21

I recently saw a post online which called into question the safety of the Moderna vaccine through an interesting argument. One of the ingredients in the Moderna COVID-19 vaccine is the ionizable amino lipid SM-102. [Source]

Information about this chemical can be found on this website. As expected, the description of this chemical is the following:

SM-102 is an ionizable amino lipid that has been used in combination with other lipids in the formation of lipid nanoparticles.1 Administration of luciferase mRNA in SM-102-containing lipid nanoparticles induces hepatic luciferase expression in mice. Formulations containing SM-102 have been used in the development of lipid nanoparticles for delivery of mRNA-based vaccines.

However, as a standalone chemical it seems to have many safety warnings and hazards. This information is available on the accompanying safety data sheet for SM-102. Here are some of the listed hazards:

WARNING This product is not for human or veterinary use.

H310 Fatal in contact with skin.

H351 Suspected of causing cancer

H372 Causes damage to the central nervous system, the kidneys, the liver and the respiratory system through prolonged or repeated exposure.

Now, my presumption is that these hazards are supposed to be overly cautionary, and also only apply to the direct handling of the raw chemical. But many people do not see it this way, and thus are reasonably skeptical about the safety of the Moderna vaccine. So, I have a couple questions:

Questions.

  1. Are all these hazards relevant to the chemical's pharmacological use as part of an mRNA vaccine? Why?
  2. How are these hazards determined in the first place?
  3. Are there examples of other chemicals with similar hazards/warnings, which are ingredients in common medical drugs?
  4. Opposite to the previous question, are there chemicals with little to no hazards/warnings, which nevertheless form key components to actually dangerous drugs?
Arturo don Juan
  • 313
  • 1
  • 2
  • 8
  • These two articles mention the toxicity of the lipid nanoparticles as a reason for these companies switching to vaccines, since those require only one exposure rather than daily exposure: https://www.statnews.com/2016/09/13/moderna-therapeutics-biotech-mrna/ https://www.statnews.com/2017/01/10/moderna-trouble-mrna/ They don't go into too much detail about the toxicity, though. – endolith May 19 '21 at 20:47

1 Answers1

50

The MSDS linked to is for a product sold as a solution of 10% SM-102 in 90% chloroform. It's listed as "SM-102" because that's the interesting/useful thing that the company is selling. It's common for chemicals to be sold packaged with solvents to make a solution. Sometimes that solvent is just water, but if the product is not water-soluble in sufficient concentrations then other solvents may be necessary. Alcohol solutions are quite common, but for more hydrophobic chemicals it may be necessary to use more "exotic" solvents.

Because chloroform is quite a dangerous chemical for people to be exposed to and because this product is mostly chloroform, the MSDS is also primarily based on chloroform, not SM-102.

You can see this in some of the language in the MSDS itself, for example:

Hazard-determining components of labeling: Chloroform

(this notes that the hazards listed below it are attributable to the presence of chloroform in the packaging)

and

· Chemical characterization: Mixtures · Description: Mixture of the substances listed below with nonhazardous additions

· Dangerous components: CAS: 67-66-3 RTECS: FS9100000 Chloroform 90.0%

· Other ingredients 2089251-47-6 SM-102 10.0%

You'd have the same hazards listed on the MSDS of 10% water and 90% chloroform. Presenting this as an argument about vaccine safety seems misleading at best.

From this fact sheet:

Each (0.5 mL dose) dose of the Moderna COVID-19 Vaccine contains the following ingredients: a total lipid content of 1.93 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.31 mg tromethamine, 1.18 mg tromethamine hydrochloride, 0.043 mg acetic acid, 0.20 mg sodium acetate trihydrate, and 43.5 mg sucrose.

(the section in parenthesis is added by me from the previous section)

Chloroform is not listed as an ingredient in the Moderna vaccine, and determinations about the safety of the vaccine should not be based on MSDS for a product that is 90% chloroform.

