‘Stunning Admissions’: White House Pressured FDA to Cut Corners on COVID Vaccine Approvals in Order to Push Mandates
The Biden administration pressured the U.S. Food and Drug Administration (FDA) to “change its procedures, cut corners, and lower agency standards,” to approve Pfizer’s COVID-19 vaccines and authorize boosters, according to a congressional report released earlier this week.
The approval was key to facilitating the Biden administration’s rollout of the fall 2021 vaccine mandates, despite safety concerns about the shots, according to the report.
“During the pandemic, politics overruled science at the government institutions entrusted with protecting public health,” Rep. Thomas Massie (R-Ky.) said in a press release announcing the report.
“The FDA abandoned its congressional directive to protect citizens from false claims and undisclosed side effects, and instead ignored its own rules to pursue a policy of promoting the vaccine while downplaying potential harms,” he added.
As a result, according to the report, “countless Americans” suffer from vaccine side effects and the FDA has lost credibility with the public.
Following the report’s release a U.S. House of Representatives Judiciary Subcommittee held a hearing Wednesday — “Follow the Science?: Oversight of the Biden Covid-19 Administrative State Response” — during which Dr. Philip Krause, former deputy director of the FDA’s Office of Vaccines Research and Review (OVRR) vaccine products provided evidence to support the report’s conclusions.
Krause testified that both he and OVRR Director Marion Gruber were relieved of their responsibilities overseeing the COVID-19 vaccines review process because the administration wanted to rush FDA approval on a faster timeline than their office could deliver and push forward the fall mandates, Vinay Prasad, M.D., MPH, reported.
The approval process was then pushed through by the director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D., and then-Acting FDA Commissioner Janet Woodcock.
Documents obtained by Children’s Health Defense (CHD) through a Freedom of Information Act Request also showed that in early 2021, both Marks and Woodcock were aware of injuries linked to the vaccines.
Krause testified that the original timeline to complete the review process for Pfizer’s Biologics License Application (BLA) for its mRNA COVID-19 product was January 2022, but the team was already shooting to have the process completed earlier.
In early July 2021, “something had happened to completely change the opinion of Drs. Marks and Woodcock regarding the urgency of completing the BLA review,” Krause testified. “It was so important to them that they did not trust the experts who led the Office of Vaccines to do it, even with their help,” he said.
Krause told the committee that on July 19, he and Gruber were taken off the review process and Marks took it over himself.
He added:
“In this meeting, Drs. Woodcock and Marks expressed concern about the rising number of COVID cases in the US and globally, largely caused by the Delta variant and stated their opinion that, absent a license, states cannot require mandatory vaccination and that people hesitant to get an EUA authorized vaccine would be more inclined to get immunized if the product were licensed.”
Marks informed staff that the goal was to complete the review as rapidly as possible, Krause said. Pfizer’s Comirnaty COVID-19 vaccine was licensed on Aug. 23, 2021.
“As predicted by Drs. Woodcock and Marks, vaccine mandates followed immediately afterwards and were announced the same day for DoD [U.S. Department of Defense] and for New York State,” Krause said.
He said that the speed with which the mandates were implemented following authorization, “suggested that the rapid review of the vaccine was motivated more by a desire to mandate vaccines than by other public health considerations.”
Given that mandates are outside of the FDA’s purview, he added, the fact that Marks and Woodcock cited the need for mandates as a reason to speed the review “strongly implies that pressure to complete the review” more rapidly than planned came from outside of the FDA, he added.
When Krause and Gruber tried to implement a slower and more deliberative process, they were demoted, Prasad wrote.
As a result, they both left the agency at the end of 2021.
Prasad noted the mandates were issued only after the administration knew the vaccine couldn’t stop transmission and “as such, the mandates were unethical.”
“Krause’s testimony shows the Biden administration engaged in inappropriate political tampering with the FDA, and the FDA leaders — Woodcock and Marks — folded to political pressure,” he added.
