First-of-their-kind genetically engineered pigs have just been approved in the US and could soon be making their way into drugs, onto dinner plates, and used for transplants.
The animals, known as GalSafe pigs, have been genetically edited to lack alpha-gal sugar on the surface of the pigs’ cells. This alteration aims to help people with Alpha-gal syndrome (AGS) who have severe allergic reactions to alpha-gal sugar found in red meat. In the US, the condition is often sparked after being bitten by a Lone Star tick, transmitting alpha-gal sugar into the person's body and triggering the allergy.
The US Food and Drug Administration (FDA) announced on Monday it has approved the gene-edited pigs for both human food consumption and as a source for potential therapeutic uses, such as drugs.
“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,” FDA Commissioner Stephen Hahn said in a statement.
The FDA is yet to explicitly test whether people with AGS can eat the pork, but its review found meat from GalSafe pigs is safe for the general population to eat. It also didn’t assess whether the pigs are safe for use in transplantation into humans. For this and any other use in new human medical products, developers must apply for further approval from the FDA.
The GalSafe pigs were developed by biotech company Revivicor Inc., a spin-off from the UK company PPL Therapeutics that helped to produce the first cloned animal Dolly the Sheep in 1996. Revivicor told the FDA they hoped to first start selling the meat by mail order, rather than in supermarkets. However, a spokesperson from the mother company, United Therapeutics, told the Associated Press that the company doesn’t know when it might be able to secure an agreement with a producer to sell its meat.
However, it appears meat is not the focus of Revivicor’s plans since the company is primarily geared towards regenerative medicine and xenotransplantation technology, the transplantation of living tissues from one species to another. In the company’s own words, its aim is to develop “superior quality, high-volume, human-compatible, alternative tissue sources” for medical use.
This isn’t the first time the FDA has given the green light to genetically edited animals. Back in 2015, the agency approved a genetically engineered form of salmon for human consumption that was edited to grow faster. Earlier this year, however, a court ruled the genetically engineered salmon was unlawful as the FDA failed to analyze the risk of gene-edited salmon escaping into the wild.
This recent decision by the FDA is unlikely to avoid backlash too. The Center 4 Food Safety, a US non-profit advocacy organization, has already criticized the FDA’s approval of GalSafe pigs, arguing it did not require the company to perform allergy tests nor provide an adequate environmental review.