America
‘They want booster approval based on studies covering about 300 people – with no control arms. BUT IT GETS BETTER. They tested it in 12 (yes, 12!) people over 65.
| Alex Berenson5 hr ago351156 |
The FDA just released its briefing book for Pfizer’s request for a third dose of Comirnaty (or is that BNT162b2? No matter! It’s approved either way, sorta).
It is every bit the mess we all expected.
Let’s go to the highlights:
Pfizer basically hasn’t bothered to test the booster AT ALL in the people actually at risk – it conducted a single “Phase 1” trial that covered 12 people over 65. The main Phase 2/3 booster trial (beware efforts to cover multiple “phases” of drug research at once, you want it bad you get it bad) included no one over 55.
No one.
As in NONE.
Which makes total sense – why test the booster in people who actually need it because they’re at high risk from the ro? Nothing good can come of that.
So that’s our trial design.
Now safety:
Of the 300 people who received the booster, one had a heart attack two months later. No worries, Pfizer concluded it wasn’t related. Yay!
Five percent of recipients had enlarged lymph nodes.
How about effectiveness?
Well, we don’t have enough data – or any data, really – telling us how well the booster will work.
But the FDA made Pfizer go back and review its data from the pivotal clinical trial from last year. Pfizer compared people who received the vaccine with those who received the placebo and THEN the vaccine (the best we can do at this point, since Pfizer blew up the trial by giving placebo subjects the vaccine, double-yay!)
Pfizer concluded that your annual risk of getting Covid-19 IF YOU ARE VACCINATED is about 7 percent.
Further:
“An additional analysis appears to indicate that incidence of COVID-19 generally increased in each group of study participants with increasing time post-Dose 2 at the start of the analysis period.”
Oh.
But don’t worry, Uncle Joe already told you you can get your booster on September 20. If it’s good enough for our fearless leader, it should be good enough for the FDA, amirite?
SCIENCE!
SOURCE: https://www.fda.gov/media/152176/download’https://alexberenson.substack.com/p/are-you-kidding-me-pfizer-volume
These people are tyrants and it is only going to get worse!
AUSTRALIA IS ALREADY DOING THIS!
‘British doctors now openly beg for more lockdowns because they say they can’t rely on vaccines
| Alex Berenson2 hr ago350144 |
This new piece from Reuters – hardly a outpost of anti-vax fanaticism – should terrify vaccine advocates.
And, honestly, scare the rest of us.
A reminder: Britain has pursued a mass vaccination strategy as aggressively as any country. It approved Pfizer’s vaccine even before the FDA. More than 80% of Britons over 16 are now fully vaccinated.
But Britain is in far worse shape than it was at this time last year, when no one was vaccinated. It is now averaging about 140 deaths a day, roughly 10 times as many as mid-September 2020. And hospitalizations and deaths continue to rise.
But Britain – which had a very strict and economically damaging lockdown last year – has essentially given up on lockdowns and other national control measures. Over the weekend, or even dropped the plan for a vaccine passport (though it has since backtracked a bit).
Now Reuters reports British physicians are warning the vaccines don’t work well enough to allow the country to return to normal:
The piece is an unfortunate exercise in unintentional irony, as when it sincerely refers to the “success” of vaccinations two paragraphs after explaining that “relying largely on vaccines… could put unintentional pressure on hospitals.”
And then there’s this:
Imagine how much higher – I mean lower, of course, definitely lower – hospitalizations would be if Britain could just get to 100% vaccinated!
The beatings will continue until morale improves.
[NOTE: The original article failed to explain that the 80% fully vaccinated figure refers only to eligible Britons – those over 16. I have corrected the error.]’https://alexberenson.substack.com/p/the-most-damning-article-about-vaccines
‘A new study from Israel, one of the most vaccinated countries in the world, claims that “fully vaccinated” people are significantly more likely to get infected with COVID-19 and develop symptoms requiring hospitalization than those who are unvaccinated and have the natural immunity that comes from catching the virus and recovering.
The study, Comparing SARS-CoV-2 natural immunity to vaccine-induced immunity: reinfections versus breakthrough infections, examined medical records of tens of thousands of people between the dates of June 1 and August 14 and is currently the largest real-world observational study to date on coronavirus immunity with respects to both vaccinated and unvaccinated people.
The study found that “fully vaccinated” people are 27 times more likely to be infected and develop COVID-19 symptoms than unvaccinated people with natural immunity. The study also found that “fully vaccinated” people are 8 times more likely to be hospitalized from a “breakthrough” infection.
“It’s a textbook example of how natural immunity is really better than vaccination,” said Charlotte Thålin, a physician and immunology researcher at Danderyd Hospital and the Karolinska Institute. “To my knowledge, it’s the first time [this] has really been shown in the context of COVID-19.” (READ MORE: CDC Director Admits Those Who Were ‘Vaccinated Early’ At ‘Increased Risk Of SEVERE Disease,’ Vaccine Effectiveness Is ‘Waning’)
As National File previously reported, the fourth wave of the COVID-19 pandemic in the US appears to be nearly twice as deadly as the second wave, which occurred months before hundreds of millions of people received vaccinations for coronavirus. According to data from the CDC, US coronavirus death rates in the first ten days September 2021 are nearly twice as high as they were during the first ten days of September 2020.
