Tag: vaccines

FDA will not require clinical trial data to authorize redesigned COVID boosters -official

The U.S. Food and Drug Administration will not require companies to submit clinical trial data on COVID-19 vaccines modified to protect against the BA.4 and BA.5 versions of Omicron in order to authorize those shots, a top FDA official said on Thursday.

Dr. Peter Marks, head of the agency’s Center for Biologics Evaluation and Research, told Reuters the agency will rely on data from clinical trials vaccine makers have run on shots designed to combat the BA.1 lineage, as well as manufacturing data, for emergency use authorization submissions before the fall.

Preclinical data from animal studies and safety data could also be available, he said.

The FDA on Thursday recommended COVID-19 vaccine manufacturers change the design of their booster shots beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 sublineages.

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New Jersey Bill Would Require College Students to Receive Coronavirus Vaccine

A proposed bill in New Jersey would require college students and staff at higher education institutions to receive the coronavirus vaccine.

Proposed by Democratic Assemblyman Herb Conaway Jr. and co-sponsored by Democratic Assemblyman Ralph Caputo, Bill A4334 would essentially require that all in-person students and staff be fully vaccinated while exempting only those who would work virtually.

“If the bill becomes law, it would go into effect in the 2022-2023 school year,” noted News12.

The bill will now be reviewed by the Assembly Health Committee and will have to pass the state Senate before it becomes law. A similar bill in the New Jersey Senate has not yet received a vote.

Colleges and universities have adopted their own vaccination policies without government mandates up until now. According to the National Conference of State Legislatures, no other state in the union has required coronavirus vaccinations for students in higher education.

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Pfizer Trial Found Vaxxed Toddlers ‘Were More Likely to Get Severely Ill With Covid’

The Wall Street Journal reported Monday that toddlers vaccinated during Pfizer’s trial were “more likely to get severely ill with Covid than those who received a placebo” and “most kids who developed multiple infections during the trial were vaccinated.”

From WSJ, “Why the Rush for Toddler Vaccines?”:

“This is a very historic milestone, a monumental step forward,” President Biden declared last week after the Food and Drug Administration authorized Pfizer and Moderna vaccines for toddlers. “The United States is now the first country in the world to offer safe and effective Covid-19 vaccines for children as young as 6 months old.”

In fact, we don’t know if the vaccines are safe and effective. The rushed FDA action was based on extremely weak evidence. […]

More troubling, vaccinated toddlers in Pfizer’s trial were more likely to get severely ill with Covid than those who received a placebo. Pfizer claimed most severe cases weren’t “clinically significant,” whatever that means, but this was all the more reason that the FDA should have required a longer follow-up before authorizing the vaccine.

Also worrisome: Most kids who developed multiple infections during the trial were vaccinated. This warranted more investigation, since experimental vaccines for other diseases sometimes increase susceptibility to infection.

Scientists are also discovering that triple-vaccinated adults who were previously infected with the Wuhan variant have a weaker immune response to Omicron, leaving them more susceptible to reinfection. This phenomenon, called “immunological imprinting,” could explain why children who received three Pfizer shots were more likely to get reinfected.

The FDA brushed aside the risk that inoculating infants against a variant no longer circulating could blunt their immune responses to Omicron and its offshoots. There’s a reason vaccine trials usually take a decade. Some steps can be accelerated, but an extended follow-up is often necessary to ensure potential side effects aren’t overlooked.

The FDA standard for approving vaccines in otherwise healthy people, especially children, is supposed to be higher than for drugs that treat the sick. But the FDA conspicuously lowered its standards to approve Covid vaccines for toddlers. Why?

An NIH study of adults who took part in Moderna’s trial (which ran through March 2021) found those with shots had fewer N antibodies after COVID infection when compared with the unvaccinated, suggesting they’re more likely to get reinfected with the virus.

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Woke National Teachers Union Agenda Includes Mandatory Masks, Vaccines and Banning the Words Mother and Father

The National Education Association’s (NEA) annual conference is underway in Chicago, and the group is calling for a national policy of mandatory masking, mandatory vaccinations, and rejecting the words “mother” and “father.”

The NEA is the largest labor group in the U.S., with more than three million members, including Jill Biden. Its president is Becky Pringle.

The Chicago conference is chock-full of woke agenda items called New Business Initiatives (NBI). They include progressive language involving issues that seem to have little to do with proper education. NBIs are proposals that delegates must vote on in order to pass. 

Terry Stoops, a conservative education expert in North Carolina, exposed this year’s NBIs in a lengthy post on Twitter.

