Friday, May 20, 2022

FDA Ordered to Expedite Release of Pfizer Vaccine Data

Agency Sought 75 Years for Disclosure; Judge Gave 8 Months 

In a win for government transparency, a U.S. District Judge ruled the Food and Drug Administration (FDA) must release, over the next eight months, thousands of documents it relied on to approve the Pfizer vaccine. The ruling rejected a request by the Department of Justice, which represented the FDA in the litigation, to parcel out the data over the next 75 years, Bloomberg Law reported.

The FDA’s request for seven decades for full disclosure stunned people. According to this timeframe, it would take until 2096—when virtually all of the scientists, attorneys and American adults alive today will have died of old age—for the agency to complete the vaccine data transfer.

“Stale information is of little value,” quoted Judge Mark Pittman in his ruling, citing the “paramount public importance” of the vaccine data in real time, and that its release should be one of the FDA’s highest priorities.

He quoted James Madison as saying a “popular government, without popular information, or the means of acquiring it, is but a prologue to a farce or a tragedy.” Pittman apparently recognized that America needs transparency and independent scientists to review this data—not in 75 years, but now. Releasing the information could help reassure vaccine skeptics that the shot is indeed “safe and effective” and, thus, increase confidence in the Pfizer vaccine.

There is likely not a “more important issue for the FDA than assuring the American public that this [vaccine] was not rushed,” the judge noted, and that its approval was grounded in data.

Pittman, a U.S. district court judge in the Northwestern District of Texas, also cited a quote from the late Sen. John McCain, the Arizona Republican and 2008 GOP presidential nominee, that excessive secrecy from a government agency “feeds conspiracy theories and reduces the public’s confidence in the government.”

The litigation over the release of the FDA’s data stemmed from a Freedom of Information Act (FOIA) lawsuit by a coalition of over 30 leading doctors and scientists representing Public Health and Medical Professionals for Transparency (PHMPT) from England, Germany, Denmark, Australia, United States and Canada.

The group was formed to make public the data used by the FDA to grant emergency approvals for Covid-19 vaccines. It had first sought the information from Pfizer, which funded, designed, ran and analyzed the data for the pivotal Covid vaccine trials. When Pfizer was not forthcoming, the group made a FOIA request of the FDA, which holds 450,000 pages of Pfizer’s raw data,” reports the British Medical Journal.  This material encompasses the vaccine-creation process and includes all Pfizer-conducted studies, outcome of these trials and findings of adverse advents.

After the FDA took the position that it could only dole out the material in batches of 500 pages a month, the PHMPT group filed a lawsuit, calling the FDA’s position “outrageous.”

PHMPT countered that the release of the documents, at a time where millions of Americans are facing mandates to get vaccinated or face repercussions such as loss of employment, is acutely time-sensitive and affects the immediate core interests of the American public.   They also argued that Title 21, subchapter F of the FDA’s own regulations stipulates that the agency “is to make ‘immediately available’ all documents underlying licensure of a vaccine.”

Given the intense public interest in the vaccine, the plaintiffs’ lawyers say that the FDA “should have been preparing to release (the data) simultaneously with the licensure. Instead, it has done the opposite.”

Judge Pittman ordered the agency to turn over 55,000 a month, “with the first production being due on or before March 1, 2022, until production is complete.” The ruling requires the FDA to start producing documents at an expedited pace — more than 12,000 pages before Jan. 31. The FDA along with the plaintiffs will be required to submit joint status reports on the progress of the Freedom of Information Act (FOIA) request every 90 days, starting on April 1.

Attorney Aaron Siri, a partner in Siri & Glimstad, who represented the group in court over the FOIA request, celebrated the ruling. “This is a great win for transparency and removes one of the strangleholds federal ‘health’ authorities have had, on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program,” the attorney wrote, according to the Daily Wire.

“No person should ever be coerced to engage in an unwanted medical procedure,” he added, noting that vaccine mandates are “a violation of this basic liberty, and unprecedented” in the history of adult vaccines in this country.

 

FDA Complains of Limited Resources, Slow Workers 

The FDA, while not disputing its responsibility to release the data, tried several ways to justify its proposed 75-year disclosure schedule. Some of the rationalizations may have tested the judge’s credulity. For example, the agency claimed its Center for Biologics Evaluation and Research, which maintains the records in question, has only 10 staff members, two of whom are “new” to the job.

“Two of those members began working for the office within the last four months and, because they are new staff members, they are not yet able to review records at the same rate as more experienced staff members,” the agency explained in its response brief. The question of why it would take new staff member multiple years to learn the ropes was not addressed.

Additionally, the FDA argued an accelerated rate of release for the documents in question will divert “significant resources away from the processing of other FOIA requests,” including those submitted prior to that of PHMPT that are entitled to earlier consideration. As a third reason for its inability to process the data in question in a timely manner, the FDA cited the need for extra time to redact personal information, and its duty to protect Pfizer’s trade secret interests.

