Using sharks in COVID-19 vaccines is short-sighted, unpredictable, and unsustainable. There are better alternatives. The industry must listen.

Shark squalene has been used as the main ingredient in some adjuvants to boost efficacy in vaccines. Squalene made from shark liver oil is used most commonly because it is cheap to obtain and easy to come by, not because it is more effective than other sources (read more).

This could spell potential disaster for sharks and humans since this resource is neither sustainable nor reliable for the mass production of a COVID-19 vaccine. Shark squalene production requires relying on a finite, wild animal population. Most shark species are already at critical levels and will not withstand an increase in demand for a global vaccine. Countries producing shark squalene may soon need the oil for their own vaccine. The supply chain has never been tested at the scale that a coronavirus vaccine would demand. There is also very little quality control and transparency in the shark squalene industry. In a nutshell, exploiting sharks for a key vaccine ingredient that can be derived from more sustainable and reliable non-animal alternatives is a detrimental and destructive approach.

OUR CALL TO ACTION

It is in the best interest of the consumers, producers, and governments to create long-term solutions for such a critical issue for humans and the environment. Relying on shark-based adjuvants could create problems in production in the long run. Therefore, we ask the regulatory agencies as well as all vaccine, treatment, and supplement manufacturers to:

A) Replace shark squalene with non-animal squalene ASAP.

B) Include non-animal squalene in all tests for current and future products that use squalene.

C) Support and develop large-scale production of non-animal squalene and therefore:

• Create a secure source that doesn’t depend on imports from countries that may control the raw materials.
• Gain greater quality control and consistency in the product.
• Make using a renewable and sustainable resource that does not rely on wild animal species the new standard in the pharmaceutical industry.

THE BACKGROUND

The majority of cheap shark squalene comes from countries that are poorly regulated in terms of fisheries and fish oil production. This creates several problems:

• There is very little transparency of what animals end up in squalene production. Reports have uncovered that protected and endangered shark species end up in the shark oil trade, which is the basis for squalene and supplement production. There is no possible way to ensure that any squalene comes purely from legally harvested species.
• There is very little quality control.
• There is a dependency on supply from countries that may soon need the oil for their own vaccine and could potentially corner the market.
• If all squalene production would suddenly shift to domestic sources, it would only magnify the problem for sharks in US or EU waters.

The alternatives are available and can be produced domestically, with great quality control:

• Shark squalene is not a unique or “magical” ingredient. The chemical structure of the compound squalene (C30H50) is identical in sharks and non-animal alternatives, meaning its efficacy in vaccines should be identical regardless of its source.
• Squalene for adjuvants can be produced from yeast, bacteria, sugarcane, olive oil, and possibly even algae. For example, Amyris, one of the producers of squalene based in California, uses a process that derives squalene from sugarcane. In their most recent statement, they explained that they can produce enough squalene for 1 billion vaccines in one month or less.
• watch this interesting video discussion (video 2) with Stefanie Brendl, Executive Director of Shark Allies, John Melo, Amyris President & CEO and Chris Paddon, Ph.D, their lead squalene scientist. It will clarify many misconceptions and focuses on solutions. And it shows just how close the industry is to replacing shark squalene for vaccine use.

WHY DOES THIS MATTER?

From a conservation perspective, there is no doubt that the overexploitation of a key component of the marine environment will have dire consequences. On a practical level, using such a finite resource for a product that will have to be made for billions of people, continuously for years to come, is impractical and extremely short-sighted.

• Currently, there are 34 candidate vaccines in clinical evaluation and 142 vaccines in preclinical evaluation, according to the WHO. Of these vaccines, 17 use adjuvants, and 5 of those adjuvants are shark-squalene based (read more).
• Early-stage clinical trial results show the Covid-19 vaccines may need second doses in quick succession, potentially per season.
• With billions of vaccines needed, the number of sharks taken every year could be in the hundreds of thousands. If the current sources in Asia become more limited, that demand could result in a shift in which regions and shark species are targeted (read more).

SHARK ALLIES ACTION

This petition is only one part of a larger campaign and is meant to show that the public supports the research of and transition to the use of non-animal squalene in vaccines. With the hope to spark more research on non-animal squalene and to raise further awareness, Shark Allies is in the process of writing and publishing a peer-reviewed paper; sharing blogs, social media posts, and newsletters with the public; and targeting the relevant manufacturers and government agencies that are involved in the squalene and vaccine industries. Shark Allies will also be collaborating with overseas organizations to address this issue globally.

This petition is addressed to: US/FDA (Food and Drug Administration of the United States of America), UK/MHRA (The Medicines and Healthcare products Regulatory Agency of the United Kingdom), EU/EMA (The European Medicines Agency), China: NMPA (The National Medical Products Administration) and all vaccine producing companies.

For more information on squalene used in vaccines and cosmetics, please visit our Shark Free Products campaign page or follow us on all social channels at @SharkAllies.

Click here to donate directly to Shark Allies. If you wish to donate on Change.org, every $20 will advertise this petition 250 extra times, but this does not go directly to Shark Allies' campaign.

Campaign graphics by Jeff Kepler, @seventh.voyage.