DECLARATION OF HEDLEY REES, B. ENG., HONS., EXECUTIVE MBA.

Pursuant to 28 U.S.C. § 1746, Hedley Rees, Bridgend, United Kingdom, hereby declares:

As Promised to Alison Conley, Subscriber:

DECLARATION OF HEDLEY REES, B. ENG., HONS., EXECUTIVE MBA.

Pursuant to 28 U.S.C. § 1746, Hedley Rees, Bridgend, United Kingdom, hereby declares:

I am over the age of 18 and fully competent to make this declaration through my education, knowledge, experience, and training, of the facts stated in this declaration.

This declaration is submitted in support of: LEGAL ACTIONS TO CONVENE A GRAND JURY AND TO PULL THE COVID-19 “VACCINES” UNDER CONSUMER PRODUCT PROTECTION STATUTES FOR LACK OF SAFETY AND EFFICACY, MISREPRESENTATION, MISBRANDING, ADULTERATION AND DEGRADATION, CAUSES.

DECLARATION FOLLOWS:

Based on my experience, knowledge, and training as a pharmaceutical and biologics supply chain management and regulatory specialist (CV here)[i], it is my professional opinion that the companies with the responsibility to develop, manufacture, and distribute the SARS-CoV-2 injections, engaged in gross deviations from the Code of Federal Regulations, Title 21 (FDA regulations), as enacted under the Federal Food, Drug and Cosmetics Act.

Additionally, it is my opinion that the US FDA failed to fulfil its own obligations in ensuring that the companies above had sufficient knowledge, skills, experience, and capability to assure integrity of their supply chains. For example, it is unprecedented for FDA to approve an NDA or BLA without physical pre-approval inspections (PAIs) carried out by FDA on drug substance (DS) and drug product (DP) manufacturers, as a minimum.

Under the circumstances above, the safety and efficacy of the SARS-CoV-2 injections is reasonably called into question, and so is the expected incidence of defective products produced due to regulatory non-compliances. The prudent action would be to immediately halt all activity involved in the development, manufacture and distribution of SARS-CoV-2 injections, and any other gene-based therapies, while suitable investigations are undertaken.

1. SARS-CoV-2 injections are categorized by FDA as Advanced Therapies, which include gene-therapies as therapeutic vaccines and other antigen-specific active immunotherapies.[ii]

2. Advanced therapies are an order of magnitude more complex to develop, manufacture and distribute, if they are to remain safe and effective.

3. Even for the more straight-forward non-Advanced Therapy products, it takes 1 – 1.5 years for FDA to evaluate and approve an application to market a new drug. The EUAs were approved within weeks.

4. On average, it takes 10 – 12 years to develop a new drug once discovery research has identified a development candidate. The SARS-CoV-2 injections were developed and manufactured in unit-dose quantities in the billions, within 6 – 9 months.

5. Please refer to US GAO Report GAO-07-49, titled NEW DRUG DEVELOPMENT: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts for further details on typical timelines.[iii]

6. The SARS-CoV-2 injections accelerated timescales could not possibly have been achieved without dangerous shortcuts being taken in the licensing process and operation of the manufacturing and distribution supply chains post-approval. There can be no doubt that errors, omissions, adulteration of materials and products, would have been rife, leading to misbranding and patient harm.

7. This is because the stages involved in developing the manufacturing process for a new drug must be carried out in series (a predefined sequence from preclinical testing to final approval). To explain, initially preclinical safety studies on the manufactured drug substance must be carried out in animal models. These involve small quantities and a limited supply chain structure for the drug substance only. If the drug substance is proven safe, trials can begin in humans.

