FDA Obfuscates Approval for Pfizer Vaccine

News: US News
by Jules Gomes  •  ChurchMilitant.com  •  August 26, 2021   

mRNA inventor slams US regulator's 'little trick,' mainstream media 'lies'

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SILVER SPRING, Md. (ChurchMilitant.com) - Contrary to claims in the mainstream media, the United States Food and Drug Administration (FDA) has not granted full approval to Pfizer's current COVID-19 vaccine but only extended its existing Emergency Use Authorization (EUA).

Only BioNTech's Comirnaty has been approved by the FDA

On Monday, the FDA wrote to Pfizer stating it is "reissuing the August 12, 2021, letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine."

However, in a second letter to BioNTech (a German pharmaceutical partnering with Pfizer), the FDA said it is granting a Biologics License Application (BLA) approval for its mRNA COVID-19 vaccine to be marketed under the proprietary name Comirnaty. 

The FDA also did not approve any COVID-19 vaccines for the 12- to 15-year age group, booster doses for any age group, or the Moderna or Johnson & Johnson vaccine currently administered under EUA in the United States.

mRNA Inventor Explains Sleight of Hand

Inventor of the mRNA vaccine Dr. Robert Malone blasted the obfuscation as "the little trick" played by the FDA by issuing "two separate letters for two separate vaccines."

"The press has actually not done their work and figured out what's actually going on here," Malone said. "Once again the mainstream media has lied to you." 

The FDA views its primary mission as approving as many drugs it can, regardless of whether the drugs are safe or needed.

"The product which has been licensed is the BioNTech product, which is substantially similar but not necessarily identical." But Comirnaty is "not yet available" in the United States and "they haven't yet started manufacturing it or labeling it," Malone explained.

The FDA acknowledges "a significant amount" of the Pfizer vaccine remains available under EUA, while there are "insufficient stocks" of BioNTech's fully approved Comirnaty. Those interested in getting the fully FDA-approved version should ask to see "Comirnaty" on the label.

Transparency Advocates Sound Off

Earlier, transparency advocates criticized the FDA decision "not to hold a formal advisory committee meeting to discuss Pfizer's application for full approval of its COVID-19 vaccine."

"The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing," asserted Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA's Psychopharmacologic Drugs Advisory Committee.

Witczak is one of 30 signatories who petitioned the U.S. drug regulator in June to "delay any consideration of a 'full approval' of a COVID-19 vaccine." The scientists asked the FDA to "slow down and get the science right" as "there is no legitimate reason to hurry." 

Dr. Malone explains the FDA fudge on Steve Bannon's War Room podcast

"We believe the existing evidence base — both pre- and post-authorization — is simply not mature enough at this point to adequately judge whether clinical benefits outweigh the risks in all populations," the petitioners maintained. 

The petition also asked for "data demonstrating a thorough investigation of all serious adverse events reported to pharmacovigilance systems, carried out by independent, impartial individuals."

Unlike the way in which clinical trials study drugs using a limited number of patients with a limited scope of health, geographic and other influences affecting safety analysis, pharmacovigilance involves reviewing adverse drug reactions over time and across a wider patient population to get a clearer understanding of possible adverse reactions.

Safety isn't on the radar screen regardless of what FDA officials would have you believe.

Diana Zuckerman, president of the National Center for Health Research, told the prestigious British Medical Journal (BMJ): "It's obvious that the FDA has no intention of hearing anyone else's opinion. But if you make decisions behind closed doors it can feed into hesitancy."

BMJ's associate editor Dr. Peter Doshi warned the FDA it was in danger of granting "a marketing license 13 months into the still ongoing, two-year pivotal trial, with no reported data past 13 March 2021, unclear efficacy after six months due to unblinding, evidence of waning protection irrespective of the Delta variant, and limited reporting of safety data."

BioNTech billionaries: Dr. Ugur Sahin and Dr. Özlem Türeci

"The crucial question, however, is whether the waning efficacy seen in the primary endpoint data also applies to the vaccine's efficacy against severe disease," Doshi wrote. "With the U.S. awash in news about rising cases of the Delta variant, including among the 'fully vaccinated,' the vaccine's efficacy profile is in question." 

The document Pfizer sent to the FDA for its Emergency Use Authorization contained no data to suggest safety or efficacy regarding anyone younger than 18 or older than age 55, pregnant or lactating mothers, autoimmune conditions or immunocompromised individuals. It also lacked data on its efficacy for transmission of COVID, duration of protection from COVID or preventing death from COVID.

Warning to the Public

Internist Dr. Meryl Nass and legal expert Robert F. Kennedy Jr. excoriated the FDA for "playing bait and switch with the American public" and urged individuals not to "play along." 

"The FDA's acknowledgment in its approval letter that there are insufficient stocks of the licensed Comirnaty but an abundant supply of the EUA Pfizer BioNTech jab exposes the 'approval' as a cynical scheme to encourage businesses and schools to impose illegal jab mandates," Nass and Kennedy explained. 

"If it doesn't say 'Comirnaty' [on the label], you have not been offered an approved vaccine," they wrote. "The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product."

With the U.S. awash in news about rising cases of the Delta variant, including among the 'fully vaccinated,' the vaccine's efficacy profile is in question.

Under the new arrangement, Comirnaty has no liability shield and victims of the Comirnaty jab could potentially sue for damages. "Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product," they added.

In 2009, Pfizer was fined a record $2.3 billion — the largest pharma settlement to date — after being deemed a repeat offender in marketing 13 drugs to patients and doctors for unapproved uses. 

The Vioxx scandal destroyed confidence in the FDA 

FDA: Safety or Sales?

Kennedy and Nass stressed that the "FDA's clear motivation is to enable Pfizer to quickly unload inventories of a vaccine that science and the Vaccine Adverse Events Reporting System have exposed as unreasonably dangerous and that the Delta variant has rendered obsolete."

The FDA has a history of approving unsafe drugs. In 2005, whistleblower Dr. David J. Graham, associate director of the FDA's Office of Drug Safety, revealed the "FDA is inherently biased in favor of the pharmaceutical industry" and views Big Pharma as "its client, whose interests it must represent and advance."

"It views its primary mission as approving as many drugs it can, regardless of whether the drugs are safe or needed," the scientist observed, testifying to how the FDA-approved drug Vioxx killed 60,000 patients out of 140,000 who suffered heart attacks as a result of the drug. 

"Safety isn't on the radar screen regardless of what FDA officials would have you believe," Dr. Graham lamented, because "when the FDA reviews a new drug, it assumes the drug is safe, and it facetiously asks the company to prove it's not safe."

"The FDA calls itself the world's leading consumer protection agency. If the public only knew the truth, they'd demand that Congress fix the problem," Graham noted.

Graham concluded Congress has no intention of upsetting the pharmaceutical industry because the FDA, Congress and Big Pharma work as a "lethal triangle" funded by the pharmaceutical giants.

--- Campaign 32075 ---


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