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Pfizer Asks Court to Dismiss Whistleblower Lawsuit Because Government Was Aware of Fraud

A lawsuit filed by whistleblower Brook Jackson alleging Pfizer and two of its contractors manipulated data and committed other acts of fraud during Pfizer’s COVID-19 clinical trials is paused following a motion by the defendants to dismiss the case.

In an interview with The Defender, Jackson’s lawyer said Pfizer argued the lawsuit, which was filed under the False Claims Act, should be dismissed because the U.S. government knew of the wrongdoings in the clinical trials but continued to do business with the vaccine maker.

Under the False Claims Act, whistleblowers can be rewarded for confidentially disclosing fraud that results in a financial loss to the federal government.

However, a 2016 U.S. Supreme Court decision that expanded the scope of a legal principle known as “materiality” resulted in a series of federal court decisions in which fraud cases brought under the False Claims Act were dismissed.

As interpreted by the Supreme Court, if the government continued paying a contractor despite the contractor’s fraudulent activity, the fraud was not considered “material” to the contract.

Pfizer is a federal contractor because it signed multiple contracts with the U.S. government to provide COVID-19 vaccines and Paxlovid, a pill used to treat the virus.

“Pfizer claims they can get away with fraud as long as the government would write them a check despite knowing about the fraud,” attorney Robert Barnes said.

The other two defendants in the case are Ventavia Research Group, which conducted vaccine trials on behalf of Pfizer, and ICON PLC, also a Pfizer contractor.

In an attempt to strengthen the False Claims Act’s anti-retaliation provisions and install new safeguards against industry-level blacklisting of whistleblowers seeking employment, Congress in July 2021 introduced the False Claims Amendments Act of 2021.

In December 2021, Pfizer hired a well-connected lobbyist, Hazen Marshall, and the law firm Williams & Jensen to lobby against the bill.

Pfizer previously was heavily fined in connection with the False Claims Act. As part of a 2009 settlement, the company paid $2.3 billion in fines — the largest healthcare fraud settlement in the history of the U.S. Department of Justice — stemming from allegations of illegal marketing of off-label products not approved by the U.S. Food and Drug Administration (FDA).

“Pfizer, one of the most criminally fined drug companies in the world, wants to weaken the laws that hold them accountable,” Barnes told The Defender.

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Twitter censors story of British mother who died after reaction to Covid vaccine

Three children in the UK were left without a mother after she died from a massive stroke determined to be caused by blood clots that formed after she received the AstraZeneca coronavirus vaccine, but Twitter is labeling conversations about this information taking place on the platform as “misinformation.”

Previously healthy Lucy Taberer, whose youngest is a five-year-old boy, succumbed to the consequences of the Covid shot 22 days after she was vaccinated. At first, the 47-year-old experienced mild side-effects, described in reports as common, to then develop a bruise, skin rash, and pain that the doctors at first dismissed as being caused by kidney stones.

In the end, it turned out that the victim’s reaction to the vaccine had been to develop blood clots that proved to be fatal.

Her death certificate reads that Taberer died of cerebral venous sinus thrombosis and vaccine-associated thrombosis with thrombocytopenia.

Local media, including Leicester Mercury, reported about it, and Taberer’s step daughter tweeted a link to the story, but was quickly shut down by Twitter, which labeled the post as “misleading.”

To add insult to injury, she was advised to click another link, provided by Twitter’s “fact-checkers,” that would “explain” why health officials think Covid vaccines are safe “for most people.”

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Canada’s Health Minister Demands COVID Booster Shots Every 9 Months to Keep Vaccine Status ‘Up-to-Date’

Last month, Canada moved the needle for the concept of being “fully vaccinated” for its citizens, saying “two doses don’t work anymore,” and now requires three doses of the COVID-19 vaccine to qualify.

The nation’s totaliarian health authorities took to Canada’s CTV to make the announcement. He noted there is now a transition to a new definition of up-to-date vaccinations.

Last June 30, Health Minister Jean-Yves Duclos told reporters that Canadians will be required to get a booster shot every nine months, possibly forever, in order to meet the government’s definition of “up-to-date” vaccinations.

“The immunity conferred by a primary series of two doses of vaccines administered in 2021 has now waned,” Duclos said during the press conference.

“Scientific studies clearly show that our protection from the initial two-dose vaccine decreases over time,” he clarified.

Duclos then told the reporters that Omicron taught us that we would never be completely protected against COVID-19 because the virus is constantly evolving.

“The virus evolves and Omicron cruelly made us aware that we will never be fully vaccinated against COVID-19. Like the virus, our immunity also evolves, and Omicron made us understand that two doses are no longer enough. We have to maintain our vaccinations up to date,” he argued.