While the Biden administration and international health authorities insist that the current outbreak of coronavirus is a “pandemic of the unvaccinated,” studies are indicating that vaccinated people are dying from COVID at a higher rate than unvaccinated people as mainstream news outlets scramble to justify them. “At first glance, this may seem alarming, but it is exactly as would be expected,” reported The Conversation.
Thus far, it appears the “safe and effective” vaccinations for COVID-19 do not prevent vaccinated people from contracting COVID-19 or spreading it to others, but that has not stopped the Biden administration from instituting unprecedented federal vaccine mandates in moves that many constitutional experts have said are “in open defiance of the Constitution.” (READ MORE: Fully Vaccinated Carry 251 Times The Normal Viral Load Of COVID-19, May Be Super Spreaders – Study)
The Israeli study, combined with other increasingly surfacing evidence, may raise questions about why the US government is imposing forced vaccinations on Americans working for large companies despite evidence indicating that vaccinated individuals are overwhelmingly more likely to catch, spread, and be hospitalized by COVID-19.’https://nationalfile.com/israeli-study-fully-vaxxed-are-27-times-more-likely-to-get-covid-compared-to-people-with-natural-immunity/
‘Current evidence on COVID vaccines does not appear to support a need for booster shots in the general public right now, according to an international team of vaccine scientists, including some from the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO).
“Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high,” Marion Gruber and Phil Krause, two senior FDA vaccine leaders, wrote in an opinion piece published Monday in the Lancet.
The scientists said the benefits of COVID vaccination outweigh the risks, but there could be risks to boosters if they 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).”
“If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines. Thus, widespread boosting should be undertaken only if there is clear evidence that it is appropriate,” the scientists wrote.’https://childrenshealthdefense.org/defender/fda-officials-science-doesnt-support-third-shot/?utm_source=salsa&eType=EmailBlastContent&eId=aa5a0bb6-27a5-463b-b611-a5b58234ade0
And I thought there were no more reasons not to believe this guy!
‘Really, what did anyone expect?
“Four Taliban members swapped for Bowe Bergdahl now in Afghan government,” by Samuel Chamberlain, New York Post, September 7, 2021:
Four of the five Taliban members released from Guantanamo Bay by the Obama administration in 2014 in exchange for admitted US Army deserter Bowe Bergdahl are part of the Islamic fundamentalist group’s new hardline government in Afghanistan, according to local media reports.
The four members of the so-called “Taliban Five” who have joined the new government are Acting Director of Intelligence Abdul Haq Wasiq, Acting Minister of Borders and Tribal Affairs Norullah Noori, Deputy Defense Minister Mohammad Fazl, and Acting Minister of Information and Culture Khairullah Khairkhah. The fifth member of the Taliban Five, Mohammad Nabi Omari, was appointed governor of eastern Khost Province last month.
Afghan outlet TOLOnews published a list Tuesday of members of the new “caretaker” government, which features several familiar faces who helped run the war-torn country between 1996 and 2001 — when the Taliban were forced from power by US-led NATO forces following the 9/11 attacks.
Wasiq, Fazl, and Khairkhah all held positions in the former Taliban government — Wasiq as a deputy intelligence chief, Fazl as army chief of staff, and Khairkhah as interior minister.
According to assessments written in 2008 by leadership at Guantanamo Bay and later made public by Wikileaks, Wasiq “utilized his office to support [Al Qaeda] and to assist Taliban personnel elude capture” and “was central to the Taliban’s efforts to form alliances with other Islamic fundamentalist groups to fight alongside the Taliban against U.S. and Coalition forces” in the early days of the Afghanistan war.
The same assessments said that Fazl was alleged to have had “operational associations with significant al Qaeda and other extremist personnel.”
Fazl and Noori, who was governor of two northern Afghan provinces during the earlier Taliban regime, are also accused of ordering the massacres of ethnic Hazara, Tajik, and Uzbek communities in the city of Mazar-i-Sharif in 1998.
Khairkhah, who helped found the Taliban in 1994, allegedly took part in “meetings with Iranian officials seeking to support hostilities against U.S. and Coalition Forces” following the invasion of Afghanistan in 2001, according to the 2008 assessments. He also was the governor of western Herat province between 1999 and 2001 and was known as “one of the major opium drug lords in western Afghanistan,” US military leadership found.
Despite the assessments recommending “continued detention” for the five, then-President Barack Obama signed off on an agreement that sprung the men from Gitmo in exchange for the release of Bergdahl, who had been taken captive by the Taliban after walking away from an observation post in Paktika Province in June 2009.
“The United States of America does not ever leave our men and women in uniform behind,” Obama said at a Rose Garden ceremony announcing Bergdahl’s release on May 31, 2014.
