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The U.S. Food and Drug Administration’s advisory panel today voted to recommend the agency allow Pfizer to amend its Emergency Use Authorization for its COVID vaccine for children 5 through 11 years old, despite a host of objections from scientists and physicians.
The U.S. Food and Drug Administration’s (FDA) advisory committee today endorsed Pfizer’s COVID vaccine for children ages 5 to 11, despite strong objections raised during the meeting by multiple scientists and physicians.
The vote passed with 17 supporting it and one abstention.
Before the shots can be rolled out, the FDA will have to formally authorize the vaccine, and the Centers for Disease Control and Prevention (CDC) must also weigh in with its own recommendations — but the Biden administration’s announcement last week that it has already ordered 68 million doses of the pediatric vaccine suggests Pfizer’s request will sail through.
During today’s meeting, the Vaccines and Related Biological Products Committee (VRBPAC) heard evidence from Pfizer and regulators, and listened to concerns from numerous experts.
According to the FDA website, as of Oct. 25, the agency had received 139,470 comments from the public prior to today’s meeting — a number federal officials described as strikingly high.
As he opened the meeting, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said, “I want to acknowledge the fact that there are strong feelings that have clearly been expressed by members of the public both for and against” authorization.
Marks stressed the only question before the experts was whether shots should be allowed, not whether to mandate them, the New York Times reported.
The dose for younger children would be one-third the strength given to people 12 and older, with two shots given three weeks apart.
Based on CDC data presented during the meeting, among children 5 to <12 years of age, there have been approximately 1.8 million confirmed and reported COVID cases since the beginning of the pandemic, and only 143 COVID-related deaths in the U.S. through Oct. 14.
In this same age group, there were 8,622 COVID-related hospitalizations through Sept 18.
“This translates to cumulative incidence rates of approximately 6,000 and 30 per 100,000 for confirmed COVID cases and COVID-related hospitalizations, respectively, among children 5 to <12 years of age,” Pfizer’s application said.
Children with underlying medical conditions, such as asthma, diabetes and obesity, made up two-thirds of severe COVID cases.
Pfizer provided safety data on two study cohorts of children ages 5 to 11, both of roughly equal size. The first group was followed only for about two months, the second for only two-and-a-half weeks.
The two-month cohort included 2,268 children ages 5 to 11. Of the 2,268 children, 1,518 received the vaccine and 750 received a placebo. Each received two shots spaced three weeks apart.
Pfizer’s study found its vaccine was about 91% effective against symptomatic COVID in children, based on 16 cases of COVID in the placebo group and three cases in the vaccinated group over the brief follow-up period.
Most side effects occurred within a couple of days and included pain at the injection site, fatigue, headache, muscle pains and chills, Pfizer said.
According to Pfizer, the number of participants in the current clinical development program was “too small to detect any potential risks of myocarditis associated with vaccination.”
Long-term safety of Pfizer’s COVID-19 vaccine “to evaluate long-term sequelae of post-vaccination myocarditis/pericarditis” in participants 5 to <12 years of age will not be studied until after the vaccine is authorized for children,” Pfizer’s application noted.
Pfizer data insufficient, kids’ risk of vaccine injury greater than COVID risk, experts say
Experts raised concerns over the lack of safety and efficacy data presented by Pfizer for use of its COVID vaccine in younger children, and they pointed to increasing safety signals based on reports to the Vaccine Adverse Event Reporting System (VAERS).
They also questioned the need to vaccinate children — whose risk of dying from COVID is “almost nil” — at all.
According to Dr. Meryl Nass, member of the Children’s Health Defense Scientific Advisory Panel, Pfizer once again did not use all of the children who participated in the trial in their safety study.
“Three thousand children received Pfizer’s COVID vaccine, but only 750 children were selectively included in the company’s safety analysis,” Nass said. “Studies in the 5-11 age group are essentially the same as the 12-15 group — in other words, equally brief and unsatisfying, with inadequate safety data and efficacy data, with no strong support for why this type of immuno-bridging analysis is sufficient.”
