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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Pfizer And Moderna To Investigate Their Own Vaccines For Myocarditis Risks

Why is Big Pharma investigating their own covid vaccines for myocarditis side effects if the vaccines were already supposedly tested and proven safe and effective?

Both Pfizer and Moderna have announced that they will be undertaking studies to determine the longer term risks of Myocarditis (an inflammatory condition of the heart which can lead to death) for people who have been injected with the mRNA based covid vaccines. The decision comes after the release of multiple medical studies which show a correlation and causation between the vaccines and an exponential increase in heart problems, specifically among men 40 years old and younger. Only a year ago the link between covid vaccinations and myocarditis was widely denied.

Studies also show that myocarditis risk increases with the number of boosters a person has taken.

Before the year 2020, the average vaccine was tested and re-tested by pharmaceutical companies and the FDA for 10 to 15 years before it could be released to the public. This was done not only because testing is a complex process with a lot of red tape involved, but also because it is the only way to discover any long term side-effects that might be associated with a particular immunization product. If you read any medical journal or scientific outline on vaccine development published before 2020, they all agree that long term testing is necessary for public safety.

Suddenly, after 2020 and the advent of public activism against the covid mandates, a host of medical “professionals” and bureaucrats began arguing that the mRNA vaccines do not need the same lengthy testing time frame because government funding allowed for everything to be accomplished much faster. This is a lie.

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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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Pfizer’s “Vaccine” Causes Astonishing Drop in Male Fertility – Men Have Not Been Informed nor Given Their Consent

When the Covid-19 vaccine rollout to the public began in late 2020, medical professionals, public health agencies, and government spokespeople all assured the public that the novel mRNA “vaccines” did not cause negative systematic effects on human bodies. They promised the public, many of whom were sceptical about the safety of a drug brought to market at “warp speed,” that the vaccines were “safe and effective.”

Those who questioned or challenged the “safe and effective” assurances were dismissed as “anti-vaxxers” and accused of wanting to kill others, especially the elderly. Few medical and public health experts spoke out about the need for long-term studies.

This attack on challengers to public health’s all-out push, and the resulting censorship of the emerging problem, resulted in catastrophic harm to male fertility.

The following is extracted from the article ‘Pfizer, FDA, CDC Hid Proven Harms to Male Sperm Quality, Testes Function, from mRNA Vaccine Ingredients’ by Amy Kelly, Program Director for the War Room/DailyClout Pfizer Documents Analysis Project as well as the COO of DailyClout.  Find more by Amy Kelly HERE.

Pfizer’s own documents and other medical studies show:

  1. Pfizer did not test “male reproductive toxicity”. Male reproductive toxicity is defined as adverse effects (negative impacts) related to sexual function and fertility in an adult male.[2]
  2. Pfizer also did not test for adverse effects from vaccinated men’s semen, on the development of their offspring.[3]
  3. mRNA vaccine ingredients travel throughout the body and gather in organs, including in the testes.[4]
  4. mRNA vaccines resulting in “anti-sperm antibodies” – that is to say, antibodies that treat sperm as an “invader”, and damage or kill it – is a known adverse event related to this form of vaccination.[5]
  5. mRNA vaccines cause a staggering drop in semen concentration and total motile count.[6]
  6. By suppressing discussion of this information, public health agencies, medical professionals, and governments globally denied and continue to deny men true informed consent.

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Pfizer CEO pulls out of testifying to EU Parliament COVID panel

Pfizer Chief Executive Albert Bourla has pulled out of an appointment to testify before the European Parliament’s special committee on COVID-19, at which he was expected to face tough questions on how secretive vaccine deals were struck.

The decision follows an audit report into the EU’s vaccine procurement strategy published earlier in the month that raised new questions about contact between Bourla and European Commission President Ursula von der Leyen that preceded a multibillion-euro vaccine contract.

