Report 98: FDA Selected Its 'Vaccines Advisory Committee' - Not Its Gene Therapy Advisory Committee - to Recommend the COVID Injections for Emergency Use, Hid Nature of Products

By Lora Hammill, BSMT, ASCP; Loree Britt; Michelle Cibelli, RN, BSN; Erika Delph, RPh; Chris Flowers, MD; Barbara Gehrett, MD; Joseph Gehrett, MD; Cassie Papillion; David Shaw; and Tony Damian

COVID-19 'vaccine' drugs are modified mRNA gene therapy products. So, why did the FDA assign the review and recommendation responsibilities to the Vaccines and Related Biological Products Committee (VRBPAC) instead of the Cellular Tissue and Gene Therapy Advisory Committee (CTGTAC)? CTGTAC was the logical FDA advisory committee for such a product. Yet the FDA insisted on calling the COVID-19 gene therapy injections 'vaccines' and assigned them to VRBPAC.

In September 2021, the Centers for Disease Control and Prevention (CDC) changed the definitions of ‘vaccine’ and ‘vaccination’ to match the output measurement (i.e., antibody titers) of the mRNA products. To date, the CDC has not logically justified its changes to those definitions, and the FDA has not explained why it selected a vaccine advisory committee to review and approve gene therapy products.

What are the roles and purposes of the various FDA committees? Are they in place to support Big Pharma or to protect the American people?

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All drug products must undergo scrutiny by the Food and Drug Administration (FDA) before they can be used in clinical trials or marketed to the general public. The FDA utilizes advisory committees of selected scientific experts to review information about drug products and to assess whether or not the drug is authorized/approved for human use. The type of drug product determines the committee assigned the task of safety and efficacy data review, and the responsibility for voting to recommend or reject authorization or approval of the drug.

The Cellular, Tissue and Gene Therapy Advisory Committee (CTGTAC) reviews data for drugs that are gene therapies, and the Vaccine and Related Biological Products Advisory Committee (VRBPAC) is responsible for the scientific data review of prospective vaccines and related biological products. Pfizer and Moderna presented drug products —BNT162b2 and mRNA-1273 respectively —to the FDA for consideration as treatments in response to the SARS-CoV-2 virus. Both drug product candidates were made from modified messenger ribonucleic acid (modRNA, often incorrectly referred to as ‘mRNA’) sequences wrapped in lipid nanoparticles. These two drugs are genetically modified mRNA products, but they were labelled by the FDA as “vaccines” and assigned to VRBPAC for evaluation.

Were the correct “experts” advising the FDA on the authorization of modified mRNA drug products?

What Is Gene Therapy?

From the FDA’s website:

“Gene therapy is a technique that modifies a person’s genes to treat or cure disease. Gene therapies can work by several mechanisms:

• Replacing a disease-causing gene with a healthy copy of the gene.

• Inactivating a disease-causing gene that is not functioning properly.

• Introducing a new or modified gene into the body to help treat a disease.

Gene therapy products are being studied to treat diseases including cancer, genetic diseases, and infectious diseases.” [Emphasis added.] [https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/what-gene-therapy]

Pharmaceutical companies manufacture the COVID-19 “vaccine” drug products using modified mRNA. Modified mRNA is taken up and utilizes a cellular mechanism to produce spike proteins for immune recognition. There is a greater potential risk of delayed adverse events following exposure to human Gene Therapy (GT) products.  Per the FDA website:

“The possibility of site-specific changes in the human genome raises the potential for

• malignancies (cancer),

• impairment of gene function

• prolonged exposure to the protein produced and the potential for autoimmune-like reactions.

For these reasons, GT products require more rigorous evaluation before receiving approval for use. Studies must answer long-term effect questions as well as assess risk to cells, tissues, and/or organs targeted by the GT product. Such studies take time to gather statistically relevant data.” [https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/cellular-gene-therapy-guidances]

Why Did the CDC Change the Definition of ‘Vaccine’ and ‘Vaccination’ in September 2021, 10 Months After EUA Was Granted to Pfizer and Moderna for Their COVID-19 Drugs?

We are unsure as to why the CDC changed the definitions for vaccine and vaccination or why the definitions were changed at that particular time. Ten months passed between the initial emergency use authorizations (EUAs) for Pfizer and Moderna and the CDC’s “vaccine” definition change. Was this for commercial reasons? Did the FDA’s approval of COMIRNATY® (the Pfizer-BioNTech COVID-19 “vaccine”) in August 2021, and the fact that the original definition of a “vaccine” did not fit the CDC's new definition, influence this decision?