Nass said, “All serious adverse events were considered unrelated to the vaccine.”
During the meeting and in its FDA application, Pfizer argued children should be vaccinated to prevent SARS-CoV-2 transmission, yet the company did not assess asymptomatic transmission.
Dr. Ofer Levy, a VRBPAC member, asked for evidence that Pfizer’s vaccine prevents transmission.
Dr. William Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development, said they did not assess whether the vaccine prevents transmission, but said there is evidence the vaccine prevents transmission in adults.
When questioned further, Gruber was unable to cite specific evidence to back his assertion.
Steve Kirsch, founder of the COVID-19 Early Treatment Fund, asked the panel how they could do a risk-benefit analysis with Pfizer’s COVID vaccine if they did not know the CDC’s VAERS under-reporting factor (URF).
Kirsch asked:
“How can you do a risk-benefit of analysis of COVID vaccines if you don’t know the URF? This is extremely, extremely important. You have been assuming it has been one. It is not one. Using a URF of 41, which is calculated using CDC methodology, we find over 300,000 excess deaths in VAERS. If the vaccine didn’t kill these people, what did?”
“How many Americans have to die before you pull the plug?” Kirsch asked.
Kirsch also questioned the panel on why Maddie de Garay’s severe adverse reaction to the Pfizer vaccine, which left her paralyzed, was not reported by the company to the FDA.
Dr. Jessica Rose, viral immunologist and biologist, told the panel EUA of biological agents requires the existence of an emergency and the nonexistence of alternate treatment.
“There is no emergency and COVID-19 is exceedingly treatable,” Rose said.
In a peer-reviewed study co-authored by Rose, myocarditis rates were significantly higher in people 13 to 23 years old within eight weeks of the COVID vaccine rollout.
In 12- to15-year-olds, Rose said, reported cases of myocarditis were 19 times higher than background rates.
“In an act of censorship, this paper has been temporarily removed and it has now been killed without criticism of the work,” Rose said, noting the timing of the removal was strange.
Rose said tens of thousands of reports have been submitted to VAERS for children ages 0 to 18.
Rose explained:
“In this age group, 60 children have died — 23 of them were less than 2 years old. It is disturbing to note that “product administered to patient of inappropriate age was filed 5,510 times in this age group. Two children were inappropriately injected, presumably by a trained medical professional, and subsequently died.”
Dr. Josh Guetzkow, a senior lecturer at the Hebrew University of Jerusalem, said expanding the EUA to children is unnecessary, premature and will do more harm than good.
Guetzkow said there is no emergency for children, especially healthy ones whose risk of severe illness and death is “almost nil.”
Guetzkow said kids with pre-existing conditions and prior COVID infections were not included in Pfizer’s study, so including them in the EUA is negligence.
“Pfizer’s trial is woefully underpowered to detect specific safety concerns, such as myocarditis, just like the adolescent study was, and if they weren’t able to detect an unexpected safety concern there, they wouldn’t be able to here,” Guetzkow said.
Guetzkow said:
“In Pfizer’s study, only .5% of controls were dropped due to important protocol violations, versus 3% in the treatment group. The odds of that happening by chance are 1 in 10,000. This deviation is poorly explained with no ITT analysis. The study is not double-blind and may be subject to bias. Most VSD safety monitoring programs have not reported results, why not wait?”
Guetzkow said, “from CDC reports, we can expect that for every 18 child hospitalizations prevented, at least 43 will end up in the hospital for all causes following vaccination,” yet, the “FDA’s risk-benefit analysis only counts myocarditis hospitalization.”
“Why ignore the V-safe data, and shouldn’t FDA verify Pfizer’s efficacy and immunobridging analysis first?” he asked.
Guetzkow said VAERS shows alarming safety signals, which cannot be attributed to increased vaccination, simulated reporting or COVID infections.
“We calculated the ratio of adverse events reported per million Pfizer vaccinations to reports per million flu vaccinations among teenagers to see what to expect in children. Serious events are reported 51% more often for Pfizer, deaths 47 times, life-threatening conditions 49 times,” Guetzkow said.
