Fact check: Are mRNA injections vaccinations or gene therapy?
According to the German government's plans, mandatory vaccination will soon be introduced. But what kind of substances are we talking about exactly? Politicians and the media say that the novel mRNA preparations - such as "Comirnaty" from Biontech - are vaccines, which would therefore be subject to similar rules and legal regulations as other well-known and long-established vaccinations. Critics, on the other hand, say they are "gene therapies" that are called vaccines only to avoid stricter legal regulation and high licensing hurdles. Which is true?
PAUL SCHREYER, Dec. 3, 2021, 21 comments,
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Vaccination is something positive, it keeps you healthy, and it is necessary - many people are sure of that, especially during the Corona crisis. While the mRNA technology now being used is a new procedure, he said, its evaluation can draw on the extensive experience gained with other vaccinations over the past years and decades. The risk is manageable. In addition, an obligation to use mRNA preparations ("compulsory vaccination") is legally within
the bounds of what is permissible - after all, there is already
compulsory vaccination against measles.
However, assessments by several experts are now casting doubt on this view. For example, Stefan Oelrich, a member of the Bayer Board of Management, recently commented on mRNA preparations in a way that raises fundamental questions. Oelrich is head of the Bayer Group's drug division, which last year
achieved global sales of 17 billion euros under his responsibility. He spoke at the opening of the annual World Health Summit in Berlin on October 24, alongside the German health minister, the WHO director, the EU Commission president and the UN secretary-general. In his welcoming speech, Oelrich
acknowledged:
"The mRNA vaccines are an example of cell and gene therapy. If we had done a public survey two years ago and asked who would be willing to take gene or cell therapy and have it injected into their bodies, probably 95 percent of people would have said no. This pandemic has opened a lot of people's eyes to innovation in a way that wasn't possible before."
As a result, the mRNA injections are not a vaccination in the sense the term has been used. According to Oelrich, they are gene therapy, which until recently was highly controversial.
Other experts also see it that way. On November 2, a week after Oelrich's statement in Berlin, a
panel of experts met in Washington at the invitation of Senator Ron Johnson to assess the campaign to administer the mRNA preparations. Among the invited experts was
Peter Doshi, professor of pharmaceutical health services research at the University of Maryland and an editor at The BMJ magazine, also known as the British Medical Journal, one of the world's most prestigious medical journals. Doshi
stated at the meeting:
"I'm one of those academics who takes the view that these mRNA products that everyone calls 'vaccines' are qualitatively different from standard vaccines. I found it amazing to learn that the Merriam-Webster dictionary changed the definition of 'vaccine' earlier this year. mRNA products did not meet the definitional criteria for a vaccine that Merriam-Webster had for 15 years. However, the definition was expanded so that mRNA products are now considered vaccines."
Merriam-Webster's dictionaries are the equivalent of the Duden dictionary in English. In fact, the definition there was changed accordingly in January 2021, at the start of the global vaccination campaign (here are the entries
before, and
after the change). Doshi tied
the following question to this:
"How would you feel about a Covid vaccine requirement if we didn't call these preparations 'vaccines'? What if these injections were called drugs instead? The scenario then is, 'We have this drug and we have evidence that it doesn't prevent infection or stop virus transmission.' But the drug is supposed to reduce the risk of becoming severely ill and dying from covid. Would you take a dose of this drug every six months, possibly for the rest of your life, if that's what it took to keep the drug effective? And would you not only take the drug yourself, but also support a legal requirement that everyone else take the drug as well?
Or would you say, wait a minute - if that's all the medicine can do, why don't we use regular medicine instead, like we normally do when we're sick and want to get better? And why make taking it mandatory? The point is: Just because we call it a vaccine, we shouldn't assume that these new products are the same as all other childhood vaccines that are mandatory. Every product is something different. If people are OK with making something mandatory just because it's a vaccine and we're making other vaccines mandatory, I think it's time to bring some critical thinking to this discussion."
Change in the law made gene therapy a "vaccination
What is the legal situation in Germany? Where is it defined what can and cannot be considered a vaccination? The Scientific Services of the German Bundestag presented a
technical classification on this in January 2021, which states with reference to EU Directive 2001/83/EC that "medicinal products containing mRNA are to be classified as gene therapy medicinal products." However, there is an exception to this, namely "medicinal products containing mRNA that are vaccines against infectious diseases".
What explains this exception? A search shows that it can be traced back to a change in the law in 2009. Prior to that change, Section 4 of the German Medicines Act stated:
"Vaccines are medicinal products (...) that contain antigens and are intended to be used in humans or animals to produce specific defensive and protective substances."
