FDA Approves ‘GalSafe’ Pigs for Food, Medicine for Alpha-Gal Allergy

in Food Allergy, Food Allergy News, Other Food Allergy
Published: December 17, 2020
A "GalSafe" pig
Courtesy Revivicor Inc.

The U.S. Food and Drug Administration has approved a line of “GalSafe pigs,” bringing considerable hope to those with alpha-gal allergy. 

Patients with alpha-gal allergy react to alpha-gal, a sugar found in meat such as beef, pork, lamb and venison. The GalSafe pigs, licensed to Revivicor Inc. in Virginia, are bred with a genomic alteration that eliminates alpha-gal sugar on the surface of the pigs’ cells. So farmers can now raise them and sell food like alpha-gal-free pork chops and bacon.

Importantly to the alpha-gal community, the FDA approval opens the door to medicines without the offending sugar. Since many medications contain pork-based gelatin or are derived from pig tissues, this can put critical medicines off-limits to those with the allergy. An example is the blood thinner heparin, which is used in medical procedures to prevent blood-clotting. 

“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 Dr. Stephen Hahn said on Dec. 14.

The FDA noted in a media release that tissues and organs from the genetically modified GalSafe pigs may play a role in organ and tissue transplants too, as alpha-gal is believed to have a role in immune rejection among alpha-gal patients.

FDA Stresses Safety

Alpha-gal allergy is an unusual one, though increasingly common in adults and especially in the southeastern United States. It develops after a bite from a Lone Star tick triggers a person’s immune system to begin producing IgE antibodies to alpha-gal. While some patients with alpha-gal allergy (also called alpha-gal syndrome) have mild symptoms, others experience severe anaphylactic reactions, sometimes including loss of consciousness.

Aware that genetic modification is a controversial subject, FDA’s Hahn stressed that this animal biotechnology is “safe for animals, safe for people.” 

The FDA says “the conditions under which GalSafe pigs will be kept are far more stringent than those for conventionally farmed pigs. Additionally, no animal safety concerns were noted for GalSafe pigs beyond those that would be expected in well-managed, commercial swine operations.”

In the community of those with alpha-gal allergy, there was much excitement for the future, for food and medicine. Expert Dr. Scott Commins of the University of North Carolina noted on Twitter: “These animals will specifically benefit human health and improve the lives of patients with alpha-gal allergy.”

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