Guetzkow asked the panel to look at the data on COVID vaccines compared to flu vaccines. Pointing to the data on reproductive organs, Guetzkow asked, “why would we expect children to take these risks to protect adults?”
There are more than 900 types of adverse events reported after Pfizer vaccination that have never been reported after flu vaccines, including 11 cases of multisystem-inflammatory syndrome (MS-C) that occurred without previous history of COVID infection, Guetzkow said.
He added that if the panel was considering authorizing Pfizer’s COVID vaccine to prevent MS-C — as Pfizer’s application suggested as one of the reasons they should — the panel should reconsider.
During another part of the meeting, Julia Barnes-Weise, director of the Global Healthcare Innovation Alliance Accelerator, said pharmaceutical companies have concerns.
“One of them is, especially for a not-yet-approved vaccine, that they could be held liable for any injury that that vaccine seems to have caused,” Barnes-Weise said.
In a preliminary analysis last week, FDA reviewers said protection would “clearly outweigh” the risk of a very rare side effect in almost all scenarios of the pandemic, PBS News Hour reported.
Children’s Health Defense (CHD) said yesterday it would take legal action against the FDA if it granted EUA for the Pfizer-BioNTech vaccine for children 5- to 11- years old.
In a letter signed by Robert F. Kennedy, Jr., CHD chairman and chief legal counsel, and Nass, Kennedy and Nass wrote:
“CHD will seek to hold you accountable for recklessly endangering this population with a product that has little efficacy but which may put them, without warning, at risk of many adverse health consequences, including heart damage, stroke, and other thrombotic events and reproductive harms.”
SUGGEST A CORRECTION
Masked and Inoculated… the Zombie Apocalypse
“We going to stomp that devil beat down in Zombieland…” – T Bone Burnett
https://www.youtube.com/watch?v=LZ1M9JSGTLk&t=128s
Happy Halloween, everyone.
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26 NYC Firehouses now closed due to employees refusing to vax. They also lost 150 ambulances for the same reason.
The sum total of this is a very dangerous reality. The government of NYC has gone mad with foolish mandates.
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Not just NYC either. From Zerohedge:
“Mandate Meltdown: 26 NYC Firestations Shuttered, LA Sheriff Warns Of ‘Mass Exodus’, Tucson Water District Faces ‘Staff Shortage’”
Read about the resistance to mandates by government employees in these cities here:
https://www.zerohedge.com/covid-19/mandate-meltdown-26-ny-firestations-shuttered-la-sheriff-warns-mass-exodus-tucson-water
Well Toni and Don. I think what’s happening now is what some of us have been calling for a “Dark winter” which was predictively programmed to us years ago. It’s very ironic that the terminology use is Mandate Meltdown which can be something frozen or a unstable nuclear reactor.
https://www.centerforhealthsecurity.org/our-work/events-archive/2001_dark-winter/Dark%20Winter%20Script.pdf
CNN models the appropriate questions regarding the “vaccine” for 5 to 11 year olds:
“If my child is 11, should I wait until she turns 12 to get a larger dose of Covid-19 vaccine? Or should she get a pediatric dose as soon as the Pfizer vaccine is available for kids ages 5 to 11?”
Answer? “Get it now.” (quiet part “…and get it later.”)
Look at the reader numbers in this attachment. It’s 37 thousand, and that’s just one newsfeed. CNN has really low television numbers, fatally low to any other network, yet their narrative still dominates online.
