FDA Records Show Top FDA Officials
Concerned About Biden Administration Vaccine Booster Timelines That “Make
No Sense”
We can confirm that the FDA’s decisions on Covid booster shots were not
entirely about “science.”
We received 112
pages from the Food and Drug Administration that show top officials
being pressured by “companies and, for that matter the Administration,
who try to impose timeless [sic] that make no sense.”
We received the records in response to a February 2022 FOIA lawsuit
against the Department of Health & Human Services filed after HHS failed to
respond to a September 3, 2021, FOIA request for records of communication
from the former director and deputy director of the FDA’s Office of
Vaccines Research and Review, Dr. Marion Gruber and Dr. Philip Krause,
respectively (Judicial
Watch v. U.S. Department of Health and Human Services (No.
1:22-cv-00292)).
Drs. Gruber and Krause reportedly resigned during the White House’s push
to approve the COVID-19 vaccine “booster shots.”
On September 13, 2021, Gruber
and Krause were among a group of resigning
doctors who agreed that, “Available evidence doesn’t yet indicate a
need for COVID-19 vaccine booster shots among the general population
…”
The records include an August 25, 2021, email
by Marion Gruber to her boss, Center for Biologics Evaluation and Research
(CBER) Director Peter Marks:
Over the last couple of days, Janssen has bombarded us with emails
regarding their booster dose studies.
***
I am also very concerned that companies (such as Pfizer and Janssen) are
trying to put pressure on OVRR [Office of Vaccines Research and Review] by
way of PR [public relations]. We need to be given time to consider their
data and cannot be pushed by these companies and, for that matter the
Administration, who try to impose timeless [sic] that make no sense (e.g.,
Sep 20)…. It appears that at least Pfizer’s data will not be aligned
with this approach and the ‘n’ [test numbers] they have is grossly
insufficient. Obviously, we have to review the data but we have taken a
peak and have serious concerns.
Lastly, and this is my personal opinion, data we have seen so far from
various companies (Pfizer, Janssen, Moderna) appear to suggest that
boosters are not needed.
In an email
exchange on August 27, 2021, Gruber replies to an email from Maureen
Hess, a communications specialist at the Center for Biologics Evaluation
and Research: “Well, the message appears to be ‘total buy-in in the
need for boosters,’ this is not how I am writing the BD [likely board
decision], I am trying to take a more neutral approach. This piece sounds
as if we already decided to approve this supplement.”
Hess responds, “Okay, I’ll make some additional edits (but JW [likely
Acting FDA Commissioner Janet Woodcock] was included on this statement –
https://www.cdc.gov/media/releases/2021/s0818-covid-19-booster-shots.html
– so our edits may be rejected above us.” After sending more emails
about edits Hess made, Gruber replies, “From my perspective this is as
good as it can get. Obviously, this statements [sic] puts us into a real
bind but the damage is already done.”
In an Aug. 20, 2021, email
exchange Dr.
Doran Fink, the Deputy Director of the FDA’s Division of Vaccines and
Related Products Applications raises questions regarding new data, that
Moderna was submitting to FDA about its COVID vaccine. Fink told Drs.
Gruber, Krause and other colleagues:
I had to bite my tongue when Peter [likely Dr.
Peter Marks, Director of the Center for Biologics Evaluation and
Research] mentioned this morning we wouldn’t be doing rushed reviews
anymore so as not to ask about the booster doses that the administration
promised to everyone by Sept 20!
***
And then there is the question of the data that will support these booster
doses – maybe I’m wrong, but my understanding is that Pfizer is
proposing that their sBLA include the Phase 1 booster data from a grand
total of 23 subjects. I’m not sure what Moderna will have, but the data
Fauci presented in the press conference from NIAID studies, which was ~25
subjects per treatment arm.
Gruber states in an August 17, 2021, email
“They [Dr. Doran’s team] fully understand that the Acting Commissioner
would like to approve this product [Pfizer Covid booster vaccine] very soon
and are trying their best to complete their review and assessment, while at
the same time, maintaining our high standards and scientific and clinical
integrity.”
Philip Krause, in an August 10, 2021 email,
complains: “It sounds like Peter [likely Center for Biologics Evaluation
and Research Director Peter Marks] thinks he has taken over all vaccine
operations, not just the Pfizer BLA [Biologics License Application]
…”
On August 23, 2021, Dr. Arnold Monto, Professor in the Department of
Epidemiology of the University of Michigan School of Public Health, emails
Drs. Gruber and Krause using the subject “VRBPAC and boosters:”
The Surgeon General last night made a statement that the FDA and CDC
advisory committees would be reviewing Hope that he misspoke about the
VRBPAC (Vaccines and Related Biological Products Advisory Committee)
Doesn’t seem to be enough time to get it organized Just got asked about
flu vaccination and Covid boosters being given at the same time. Gave my
personal information, don’t
Gruber then replies to Monto: “We will be discussing the ‘booster
question’ and related submissions including whether VRBPAC should be
held. We do not know yet and you are right that timing will be an issue
once again.”
