Genetically engineered pigs have been approved by the US Food and Drug Administration – the first time an intentional genomic alteration has been given clearance for both food and medical use.
The pigs, called GalSafe pigs, are without a sugar on their skin that can cause a severe allergic reaction among some people.
Without the molecule alpha-gal sugar, these animals can be used for tissue and organ transplants for patients with Alpha-gal syndrome, a disease contracted from tick bites, and allow them to consume the white meat without repercussions.
The FDA determined during its review that GalSafe pigs pose no threat to the environment and has a low microbial food safety risk.
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Genetically engineered pigs have been approved by the US Food and Drug Administration – the first time an intentional genomic alteration has been given clearance for both food and medical use (stock)
FDA Commissioner Stephen M. Hahn, MD, said in a Monday statement: ‘Today’s first ever approval of an animal biotechnology product for both food and as a potential source for biomedical use represents a tremendous milestone for scientific innovation.’
‘As part of our public health mission, the FDA strongly supports advancing innovative animal biotechnology products that are safe for animals, safe for people, and achieve their intended results.’
‘Today’s action underscores the success of the FDA in modernizing our scientific processes to optimize a risk-based approach that advances cutting-edge innovations in which consumers can have confidence.’
Revivicor, a spinoff from PPL Therapeutics that cloned the first mammal from an adult mammal Dolly the sheep in 1996, is licencing GalSafe pigs.
The pigs, called GalSafe pigs, are without a sugar on their skin that can cause a severe allergic reaction in some people. Without the molecule alpha-gal sugar, these animals can be used for tissue and organ transplants for patients with Alpha-gal syndrome (stock)
The firm is now working with genetic engineering to design pigs that are safe for the general population to consume, as well as for medical purposes.
Pigs have long been used for tissue and organ transplants, but for those allergic to alpha-gal sugar the transplant is typically rejected by the body.
The company Xenotherapeutics is using GalSafe pigs in three trials for skin transplants for burn victims who have Alpha-gal syndrome and plans to conduct three more at Massachusetts General Hospital.
‘In the U.S., the condition most often begins when a Lone Star tick bites someone and transmits alpha-gal sugar into the person’s body,’ the FDA shared in a statement.
‘In some people, this triggers an immune system reaction that later produces mild to severe allergic reactions to alpha-gal sugar found in red meat.’
Revivicor, a spinoff from PPL Therapeutics that cloned the first mammal from an adult mammal Dolly the sheep in 1996 (pictured), is licencing GalSafe pigs
During its review, the FDA analyzed the potential impact that the approval of the intentional genomic alteration (IGA) in GalSafe pigs would have on the environment and found it is no greater than from conventional pigs.
‘The conditions under which GalSafe pigs will be kept are far more stringent than those for conventionally farmed pigs,’ the FDA shared.
‘Additionally, no animal safety concerns were noted for GalSafe pigs beyond those that would be expected in well-managed, commercial swine operations.’
The agency also found that the microbial food safety risk is low.
This is not the first time the FDA has approved IGA in animals for either medical or food purposes.
In 2009, the process was granted for modified goats that produced a drug in their milk that is used to prevent blood clots.
The therapy with the milk is called ATryn and is administered to those with a rare disease called hereditary antithrombin deficiency.
The modification of chickens was approved in 2015 to produce a drug from their eggs to treat a protein deficiency and in the same year, salmon was the first to be genetically engineered as food.
However, the GalSafe pigs are the first in history to be approved for both food and therapeutics.