8. Larger quantities and batches are typically required to cover phase 1 and phase 2 requirements. As production is scaled up, or the process may be adjusted for technical or other reasons, the manufactured product can change in molecular structure. It is quite possible that a product that is safe at small scale, can turn toxic, or less potent, at a larger scale. New safety studies in animal models must be carried out on the new process. Again, for phase 3 studies, as the number of patients on studies increases significantly, larger quantities and batches are required. There may also be another scale up prior to approval and launch to provide the much great quantities for commercial supply. The public has repeatedly been told that the trials for the Sars-Cov-2 injections took place in parallel instead of in series, to speed up the process. It is my opinion that by developing the injections in this way, without following the accepted protocols, by proceeding through the steps in order, the vital checks on scaling up the injections will have been missed. It is possible that the finished Product will be toxic to the recipient, or inactive. In my opinion, this is dangerous and leads to serious safety concerns.

9. The rolling review conducted all three phases of clinical trials in parallel and precluded any testing of manufactured drug substance safety prior to administration in humans. In my professional opinion this amounts to gross negligence by those involved. FDAs long established licensing process includes Module 3, the chemistry, manufacturing, and controls (CMC) section of the electronic Common Technical Document (eCTD). The eCTD is the electronic document that must be submitted by applicants to market a new drug, as laid down in CFR Title 21.[iv] It is unprecedented for FDA to forgo this evaluation, as it is there to ensure patients are kept safe from harm.

10. The evaluation of Module 3 requires FDA to scrutinize a massive amount of data related to the supply chain, as submitted by the sponsor company in the eCTD (BioNTech and Moderna). Those data include, but are not limited to, details of in-house manufacturing, third-party organizations such as contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs), suppliers of materials and products along with their specifications, process development protocols, process validation reports, analytical methods development protocols, and a host of other data and information related to activities that fall within the CGMP umbrella, and other industry recognized standards, such a USP <1079>, Good Storage and Distribution Practices for Drug Products.

11. The SARS-CoV-2 injections also required a greater degree of scrutiny as they are biological products, not the simpler small molecule products produced using industrial chemistry. Biological products are manufactured from living things, which means they are inherently unstable and subject to significant variation in clinical performance depending on the facility and equipment (such as transfer tubing and stainless-steel vessels) they are manufactured in. Their clinical performance also varies with the potency (titer) of input materials and changes to environmental temperature outside a safe range (such as -80°C to -60°C for the BioNTech injections). In summary, biological products can become toxic or ineffective during manufacture throughout the supply chain, and also cannot be considered clinically ‘equivalent’ to other apparently similar biologic products without bioequivalence testing. The accelerated development timelines would not have allowed that to take place, posing another huge risk to safety if they are used interchangeably.

12. The relevant FDA licensing document that applies to the SARS-CoV-2 injections is titled Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs). This applies to the companies wishing to obtain an approval of an investigational new drug (IND) application to study their drug in humans, referred to here.[v]

13. Section V, titled: MANUFACTURING PROCESS AND CONTROL INFORMATION (MODULE 3 OF THE CTD), details the data and information required to be evaluated by FDA prior to any studies in humans. The workload is substantial and would certainly require at least the 3 years typical timeline in 1. above. For such a complex biological product classed as an advanced therapy, it would be reasonable to expect it to take considerably longer.

14. Based on the above and to ensure at least a minimum level of scrutiny, FDA should have carried out pre-approval inspections (PAIs) on ALL drug substance and drug product manufacturers, whether they be owned by the sponsor companies or working under contract to the sponsor companies. This has always been a mandatory component of FDAs drug approval process, as these steps are pivotal to the safety and efficacy of a drug. If this had been done, it is certain that the FDA inspectors, who are invariably highly experienced at getting to the core of CGMP issues, would have identified a host of critical observations, calling for immediate cessation of activities.

15. From my industry knowledge and experience, the Pfizer/BioNTech drug substance was manufactured at Wyeth Biopharma, Andover, US; BioNTech Manufacturing, GmBH Germany; and Rentschler BioPharma SE, Laupheim, Germany. For the drug product, it was Pfizer Manufacturing Belgium NV, Puurs, Belgium.