The Pfizer and Moderna COVID-19 drug products were labelled as “vaccines” well before the “vaccine” definition changed, and the FDA assigned VRBPAC as the advisory committee reviewing the COVID “vaccines”-related data as early as May of 2020. But, are these COVID drugs truly “vaccines,” or are they gene therapies, as defined by the FDA? The distinction matters since it drives the review and approval processes for the drugs.

How Do the Functions and Authority of VRBPAC Differ from CTGTAC?

Table 1 compares the roles of the two advisory committees: the Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the Cellular, Tissue, and Gene Therapy Advisory Committee (CTGTAC). The FDA website lists the duties and scope of activities with which each of the advisory committees are charged.

Table 1:

The public relies on United States regulatory public health agencies to safeguard them from potential harms. The FDA has the job of protecting the citizens from drugs and other biologic drug products that can cause harm to humans, whether or not the harms are due to negligence from the drug companies or unintended consequences of the proposed treatment(s).

The FDA, a U.S. regulatory agency, provides guidance to drug companies to ensure they follow best practices in manufacturing drugs and biologics intended for human use. Pre-clinical trials involving animal studies follow strict guidelines. The drug maker must adhere to protocols which monitor safety and toxicity information. Once the drug candidate progresses to the human clinical trial phase, expectations are even higher surrounding the monitoring and documentation of safety, dosing, and other signals that will ensure the product is safe for humans.

“Developers of gene therapy products must adhere to additional regulations beyond that of traditional small-molecule therapeutics, due to the unique mechanism-of-action of gene therapy products, and the subsequent novel risks arisen.” [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5733859]

In an effort to provide another layer of approval process oversight, the FDA selects the members of both the VRBPAC and the CTGTAC advisory committees who then advise the FDA. While it might appear to be the case, these are not outside, independent advisory committees since some committee members are government health agency employees. Legally, the persons involved in voting are expected to follow federal rules per the website:

“Non-Federal members of this committee will serve as Special Government Employees, representatives, or Ex-Officio members. Federal members will serve as Regular Government Employees or Ex-Officio. Ex Officio voting members one each from the Centers for Disease Control and Prevention, and the National Institutes of Health may be included.” [https://www.fda.gov/advisory-committees/vaccines-and-related-biological-products-advisory-committee/charter-vaccines-and-related-biological-products-advisory-committee]

“18 U.S.C. 208(a) prohibits all employees, including Special Government Employees, serving on advisory committees, from participating in any particular Government matter that will have a ‘direct and predictable effect’ on their financial interests.” [https://www.fda.gov/media/87421/download]

Emergency Use Authorization (EUA) Eligibility

It is important to note a “vaccine” can be authorized for emergency use. The FDA assigned the modified mRNA COVID-19 drug product reviews to VRBPAC, the vaccine advisory committee. VRBPAC subsequently recommended both the Pfizer and Moderna COVID-19 drugs for approval as vaccines. The FDA then authorized the COVID-19 “vaccines” for public use in people ages 16 or 18 and older under an emergency use authorization (EUA) for Pfizer (BNT162b2) and Moderna on December 10, 2020, and December 17, 2020, respectively.

How Are We As Consumers Impacted?

Marketing the COVID-19 products as “vaccines” offered decided advantages to those intent on swift injection of the masses. The public recognizes the term “vaccine” and generally thinks of vaccines as safe to take, based on decades of familiarity with traditional vaccines.  However, if the vaccine versus gene therapy distinctions presented in this report had been openly and publicly discussed when the COVID-19 shots became available, would the general public have lined up as enthusiastically and confidently to take multiple injections of what is clearly a gene therapy product?

At the World Health Summit in 2021, Stephan Oelrich from Bayer, the well-known drug maker, admitted to the potential hesitancy mentioned above. In his address to the attendees, Oelrich said, “Ultimately the mRNA vaccines are an example for that cell and gene therapy. I like to say that if we had surveyed two years ago, in the public, ‘Would you be willing to take gene or cell therapy and inject it into your body?’ we would have probably had a 95% refusal rate.” [Emphasis added.] [world health summit 2021 - Search Videos (bing.com)]

The pharmaceutical industry, with assistance from world governments, deceived the general public about the type of drug being publicly mass distributed and injected to allegedly prevent COVID-19.