Bryan Krause
  • 14,047
  • 4
  • 34
  • 54
  • Thanks I hadn't seen that. I don't quite understand though, why chloroform is being mentioned at all. Isn't this data sheet supposed to be for the safety of SM-102, not chloroform? My guess would be that SM-102 is simply stored in a solution, 90% chloroform and 10% SM-102, and the data sheet is for the entire solution. – Arturo don Juan May 17 '21 at 20:02
  • 20
    @ArturodonJuan The data sheet is for safety of a jar in the lab which contains solvent + some compound of interest, and solvents are quite important to safety. You can't ignore them, especially since solvents themselves are often flammable poisons, it's just important to recognize that this is what MSDS are for: labeling jars in the lab, not for talking about the safety of some individual ingredient. I agree that the info about the solvent is buried a bit, other times you might have an MSDS that explicitly lists the solvent at the top. But if you search "chloroform" it's all over the sheet. – Bryan Krause May 17 '21 at 20:18
  • 1
    Okay that answers my questions. It makes sense to use such labelling when dealing with the literal jars. I guess the post I was referring to was taking advantage of the fact that taken out of context, the safety labelling is quite misleading. By the way, this is the post: https://www.tiktok.com/@pntbuttrfalcon303/video/6962178128382840070?lang=en&is_copy_url=1&is_from_webapp=v1 – Arturo don Juan May 17 '21 at 20:48
  • 16
    Yeah, that tends to be true of all sorts of anti-vax arguments, whether due to inexperience/lack of knowledge and a dose of confirmation bias, or outright intentionally lying about data. They often seize on some minor glint of truth to support an argument that has no actual ground to stand on. – Bryan Krause May 17 '21 at 20:58
  • What seems strange to me is that the safety sheet says it's for SM-102 but when you get into the details you see it's SM-102 in chloroform. How can SM-102 be both the product and a component of the product?? – Loren Pechtel May 18 '21 at 04:23
  • 16
    @LorenPechtel It's just the label given to the jar that's sold, and it makes sense to name it after the "active ingredient" rather than the solvent. When you buy a jar of pickles, you just refer to them as pickles, when more accurately you might say they are pickles in brine. – Bryan Krause May 18 '21 at 04:59
  • 2
    @LorenPechtel Many chemicals come along with a solvent, preservatives, pH stabilizers, etc. Sometimes that's just water, but a lot of times the solvent itself is something toxic, for various reasons. When you buy these chemicals from a lab supply, the SDS you will get covers the contents of the container as a whole. SM-102 itself is a particular molecular compound, which is one of the components of the container. The whole point of this particular product is to give you SM-102, which is in a chloroform solvent, so the product is just called SM-102 also. – Aidan May 18 '21 at 20:27
  • 8
    People need to understand that (M)SDSs are to assess occupational hazards (and to lesser extent, environmental) and are to be used in this context only. For pharmaceutical products, the relevant information are contained in monographs. – xngtng May 18 '21 at 22:49
  • 4
    @xngtng It may also be worth noting that it takes a bit of technical familiarity with them to appreciate the level of meaningful risk. If you read the MSDS for, say, hydrochloric acid right after learning your stomach is producing it every day, you might be quite puzzled how anyone is alive at all. – Bryan Krause May 18 '21 at 23:21
  • 7
    Or reading the safety sheet for acetic acid after a balsamic salad... SDSs contains many pro-forma information. I remember the fire safety section for distilled water literally said "In case of fire, use water spray to extinguish." (Of course, the information is still useful e.g. in case of special containers that have particular fire safety concerns) – xngtng May 18 '21 at 23:27
  • 5
    "I remember the fire safety section for distilled water literally said "In case of fire, use water spray to extinguish."" This seems less than optimal - if something is going to catch water on fire (and there are chemicals like chlorine trifluoride that can do that), I'm pretty sure that said fire isn't going to be extinguished by spraying more water onto it! – nick012000 May 19 '21 at 06:07
  • 2
    @nick012000 then I hope you have the MSDS for chlorine trifluoride also in reach, since someone is messing with that ugly stuff. – Julian May 19 '21 at 14:43
  • @xngtng The data about toxicology and safety should be in the Dossier resp. Common Technical Document CTD. The individual monographs of USP, PhEur, BP and so on have no infomations about health or safety. – Julian May 19 '21 at 14:49
  • 1
    @Julian I'm not referring to monographs for pharmacopoeia entries. Now I checked again apparently Canada might be the only one using the name Product Monograph for comprehensive information document on marketed drugs (e.g. Product Monograph of the Moderna vaccine). – xngtng May 19 '21 at 15:24
  • @xngtng seems like the Information for healthcare professionals. I found no direct link – Julian May 19 '21 at 20:42
  • 2
    Another important thing to remember about just going by an MSDS for a particular chemical, especially for hazards related to human ingestion/injection/exposure, is that the dose matters a lot to the relevant hazards. Almost anything is mostly harmless in sufficiently small doses (though those doses may be very, very, very small for some chemicals.) Similarly, almost anything is very dangerous in sufficiently high doses. Even water will kill you if you ingest (or inject!) enough of it in a short enough time period. Relevant xkcd. – reirab May 19 '21 at 20:46