16. In the case of Moderna, Lonza, Visp, Switzerland manufactured the drug substance [vi] and Catalent Pharma Solutions, Bloomington, US manufactured the drug product.[vii]

17. There have been FDA inspections post-approval, and these have been deeply concerning, raising a red flag over BioNTech’s and Moderna’s capability to provide the required oversight of the entire supply chain. The findings of two post-EUA FDA inspections of Rentschler BioPharma SE, Laupheim, Germany (BioNTech drug substance) and Catalent Pharma Solutions, Bloomington, US (Moderna drug product), published in the industry press, were alarming, to say the least: Rentschler slapped with FDA Form 483 citing lax manufacturing procedures[viii] and Moderna’s new booster launch tripped up by production issues at Catalent plant.[ix] There is also further evidence of Catalent’s CGMP violations, suggesting these are not isolated incidents: Catalent’s Belgium operations get a second FDA scolding within 1-year span[x]

18. For convenience, the FDA inspection reports quoted in the articles, known as FDA Form 483s, are referenced separately here. [xi] [xii] [xiii]

19. There is yet more evidence of contract development and manufacturing organizations (CDMOs) engaged in manufacture of SARS-CoV-2 injections failing foul of FDA regulations. In this article, Emergent’s Covid vaccine problems more extensive than previously known,[xiv] an example of many publishers covering the story, Emergent mixes together two different products being manufactured on behalf of two different companies. This again raises a red flag in respect of the sponsors of the SARS-CoV-2 injections being capable of proper oversight of its contractors.

20. The FDA Form 483s lead me to conclude that ALL the organizations inspected had deep-rooted systemic issues that would take years to remediate. It was the responsibility of BioNTech and Moderna to take immediate action, as clinical trial sponsors. In practice, they did nothing. I can only conclude that both companies would have been incapable of taking appropriate action anyway, even if it was prepared to do so. This is because they do not have in their employ the skills and experience required to manage fully outsourced (virtual) biological product supply chains.

21. I have referred to the history of BioNTech published on its website, noting the claimed timelines:

i. 2008 - BioNTech is founded by Prof. Ugur Sahin, M.D., Prof. Özlem Türeci, M.D., and Prof. Christoph Huber, M.D., to develop and produce treatments for individualized cancer immunotherapy. (Seed round 180m USD)

ii. 2012 - Start of the first Phase 1 clinical trial with RNA immunotherapy in melanoma, today known as our FixVac approach

iii. 2013 - Start of the first Phase 1 clinical trial with RNA Immunotherapy in melanoma – the first trial of an individualized immunotherapy (iNeST) in humans.

iv. 2014-2018 - Strategic collaborations across the pipeline (Bayer Animal Health, Genentech, a member of the Roche Group, Genmab, Siemens, Sanofi, Regeneron, Genevant, Pfizer, University of Pennsylvania).

v. 2018 - Completion of 270 million USD Series A financing round.

vi. 2019 - BioNTech becomes a publicly traded company on the NASDAQ Global Select Market under the ticker symbol BNTX.

vii. 2020 - Beginning of “Project Lightspeed” to quickly develop a safe and effective vaccine to address the emerging SARS-CoV-2 pandemic. The Pfizer-BioNTech COVID-19 vaccine is the first vaccine to receive emergency use authorization following a worldwide Phase 3 trial.

viii. 2020 - Publication of first peer-reviewed paper for the COVID-19 vaccine candidate BNT162b1

ix. 2020 - Establishment of BioNTech Manufacturing Marburg to produce COVID-19 vaccine, which became one of the largest mRNA manufacturing facilities in 2021.

22. The above timeline shows that in the first five years, BioNTech had only completed one safety study in a cancer indication (skin), nothing for an infectious disease, such as a coronavirus. A phase 1 study provides no evidence of efficacy. Why then would all the companies listed above strike deals with BioNTech between 2014 – 2018? My prima facie conclusion is that they were acting in collusion with the larger pharmaceutical companies in 16 iv. above to provide support. Further investigations would be required to confirm this.

