Were any components of the Pfizer vaccine not recommended for humans?

The discovery, contained in official documents, would have the effect of “bomb”. It has been a few days that Internet users believe they have proof that the BioNTech / Pfizer vaccine was not intended for use on humans. Holding up a document presented as the fact sheet for a component of the vaccine, ALC-0315, several Twitter users have cried foul.

“On the site of the EMA of Europe, we find today the document of the characteristics of the vaccine Biontech. Under point 6 page 16, there are two ingredients: ALC-0315 and ALC-0159 whose producer is Echelon Biosciences Inc. “, explains one of them in a post shared more than 2000 times. The latter is convinced: “The Biontech Pfizer and Moderna vaccine cannot be given to humans. Share if you know of anyone who can post this info. Vaccination is over!” Another, presenting himself as a researcher in biochemistry, addresses the vaccinated on the planet: “You are the guinea pigs: 4 billion rats! Not for human use…”

On this shared document in PDF format (see above) we can read: “ALC-0315 is an ionizable lipid which has been used to form lipid nanoparticles for RNA delivery. ALC-0315 is one of the components of BNT162b2 vaccine against SARS-CoV-2, in addition to ALC-0159, DSPC and cholesterol. This product is for research use only and not for human use. “ It is this last sentence which has attracted attention and which would constitute proof that the vaccine cannot be administered to humans.

So what are we talking about? The products mentioned here indeed belong to the lipid family and are used in the mRNA vaccine developed by BioNTech / Pfizer. Concretely, this vaccine is composed of an active substance, RNA, and excipients, that is to say all the substances different from the active principle. These excipients are in this case synthetic lipids, which are used to wrap the RNA so that it penetrates better into the cell and whose role is detailed here by Futura Sciences. Alongside these substances, soberly called ALC-0315 and ALC-0159, there is also synthetic cholesterol. “These lipids are used in the formulation of a drug without having a therapeutic action, they are inert”, according to Sonia Khier, pharmacology researcher at the University of Montpellier.

In reality, the Pfizer laboratory produces the active substance of the vaccine but subcontracts the production of these lipids to an American company: Echelon Biosciences. We found the famous shared file on the company’s website. The product ALC-0315, which sells for $ 75 to $ 390 depending on quantity, is presented similarly. The same goes for the product ALC-0159, which this time is sold more expensive (from 125 for 5 mg to 495 for 25 mg). This document is therefore not a trick but the last sentence, held as proof by Internet users, is slightly different. We can read here that“this is a reactive quality product, intended only for research” (see below).

But does that mean these products should never have been purchased by Pfizer to be included in its Covid vaccine? No, and this was denied by the subcontractor himself. In a series of tweets posted on December 8 and largely unnoticed, Echelon Biosciences looks back on this campaign of “disinformation“which targets it and on this famous sentence appearing on the sheets of its products: “We have been selling some of the compounds found in vaccines for a few months now. Since we don’t make them under the same GMP conditions as the companies that make the vaccines, we are only selling them as ‘research only’.”

GMP refers here to “good manufacturing practices” or “good manufacturing practices”, these rules for the production and marketing of drugs. In the United States, they are issued by the Food and Drug Administration (FDA), the drug agency. Clearly, Echelon Biosciences explains that the mention “‘research use only’ does not mean that a compound or reagent is not safe for use in humans” but that it corresponds to its status. That is to say for the purposes of using its products, which it sells to laboratories and which are not intended to be placed on the market as is. “We didn’t invent these compounds. We are selling them to other scientists who are looking for new ways to use them to potentially help people.”, specifies the subcontractor.

Asked at the same time about this mention, Sonia Khier explains that when they are sold, “some substances in the composition of a drug may be labeled ‘research only’. But that has nothing to do with the dangerousness”. According to the researcher, this argument is also absurd: “We absorb lipids from our food every day. So we can’t say that they are not intended for human use”. A vaccine, on the other hand, enjoys the status of “medicine for human use” and must meet specific standards, as detailed by the ANSM, the National Medicines Safety Agency.

The mention appearing on the components of the vaccine does not therefore refer to the prohibition to be used on humans but to a simple question of regulation. As for the fact that the sentence used by Internet users has been modified by Echelon Biosciences on its site, this can be logically explained by a concern for clarity on its part. His official response to this false information has only been shared a dozen times on Twitter.

Do you want to ask us questions or provide us with information that you think is unreliable? Do not hesitate to write to us at [email protected]. You can also find us on Twitter: our team is there behind the @ verif_TF1LCI account.