Duclos made it clear that “up-to-date” means Canadians should get a booster shot every nine months as the term “fully vaccinated” no longer makes sense.

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The Insufferable Arrogance of the Constantly Wrong 

The media, and the people who work in and around it, the Blue Checks™ of Twitter, have upped the ante over the past few years regarding how far they are willing to go to enforce various preferred narratives. 

Pick any major story of the past three years—e.g. Lab Leak, Jussie Smollett, Russiagate, Ukrainian Biolabs, Ivermectin, Hospitalizations From COVID v. With Covid, January 6th, ‘Transitory’ Inflation, and of course Hunter’s Laptop—and you will find absolutely hysterical narrative pushing up front followed by retractions, corrections, and outright denials as reality became undeniable. 

In the meanwhile, our civilization was ripped apart, our citizens were gaslit and impoverished, and in countries across the Western world, innocent people were removed from polite society, branded as lepers, and fired from their jobs. 

Why? Because there is one story that just won’t die and for which no corrections have been issued—the shibboleth that vaccination can prevent infection, transmission, and help “end” COVID.

While there is never an excuse for hateful rhetoric towards, and intervention in, the personal medical choices of law-abiding Americans, perhaps one could have, kinda sorta, understood the campaign if the new vaccines had provided long-lasting immunity and prevented community transmission. They do not. 

Early on we were told: “Nine out of ten [vaccinated] people won’t get sick” (Columbia University feat. Run-DMC, February 12th, 2021, no this is not a joke); “Vaccinated people do not carry the virus, don`t get sick” (Dr. Rochelle Walensky, March 29th, 2021); “When people are vaccinated, they can feel safe that they are not going to get infected” (Dr. Anthony Fauci, May 17th, 2021). 

And by mid-summer, 2021, we were still being told that unequivocally, these vaccines were a resounding success worthy of uncritical support. On July 27th in Scientific American, Dr. Eric Topol wrote, “Vaccination is the closest thing to a sure thing we have in this pandemic.” Not to be outdone, Dr. Anthony Fauci of the NIAID told CBS on August 1st, that the unvaccinated were responsible for “propagating this outbreak.” 

But on July 29th, 2021, the Washington Post reported a scoop that the CDC was privately acknowledging that the vaccinated could spread COVID as easily as the unvaccinated. Occasionally, they are forced to report inconvenient facts. And August 5th, CDC Director Walensky told CNN’s Wolf Blitzer that, “They continue to work well for Delta, with regard to severe illness and death — they prevent it. But what they can’t do anymore is prevent transmission.”

While there is a mountain of medical literature available demonstrating quite clearly the failure of these vaccines to prevent infection and transmission, the August 5th declaration from the CDC Director should have made clear that being vaccinated is contributing in no way to the safety of others, nor to the eradication of this virus. 

In fact, Israeli Health Minister Nitzan Horowitz was even caught on tape in September of last year explaining that the use of the Israeli Green Pass wasn’t intended to make a difference epidemiologically, but because it would help convince people to get vaccinated. And even vaccine poobah Bill Gates admitted in a late 2021 interview, that, “We got vaccines to help you with your health, but they only slightly reduce the transmissions.”

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COVID-19 Vaccination Reactivates Highly Contagious Virus

Doctors and scientists are seeing an increase in the reactivation of the chickenpox virus, known as varicella-zoster virus (VZV), following the COVID-19 injections.

The chickenpox virus is one of the eight herpes viruses known to infect humans. After a person contracts and recovers from chickenpox, the virus never leaves the body but lies dormant in the nervous system for life.

The chickenpox virus will show up as shingles, or herpes zoster (HZ) when it gets reactivated.

Federal health authorities claim that there’s no correlation between COVID-19 injections and shingles, but studies show that there is a higher incidence of shingles in people who’ve received the vaccine.

Israel was one of the earlier countries to publish a case series of six women (out of 491 participants) with an autoimmune disorder who developed shingles 3 to 14 days after receiving the first or second dose of Pfizer COVID-19 shot. None of the 99 participants in the control group developed shingles. The study was published in the journal Rheumatology in April 2021.

“To our knowledge, there were no reports of varicella-like skin rash or HZ in the mRNA-based vaccines COVID-19 clinical trials and our case series is the first one to report this observation in patients within a relatively young age range: 36–61, average age 49 ± 11 years,” the authors wrote.

They hoped that publishing the case series would “raise awareness to a potential causal link between COVID-19 vaccination as a trigger of HZ reactivation in relatively young patients with stable AIIRD [autoimmune inflammatory rheumatic diseases].”

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