23. The same applies to Moderna. Incorporated in 2010, Moderna signed a lease to build a 200,000 sq ft GMP mRNA clinical manufacturing facility in Norwood, MA., in 2016. They were, however, still at the discovery research phase with their mRNA technology and in no position to embark on trials in humans—yet they did.

24. This appears hugely problematic, and normally the premises of small companies developing drugs would be inspected by FDA to cover all areas where they impact CGMP and other quality standards, such as Good Clinical Practice (GCP) and Pharmacovigilance procedures. If this has not happened, then it should take place urgently.

25. Moving from manufacture to product distribution, there is significant evidence of serious violations in the storage and transportation of the temperature sensitive biological materials and products at each stage in the supply chain. The main stages are:

i. Manufacture of starting materials (animal cells)

ii. Upstream processing

iii. Downstream processing

iv. Packaging and labelling

v. Distribution through wholesaler networks

vi. Patient administration by qualified staff

26. When transporting materials and products from one stage to the next, the temperature range registered with FDA must be always adhered to during the journey. Temperature monitors must be positioned inside the packaging, to provide a real-time trace of the temperatures. Monitors must be activated at the start of the journey and deactivated at the end, where the trace is downloaded for inspection. Any excursion(s) outside the range must be investigated to ensure quality has not been impacted. If quality is found to have been impacted, the material or product must be rejected and destroyed.

27. This is a long-running problem in the industry because the companies in the supply chain are different legal entities, so allocation of responsibilities for actioning the requirements in 15. above pose a significant risk of breaking down. The STAT article offers an example of how this has occurred in practice. [xv] There can be no doubt that there have been numerous non-compliances here, especially given the accelerated timescale for development and manufacture.

28. Stages v. and vi. are arguably the most troubling of all. The industry routinely distributes drugs through a well-established wholesaler network that is dominated by the three companies, namely McKesson, AmerisourceBergen, and Cardinal Health. These companies have a long history of working within the highly regulated storage and distribution of drugs and are embedded into US Health systems, requiring staff to be trained and equipped to meet the standards required. The SARS-CoV-2 injections, because they were frozen down to temperatures below which the distribution network was geared up for, had to bypass this network. Instead, they were shipped directly, via third party logistics providers, to facilities such as hastily constructed vaccination centres, supermarkets, and other make-do facilities. Not only that, but the injections had not completed manufacture. They were sold into the distribution network by Pfizer and Moderna packaged in cardboard trays, in quantities of 195 vials per tray, with each vial containing multiple doses in need of saline diluent to be added. This involved untrained staff, with no quality system providing standard operating procedures to guide their work, to convert the part manufactured product into a single unit-dose for patient administration. It is impossible to overstate how dangerous this is. Never in the history of the industry have commercially available licensed drugs been supplied in a form that cannot be administered to, or consumed by, a patient with significant finishing operations still to be carried out.

29. This means that the label claim normally awarded by FDA as the final stage of drug approval, could not have been determined for the EUAs, as there were further operations to be carried out in addition to those included in the eCTD. These additional operations, such as thawing of bulk vials, addition of saline diluent, mixing the product to a homogeneous consistency, will alter the performance of the injections. In my professional opinion, this renders all SARS-CoV-2 injections misbranded.

30. It is also appropriate to point out the primary responsibility for pharmacovigilance lay with the companies developing and selling the drugs. FDAs responsibility is to ensure these companies have an effective process in place to respond immediately to any report of a serious adverse event (SAE). Again, this can only be assessed by FDA physically inspecting each company’s place of work, in this case BioNTech, Pfizer and Moderna.

31. I also have deep concern over conferences springing up hailing advanced (including gene) therapies as the future for the pharmaceutical industry. One such example is Advanced Therapies 2023, held in London March 14-15, with FDAs Peter Marks as a Keynote speaker. Next year’s can be seen in the reference. [xvi]

32. This article from March this year is also troubling: Dr Marks FDA’s Marks hopes to align global regulators to boost gene therapy.[xvii]

33. The companies involved in developing gene therapies appear to have little or no understanding or experience of regulated drug development, supply chain management, and distribution of safe and effective drugs. In my professional opinion, FDA should be prioritising tackling the risks to patient safety that are eminently clear, following the catastrophic outcome with the experimental SARS-CoV-2 injections.