Were consumers aware the emergency use authorized, COVID drugs did not work? Early post-marketing data and data from the clinical trials showed that the COVID-19 “vaccine” was not effective at protecting the person from COVID-19 or reducing transmission of it. [https://www.phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf] When the CDC changed the “vaccine” definition to be less specific, it created a persuasive loophole to facilitate the government’s stated goal of mass public vaccination. This improper categorization of the drugs as “vaccines” rather than gene therapies, provided the public a false sense of security that they would be protected from illness, when in fact the modified mRNA drugs were built on a novel platform with no long-term safety or efficacy record.

The harmful consequences of the mis-categorization of the products continue unfolding. Could the deaths and serious adverse events from these shots have been avoided if they were classified properly and required to undergo the higher level of scrutiny required for gene therapy products?  Had the proper gene therapy advisory committee reviewed the data, would it have hesitated to recommend approval of drugs using this experimental platform?

A comparison of the FDA’s own policies answers these questions. The gene therapy testing and approval process is decidedly more demanding.

The FDA provides guidance in the code of federal regulations (CFR) for cellular and gene therapy (CGT) products which require:

• more rigorous testing

• proof of potency

• safety

• stability

“Similarly, potency measurements are used to demonstrate that only product lots that meet defined specifications or acceptance criteria are administered during all phases of clinical investigation and following market approvals.” [Emphasis added.] [https://www.fda.gov/vaccines-blood-biologics/biologics-guidances/cellular-gene-therapy-guidances]

Searching the FDA’s guidance regulations for vaccines versus gene therapy products, we found Section 610.15 of the Code of Federal Regulations on General Biological Product Standards, which states that vaccine products “shall meet generally accepted standards of purity and quality.”  [Emphasis added.] [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=610.15]

It is clear, by the FDA’s own words, that gene therapy products undergo a much more thorough level of scrutiny.

As we move into an examination of the actual advisory committee meetings, it should be noted that the FDA publicly releases minutes and video of these meetings  at its own discretion. This potential lack of transparency is important to our investigation. Does the FDA have additional documentation about the rationale behind classifying these products as “vaccines” rather than gene therapies?

During the Advisory Committee Meetings, What Questions Were Asked? Who Voted? How Did They Vote?

The FDA publishes VRBPAC meeting minutes on its website. These minutes capture the topics discussed at each meeting and often conclude with a vote around a specific question that the meeting addresses. At the end of the day, the VRBPAC members cast their votes, resulting in recommendations to the FDA on the given topics. An analysis of the votes cast to approve the COVID-19 “vaccines,” across all age groups, demonstrates an overwhelming push to approve these novel products.  Meeting after meeting, the vote tally was essentially a landslide in favor of authorizing use of COVID-19 “vaccines” in humans as young as six months of age.[https:www//fda.gov/advisory-committees/committees-and-meeting-materials]

VRBPAC held general discussions about viral pathogens and about COVID-19 in its March 2020 and October 2020 meetings. The meetings listed below, starting in December of 2020, included discussions with deciding votes on committee recommendations to the FDA.

• Dec 10, 2020, Topic: discuss/vote Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 “vaccine” (BNT162b2) 16 years and older.

• Dec 17, 2020, Topic: discuss/vote EUA for Moderna COVID-19 “vaccine” (mRNA-1273) 18 years and older.

• June 10, 2021, Topic: discussion to expand the EUA for Pfizer COVID-19 “vaccine” to adolescents and pediatrics.

  • NOTE: For expanding the Pfizer Emergency Use Authorization for 12- to 15-year-olds, a vote was not registered in the meeting minutes (June 2021 see orange column in Table 2). However, the transcript indicates that the advisory committee did generally recommend adolescents 12- to 15-years-old could receive COVID-19 “vaccines.”

• August 23, 2021: FDA announces approval for “Pfizer-BioNTech COVID-19 Vaccine,” marketed as COMIRNATY®, for 16 years and older. (FDA website does not list a related VRBPAC meeting with minutes.)

The discussion during the committee meeting on September 17,2021, centered around the approval of a Biologics Licensing Agreement (BLA) for the Pfizer COVID-19 “vaccine” booster. Approval for a BLA, in contrast to the existing emergency use authorization, would allow Pfizer to sell the drug product directly and not be limited to emergency use. A YES vote by the committee would have resulted in an official FDA approval for the drug’s use as a booster for persons ages 16 and over. The VRBPAC members voted no in the majority on this issue. The members expressed concerns about post-authorization data which demonstrated increased risk of myocarditis and pericarditis from the “vaccine,” with the highest risk in males 16- to 17-years-old.

• Sep 17, 2021, Topic: discussion/vote on two questions:

  • 1) Do the safety and efficacy data from clinical trial C4591001 support approval of COMIRNATY® booster dose administration at least six months after completion of the primary series for use in 16 years and older?