In 2009, that changed. In March of that year, shortly before the outbreak of swine flu, the German government presented a bill "to amend regulations under pharmaceutical law" that was necessary, among other things, to bring the Medicines Act into line with
a European regulation that governed the handling of novel gene therapeutics. The health minister responsible at the time was Ulla Schmidt (SPD). Hidden in the
72-page bill on page 10 was the following inconspicuous proposed amendment, which is difficult to understand without further context:
"In paragraph 4, after the word 'antigens' the words 'or recombinant nucleic acids' and before the period at the end the words 'and, insofar as they contain recombinant nucleic acids, are intended exclusively for the prevention or treatment of infectious diseases' are inserted."
By way of explanation, the term "recombinant nucleic acids" also includes artificially produced mRNA. In June 2009, the Bundestag's Health Committee
recommended that members of parliament adopt the government's 72-page draft amendment. The CDU's representative on the committee
at the time was Jens Spahn. The draft was passed by the Bundestag shortly thereafter, in July 2009, and thus declared applicable law. Since then, Paragraph 4 of the Medicines Act has read as follows (the new additions are highlighted in bold):
"Vaccines are medicinal products (...) that contain antigens or recombinant nucleic acids and are intended to be used in humans or animals to produce specific defensive and protective substances and, insofar as they contain recombinant nucleic acids, are intended exclusively for the prevention or treatment of infectious diseases."
Without this politically determined change in definition, the mRNA preparations whose mandatory use is currently planned would legally be considered gene therapeutics rather than vaccinations. The physician Wolfgang Wodarg, at that time member of the health committee of the Bundestag, explained on inquiry to Multipolar that this detail of the law change was not well-known also to him at that time. According to Wodarg, the decision was made "in the last session before the election campaign summer break without any debate".
In addition, the EU Commission
amended a directive "with regard to advanced therapy medicinal products" in September 2009. Since then, the following definition can be found in this directive:
"A gene therapy medicinal product means a biological medicinal product which has the following characteristics: it contains an active substance which contains a recombinant nucleic acid (...) Vaccines against infectious diseases are not gene therapy medicinal products."
Growth market mRNA drugs
Novel gene therapies with mRNA drugs have also been massively promoted by manufacturers in recent years in order to compensate for sharp drops in sales in the market segment of patent-protected drugs. The Ärztezeitung
wrote about this in February 2021:
"By 2023, the pharmaceutical industry's revenue losses due to patent expirations are estimated at more than $121 billion worldwide, of which $95 billion in the U.S. alone. (...) A countermeasure by the pharmaceutical industry with innovations is particularly promising. The emerging novel therapeutic options (e.g. mRNA, bi-specific antibodies, gene therapy) not only give hope to patients but, if successfully approved, will also push manufacturers' sales and profit curves to new heights. After all, with improved efficacy and fewer side effects, the price of the drug plays a rather subordinate role, at least when there is little or no competition. Investors who bet on the right sector fund early on can also benefit from rising (share price) curves."
Biontech: "Novel and unprecedented category of therapeutics"
The company Biontech had virtually no experience with vaccines before the Corona crisis. They were primarily researching individualized mRNA immunotherapies for cancer patients until 2019. Although a collaboration with Pfizer had begun in 2018 to develop an mRNA "vaccine" against influenza, the project was in its infancy until the Corona Crisis - and remains so today. According to company statements from late 2019, they were more than a year away from starting the first clinical trials at that point. In fact, the first clinical trials of an mRNA drug designed to protect against influenza ("BNT 161") did not begin
until September 2021, three years after the announcement.
In October 2019, Biontech went public in the U.S. to raise additional investor capital. To mark the occasion, the company openly
explained the "risks associated with our business" in a lengthy annual report:
"To our knowledge, there is currently no precedent for an mRNA-based immunotherapy, such as the one we are developing, being approved for sale by the [U.S. Food and Drug Administration] FDA, the European Commission or any other regulatory agency elsewhere in the world. (...) The product candidates we develop may not be effective or may be only moderately effective or may have undesirable or unintended side effects, toxicities or other characteristics that could prevent marketing approval or limit commercial use. (...)
The development of mRNA drugs carries significant clinical development and regulatory risks because they represent a novel and unprecedented category of therapeutics. As a potential new category of therapeutics, to our knowledge, no mRNA immunotherapies have yet been approved by the FDA, EMA, or any other regulatory agency. (...) To date, there has not been a Phase 3 trial of an mRNA-based product or a commercial mRNA-based product. (...) Currently, mRNA is considered a gene therapy product by the FDA."
So much for Biontech's October 2019 self-report.
Conclusion
The assumption that mRNA preparations, such as Biontech's, are vaccines is based on a political definition change that was decided without parliamentary debate and hidden in a 72-page amendment 12 years ago. The two resolutions passed by the EU Commission and the German parliament in 2009 allow manufacturers of mRNA preparations to circumvent the stricter legal regulation for gene therapeutics as long as they can declare that the drugs are directed against infectious diseases. In fact, however, it is gene therapy or a genetically engineered drug.