Plaintiffs’ lawyers argued—and Judge Pittman agreed—that all of these considerations take a back seat to the core interests of the American people affected by the vaccine mandates. “A majority of Americans are now mandated to receive a Covid-19 vaccine under penalty of losing a job, or worse,” the lawsuit noted. Compounding the dilemma is the fact that “Americans, if injured by the vaccine, cannot sue Pfizer which enjoys full liability protection,” as do all the big pharmaceutical manufacturers of vaccines.

“There is virtually no other product on the market where a consumer is prohibited from suing the company that manufactures, markets, and reaps profits from the product. Thus, it is extraordinary,” the brief said, “that Americans must take this product under penalty of expulsion from work, school, the military and civil life, but they cannot sue Pfizer for any resulting injuries.

 

108 Days

The brief laid out the enormous sums of taxpayer funds paid to Pfizer to promote development of its vaccine.

“The Executive Branch gave Pfizer $1.95 billion to begin vaccine development through an advance-purchase agreement,” the lawsuit stated. “It then paid Pfizer more than $15.7 billion collected from the American people to purchase that product. Thereafter, it spent $18.75 billion more of the American people’s money promoting that product. Yet, when it comes to being transparent with those same American people, the FDA cannot muster the resources to timely produce the same documents it reviewed for licensure in 108 days?

“Just as the government found the resources for Operation Warp Speed, it must now do the same to produce these critical documents with the same warp speed,” the plaintiffs argued. “It is difficult to imagine a greater need for transparency than immediate disclosure of the documents relied upon, to license a product now being mandated to over 100 million Americans.”

The plaintiffs asked the court to require the FDA to release all the material no later than March 3, 2022—a 108-day period beginning from the date the lawsuit was filed. “This is the same span of time it took the FDA to review the relevant documents for the far more complex task of licensing Pfizer’s Covid-19 vaccine,” wrote attorneys Aaron Siri and John Howie in court papers.  “When asked to share those documents with the public, however, the FDA claimed it needed over 20,000 days.”

That grossly inflated timeline was essentially a refusal to honor its promise of transparency, the plaintiffs charged.

“For the government to seek to withhold the data until almost every adult American alive today is dead,” attorney Siri wrote, “is destructive to liberty and antithetical to the openness required in a democratic society.”

In addition, the brief noted, the nation needs the scientific community, both inside and outside the government, to address the failings with the vaccine program, including mutants that evade vaccine immunity and the fact that vaccinated individuals can still transmit the virus.

The brief quotes Yale School of Public Health and Yale School of Medicine, Dr. Harvey Risch, a member of PHMPT, who explains that “independent scientists and epidemiologist need this data immediately. We are still in a pandemic, the vaccines are failing, children are starting to be vaccinated, and we are moving on to boosters for all eligible Americans. We therefore need to have as complete an understanding of these vaccines as soon as possible.  Collective efforts of all scientists in the United States will produce more insights at a quicker pace than if the FDA hoards data, prohibiting others from getting involved.”

 

President Biden and Transparency

Full disclosure would help reassure vaccine skeptics that the shot is indeed “safe and effective and, thus, increase confidence in the Pfizer vaccine,” the lawsuit reasoned. It went on to quote then-candidate Joe Biden, declaring to the American people in Jan 2020, “You’ve got to make all of it [the vaccine data] available to other experts across the nation so they can look and see, so there’s a consensus this is a safe vaccine.”

On September 7, 2020, on national television, Biden reiterated his pro-transparency stance. “I get asked the question, ‘If President Trump announced tomorrow we have a vaccine, would you take it?’ Only if it was completely transparent and other experts in the country could look at it. Only if we knew all of what went into it.”

He then insisted to the American people that “we need total transparency so scientists outside the government know exactly what is being approved.”

Despite these explicit assurances, the federal executive has been hiding Pfizer’s data from the public, all the while orchestrating an agenda that will make it impossible to participate in American society without receiving the Pfizer vaccine, the lawsuit argued. Some mandates now require three doses of Pfizer’s vaccine, and the number of doses Americans must receive to simply keep their job and otherwise engage in mainstream society is only expected to increase over time.

“What makes this all the more incredible,” the brief underlined, “is that Pfizer’s vaccine does not prevent infection and transmission.  Meaning, at best, Pfizer’s vaccine provides personal protection, akin to taking statins. We may want people to take their heart medicine, but we don’t mandate them to do so. That is simply authoritarian.”

 

*****

CDC Gets A Reality Check

In addition to the FDA’s raw data on the safety monitoring of the Pfizer shot, scientists seek transparency surrounding the actual decision-making that shaped the trials. The CDC has admitted that while Covid vaccines may blunt severe illness and death, they do not prevent infection or transmission of the disease, and scientists want to know why these features were not part of the design.

