Squalene: How COVID-19 May Threaten the Natural Marine Order
Baja California Sur, Mexico. Fishermen bring in a haul of sharks to be finned and gutted. Perrin James.
Squalene, a compound extracted from the livers of sharks, is being used in many preclinical trials for COVID-19 vaccines, putting the lives of half a million sharks at risk. This increase in squalene demand threatens to disrupt the symbiotic oceanic ecosystem, but it is not unavoidable. On the contrary, a viable biosynthetic alternative, exists that can spare further decimation of the already dwindling shark population.
The problem comes down to cost. With billions of people requiring multiple phases of a future vaccine at a rate that has never been administered before, shark squalene remains a cheaper alternative to its biosynthetic cousin.
In 2020, the danger against sharks has never been greater. With the rapid onset of the COVID-19 pandemic, vaccine production has sent the squalene industry into overdrive.
At a fundamental level, depending on non-renewable resources for mass-produced pharmaceuticals is an inefficient and fixed system. With an industry amassing over a trillion dollars a year, it is crucial to examine economic and environmental sustainability in determining longevity and production.
While historically the largest threat to sharks has been finning, the extraction of squalene from shark liver has emerged as a comparable danger to the livelihood of the essential species. And people at the forefront who are directly exploiting and utilizing these elements - don’t even realize the ensuing impact.
Sharks are pivotal to maintaining the natural order of marine ecosystems and currently over 2.7 million sharks are harvested annually for this industrial use with little regulatory oversight.
The difference between squalene and other finite resources is that there is an, albeit more costly, plant-based alternative that can be manufactured with widespread awareness. While this persisting issue has gained prominence in the last few years, 2020 has shone a new lens on what would happen if the shark population were to dwindle. In the past, pharmaceutical-grade squalene has only accounted for approximately 1% of global demand, cosmetics amassing 90%, but this year suggests otherwise which poses an opportunity for education.
Photographer: Perrin James - Shark Fishermen in Mexico
The word squalene stems from the origin of the Latin squalus, which refers to a genus of sharks. Squalene is a naturally occurring oil containing fatty acids that acts as an antioxidant, protecting the skin barrier and organs in humans and many animals. The cosmetic and pharmaceutical industry has introduced squalene (and its hydrogenated alternative squalane) in its products over the past forty years (initially as an emollient in the 1950s), to the point of ubiquity. Sharks thus emerged as the predominant, cost-effective source due to their size and obtainability.
To extract squalene from a shark, liver oil must be harvested from the organs of a dead specimen. While this can include the byproducts of sharks caught for their meat or fins, there are still a large majority killed for this explicit purpose. The oil is then concentrated with varying degrees of purity depending on the commercial or medical product, ranging from cosmetics like moisturizer, eyeshadow and sunscreen for its anti-aging properties, to lamp fuel, medicines, and most importantly, as a coadjuvant in vaccines. While over fifty species are targeted, deep water sharks are preferential because their bodily weight is 20-30% liver. In 2012, it was reported that 2,200 tons of shark liver oil were needed globally, with over 3,000 sharks needed to amass one ton.
With the recent dissemination of this exploitative practice, holding each industry accountable for what their demand is contributing and exploring feasible alternatives to combat overfishing is vital. Achieving corporate environmental responsibility is a universal predicament, but in the case of pharmaceuticals, the overhead attendant to acting ethically can be absorbed. Currently the leading squalene manufacturers are based out of Japan, France, US, India, and Turkey, collectively amassing an industry worth hundreds of millions, with the stateside companies placing a higher focus on sustainable solutions.
Photographer: Perrin James - Shiver of sharks
In the unprecedented age of COVID-19, there has been a universal sprint to develop a vaccine to counteract the pandemic. An adjuvant is a component of many vaccines used in conjunction with a reduced amount of antigen to improve the efficacy of the immune response. Squalene has most recently been used as a main ingredient in the adjuvants for malaria and flu vaccines with no mass-produced natural alternative. An emulsion of squalene is used to help stimulate the immune reaction and reduce the amount of substance needed (pertinent for condensing large-scale production) - principally as MF59 (1990s) and AS03 (developed for 2009 flu pandemic), which are oil-to-water emulsions of squalene oil in flu vaccines. This use of squalene is not only unethical, but more notably, avoidable.
In a number of the preclinical trials for COVID-19 vaccines squalene is being tested to strengthen the adjuvant. Companies like GlaxoSmithKline are slating that they may need a billion doses of adjuvant for commercial release, at 10mg a dose. When speaking with Stefanie Brendl of Shark Allies, the woman who broke this initial research and launched a petition for fair use back in September against the FDA, she stressed that there is a critical disconnect regarding public awareness of squalene usage in vaccines that can be addressed before it's too late. And if not now, then moving forward.
