a report published in The Lancet on Monday, the 18 officials write that there is no evidence supporting the need for boosters because fully vaccinated people still have high levels of protection against hospitalization or death.

Instead, they say, vaccine doses should be donated to areas with lower vaccination rates to prevent the emergence of more COVID-19 variants.

Although the administration is ready to roll out boosters starting September 20, President Joe Biden said last week that any decisions - including when to authorize boosters and who should receive them - will be left up to the FDA and the Centers for Disease Control and Prevention (CDC). 

The group of FDA authors of the new report include Dr Marion Gruber and Dr Philip Krause, who plan to step down in the coming months due to disagreements over the rollout of vaccines.

'Although the idea of further reducing the number of COVID-19 cases by enhancing immunity in vaccinated people is appealing, any decision to do so should be evidence-based and consider the benefits and risks for individuals and society,' the officials wrote in the report. 

'COVID-19 vaccines continue to be effective against severe disease, including that caused by the Delta variant. 

'Most of the observational studies on which this conclusion is based are, however, preliminary and difficult to interpret precisely due to potential confounding and selective reporting.'

Like many other vaccines, the Covid jabs have declining efficacy over time. 

The Delta variant, which is now the dominant variant in the U.S. and across the world, is also believed to have an increased ability to cause breakthrough cases.

According to a study by the Mayo Clinic - which was cited by White House officials as data supporting the need for boosters - the Pfizer-BioNTech vaccine is only 42 percent effect against the variant and the Moderna vaccine is 76 percent effective.

The same study finds that the vaccines are 75 percent effective at preventing hospitalizations or deaths from the virus, though. 

Whether the waning effectiveness of the vaccines is because of features of the Delta variant in particular, or just a decreasing effectiveness over time in general, could not be determined.

But as long as the vaccines are effective at preventing severe disease and death, that's the most important factor, the officials wrote.

'Even if boosting were eventually shown to decrease the medium-term risk of serious disease, current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations,' they wrote.

Vaccinating others abroad could also prevent the creation of variants which eventually find their way to the U.S., like the Delta variant that originated in India.

The vaccines also have rare, but potentially dangerous side effects, though, and every time a person receives a shot there is a chance they suffer one of the symptoms.

Receiving boosters a person does not need could be opening them to unneeded risk.

'There could be risks 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,' the report reads.

The officials are not entirely writing off boosters, though, saying that there could be need for them in the future, just not now. 

'Boosting might ultimately be needed in the general population because of waning immunity to the primary vaccination or 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,' they wrote.   

The letter could prove to be yet another setback for the White House's attempt to get vaccine booster shots out.

Last month, health officials announced the those who received the Pfizer-BioNTech or Moderna vaccine would be eligible for a third shot eight months after receiving their second, starting September 20.

The move was pending approval from the regulators like the FDA, though, and it appears they will not be approved by the planned roll out date next Monday.

Gruber and Krause were frustrated by the decision from the White House to make the public announcement for the shots before approval, leading to the pair - who are crucial to the FDA's process of approval of vaccines -  announcing they will soon resign.

Gruber is the director of the Office of Vaccines Research and Review at FDA's Center for Biologics Evaluation and Research (CBER).

Krause is the deputy director of CBER.

The office is responsible for regulating 'biological products for human use under applicable federal laws,' according to the FDA. 

In essence, the office is largely responsible for making final decisions regarding things like vaccines, and making sure they are safe for human consumption.

Gruber is one of the most important figures in the approval of vaccines. 

Now with senior officials choosing to publicly oppose the measure, the White House's plans could be in turmoil.

Pfizer is Getting Desperate "Third Time's The Charm"


Pfizer says Israel data shows third Covid shot restores protection from infection to 95% as it makes case to FDA for boosters.

While the effectiveness of the mRNA vaccine wanes over time, a booster shot was shown to elicit an immune response similar to the protection generated after a second dose, Pfizer said.

The company and its partner on the Covid vaccine, BioNTech, are seeking the agency’s OK to distribute booster doses to people 16 and older across the U.S.

The FDA released the data as the agency faces pressure from the Biden administration to authorize booster shots for the general population as early as next week. 

A third dose of Pfizer’s Covid vaccine six months after a second shot restores protection from infection to 95% in a real-world setting in Israel, according to data submitted by the company to the Food and Drug Administration.

While the effectiveness of the mRNA vaccine wanes over time, a booster shot was shown to elicit an immune response similar to the protection generated after a second dose, Pfizer said in a 52-page presentation released by the agency Wednesday.

Pfizer said data from Israel’s Covid vaccination program administering boosters to the entire population show that a third shot “has a reactogenicity profile similar to that seen after receipt of the second primary series dose and restores high levels of protection against Covid-19 outcomes (back to approximately 95% protection).” The data was collected from July 1 through Aug. 30 when the delta variant was surging throughout the country.

The FDA released the data as the agency faces pressure from the Biden administration to authorize booster shots for the general population as early as next week. But agency staff declined to take a stance on the need for a third shot, citing the lack of verified data in a 23-page report released later Wednesday.

The staff said it’s reviewing other “potentially relevant” studies on waning immunity from Pfizer’s vaccine, but the studies have produced mixed results and some of that data may be more reliable than others. The Israeli data came from an observational study, which doesn’t adhere to the same standards of a formal clinical trial.

“It should be recognized that while observational studies can enable understanding of real-world effectiveness, there are known and unknown biases that can affect their reliability. Due to these biases some studies may be more reliable than others,” the FDA staff wrote in their analysis.

Pfizer’s report is meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee, which meets Friday to review the request by Pfizer and its coronavirus vaccine partner, BioNTech, to approve Covid booster doses for the general public. The documents published offer a glimpse of the FDA’s view on third shots.

Based on the data, Pfizer said it “is requesting licensure of a booster dose of [the Pfizer vaccine] administered intramuscularly approximately 6 months after dose 2 in individuals greater than 16 years of age.”

The company also included data from a Phase 3 trial of about 300 people aged 19 to 55. One-third of participants were overweight and one-third were obese, according to the documents.

Pfizer and BioNTech are seeking the agency’s OK to distribute booster doses to people 16 and older across the U.S.

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COVID-19 vaccine booster not yet authorized or recommended for general public

"I will only ever consider any covid shot whether it's a vaccine or a booster or whatever when I see commercials on TV for it and it explains all of the side effects."

COVID-19 vaccine booster not yet authorized or recommended for general public

Many people are wondering when COVID-19 vaccine booster shots will be available to the public. Right now, only moderately to severely immunocompromised people, such as those who received an organ transplant or are undergoing cancer treatment, are eligible to receive a third (supplemental) dose of an mRNA vaccine. The CDC recommends this supplemental dose, meant to boost antibodies and bolster protection, be given at least a month after the second shot in the two-dose series.

While the CDC and the FDA are evaluating whether some additional populations might benefit from a third mRNA vaccine dose, or booster, it is not yet authorized or recommended. According to the CDC, the goal is for people to start receiving a COVID-19 booster shot beginning in the fall, with individuals becoming eligible starting eight months after they received their second shot of an mRNA vaccine in a two-dose series. We will update you as soon as the official guidance changes and booster shots are available.

Looking ahead to booster shots becoming widely available, we spoke to Otto Yang, MD, a professor in the Division of Infectious Diseases at the David Geffen school of Medicine at UCLA, about the supplemental, or booster dose, including what side effects people are likely to experience and when people who received the one-dose Johnson & Johnson vaccine can expect to be offered their second shot. 

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