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US Pharmacopeia: Use Synthetic Proteins to Test Vaccines, Not Horseshoe Crabs

US Pharmacopeia: Use Synthetic Proteins to Test Vaccines, Not Horseshoe Crabs

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Vaccines are a hot topic today, and have become especially so in the face of COVID-19. What you may not know is that the entire vaccine industry over the past 40 years has been completely dependent upon the blood, and suffering, of Atlantic horseshoe crabs, who are not actually crabs, but arthropods. A synthetic alternative exists, and it's time to make it the standard.

Unfortunately for them, in 1956 a lab worker discovered that when horseshoe crab blood interacts with endotoxins — a type of bacteria and contaminant — a component in that blood called limulus amebocyte lysate, or LAL, clots around the toxin. It was quickly realized this blood could be used as a generalized test to check for contaminants in vaccines, and it has now been used for decades.

 

Each spring, when horseshoe crabs head for the shore to breed, some half million individuals are rounded up, either dredged from the ocean floor or captured on the beach as they are laying their eggs. This is only the beginning of their nightmare. After capture, they're taken to a lab, where they are cleaned and sterilized, restrained, strapped upside down to stainless-steel counters, and jabbed with a needle into the vein near their heart which extracts up to 40% of their blood. All the while they are slowly suffocating as their gills dry out. They are released back into the wild afterwards, but it's estimated that 30% do not survive the terrifying and rather gruesome process. This is exactly the sort of horror-filled alien abduction narrative we might describe if something terrible like this happened to us.

 

In Defense of Animals
If only it was as simple as making a pledge to each other to survive.

Moreover, it is suspected that horseshoe crabs who have been bled don't produce as many eggs as they normally would. According to National Geographic, 1.24 million horseshoe crabs were estimated to have spawned in Delaware Bay in 1990. As of the last count in 2019, the number was estimated to be 335,211. According to the BBC, American horseshoe crabs are close to qualifying for endangered species status.

Lastly, this is not only harmful to horseshoe crab species, but also to the entire ecosystem in which they live. Horseshoe crab eggs are vital food sources for many species, including striped bass, flounder, diamondback terrapins, and migratory shorebirds such as red knots and ruddy turnstones.

In Defense of Animals
While this horseshoe crab won't become a victim of Charles River Laboratories, he is instead a victim of human captivity, trapped in an aquarium. In the wild he could have lived to be 20 to 40 years old.

What is especially maddening about this situation is that a synthetic alternative to horseshoe crab blood now exists — Recombinant factor C, or rFC — that research has proven is as safe and effective as horseshoe crab blood. While it is approved for use in Europe, Japan, and China, the U.S. Pharmacopeia, the organization that sets the scientific standards for drugs in the U.S., has declined to affirm rFC as equivalent to LAL.

For forty years the horseshoe crabs have lost their comfort, health, and even lives for our desired outcomes.. Today, synthetic and equally effective treatments now exist. It's time for the cruelty to end.

What YOU Can Do — TODAY:

 

 

Letter to Decision Maker(s) for reference:

Subject: Approve rFC for Endotoxin Testing. Leave out horseshoe crabs.

As someone concerned with animal welfare, wildlife and public health, and one of over 250,000 In Defense of Animals supporters, I’m writing to urge the USP to swiftly approve of the use of a synthetic alternative to horseshoe crab blood for endotoxin testing. 

I was shocked to learn that U.S. Pharmacopeia has yet to include Recombinant factor C (rFC) in its list of approved bacterial endotoxin tests as an alternative to the limulus amebocyte lysate (LAL) based testing standard, which is reliant on the brutal capture and blood draining of Atlantic horseshoe crabs. 

The USP’s approval of rFC is urgently needed for a number of reasons.  American horseshoe crabs are close to qualifying for endangered species status. This is partially due to the use of horseshoe crabs as fishing bait, but it is also the result of the utilization of horseshoe crabs for LAL. It is estimated that each year, 30% of the horseshoe crabs captured for LAL extraction die as a result of the process. Moreover, it is suspected that horseshoe crabs who have been bled don’t produce as many eggs as they normally would. Horseshoe crab populations have seen a decline over recent decades. 1.24 million horseshoe crabs were estimated to have spawned in Delaware Bay in 1990. In 2019, the number was estimated to be 335,211. Terrifyingly, the 2020 horseshoe crab count was cancelled due to the pandemic, just as the demand for horseshoe crab blood for vaccines was skyrocketing. In a normal year, pharmaceutical companies conduct roughly 70 million endotoxin tests. And 2020 and 2021 are no normal years, with more than 100 different vaccines currently being tested for COVID-19. 

Then there is the question of the ethics of the procedure as a whole, especially in light of an existing synthetic alternative. Horseshoe crabs are animals with nervous systems and the capacity to suffer. Yet, each spring, as they head for the shore to breed, some half million horseshoe crabs are rounded up, either dredged from the ocean floor or captured on the beach as they are laying their eggs. This is only the beginning of their nightmare. From here, the horseshoe crabs are taken to a lab, where they are cleaned and sterilized, restrained, strapped upside down to stainless-steel counters, and each inserted with a needle to a vein near their heart which extracts up to 40% of their blood. All the while they are slowly suffocating as their gills dry out. 

Lastly, this is not only harmful to horseshoe crab species, but also to the entire ecosystem in which they live. Horseshoe crab eggs are vital food sources for many species, including striped bass, flounder, diamondback terrapins , and migratory shorebirds such as red knots and ruddy turnstones. 

The European Pharmacopeia has already recognized rFC as an equivalent, noting several advantages including its reproducibility, quality, sustainability and specificity, as have regulating bodies in Japan and China. I sincerely hope you will take quick steps to add rFC to the USP-NF for endotoxin testing.

Thank you for your immediate consideration and action on this important issue.

Sincerely,

Signed

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