Tag: big pharma

Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age. With the high level of respiratory illnesses currently circulating among children under 5 years of age, updated COVID-19 vaccines may help prevent severe illness and hospitalization.

If authorized, children in this age group would receive a primary series consisting of two 3-µg doses of the original Pfizer-BioNTech COVID-19 Vaccine followed by a third 3-µg dose of the Omicron BA.4/BA.5-adapted bivalent vaccine. An application to extend Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine marketing authorization in the EU to include children ages 6 months through 4 years is under discussion with the European Medicines Agency (EMA).

The Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is currently authorized as a booster dose for ages 5 years and older in the U.S. and European Union (EU).

The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY®) are based on BioNTech’s proprietary mRNA technology and were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (Original) and BNT162b2 Bivalent (Original/Omicron BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

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Top epidemiologist slams federal health agencies for acting like ‘PR department’ for drugmakers

One of the nation’s top epidemiologists is blasting federal health agencies, saying science has proven they have been wrong about everything from vaccine efficacy to mask protections during the COVID-19 pandemic and have eroded their trust with the public by acting like a “PR department” for drug and vaccine makers.

Dr. Harvey A. Risch, professor emeritus at the Yale School of Public Health, told the “Just the News, No Noise” television show on Friday that agencies like the Centers for Disease Control and Prevention (CDC), the National Institutes of Health and the U.S. Food and Drug Administration manipulated statistics to portray plausible theories as scientific fact through the coronavirus emergency.

“When you play fast and loose with statistics trying to be plausible, that’s not science,” he said.

The end result, Risch said, was that public health agencies’ proclamations have been proven wrong repeatedly, eroding essential trust with the American public.

“Where we ended up is that the government said, you know, ‘You won’t get the infection if you get vaccinated,'” he said. “That was untrue. ‘You won’t spread the infection if you get vaccinated.’ That was untrue. It said reasonably that you won’t get sick or die from the infection if you get vaccinated. That’s, as we are seeing, not true. The majority of people now dying from COVID are vaccinated.”

Risch said the latest hit to federal officials’ credibility came with a new peer-reviewed randomized study that found N-95 respirator masks — long portrayed as superior virus filters — provided no better protection from the COVID-19 virus than cloth surgical masks and that neither provided significant protection to patients or medical providers.

Missouri Attorney General Eric Schmitt also claimed that retiring National Institute of Allergy and Infectious Diseases Director Anthony Fauci, whose flip-flops on masking led to mass public confusion early in the pandemic, couldn’t name any studies showing mask effectiveness in his recent deposition in state-led litigation against alleged federal censorship.

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Biden Has Handed America Over To The Biodefense Cartel

On the heels of Biden’s September 12th Executive Order titled The National Biotechnology and Biomanufacturing Initiative, I wrote two days later that it “is a complete capitulation of our government to Big Pharma, the biotechnology industry and the entire transhuman cabal that wants to create Humanity 2.0 by changing our genetic structure.”

The Initiative literally opens the floodgates of taxpayer resources and turns over government control to the biotech and Big Pharma industry. Some highlights include:

  • “We need to develop genetic engineering technologies and techniques to be able to write circuitry for cells and predictably program biology in the same way in which we write software and program computers; unlock the power of biological data, including through computing tools and artificial intelligence; and advance the science of scale-up production while reducing the obstacles for commercialization so that innovative technologies and products can reach markets faster.”
  • “bolster and coordinate Federal investment in key research and development (R&D) areas of biotechnology and biomanufacturing in order to further societal goals”
  • “Building a Vibrant Domestic Biomanufacturing Ecosystem.”
  • “expand training and education opportunities for all Americans in biotechnology and biomanufacturing.”
  • “Federal investments in biological sciences, biotechnology, and biomanufacturing to enhance biosafety and biosecurity best practices throughout the bioeconomy R&D enterprise.”

In sum, our nation has become the vassal of the biodefense cartel to finance its R&D, build its manufacturing capacity and train workers to fill its factories. What’s wrong with this picture?