On September 22, 2021, the FDA approved use of a booster dose of the Pfizer
drug. According to the organization’s news
release, the FDA, “amended the emergency use authorization (EUA) for
the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster
dose, to be administered at least six months after completion of the
primary series” for people at “high risk” of “severe
COVID-19.”
These documents confirm a politicized approval process for the
controversial Covid-19 vaccine booster shots. It is a scandal that took
months and a federal lawsuit to expose these troubling facts about this
unprecedented and seemingly never-ending vaccine operation.
Judicial Watch Sues for Emails of Dr. Fauci’s Spouse, Christine
Grady
We want basic information about the work Dr. Anthony Fauci’s wife, Christine
Grady, who is also employed by the National Institutes of Health. The
Biden administration is trying to block us.
We filed a FOIA suit against the Department of Health and Human Services
for her emails referencing the COVID-19 and related vaccine controversies.
She is an important government official who serves as chief of the Clinical
Center’s Department of Bioethics. (Judicial
Watch. v. U.S. Department of Health and Human Services (No.
1:22-cv-02112)).
We sued after NIH responded to our September 9, 2021, FOIA request on
October 6, 2021, by stating that it had recently processed a similar
third-party FOIA request and asking if we would limit our request to mirror
the third-party’s request. We denied this request.
Our FOIA request asks for:
- All emails sent to and from NIH Clinical Center/Department of
Bioethics Director Christine Grady regarding vaccines for the prevention
and/or treatment of SARS-CoV-2 and/or COVID-19.
- All emails sent to and from Ms. Grady referencing the terms
“Antibody Dependent Enhancement,” “ADE” (when used to represent
Antibody Dependent Enhancement), “pathological priming,”
“pre-priming,” “paradoxical immune enhancement,” and/or “disease
enhancement.
- All emails sent between Ms. Grady and [National Institute of Allergy
and Infectious Disease] Director Anthony Fauci.
NIH has been hiding Ms. Grady’s emails for almost a year in violation of
FOIA law. This is the very definition of a cover-up. The unlawful cover-ups
of Fauci family government records strongly suggest that there is something
to hide.
This is part of our ongoing investigation into the US government’s
handling of the COVID-19 pandemic, including the activity of Dr. Fauci and
his wife.
Last week, we filed a FOIA lawsuit
on behalf of American Transparency (OpenTheBooks.com) against HHS for
Grady’s employment and financial disclosure records.
An October 2021 lawsuit uncovered
that over a 10-year period, Fauci and others at NIH received more link to
than $350 million in secretive “royalty” payments from drug companies
and other third parties.
Another Judicial Watch lawsuit
also just uncovered that an infamous Fauci agency grant tied to the Chinese
Wuhan Institute of Virology and gain of function research had been under
FBI investigation.
We’ll be sure to let you know if and when any new emails in this case
come in.
Judicial Watch Sues for Naval Academy Critical Race Theory
Records
The Marxist Critical Race Theory has spread throughout our military.
We filed a FOIA lawsuit against the U.S. Department of Defense for records
related to the United States Naval Academy implementing Critical Race
Theory (CRT) in the training of midshipmen. (Judicial
Watch. v. U.S. Department of Defense (No. 1:22-cv-02172)).
We sued after the agency failed to respond to an August 5, 2021 FOIA
request for:
- Any and all PowerPoint presentations used for training and/or
classroom instruction discussing Critical Race Theory, CRT (when used to
represent Critical Race Theory); and/or “white supremacy.”
- Any and all emails referencing Critical Race Theory, CRT (when used to
represent Critical Race Theory); and/or “white supremacy” sent between
mil and/or .gov email accounts and any of the following USNA officials:
Superintendent VADM Sean Buck and/or Deputy Superintendent CAPT James
Bates.
Marxist Critical Race Theory and its racial division have no place in the
Naval Academy, which is training the next generations of Navy leadership.
That the Pentagon has been unlawfully hiding these records for a year
suggests something awful is afoot.
On June 24, 2022, The Federalist reported
that the US Navy, “issued an instructional
video training its members to create a ‘safe space’ by using
‘correct’ pronouns. The video emphasized how service members must use
‘inclusive languages’ and not ‘misgender’ others.”
In June, we uncovered
over 700 pages of documents revealing critical race theory (CRT)
instruction at the U.S. Military Academy, West Point. One training slide
contains a graphic titled “MODERN-DAY SLAVERY IN THE USA” and many of
the documents denounced “whiteness.”
I appeared
on “Tucker Carlson Tonight” to discuss these documents and the US
Navy’s pronouns. In speaking about what we have uncovered in their
investigation, I warned:
They suggest that blacks are still the equivalent of slaves today, and
they’re pushing queer theory, which is a “cousin” of the Marxist
critical race theory.
And so our military is being undermined from within. This is the type of
Marxist revolutionary (agenda) that our military was designed during the
Cold War to try to protect this nation from. And now they’re on the
inside.