“Why weren’t vaccine trials designed to test the vaccine’s efficacy against infection and spread of SARA-CoV-2?” demanded a British Medical Journal article. “Regulators and public health bodies need to release this information. The result of this failure has had enormous impact on mortality rates worldwide.”

Had FDA and CDC regulators insisted on [evidence of] this outcome, countries would have learned sooner about the lack of efficacy against transmission and been able to plan accordingly, the article said.

Underlining this grave failure, an article in the NY Times describes CDC Director Rachelle Walensky as being “stunned” upon learning “that vaccinated Americans were spreading the coronavirus,” as the Delta variant began sweeping parts of America.

“As Walensky was briefed about a cluster of breakthrough cases in Provincetown, Mass., the reality sank in,” the Times article said. “Being vaccinated would not as it turned out, prevent people from becoming infected with the variant or transmitting it. “It was a ‘heart sink’ moment,” Walensky recalled in an interview.

The article went on to note that “the discovery called into question the Biden Administration’s almost single-minded focus on vaccination as the path out of the pandemic.”

 

Those Bedeviling Escape Mutants

The issues of variants escaping Covid vaccines, waning vaccine immunity and the shots’ inability to prevent transmission have been largely censored in the mainstream press. But they have been widely aired in the writings and speeches of multiple clear-eyed physicians and scientists.

These experts, including the renowned Dr. Robert Malone, inventor of the mRNA technology, leading cardiologist Dr. Peter McCullough, and virologist Dr. Geert Vanden Bossche have regularly spoken out about “leaky vaccines.” They have spoken forcefully of the need to develop aggressive early treatment and therapeutics for Covid patients, both vaccinated and unvaccinated.

Some of these specialists began forewarning the public about vaccines “that are not effective nor fully safe” long before the real-life scenarios about vaccines that couldn’t prevent Covid infection “stunned” Dr. Walensky’s in July 2021.

Among the many doctors who sought early on to raise public awareness about the need for developing vaccines that treat mutant strains, pulmonologist Dr. Jean-Jacques Rajter of Florida, who this writer interviewed for Yated in Oct. 2021, and immunologist Dr. Ryan Cole of Idaho framed this message to listeners whenever they could.

Dr. Rajter used his appearance before the Senate in 2020 to drive home the critical importance of early treatment as well as acknowledging the limitations of vaccines. In a foreshadowing of recent evidence about vaccines’ waning efficacy, Dr. Rajter told the Senate hearing that Covid vaccines, while important, may not prove fully effective and “may not provide long-term immunity.”

“Even if they are 80 per cent successful, we still need to treat the 20 per cent who become ill with Covid notwithstanding vaccination,” he told the senators.

In the interview with Yated, Dr. Rajter said the Pfizer, Moderna, J&J vaccines and booster shots were designed to combat the original “Alpha” strain of Covid 19, and were not as efficacious against Delta, the prevalent strain causing the vast majority of Covid infections at the time. Nor was it likely they would be successful in crushing future strains, he said.

“The vaccines and boosters are not geared for mutants,” he explained. “This may account for why we see so many breakthrough infections in vaccinated people. Just as the flu vaccine has to be redesigned each year to target the new flu strain, the same is true of the Covid shot. It is a mystery why the drug manufacturers and public health agencies have not recognized this.”

Time, as we know, has proven the correctness of his assessment. None of the available Covid-19 injections are capable of stopping the spread of the virus, with respect to the now-dominant Omicron variant. In fact, credible evidence from places like Israel, Iceland and Gibraltar – several of the most highly vaccinated regions in the world – demonstrate that Covid-19 vaccination rates appear to correlate with massive increases in both Delta and Omicron cases, a fact that has bedeviled the most seasoned researchers. Scientists and researchers are sifting through one theory after another in attempting to interpret these facts.

With the highly infectious spread of the Omicron wave, and the discovery that vaccinated and unvaccinated people have proven to be equally susceptible to the disease, no one seriously disputes that Covid vaccines have failed to contain the latest strain. Even Bill Gates, who donated $1.75 billion to Covid-19 vaccine development, admitted the currently available vaccines “aren’t durable enough and should be better at preventing infection,” Fox Business News reported last week.

“The vaccines we have prevent severe disease and death very well but they are missing two key things,” Gates was quoted as opining in a Twitter conversation. “First, they still allow infections (breakthrough) and the duration appears to be limited. We need vaccines that prevent re-infection and have many years of duration.”

Share on twitter
Twitter
Share on whatsapp
WhatsApp
Share on facebook
Facebook
Share on pinterest
Pinterest
Share on linkedin
LinkedIn

LATEST NEWS

Hopeful

This week, we celebrate Lag Ba’omer and the legacy of Rabi Shimon bar Yochai. We celebrate the conclusion of the plague that affected the 24,000

Read More »

NEWSLETTER

Subscribe to stay updated