1st Response from the EU - Head Of Health

Sep 14, 2022

Dear Mr Kalleli,

Thank you for your email of 4 April 2022 in which you provide us with your input on matters concerning the COVID-19 vaccines.

In your message, you argue that the COVID-19 vaccines authorised so far in the EU fall in your view under the definition of gene therapy medicinal products.

Please note that, as mentioned in Directive 2001/83/EC, Annex I, Part IV (as amended by Commission Directive 2009/120/EC):

Gene therapy medicinal product means a biological medicinal product which has the following characteristics:

(a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence;

(b) its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.

Pause for input;

The American Society of Gene & Cell Therapy (ASGCT);

Definition of gene therapy is the introduction, removal or change in genetic material spesifically DNA or RNA into the cells of a patient to treat a specific disease. Becouse the Pfizer and Moderna Vaccines deliver mRNA in to cells, we consider them to fall under our definition of gene therapy.

Back to the letter;

Gene therapy medicinal products shall not include vaccines against infectious diseases.

Pause;

Pay infinent attention to the following;

The following companies think it is a Genetic Vaccine for infectious diseases;
Hansonwade, Thermofisher, CureVac, AstraZeneca, Moderna, Pfizer, INOVIO, BioNTech, GSK

The letter continues;

Therefore, irrespectively of whether a vaccine against infectious diseases contains recombinant nucleic acids and regulates the expression of human genes, it does not fall under the definition of gene therapy under the EU legislation.

This definition was introduced in the EU legislation in 2009, well before the EU authorization of the Covid-19 vaccines.

Pause;

This is what is known as;

Color of law simply means that a person in a government official capacity, who holds the authority to implement the law, commits an illegal action under the appearance of authority, which exceeds such authority.

Specifically, it is a violation of federal law for a lawful process to be perverted or used by a civil servant for an illicit purpose to intimidate, unduly burden, or harm another.

LINK:

https://www.lawinsider.com/dictionary/color-of-law

Color of Office: The term "color of office" refers to an act usually committed by a public officer under the guise of authority but exceeds what is lawful. The principle behind the color of office is that it protects the public from officials who misuse their authority. It is significant because it provides a legal remedy for those who have been wronged by the misuse of power.

References: https://www.law.cornell.edu/wex/color_of_office

The letter continues;

I would like to reassure you that all medicinal products authorised in the EU – including those categorized as gene therapy, vaccines, biologicals, or chemically-based medicinal products - undergo a strict quality, safety and efficacy assessment according to the high standards required by the EU legislation.

These high standards also apply to labeling and classification of pharmaceutical products.

Pause for Information from the letter from Mr Adam Griffiths at Hansonwade;

Adam writes;

Dear Kjell Tore

I’m currently researching on Genetic Vaccines Advanced Analytical tools, namely comprehensive methods to assess plasmid purity, viral vector evaluation, and assays for mRNA.

Regardless of vaccine technology, it is essential to confirm that a desired antigen is expressed and that adequate T-cell responses are achieved, ensuring that novel quality vaccines are continued to be brought to market after COVID-19, not just for infectious diseases, but also for other high interest areas such as cancer and rare diseases.

This new summit planned for early 2021 in a physical format will focus on the analytical development of mRNA, DNA, and viral vector-based vaccines, and will be the sister summit of the recent Genetic Vaccine Development for Infectious Diseases Summit, which took place in May this year:

https://genetic-vaccine-development.com/

Adam Griffiths M.Sc

Senior Program Manager, Vaccines

Hanson Wade

The letter continues;

A marketing authorisation is granted to a medicinal product in the EU only after its quality, safety and efficacy have been thoroughly evaluated and a positive benefit-risk balance related to its use has been concluded.

Pause for input from the Genetic Vaccine Summit;

From initiation of clinical development in March 2020 to initial authorizations in December 2020.

While conducting Phase 1, Phase 2, and Phase 3 studies safely and in parallel.

(Input: Meaning we ran all the trails at the same time)

Facts from the world’s first RNA drug Onpattro:

Fun fact; Onpattro uses the same Lipid Nano Particle technology (MC3) as the Pfizer/BionTech Genetic Vaccine for Covid-19.

Input from the safety package insert of the world’s first RNA drug Onpattro;

You should not use Onpattro if you are pregnant unless your doctor advises. If you are of childbearing age and intend to use Onpattro, you should practice effective contraception.
Breast-feeding
Ingredients of Onpattro may pass into breast milk.
Talk to your doctor about stopping breastfeeding or treatment with Onpattro.
Children and adolescents
Onpattro is not recommended in children and adolescents under 18 years of age.

From the Norwegian Medicine Agency

Patisiran (Onpattro)

Type of method: Drug; Gene therapy

Area: Neurology

Active substance: Patisiran

(Input; You see Onpattro is not a genetic vaccine against infectious diseases so therefore it is a Gene Therapy Product.)

As just stated by EMA;

Gene therapy medicinal products shall not include vaccines against infectious diseases.

Last note regarding Onpattro;

while it is an approved drug, it’s still classified as an investigational drug.
The same classification also holds true for all the Genetic Vaccines for Covid-19.

The FDA Definition of an investigational drug is:

A substance that has been tested in the laboratory and has been approved by the U.S. Food and Drug Administration (FDA) for testing in people. Clinical trials test how well investigational new drugs work and whether they are safe to use.

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The letter continues;

Furthermore, pharmaceutical products that have been granted a marketing authorisation by the European Commission are under constant monitoring by national competent authorities and by the European Medicines Agency (EMA), under an efficient Pharmacovigilance system, which ensures timely detection of any potential risk and swift appropriate action.

The EMA webpage ‘COVID-19 Vaccines: Authorised’2 is regularly updated and contains detailed safety updates for each COVID-19 vaccine authorised in the EU.

I would like to reassure you that the European Commission and the EMA are fully committed to ensure the highest protection of the health of EU individuals.

Yours sincerely,

Olga Solomon

Head of Unit

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Link to letter;

https://drive.google.com/file/d/1KpKiuXdzfc4Td6qi-PT_PQVHwJGmAJsT/view?usp=drivesdk

Highlighted;

https://drive.google.com/file/d/1TMU0hCkCnF_JW9jmu7Owv-dWb6cIgSih/view?usp=drivesdk

1 https://vaccination-info.eu/en/vaccine-facts/monitoring-vaccine-safety-and-reporting-side-effects

2 https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines/vaccines-covid-19/covid-19-vaccines-authorised#authorised-covid-19vaccines-sectionElectronically signed