Woodcock, now retired from the FDA, has since expressed regret about not doing more to respond to the concerns of the vaccine-injured, telling The New York Times she is “disappointed” in herself
Marks is still at the FDA, where Prasad said he “has been doing a bad job,” recently authorizing a product from Sarepta Therapeutics despite a failed study and a negative decision from reviewers.
Robert F. Kennedy Jr., independent presidential candidate and CHD’s chairman on leave, tweeted that Marks also made commercials for the vaccine, claiming it was safe and effective in pregnancy and for children. “Had Pfizer said that, it would have been a crime,” Kennedy said.
In his testimony, Krause also made a series of comments confirming early knowledge of myocarditis — with rates as high as 1 in 5,000 for young men in early studies — and the protection conferred by natural immunity.
He also said that he did not take a booster shot.
Chief Nerd called Krause’s comments “stunning admissions” and posted a video clip on X, formerly known as Twitter:
? Fmr. FDA Vaccines Deputy Dr. Philip Krause Makes a Series of Stunning Admissions Which Were Once Referred to as ‘Conspiracy Theories’
— Chief Nerd (@TheChiefNerd) June 26, 2024
“The rates of myocarditis in these young men was quite high. In the early studies, it appeared to be around 1-in 5,000 vaccinees. We still… pic.twitter.com/k0UdRaw5tg
New Documents Link White House Advisor Slavitt to Pfizer and Twitter Amid Covid Speech Debate
More internal documents originating from X have emerged, revealing some of the dynamics and ways used by the US government to, through one kind or another of roundabout pressure, nudge social platforms in the direction of censoring speech around Covid topics.
How this happened on the now former Twitter is what the documents reveal, and it all goes back to 2021 when a former Biden administration “Covid response” adviser, Andy Slavitt (who was at the point of these interactions still using the White House email address), put major Covid vaccine-maker Pfizer’s board member Scott Gottlieb in touch with Todd O’Boyle.
Alex Berenson, who has an active lawsuit against the Biden administration’s censorship attempts, has reported on this, suggesting that it was O’Boyle’s role was to, as a senior lobbyist for Twitter, interact with the White House. “I wonder if you would be open to a 20 minute call with Scott Gottlieb and me about a policy matter,” reads one email Slavitt sent to O’Boyle.
All this was happening just as the debate around Covid vaccines was heating up. Specifically, there was rising skepticism about the effectiveness of these jabs, and this was the time when the infamous “booster shots” made their debut.
This, according to the documents, sprung Pfizer (who clearly benefited from selling as many “boosters” as possible) to action, with Gottlieb at one point telling O’Boyle there was concern about “false narratives on key public health issues.”
That’s one way of saying that criticism of the vaccine needs to be suppressed as misleading.
Next in this particular chain of events – a part of a bigger controversy that some consider to be no less than a US government-Big Tech collusion – was O’Boyle letting Twitter’s US public policy head Lauren Culbertson know about Gottlieb’s sentiment.
Culbertson then shared this with other Twitter execs, indicating that – although the Pfizer board member’s remarks, as well as those made by Slavitt, were carefully worded – they were in fact directly related to the Biden administration’s pressure to shut up vaccine skeptics on Twitter.
But it wasn’t the only form of pressure social platforms were experiencing at the time.
Some observers – and victims of censorship – see repeated threats of “reform” or “review” of Section 230 (which protects internet services from legal liability) as something the White House used to “prime” these companies to become susceptible to other kinds of pressure.
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Supreme Court Set To Rule on Trump Immunity Case Today
The Supreme Court will release its final opinions today on whether Trump should be declared immune from prosecution with regard to the “classified documents” case brought against him in Florida by prosecutor Jack Smith.
Trump’s attorneys have argued that former US presidents should enjoy a broad degree of immunity from criminal charges for particular activities while they were in office.
The Supreme Court challenge has brought the “classified documents” case to a halt, and it’s unlikely that there will be a trial before November.
Although lower courts have rejected the Trump legal team’s arguments, a number of Supreme Court Justices appeared to support them during oral hearings in April.