https://www.cnn.com/interactive/2020/health/coronavirus-questions-answers/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+rss%2Fcnn_topstories+%28RSS%3A+CNN+-+Top+Stories%29#if-my-child-is-11-should-i-wait-until-she-turns-12-to-get-a-larger-dose-of-covid-19-vaccine-or-should-she-get-a-pediatric-dose-as-soon-as-the-pfizer-vaccine-is-available-for-kids-ages-5-to-11
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The Climate Change scam and Kung Flu policy are on a convergence course. I always thought it was intriguing that no one in the climate change camp wants to even acknowledge geo-engineering. One of my favorite bands all time is Midnight Oil from Australia. They were founded in 1978 and still producing new music. They posted something on Fake Book sounding the climate change alarm and scar mongering. I posted a small selection of the 160+ US patents on weather modification. No one wants to do anything with my comment but post laughing emogees. They can’t even acknowledge the information because it destroys their narrative that our lifestyles must be altered drastically…. if “climate change” is intentional and not incidental. Instead of climate change it could be called climate hijacking and hunger gaming. The smart firestorms that were created from the ether in the Hunger Games and lightning strikes on demand in the sequel should hit people right between the eyes. What does it take for people to notice the same forces that brought us Climate Change and carbon credit trading scammed us with Kung Flu and also created the transgender agenda and the synthetic war on terror.
David Icke is too far out for many truthers with the “shape shifting lizard people are really in charge” scenarios. However his latest interview is quite insightful. He is predicting the climate change and kung flu policy convergence that is really not all that difficult to see coming. Think Vaccine Passport/Carbon Footprint/Social Credit/Driver’s License all rolled into one ass reaming tyranny.
https://beforeitsnews.com/international/2021/10/david-icke-speaks-out-the-study-for-truth-2507125.html
Dave, in all fairness, he hasn’t spoken of the reptilian connection in quite a while….not that I follow him religiously, but I have not heard much if any for a few years. Of course, that is how he’ll be remembered by most narrow minded thinkers. Regardless, he’s been on top of the vid scam from day one with those interviews with Brian Rose that were initially censored when it came to the 5G connection. Btw, I have heard from several inside people (Jason Bossman being one and my neighbors son being another who is an actual millionaire from building those cell towers up on Long Island) that true 5G does not exist…at least in the US. It’s a lie like all else.
Anyway, when those passports come about and I am unable to buy food or necessities (give not a damn about a car as long as I have a thumb), my existence on this particular plane will have come to an end. Don’t get me wrong….I do not see that happening, but I will not live under those circumstances. That would NOT be life as intended by my creator.
Also, since you are into music, I notice Dylan is touring again, but all the venues so far are requiring tests etc. Sorry, Bob…that will not work for me. I also see that Van the Man is on tour. And even at Eckerd hall in Tampa (yuppieville if ever there was one) the same is being required. And I really wanted to see Van considering his recent album protesting all this BS. And he’s the only performer of that stature saying a damn thing. Thanks, Van, but I still will not be tested or wear a mask for you or Dylan.
I remember having a convo with you and Will regarding David Icke and how the reptilian agenda turned me off but it was the Tavistock Institute slickness of his persona that come across as a truther but I’m not buying it. But such is life and he’s spot on with his assessment of both globalist agenda. I saw a video last year of Rosa Koire (whom I met in Washington D.C. about 10years ago) stating the same thing and that this scamdemic was the turning point of the Climate change agenda. I’ll try to find that video for y’all.
5G does not exist and has nothing to COVID 19 or any supposed biological airborne pathogen. Our internet and telecommunications is still mostly undersea cables and I have seen a lot of them scuba diving in the Bahamas where most of them are laid.
https://www.cnn.com/2019/07/25/asia/internet-undersea-cables-intl-hnk/index.html
Good to see you get it, Salty.
Salty, you seem to have a degree of tech knowledge. I had posted this image previously to no response, so I’ll try again…There are hundreds of these stored right off the main drag in Live Oak Fl….have any idea what they may be?
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Hey Will ,this is my reply to your photo and inquiry. It’s known as a ‘Comm box ‘ in the military who created it many years ago and T-mobile which was Nextel many moons ago adopted this technology. Nextel was started by Senator Mark Warner of Virginia and some of his intelligence buddies from DARPA. He is the intelligence committee chairman in the Senate.
https://www.t-mobile.com/news/network/emergency-response-team-2020-impact
In the above promo piece, T-Mobile states that 2020 was a very active disaster season…. Lol ! And that why their SatCOLT trucks are needed. I say never let a good created crisis go to waste.
Funny this year was not an active Hurricane season as 2019 or 2020. Hmm… maybe they preparing for something?