  • 2) Based on the evidence available, including safety and efficacy data from clinical trial C4591001, do the benefits outweigh known and potential risk of COMIRNATY® booster for use in 65 years and older and individuals at high risk of severe COVID-19?

The distinction in the second question above of only extending booster use to ages 65 and older and individuals at high risk was not communicated to the public. In 2021, media messages from television to radio were a constant barrage of “get your booster” with no clear language stating that the approval was only for those 65 and older and individuals at high risk. Question Two received a unanimous ‘Yes’ vote to authorize the COMIRNATY® boosters for 65 and older and individuals at high risk.

• Oct 26, 2021, Topic: discuss/vote to extend the Pfizer EUA to five through 11 years

• June 14, 2022, Topics:

  • Extend the EUA for Moderna COVID-19 2-dose series (100 µg each dose) in children 12 to 17 years.

  • Extend the EUA for Moderna COVID-19 2-dose series (50 µg each dose) in children six to 11 years.

  • Unanimous vote of YES for both questions.

• June 15, 2022, Topics:

  • Extend the EUA for Pfizer COVID-19; 3-dose series (3 µg each dose) in children six months to four years.

  • Extend the EUA for Moderna COVID-19; 2-dose series (25 µg each dose) in children six months to five years.

  • Unanimous vote of YES for both questions.

Table 2: VRBPAC Voting Record

Note: The orange column for 10Jun2021 indicates that there was no formal vote on the topic of extending the EUA for COVID-19 “vaccine” to adolescents 12-15 years old.

What Types of Expertise Were Represented on the Advisory Committees?

We provide a detailed description of the committee members and their credentials in the appendices. Table 3 shows the levels of expertise represented on each of the committees.

Table 3: Expertise for the Committees

While the VRBPAC is heavily weighted towards pediatrics and infectious disease, it does not include experts in cardiology or neurology which were two of the most reported serious adverse events associated with the modified mRNA COVID-19 “vaccines.” [https://wonder.cdc.gov/vaers.html]

Whether or not the VRBPAC members were qualified to assess a gene therapy product and whether or not the expertise they brought to the table was sufficient to monitor the emerging safety signals is highly debatable.  But, considering the collective knowledge available, it is interesting to explore what the advisory committee members said at the meetings. Meetings last several hours each resulting in hundreds of pages of meeting transcripts. You can read them all; however, here are a few notable highlights.

Quotes from VRBPAC Members During Committee Meetings:

Dr. Hannah Kirking’s comments added important data regarding the negligible impact of COVID-19 on younger age groups. Yet the ‘YES’ votes to approve, in children and ultimately infants, became unanimous.

June 10, 2021: Dr. Hannah Kirking (CDC)

“Risk of symptomatic and severe illness is lower in children and in adolescents relative to most adult age groups.”

“The same pattern with children being less symptomatic has definitely held up through several studies throughout the pandemic.”

“Children have lower hospitalizations than adults of all ages.” [Emphasis added.]

In fact, the hospitalization rate was presented as 0.4 per 100,000 or 0.0004%. This negligible rate demonstrates that the COVID-19 risk for children was extremely low; so, for children, there was no benefit from the “vaccines” to outweigh the risks.

The topics of onset of dose-dependent symptoms from the “vaccine,” as well as the emergence of safety signals were discussed as early as June 2021. Yet the ‘YES’ votes to approve continued.

The Vaccine Adverse Events Reporting System (VAERS) is used to gather adverse event data and to look for “safety signals” — signals which indicate that an adverse event is occurring at higher frequency and may require further attention and investigation. VAERS is owned and maintained jointly by FDA and CBER.

June 10, 2021: Dr. Tom Shimabukuro (CDC) presented data from VAERS.

“The median age of reported patients is younger, and the median time to symptom onset is shorter among those who developed symptoms after dose 2 versus dose 1.”

“There were more Adverse Events reported after the second dose than the first dose.”

“I think we had strong evidence of causal relationship (referring to thrombotic thrombocytopenia) fairly early on after the vaccine started to be used.” [Emphasis added.]

June 10, 2021: Dr. Steven Anderson (CBER) looking at safety signals from VAERS while discussing the adverse events:

“You can see that some of them that we’re looking at, obviously, have now signaled.” [Emphasis added.] (Referring to:

• Anaphylaxis

• Thrombosis with thrombocytopenia (cerebral venous thrombosis)

• Myocarditis

Were the committee members below suggesting the sole, overarching goal was to get COVID-19 injections approved, with no regard to the safety and effectiveness of the products?

