Shark Squalene in a COVID-19 Vaccine?
We are in no way trying to hinder or slow down the development of a COVID-19 vaccine or any other critical treatment that is needed to protect humanity from illness. We are asking that sustainably sourced squalene is used in all non-critical applications and where the alternative is just as effective as shark squalene, and that all future testing of adjuvanted vaccines is giving non-animal-derived squalene sources equal consideration.
As mentioned in a previous blog, there are more sustainable alternative sources of squalene, such as plants, fungi, and bacteria, that could be used to produce squalene for adjuvants. It is unclear, however, why so little research seems to be available on the efficacy of squalene from these alternate sources in vaccines. One study found that there was no difference in the efficacy of a plant versus a shark squalene based MF59 in the treatment of N. meningitidis B (can lead to meningococcal meningitis) and influenza (Brito et al. 2011). Another study found that yeast-derived squalene was just as effective and safe as shark squalene in adjuvants (Tateno et al. 2020). This means that it is possible to have success in the treatment of an illness using squalene from an alternative source. As of recent, we can confirm that the efficacy of sugarcane derived squalene is equal to that of shark derived squalene. In fact, it is superior to shark squalene because it is controlled, making the product more pure, consistent and stable.
There are some obstacles we face in this field. One of the challenges is that there is little existing information on the COVID-19 vaccines that some companies are producing, making it difficult to determine the ingredients of their vaccines. Companies may be hesitant to release that information or agree to change the source of their squalene for two reasons:
In the U.S., the FDA requires that a vaccine be re-evaluated following any change in its ingredients, potentially costing millions of dollars.
The cost of obtaining non-animal squalene such as plant squalene is more expensive than shark squalene (although this is not entirely true).
The good news is that many of the COVID-19 vaccines in the testing phase do not use an adjuvant, or if they do, use ingredients other than squalene, demonstrating that adjuvants can even be produced without squalene. As of March 5, 2021, there are 79 candidate vaccines in clinical evaluation, and 182 in pre-clinical evaluation, according to the WHO. Of these vaccines, we know of 20 that use adjuvants, and at least 6 of those adjuvants are shark squalene based (GSK/Sanofi, GSK/Innovax, GSK/Vir Biotechnology, Seqirus/University of Queensland/CSL, Medicago Inc. and Farmacologós veterinarios SAC/Universidad Peruana Cayetana Heredia). As of February 2021, GSK/Sanofi, who are using a shark squalene-based adjuvant, had some setbacks in vaccine development but are now continuing to phase 3 of development. Additionally, Clover Biopharmaceuticals has discontinued vaccine development using GSK’s shark squalene adjuvant and are instead using Dynavax’s adjuvant, which does not contain any squalene. In May, Via Biotechnology/GSK’s antibody medicine was authorized for emergency use, making it the first approved COVID-19 treatment with shark-based squalene. We know of at least one adjuvant, called “Matrix-M”, which is a saponin-based adjuvant. Saponin is a plant-derived ingredient. However, there is not much transparency as to the ingredients of many of these vaccines and adjuvants, so it is difficult to know exactly the composition or ingredients of some of the other adjuvants.
From a chemical standpoint, squalene from different sources should be identical, as its chemical structure remains the same (C30H50), meaning that non-animal squalene should be just as effective in vaccines as shark squalene. If more research can be done on this topic, and all squalene has the same effect in vaccines, pharmaceutical companies may be able to change this ingredient fairly seamlessly without having to reevaluate their vaccines. Olive oil squalene is already being used in adjuvants, but at a small scale, showing the potential for non-animal squalene in the pharmaceutical industry. And as stated previously, we now know that sugarcane-derived squalene is currently being used in vaccine adjuvants.
If COVID-19 vaccines containing shark squalene prove to be effective, large quantities of deep-sea sharks will be killed.
*Please refer to our Science and Research page for all research backing these claims.