Salty…thanks so much for that reply and info. Very good to know.
No doubt they are preparing for something. Literally hundreds of these in a town as small as Live Oak or Suwannee County for that matter…hidden in plain site right off Rte 129 going through the heart of town.
Adding to my post of 7:06 AM today, here’s Tucker’s take on this “giveaway’. From Tucker: ” We have just read the single most deranged news story EVER created in this country.” (referring to that article I posted earlier from the WSJ) 10 minutes
ANYTHING BELOW THIS LINE IS NOT WRITTEN BY ME
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Tucker: This is the most deranged story in American history. NO WAY! WTF?
https://choiceclips.whatfinger.com/2021/10/29/tucker-this-is-the-most-deranged-story-in-american-history-no-way-wtf/
Hey Will…reparations for illegal aliens story too crazy to be believed. It dovetails with China Joe’s fly by night invader dispersal program.
Dave, I am thinking this could be the final straw. And where the hell is the money coming from? Is this part of that 27.5 trillion that the black side may have gotten their hands on? Oh, what the hell, what’s another billion or so of taxpayers money, eh? I do not see how this can possibly go through without a major backlash. I, as many, have worked all my life and I am embarrassed to tell you the pittance I get from SS. Granted, I have no real debt, but that’s because of my planning, and nothing given to me from this thing, this swamp monster we laughingly call a government supposedly led by a hapless masked doppelganger and a den of thieves and ne’er-do-wells we have the nerve to deem a CONgresss. Let’s Go Brandon!
In case you think the ‘vid plandemic is something new, listen to the following. They tried something similar 70 + years ago and it seems they’re doing it again for more immediate results. The estimate is that 90 million have died since as a result of various disease created by the “polio” vax. Must listen, as this is just history repeating itself to get better results for these satanic evil creatures. 25 minutes
ANYTHING BELOW THIS LINE IS NOT WRITTEN BY ME.
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Manmade Polio Cancer Virus via the …from the 50’s and 60’s that killed 90 Million per the CDC!!!!
https://153news.net/watch_video.php?v=YMMGY316GHN6
Here’s something that will get your blood from simmer to boil. Of course, it’s only a proposal that may have the only purpose of inciting us peasants further, but it seems to be seriously under consideration. Remember, this could amount to 1 billion dollars of YOUR tax money to pay the families ILLEGALLY in our country that COULD AMOUNT TO ONE MILLION DOLLARS PER FAMILY. Correct, one million dollars per family….an amount most will never save all their lives despite how hard they have worked.And I use to support the ACLU.
Biden Considering Paying Illegals Separated From Their Families $450,000 to Compensate for “The Trauma”
It’s short, so I’ll paste the entire story from the following link.
ANYTHING BELOW THE STARS ARE NOT MY WORDS.
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https://iotwreport.com/biden-considering-paying-illegals-separated-from-their-families-450000-to-compensate-for-the-trauma/
This is absurd. This is the final straw. They are going to reward criminals for sneaking into our country? Of course they were separated from their families, that’s what happens when you break the law. How loud would the government laugh if I sued them for putting me in jail, separating me from my family, if I didn’t pay my taxes?
wsj-
The Biden administration is in talks to offer immigrant families that were separated during the Trump administration around $450,000 a person in compensation, according to people familiar with the matter, as several agencies work to resolve lawsuits filed on behalf of parents and children who say the government subjected them to lasting psychological trauma.
The U.S. Departments of Justice, Homeland Security, and Health and Human Services are considering payments that could amount to close to $1 MILLION a family, though the final numbers could shift, the people familiar with the matter said. Most of the families that crossed the border illegally from Mexico to seek asylum in the U.S. included one parent and one child, the people said. Many families would likely get smaller payouts, depending on their circumstances, the people said.
The American Civil Liberties Union, which represents families in one of the lawsuits, has identified about 5,500 children separated at the border over the course of the Trump administration, citing figures provided to it by the government. The number of families eligible under the potential settlement is expected to be smaller, the people said, as government officials aren’t sure how many will come forward. Around 940 claims have so far been filed by the families, the people said.