As Bergdhal returned to the United States, the Taliban Five were flown to Qatar, where much of the Taliban’s political leadership resided at the time. Among those aghast by the price paid for Bergdahl’s return was then Sen. John McCain (R-Ariz.), who told CBS’ “Face The Nation” that the Taliban Five were “the hardest of the hard core” and “the highest high-risk people.”
In 2015, Bergdahl was charged by the military with desertion with intent to shirk important or hazardous duty and one count of misbehavior before the enemy by endangering the safety of his fellow soldiers. In 2017, he pleaded guilty to both charges and was sentenced to a dishonorable discharge, a reduction in rank and a fine. Bergdahl has since appealed to federal court in a bid to get his conviction overturned.
The new Taliban government also features Acting Interior Minister Sirajuddin Haqqani, who is on the FBI’s most-wanted list with a $5 million bounty on his head and is believed to still be holding at least one American hostage. He headed the feared Haqqani network that is blamed for many deadly attacks and kidnappings….’https://www.jihadwatch.org/2021/09/four-taliban-members-obama-traded-for-deserter-bergdahl-are-in-the-new-afghan-government
‘Reports over the last few months about the proposed multi-billion-dollar settlements to end huge opioid-related lawsuits clearly reflect the attitude of drug manufacturers and distributors.
Even as they agree to pay record amounts, industry leaders and their public relations representatives maintain there is no connection between Big Pharma and narcotic addiction in the U.S.
Purdue Pharmaceuticals, which marketed the opiate derivative OxyContin as non-addictive, is demanding broad legal immunity in exchange for its $4.5 billion settlement.
With the announcement of the $26 billion offer, Michael Ullmann, executive vice president and general counsel of Johnson & Johnson, gave a carefully worded statement:
“We recognize the opioid crisis is a tremendously complex public health issue, and we have deep sympathy for everyone affected. This settlement will directly support state and local efforts to make meaningful progress in addressing the opioid crisis in the United States.”
With consistent strategy, and in the wake of Big Pharma’s benevolent status for rapid development of COVID-19 vaccines, the defendants are not taking any responsibility for contributing to the opioid epidemic.
Rather, for their billions, they are demanding all states and municipalities involved in all lawsuits agree to never again associate their products with drug addiction.
Corporations have offered to buy silence about their complicity in the death of half a million people over the last 20 years. This attempted bribe mirrors the morality of a continuing supply of addictive drugs to the uncounted millions who today suffer from prescribed opioid abuse.
Addicts who avoid or survive an overdose must navigate through a society that allows access to narcotics while designating the addicted as outcasts and criminals. Whether the source of their drugs is imported opiates or prescribed pain killers, their suffering is substantially enhanced by a hostile culture and negligent government oversight.
We have turned a blind eye to what is effectively a licensed drug cartel that exploits the vulnerable.
The attorney general of Pennsylvania, Josh Shapiro, directly involved in both the Purdue and Johnson & Johnson lawsuits, gave a succinct analysis of his perspective:
“These deaths did not have to happen. This epidemic was manufactured by an army of pharmaceutical executives and drug distributors.”
Short-sighted oversight
Government regulators could have prevented this ongoing tragedy.
The U.S. Food and Drug Administration (FDA), empowered to protect the public, has not been able to resist the commanding influence of the pharmaceutical industry.
The FDA continues to fail in minimizing the pain and suffering of addicts and their families, ravaged by a preventable epidemic of drug dependence.
Dr. Raeford Brown, a former head of the FDA advisory committee for approval of new opioid painkillers, in 2019 said:
“The modus operandi of the agency is that they talk a good game and then nothing happens. Working directly with the agency for the last five years, as I sit and listen to them in meetings, all I can think about is the clock ticking and how many people are dying every moment that they’re not doing anything. The lack of insight that continues to be exhibited by the agency is in many ways a willful blindness that borders on the criminal.”
The U.S. government’s war on drugs was misdirected: It should have been waged against the pharmaceutical industry.
But clearly, there hasn’t been an inclination to change anything, primarily because the FDA and Big Pharma have always had a mutually beneficial relationship.
Could it be because the opioid oversight division of the FDA relies on pharmaceutical giants for 75% of its budget? Or perhaps it is due to the revolving door between regulators at the FDA and Centers for Disease Control and Prevention and drug industry professionals.
Both of these ongoing structural allowances are overt symptoms of the lack of will to end the flow of huge earnings.
Prescription drugs like Fentanyl and OxyContin, and similar opioids, have been abused because of profit-driven policies that result in ineffective efforts to regulate and restrict their use.
Even as acceptance of a settlement offer is considered, opioid addiction and its ensuing tragic consequences are on the increase.
Beyond huge civil suits, it seems there is no effort to reveal the details of the insidious relationship between profiteers and regulators — and not because the public isn’t aware of the destructive alliance.’https://childrenshealthdefense.org/defender/covid-vaccines-public-deserves-more-than-just-trust-us/?utm_source=salsa&eType=EmailBlastContent&eId=4ef62aac-dc30-4184-ae62-e53d1ceb3ab7
whatyareckon 