Chief Justice Roberts, for example, questioned the appeals court ruling that rejected Trump’s immunity claims. He said the appeals courts did not make it clear whether it believed the official indictment against Trump was targeting his official or private acts.
Justice Brett Kavanaugh said that the “classified documents” case “has huge implications for the presidency, for the future of the presidency, for the future of the country.”
Other Justices, including Elena Kagan, appear to support the prosecution.
“The Framers did not put an immunity clause into the Constitution. They knew how to,” Justice Kagan said.
“And, you know, not so surprising, they were reacting against a monarch who claimed to be above the law. Wasn’t the whole point that the president was not a monarch and the president was not supposed to be above the law?”
Former president Trump has pleased not guilty to 40 criminal counts related to his handling of classified documents. Prosecutors have alleged that he refused to return documents containing classified information relating to subjects like US nuclear capability.
Zelensky Outlines Model for Talks with Russia
Kiev does not rule out future peace talks with Moscow but they can only be held through intermediaries, Ukrainian leader Vladimir Zelensky told the Philadelphia Inquirer on Sunday. He suggested that the format used to broker the 2022 Black Sea grain deal could be useful for this purpose.
Kiev has previously refused to accept Russia’s terms as a basis of talks and accused Moscow of being incapable of good-faith negotiations. In late 2022, Zelensky even issued a decree, proclaiming the “impossibility” of holding talks with Russian President Vladimir Putin.
Moscow, meanwhile, has maintained that it is ready to restart negotiations but only if Kiev renounces claims on the territories that have been acquired by Russia during the conflict. In autumn 2022, four former Ukrainian territories – the two breakaway Donbass republics and the regions of Kherson and Zaporozhye – formally joined Russia following a series of referendums. Ukraine has never recognized the voting results and continues to lay claim to these regions, as well as Crimea, which joined Russia following a similar referendum in 2014.
In his interview with the Philadelphia Inquirer, Zelensky said that Ukraine “can find a model” for a potential settlement with Russia. He pointed to the deal brokered two years ago by Türkiye and the UN that allowed the establishment of a corridor for agricultural exports from Ukrainian ports.
Read more Ukraine ‘wants peace as soon as possible’ – Zelensky aide
According to Zelensky, Ankara and the UN had signed separate agreements with Moscow and Kiev. “It worked,” he said, adding that the grain corridor then existed “long enough.”
Moscow and Kiev were close to reaching another grain deal in March, but Ukrainian negotiators abruptly walked away after two months of talks, according to Reuters.
Agreements on “territorial integrity, energy and freedom of navigation”could be struck between Moscow and Kiev in the same format, Zelensky stated. He suggested that other countries could be invited to mediate.”No one should say that it is … just Europe and the US,” he said, adding that nations from Asia, Africa, and South America should participate as well and help prepare the documents that would be presented to Moscow and Kiev.
“So far, there is only this model,” Zelensky said. He stressed, however, that the final agreement should “suit” Kiev and be based on Ukraine’s terms.
Read more Ukraine does not want to ‘prolong war’ – Zelensky
Zelensky has long sought to promote his own 10-point “peace formula,”most recently during the summit in Switzerland on June 15-16, which Russia did not attend. Moscow has flatly rejected Zelensky’s terms, insisting that the status of its newly acquired territories is non-negotiable. Putin further demanded in June that Kiev withdraw all troops from the parts of the four Russian regions it currently controls.
According to Putin, Ukraine must also renounce its plan to join NATO and become a neutral country, as well as limit the size of its army.
Despite rejecting Russia’s terms, Kiev has recently been signaling its willingness to end the fighting. In June, the deputy head of Vladimir Zelensky’s office, Igor Zhovkva, said that Ukraine wanted “peace as soon as possible.” Zelensky himself said last week that Kiev did not want to “prolong the war” and make it “last for years.”
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All American military bases throughout Europe have been placed on high alert due to a potential terrorist attack against facilities or personnel. An unnamed official told Fox News: “There is credible intel pointing to an […]
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