The total potential payout could be $1 billion or more.
more:
https://www.wsj.com/articles/biden-administration-in-talks-to-pay-hundreds-of-millions-to-immigrant-families-separated-at-border-11635447591?st=qmqxq60gjmhpb2y&reflink=desktopwebshare_twitter
If you care not about what is being done to your children (usually because you do not want to suffer the consequences of having to home school your children, speak up at school board meetings, succumb to peer pressure et al), maybe you do care about torturing animals (beagles in this case) to the point of death or eventual euthanasia. For this alone, Fauci and his cohorts should be imprisoned AND eventually HUNG for the millions of HUMANS they have maimed or killed. How this continues is inexplicable and inexcusable. Watch this with caution…it’s short but heart shattering. I have a lab/setter and a lab/bull mix. All these creatures wish to do is protect and serve me. Please send this around as it could bring some outrage. 2 minutes on Jim’s BitChute
https://www.bitchute.com/video/KndcRUNAHK2l/
A few more horrific details of Fauci overseeing the torture of innocent animals on the floor on CONgress…start at 3:15…….
https://153news.net/watch_video.php?v=MG5OKBWGG1O9
Fauci has more horrors in store for the world. The longer he’s in office the worse it gets. Trump should have gotten rid of him in the first week but Trump was too weak to get rid of anyone. Many of Trump’s campaign promises of justice came to…… n o t h I n g. Trump’s huge weak point is his mad love affair with doctors.
As powerful and as informed a speech as you will hear anywhere from Rep. Roy (21st District, Texas)….Bravo Roy!
Please do not miss this amazing oration!
“…..they shouldn’t believe the LIES coming out of our national health leaders….”
https://www.bitchute.com/video/WTpQYQ7S2c0Q/
Vaccines have caused one’s natural immunity levels to drop after administration. Moreover, since the genitals are stoked with higher levels of virus borne toxins in children, we can potentially expect an increase of sterility cases being generated. The boondoggle continues…..
By observing the serious results of adults taking this experimental injections, I would imagine children would have a similar type of experience.
If the real vaccines cause huge numbers of autistic damages to children, gawd only knows what millions of kids will suffer with Covid 19 jabs. I believe they target 28 million kids with Covid 19 inoculations.
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Sociopath and pederast run America. And if you’re fucking stupid enough to jab your children or grandchildren with this bio weapon you don’t deserve to be a parent. And should be shot by a firing squad.
Salty, I could not agree more…here’s what i posted on a different article. You and I are in the same boat:
As if it’s not bad enough we inject our children something like 90 times with one damn poison or another before they are 18……NOW, we will allow them to inject our progeny with a falsely approved injection to satisfy the stock holders of Pfizer et al. who really run WHO, the FDA and the NIH…and the government. It’s disgusting, it’s genocidal, it’s inhuman and ultimately illegal….not that law exists in America any longer; it’s obviously disappeared with he, she, any hint of normalcy, police, fair elections, a press that’s not bought and paid for, trustworthy judges, accountability and all else that constitutes a sensible civilization. The decline of the Roman Empire has nothing on us. Caligula was a monk compared to what’s going on now. As far as I am concerned, any parent who allows this death shot to be administered to their child is as guilty as those pushing it. AND I give not a crap about consequences. ARE THE CONSEQUENCES MORE IMPORTANT THAN YOUR CHILDS LIFE? As someone who lost a child at 10 months old, I can tell you the pain NEVER goes away. I damn these bastardz to hell.
Tucker doing what Tucker does:
https://generaldispatch.whatfinger.com/tucker-blasts-fda-panel-approving-vaccine-for-children-lunacy-on-merits-according-to-the-science-no-reason-for-kids-of-this-age-to-be-vaccinated-none/
And more…finally a doctor of epidemiology from Yale with whom I agree. If they force a vax on your child, home school them!!
https://uncoverdc.com/2021/10/27/yale-professor-pull-children-from-schools-that-force-vaccines/