I am giving this declaration to: PROVIDE WRITTEN TESTIMONY TO SUPPORT LEGAL ACTIONS TO CONVENE A GRAND JURY AND TO PULL THE COVID-19 “VACCINES” UNDER CONSUMER PRODUCT PROTECTION STATUTES FOR LACK OF SAFETY AND EFFICACY. MISREPRESENTATION, MISBRANDING AND ADULTERATION/DEGRADATION, CAUSES.

I declare under penalty of perjury under the laws of the United States of America that the foregoing is true and correct.

Executed on this the 21st day of June 2023.

Hedley Rees

Director, PharmaFlow Limited

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[i] Hedley Rees CV: https://www.dropbox.com/s/v3yks45fubbgbls/CV_HR_JULY_2022.pdf?dl=0

[ii] Overview Office of Tissues and Advanced Therapies and Division of Cellular and Gene Therapies Research Program, Raj K. Puri, M.D., Ph.D. Director, Division of Cellular and Gene Therapies Office of Tissues and Advanced Therapies https://www.fda.gov/media/140940/download

[iii] https://www.gao.gov/assets/gao-07-49.pdf

[iv] Electronic Common Technical Document (eCTD) v4.0 TECHNICAL CONFORMANCE GUIDE: https://www.fda.gov/media/135573/download Accessed February 23, 2023.

[v] Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): https://www.fda.gov/media/113760/download Accessed February, 23 2023.

[vi] Lonza and Moderna Enter New Agreement to Double Drug Substance Production for COVID-19 Vaccine in Visp: https://www.lonza.com/news/2021-04-29-05-00 Accessed February 23, 2023.

[vii] Moderna and Catalent Announce Long-Term Strategic Collaboration for Dedicated Vial Filling of Moderna’s COVID-19 Vaccine and Clinical Portfolio: https://www.catalent.com/catalent-news/moderna-and-catalent-announce-long-term-strategic-collaboration-for-dedicated-vial-filling-of-modernas-covid-19-vaccine-and-clinical-portfolio/ Accessed February 23, 2023.

[viii] Rentschler slapped with FDA Form 483 citing lax manufacturing procedures: https://www.fiercepharma.com/manufacturing/rentschler-slapped-form-483-citing-lax-manufacturing-procedures Accessed February 20th 2023

[ix] Moderna’s new booster launch tripped up by production issues at Catalent plant: https://www.fiercepharma.com/manufacturing/fda-cites-catalent-issues-indiana-plant-which-caused-delay-moderna-booster Accessed February 20th 2023

[x] Catalent’s Belgium operations get a second FDA scolding within 1-year span: https://www.fiercepharma.com/manufacturing/catalents-belgium-operations-get-second-fda-scolding-inside-12-months Accessed February 20th 2023.

[xi] https://www.fda.gov/media/159164/download

[xii] https://www.fda.gov/media/161643/download

[xiii] https://www.fda.gov/media/162470/download

[xiv] Emergent’s Covid vaccine problems more extensive than previously known. https://www.politico.com/news/2022/05/10/emergent-covid-vaccine-problems-00031266

[xv] Pfizer decision to turn off temperature sensors forced scramble to ensure Covid-19 vaccines kept ultra-cold: https://www.statnews.com/2020/12/17/pfizer-decision-to-turn-off-temperature-sensors-forced-scramble-to-ensure-covid19-vaccines-kept-cold/

[xvi] https://www.terrapinn.com/congress/advanced-therapies/index.stm

[xvii] https://www.reuters.com/business/healthcare-pharmaceuticals/fdas-marks-hopes-align-global-regulators-boost-gene-therapy-2023-03-29/