Lobbyist Brother of Top Biden Advisor Profits Immensely from WH
Ties
It pays to know someone in the White House. Are you surprised? Once
struggling lobbyist Jeff Ricchetti has clearly benefited once his brother
Steve became Biden White House Counselor. Our Corruption
Chronicles blog reports.
Despite President Biden’s order
to “restore ethics in government” by banning members of his
administration from using public service for private gain, his top
advisor’s lobbyist brother is profiting immensely from ties to the
administration after struggling for years. Records obtained by Judicial
Watch show Jeff Ricchetti’s small lobbying firm had just one client in
the years leading up to Biden’s election but has made an unbelievable
turnaround since his brother, Steve Ricchetti, became White House
Counselor. In fact, Ricchetti Inc. has made a killing since Steve, a
longtime Biden confidant and one of the president’s most trusted aides,
became the commander-in-chief’s top advisor. A slew of recently filed
lobbying disclosures obtained by Judicial Watch show that Ricchetti Inc.
raked in hundreds of thousands of dollars in revenue in just one
quarter.
The exceptionally profitable quarter illustrates an upward trajectory for
the once-struggling little firm that began thriving in the aftermath of
Steve’s White House appointment after many sluggish years. In the first
half of 2021, the firm made $1.7 million, more than quadruple the $370,000
it earned during the same period the previous year, according to filings
obtained by a mainstream
newspaper. Jeff’s client list grew quickly when Biden won the
Democratic nomination, the article states, and his firm has since enlisted
high-profile clients such as General Motors, Amazon and several drugmakers.
The Ricchetti brothers—63-year-old Steve and 60-year-old Jeff—are
considered one of the most important power brokers in government. “Not
since the heyday of John and Tony Podesta, who served in the Obama White
House and dominated K Street, respectively, have siblings wielded so much
public and private power in Washington,” reads a national news
story published last year. “While John Podesta held a series of
high-ranking positions in the Clinton and Obama White Houses, Tony Podesta
built one of the largest influence-peddling operations in the capital
city,” the article continues. “He minted money, party-hopped around
town in red leather shoes and amassed a museum-quality collection of
artworks valued in the tens of millions of dollars.”
The latest lobbying disclosures obtained by Judicial Watch show that most,
though not all, of Jeff’s new clients are in the vaccine or
pharmaceutical industry. In all, the records show an estimated $860,000 in
revenue for the second quarter. That includes $80,000 from Vaxart, which is
currently conducting trials for an oral COVID-19 vaccine. An animal study
for the vaccine was funded by the Gates Foundation. The first disclosure
showing Jeff Ricchetti as a paid lobbyist for the company was in January
2021. Seven months later, the Food and Drug Administration (FDA) approved
the vaccine candidate as an investigational new drug, the records confirm.
The White House Counselor’s little brother also earned $80,000 to lobby
the administration on behalf of Pardes Biosciences, which is developing a
therapeutic for COVID-19. Its Investigational New Drug (IND) application
was approved by the FDA in February, the lobbying disclosures
reveal.
Jeff’s firm also made $90,000 from TC Energy (formerly TransCanada), the
company that was developing the Keystone XL pipeline, which was supposed to
carry more than 800,000 barrels of oil daily from Canada to the U.S.
President Donald Trump granted the permit for the project, but Biden
revoked it in his first day as president. TC Energy is seeking $15 billion
in damages from the Biden administration as compensation for rescinding its
permit to build the 1,200-mile pipeline and it is not entirely clear what
Jeff’s role is in the matter, though he is being generously compensated.
Jeff’s lobbying firm was also paid $50,000 by a tech company,
InterDigital, working on wireless communications and fifth-generation
wireless (5G). Four months before the 2020 election Ricchetti Inc.
registered InterDigital as a client and by September 2021 the company was
awarded a $525,000 contract from the Department of Defense (DOD), its first
federal deal in nearly a decade and a half.
The most recent quarterly records also show that a global semiconductor and
display panel manufacturer called Applied Materials paid Jeff’s firm
$60,000. The specific lobbying subject is described in the documents as
“issues related to U.S.-China relations and potential impact on
commercial relationships, including the manufacture of semiconductor
equipment and energy storage and battery technologies.” Industry
publications report that the company, which owns a subsidiary in China, is
expected to benefit from the CHIPs Act that was recently approved by the
Senate to provide $52 billion in subsidies to build computer chips in the
U.S. Other Ricchetti Inc. earnings recorded in the latest quarterly
disclosure include Amazon ($90,000), Pharmaceutical Research and
Manufactures of America ($60,000) and General Motors ($60,000). Biden’s
election and his brother’s White House position have clearly paid off for
Jeff, despite the president’s ethics order. An analysis conducted by
Judicial Watch found that in 2021 and 2022, he has signed a firm high of 15
new clients, compared to: Zero in 2014, two in 2015, two in 2016, zero in
2017, zero in 2018 and just one client in 2019. Registration dates for the
new clients are all clustered around the election, according to the records
obtained by Judicial Watch.
Until next week,
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