Investigational vaccines or not?

As part of our “intoxication against intoxication” file (see introduction here), we focus here on the character deemed false or misleading by AFP and RTL on the fact of qualifying vaccines as “investigational treatments”.

What immediately calls into question in the AFP article which was used by RTL is the degree of confidence in the official narrative, taken from the sites of the health authorities. Since when are the authorities (of health in this case) supposed to serve as a reference to establish the truth? We will not dwell on the scandals in which they have been involved in the recent past, but the fact that their remarks are taken up without more critical spirit concerns us all the more since the media are generally less complacent when it is about pesticides, air quality or endocrine disruptors (see for example what our authorities are doing with glyphosate).

On the other hand, as far as substance is concerned, it should be noted that these are formulations that are at the very least usual, even banal. for anyone concerned about the quality of a product, be it a medicine or a pair of shoes. It is therefore a real commercial argument that these authorities deliver to us, which informs us that the vaccines “meet all the quality, safety and efficacy requirements defined in the pharmaceutical legislation of the European Union”. Which should be enough, according to AFP and RTL, to reassure the citizen.

However, the fact remains that, despite all the reassuring words found on official sites, to assert that current vaccines are safe when the initial phase 3 pivotal study (which lasts 24 months) is not finished amounts to saying that the rocket will obviously put its satellite in the right orbit since it took off 15 seconds ago and was developed according to the most demanding quality criteria. History shows us what it is for rockets and, a little later in our article, for vaccines.

The fact remains that there are more than one scientist, such as Professor Perronne, to dare to claim that these vaccines are investigational treatments. Rather than seeking to contradict these statements with other marketing statements or flyers, we asked ourselves where they are coming from and what they could be supported by.

Definition of investigational medicinal product

Because if marketing can allow itself a pretty prose to sell its goods, the legal is there in general to set out a framework. We are therefore surprised to note that the AFP journalists (although professional) did not look in this direction since it is the first that we, citizen-journalists for the occasion, have thought of looking in order to disentangle the truth from the wrong in looking for a definition of “investigational vaccine”.

This is how we quickly found that European legislation (article 2 alinea d of directive 2001/20/EC) clearly informs us about what an investigational medicinal product is, namely an ” pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial […] “.

On the strength of this discovery, we wanted to make sure with an expert that vaccines fell well within the definition of drugs. It was a toxicologist, who is also an expert with the courts, who confirmed to us that Directive 2001/83/EC (title I, article 1, paragraph 4) defines vaccines as falling within the category of “immunological medicinal product”.

There is therefore a valid reason to consider these vaccines as investigational. However, specifies our expert, it is not correct to consider the vaccinated as guinea pigs, because the real guinea pigs that are the participants enrolled in the clinical trials benefit from a follow-up, unlike the ordinary person vaccinated during the vaccination campaigns that roll out at the same time. The legal statutes are very different and, with an identical vaccine, one may argue that the “guinea pigs” are better treated than the lambda individual.

In any event, since the Covid vaccines are currently in the clinical trial phase, it is not aberrant to qualify them as investigational since this is how our legislation defines them. And it is indeed the fact of declaring the opposite, and of affirming like RTL that to qualify these vaccines as investigational is a matter of intox, which seems, to us citizens, totally misleading. But there is worse.

Inappropriate assessment protocols

Because in our exchange with the expert we consulted, we learned that the vaccine evaluation protocols were completely unsuitable for mRNA vaccines.

The WHO published at the end of August 2020, following the meeting of an expert committee, a report mentioning the absence and the need for a regulatory framework for the evaluation of mRNA vaccines. No action was then advocated given the “significant differences in how mRNA vaccines are produced and assessed”, which would require the production of a specific document.

It was on November 25, 2020 that a first document entitled “Considerations for the evaluation of Covid 19 vaccines – Points to consider for manufacturers of Covid 19 vaccines ” was published. As its title indicates, this document is at this stage more reflections and recommendations than directives. It addresses in particular its point 6 the “Considerations for ensuring the quality, safety and efficacy of RNA vaccines (under development) ”.

However, this document has not since then given rise to the formalization of normative rules for the evaluation of mRNA vaccines, which means that these “considerations” currently only have an informative value and that the quality, the safety and efficacy of RNA vaccines is not currently subject to any specific precautions.

One can thus deplore, for example, that no reference to these “considerations” is made, neither in the evaluation report, nor in the risk management plan (which is moreover incomplete) of the Pfizer BioNTech vaccine which, in fact , was evaluated according to the rules applicable to conventional vaccines. Consequently, only the direct components of the vaccine have been evaluated, but not the Spike protein that it causes our body to produce and of which we therefore know nothing of possible misfolding, aggregation, interactions with other biomolecules and therefore potential cellular disturbances and pathogenicity in the short, medium and long term. The means to ensure the percentage of intact mRNA are a real concern for the quality of manufacture, precisely as the Pfizer leaks revealed by the British Medical Journal have revealed significant variations that raise questions about the level of assurance on the efficacy and safety of the Comirnaty vaccine.

In its latest annual report , Pfizer explicitly recognizes as a risk the possibility of an unfavorable outcome of ongoing clinical trials.

Let us add, to finish demystifying the official narrative, that the 30 years of hindsight which serve to support it have only concerned research and not development, and that the only vaccine using these technologies which has been launched before is the controversial Dengvaxia whose mass administration was discontinued after 2 years and (officially) 600 dead. Which brings us back to the rocket ship metaphor. And to the reminder of Professor Perronne that it takes at least 10 years to develop a vaccine.

We are therefore concerned to see that the narrative of the authorities, as taken up by AFP, and which indicates, let us reread it carefully, that the vaccines “meet all the quality, safety and efficacy requirements defined in the pharmaceutical legislation of the European Union” is true stricto sensu but inherently constitutes a deception as to the level of assurance that these requirements provide on mRNA vaccines.

It thus seems legitimate to us to worry about what could appear as a chain of negligence highlighting the unfinished state, undoubtedly “investigational” therefore, of the sector.

For us, citizens, the verdict is clear: as regards the investigational nature of vaccines at the present time and the level of assurance that current evaluation methods offer us, the intox is on the side of the authorities, AFP and RTL. We therefore intend to require AFP to review their article on this point.