The Executive Order required a number of reports to be compiled and submitted to the President on how to implement the Order. Just one month later, the White House released the National Biodefense Strategy and Implementation Plan. It dovetails perfectly with the Executive Order except that preparation started on the first day of Biden’s presidency. According to the American Economic Association (AEA),

Today, the Biden-Harris Administration fulfills a commitment that President Biden made on his first day in office: to review existing national biopreparedness policies and develop recommendations for how the Federal Government should update them, based on lessons learned from the ongoing COVID-19 pandemic and other biological threats our Nation faces.

Thus, we can see that this massive transfer of power actually started with Biden’s election and has been orchestrated for theater ever since.

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Pfizer Plans to Hike Price of US COVID-19 Vaccine by 400 Percent

Pfizer is looking to raise the price of its COVID-19 vaccines in the United States by up to four times once Washington’s purchase program ends, according to the company’s U.S. president, Angela Lukin.

Pfizer’s COVID-19 vaccine is presently provided free for all Americans by the U.S. government. Next year, when the U.S. public health emergency expires, the COVID-19 vaccine market will move to private insurance. The federal government is paying roughly $30 per dose for the Pfizer vaccine. When the government purchase program shuts down, Lukin expects a dose to be priced around $110 to $130.

“We are confident that the U.S. price point of the COVID-19 vaccine reflects its overall cost-effectiveness and ensures the price will not be a barrier for access for patients,” Lukin said, according to Reuters.

The Pfizer executive is expecting the vaccine purchase to transfer to the private sector, “at the earliest,” by first quarter 2023. According to Lukin, the vaccine will continue to be available for free for people who have government or private insurance.

In 2021, Pfizer made almost $37 billion through COVID-19 vaccine sales, with overall revenues doubling, to $81.3 billion. The company is expecting revenues to reach $98 billion to $102 billion this year.

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Pfizer Exec Concedes COVID-19 Vaccine Was Not Tested on Preventing Transmission Before Release

A company executive admitted in a European Parliament hearing Pfizer was unsure its COVID-19 vaccine would stop transmission last year.

Pfizer’s Janine Small, president of international developed markets, acknowledged the vaccine manufacturer did not know if the vaccine would stop people from spreading coronavirus.

The Epoch Times further reported:

Roos, of the Netherlands, argued in a Twitter video Monday that following Small’s comments to him, millions of people around the world were duped by pharmaceutical companies and governments.

“Millions of people worldwide felt forced to get vaccinated because of the myth that ‘you do it for others,’” Roos said. “Now, this turned out to be a cheap lie” and “should be exposed,” he added.

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Tim Ryan Took Money From Opioid Distributor Whose Executives Mocked Addicts as ‘Pillbillies’

On the campaign trail, Rep. Tim Ryan, the Democratic Senate candidate in Ohio, likes to tell voters about his work as co-chair of the Congressional Addiction, Treatment, and Recovery Caucus and to attack pharmaceutical companies for profiting from “getting so many millions of Americans hooked on opiates.” None of that stopped him from accepting money from a political action committee funded by an opioid distributor whose executives mocked addicts as “pillbillies,” a Washington Free Beacon review of campaign finance documents found.

The $1,000 donation came from AmerisourceBergen PAC in November 2019. Emails revealed in 2021 during a lawsuit against the company for its alleged role in the opioid crisis showed AmerisourceBergen’s executives expressing broad contempt for poor whites suffering from addiction, which at the time was largely fueled by pharmaceuticals such as OxyContin.

In one exchange, a senior AmerisourceBergen executive circulated a parody song containing references to “hillbilly heroin,” “a bevy of Pillbillies” and a reference to Kentucky as “OxyContinville.” Another email shared between executives joked about how crackdowns against so-called pill mills—doctors who illegally prescribe opioids to customers—in Florida will lead to a “max [sic] exodus of Pillbillies heading north.” 

The donation could prove to be a political liability for Ryan, a Democrat running in a state that has been inordinately impacted by the opioid crisis. The Associated Press reported earlier this month that opioid distributors donated at least $27,000 to Ryan’s political campaigns since 2007.

At the same time, the AP found, Ryan voted against bills meant to increase funding for anti-opioid initiatives, such as spending packages for addiction treatment. In a statement to the AP, Ryan’s campaign said one of the donors, Cardinal, is a large employer in Ohio.

The Ryan campaign did not respond to a request for comment.

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