Squalene has been used commercially for decades but has never been produced at the rate that a pandemic demands, and both the known and unknown effects could be fatal. Brendl revealed that when speaking with pharmaceutical companies directly, the majority of individuals don’t know where squalene comes from and how it is made, attributed to little awareness about its usage and how seamlessly we can explore replacements. Ingredient labels rarely state the origin of its primary inclusion, and people have a legal right to know what they are ingesting. Few have explored squalene through a critical lens because there is so little available information and amidst a demanding medical crisis, it is time to start.
Photographer: Perrin James - Fishermen in Mexico
If we continue at the same rate with the extraction of shark squalene, the detriment to the balance of the ecosystem will be deadly. Sharks are apex predators that fend off the weak, intervene destructive populations, protect reefs and have indirect control over prey species. They are instrumental in implementing fear and order to marine life, and their destruction could lead to devastating consequences. Slowly removing a predator from an ecosystem can lead to behavioral changes amongst prey, disrupted migration patterns, population sickness, in addition to deep water explosions, and habitat degradation.
While the origin of squalene suggests its relation to a shark, it can also come from naturally occurring compounds - bacteria, algae, sugar cane, and wheat - with largely the same chemical composition. The highest potency alternatives currently extracted are amaranth, olive, walnut and other seed varieties. When squalene was popularized, sharks were the easiest and cheapest way to access the compound. Scant research was conducted into realistic and sustainable alternatives at its earliest stages because the availability, price, and potency that sharks provided outweighed the environmental impact. Flora-sourced squalene currently poses a 30% financial spike that most companies are not willing to absorb.
No research thus far has pointed to sustainably-sourced squalene having any adverse medicinal impact compared to the shark-derived alternative. Biosynthetic alternatives remain equally viable and identically effective, and have yet to be proven otherwise. Most concerningly however, is how the squalene market has continued to remain unregulated with no legal requirement to report the source of the ingredient leaving consumers in the dark. A matter plagued by teleology, the squalene dilemma joins the category of monopolized health plights that have subsumed environmental concerns and have been shielded from public knowledge under the influence of corporate gain. This has ranged from products like cigarettes to other known carcinogens like parabens and BPA. Comparably, the largely elusive squalene trade can be likened to a lack of awareness about the practices behind the fur industry and clubbing of baby seals. In the context of the present health crisis, the best case scenario in the short-term for managing squalene usage appears to be the distribution of multiple vaccines by different companies until a more ethical alternative can be developed.
Photographer: Perrin James
Harvesting a critical component from a wild animal is simply unsustainable, and while Stefanie and other researchers are not suggesting we slow the production of COVID-19 vaccines in favor of saving the sharks, the benefit of switching to sustainable feedstock is not just about ethics but also about reliability. By shifting to squalene produced from natural substances like plants and bacteria, there is an element of control that cannot be achieved utilizing sharks. There is a stark difference between a product that can be grown and regulated in a greenhouse, and extracting from a deep water shark liver that is filtering out chemicals to then be injected into the body.
In a lab, purity can be controlled, and with an equal level of investment targeted at R&D for both plant and shark squalene, alternatives can be effectively and safely explored. Some of this work is already taking place with sugarcane, just at a higher price and extraction threshold, the US-based Amyris taking the lead on sustainable development targeted at preserving sharks and low-cost sustainability. Furthermore, the prohibitive measures taken against the cosmetic industry already need to be applied equally to pharmaceuticals that often evade federal mandates. Companies like L’Oreal and Unilever are paving the way, having removed a majority of marine squalene from their product line due to corporate pressure.
The reality is that pharmaceutical and cosmetic companies are capable of changing their practices in spite of the economic pressure, and very well may be forced to if the right steps are not taken. This is an issue regarding ethics, efficiency, sustainability, and reliability that can be resolved with awareness and education. It is beyond a responsibility we have to our oceans, but in exploring a comprehensive critical perspective of what are actually the most effective and safe ingredients to be used in requisite vaccines, let alone medicines, supplements, and cosmetics. While the first and even second round of COVID-19 vaccines are likely not within the timeframe needed to formulate a viable synthetic alternative, and saving lives are of the utmost importance, we have a window to educate about a widely unknown phenomenon and actually make a difference in the future of the deep ocean. In the meantime, we can hopefully dispel the impact by relying on companies synthesizing ethical alternatives until the multi-range of trials determine the most successful counterpart.
Photographer: Perrin James