June 10, 2021: Dr. Arnold Monto stated,

“In terms of not having approval or licensure, then if you don’t have use, then you’re not going to have events to follow.” [Emphasis added.]

June 10, 2021: Dr. Eric Rubin stated,

“Remember here that we are deciding whether or not this vaccine becomes available. We’re not deciding how it’s used.”

The message brought to the public in August 2021 was “FULL FDA APPROVAL” of the COVID-19 “vaccine.” Did Janet Woodcock and the FDA ignore all of the deaths and adverse events reported by Pfizer in its post-marketing report and continue the near obsessive desire to vaccinate everyone, even six-month old babies?

August 23, 2021: Dr. Janet Woodcock (Acting FDA Commissioner) made a public announcement regarding the approval of COMIRNATY®, the Pfizer-BioNTech COVID-19 vaccine, for use in individuals 16 years and older.

“The FDA approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product.” [Emphasis added.] [https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine]

After what our investigation has revealed regarding the differences between the gene therapy and “vaccine” regulatory guidelines, how can Dr. Woodcock be confident that the COVID-19 “vaccine” meets rigorous, high standards?

What is the takeaway from Dr. Cody Meissner’s comment below ? The booster is insignificant? Ineffective? If data suggests the booster was/is ineffective, why is the U.S. government still promoting its use?

September 17, 2021: Dr. Cody Meissner said,

“As has been stated, I don’t think a booster dose is going to significantly contribute to controlling the pandemic. And I think it’s very important that the main message that we still transmit is that we’ve got to get everybody two doses.”  “This booster dose is not going to make a big difference.”

Dr. Paul Offit’s comment below seems to be echoing Dr. Monto’s comment about getting children vaccinated in order to “learn more.” Learn more about what? Learn more about the adverse effects from the “vaccine” in children? Is Dr. Offit suggesting children should be experimental subjects to see how many more harms this drug can create?

June 15, 2022: Dr. Paul Offit stated,

“And as more and more children are vaccinated, we’ll learn more.” [Emphasis added.]

Note: The discussion topic at the June 2022 meeting was to extend the EUA for both Moderna and Pfizer, respectively, for use in six months to five years old and six months to four years old.

Was there internal pressure on the committee members to vote ‘YES’? If so, from whom?

June 15, 2022: Dr. Archana Chatterjee said,

“I am also thinking back, like Dr. Levy, to December 10, 2020, which is the day that we authorized the very first vaccine for use in people who are 16 years of age and older. And I was actually one of the no votes, which got me into a lot of trouble.” [Emphasis added.]

What Have We Learned from This Initial Review of the Advisory Committees?

• The Cell Tissue and Gene Therapy Advisory Committee (CTGTAC) should have been the advisory committee selected to review data related to the modified mRNA drug products. Modified mRNA is, by definition, a genetically modified product. [https://investors.biontech.de/node/6751/html]

• The CDC changed definition of “vaccine” mid-stream. It was different before September 2021.

• In 2021, executives at pharmaceutical giant Bayer admitted that two years prior in 2019 the general public would have been hesitant to voluntarily get injected with a gene therapy product. [world health summit 2021 - Search Videos (bing.com)]

• The FDA placed the COVID-19 drug products into the vaccine advisory committee for evaluation and approval voting. This was not the correct committee to review the data on gene therapy products.

• Based on its mission of being “responsible for protecting the public health by ensuring the safety, efficacy, and security of human…drugs, biological products, and medical devices” and the data it had, the FDA should have been aware of the dangers of modified mRNA drug products when issuing COVID-19 “vaccine” EUAs [https://www.fda.gov/about-fda/what-we-do]. However, even when the evidence began to mount as early as Spring 2021 for COVID “vaccine”-related adverse events in the Vaccine Adverse Event Reporting System (VAERS) database and the excess deaths reported in otherwise healthy individuals became too big to ignore, the FDA did not recall the clearly harmful modified mRNA drug products and failed to do its job of “…protecting the public health.”

What Do We Still Need to Learn?

Examination of the VRBPAC meetings subsequent to the original emergency use authorization in December 2020 raised more questions about the advisory committee’s policies and procedures.

Who decided that a modified mRNA drug product should be treated as a “vaccine”?

What evidence was provided to the committee to support authorization of the COVID-19 “vaccines”?

What questions did the advisory committee members ask during these meetings?

How diligently did they perform their duties?

Answers to these questions are required.

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APPENDIX 1: ADVISORY COMMITTEE MEMBERS - VRBPAC

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