The head of the U.S. pharmaceutical giant, the largest supplier of COVID-19 vaccines to the EU, was scheduled to appear before the panel on October 10. The committee is meeting with key officials involved in the EU’s vaccine procurement process to draw lessons on how to respond to future pandemics. Other pharmaceutical executives have addressed the committee, including the CEO of Moderna and senior officials from AstraZeneca and Sanofi.

The committee’s chair, Belgian MEP Kathleen Van Brempt, told POLITICO she “deeply regrets” the decision taken by Pfizer.

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Pfizer Bars Whites From Applying For Prestigious Fellowship

No white people need apply for Pfizer’s new “Breakthrough Fellowship” program.

From The Washington Free Beacon, “No Whites Allowed: Pfizer Fellowship Flagrantly Violates the Law, Lawyers Say”:

The pharmaceutical giant Pfizer offers a prestigious fellowship that bars whites and Asians from applying. Trumpeted on the company’s website as a “Bold Move” to “create a workplace for all,” civil rights lawyers are characterizing it in a different way: as a blatant violation of the law.

“This Pfizer program is so flagrantly illegal I seriously wonder how it passed internal review by its general counsel,” said Adam Mortara, one of the country’s top civil rights attorneys.

Pfizer’s “Breakthrough Fellowship” offers college students multiple internships, a fully funded master’s degree, and several years of employment at the pharmaceutical giant. It also restricts applications to “Black/African American, Latino/Hispanic and Native American” students, the fellowship requirements state.

In a Frequently Asked Questions brochure about the nine-year program, Pfizer asserts that it is an “equal opportunity employer.”

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War Zone: New Pfizer Data Reveal Horrifying Rates of Miscarriage

Since the rollout of the experimental COVID shots, U.S. health officials have adamantly claimed the shots are safe for pregnant women, and have been urging all pregnant women to get the jab “to protect themselves and their babies.” To this day, the U.S. Centers for Disease Control and Prevention recommends the COVID shot for:1

“… people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future.”

The CDC further recommends:2

“People who are pregnant should stay up to date with their COVID-19 vaccines, including getting a COVID-19 booster when it’s time to get one.”

And claims:3

“Evidence continues to build showing that:

  • COVID-19 vaccination during pregnancy is safe and effective.
  • There is currently no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems in women or men.”

All the while, they’ve had Pfizer data showing the shots cause shocking rates of miscarriage which, adding insult to injury, have been blatantly miscategorized as a “recovered/resolved” adverse effect.4 Who in their right mind would consider DEATH a resolved side effect unless they had a depopulation agenda in mind all along?

I don’t see how this could be described as anything but a criminal cover-up. The only reason we know any of this is because U.S. District Judge Mark Pittman ordered the U.S. Food and Drug Administration to release Pfizer documents at a rate of 55,000 pages per month. The FDA and Pfizer had asked to release the documents at a pace of 500 pages per month, which meant it would take 75 years to disclose them all.5

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Nate Silver: ‘Liberal elites’ pressured Pfizer to delay vaccine until after 2020 election

Nate Silver claimed “liberal public health elites” pressured Pfizer to delay fast-track approval of its COVID-19 vaccine until after the 2020 presidential election — thus denying then-President Donald Trump a political win before voters headed to the polls.

The number-crunching data journalist reacted to an article by Politico that cited a House report that claimed the Trump administration sought to expedite approvals for both vaccines and “unproven treatments” for COVID-19.

“‘Trump pushed for vaccine approvals too fast’ is the worst possible critique of the Trump administration’s COVID policy,” Silver, founder of the Disney-owned FiveThirtyEight political news and analysis website, tweeted.

“That probably saved a lot of lives. If anything approval should have been faster.”

In a subsequent tweet, Silver wrote that “liberal public health elites” pushed Pfizer to “change its original protocols” that govern its authorization of vaccines so that the decision would be put off until after Election Day two years ago.

Silver noted that Pfizer’s decision “had the convenient side-effect of delaying any vaccine announcement until after the election” and that the story “deserves more scrutiny.”

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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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