Sunday, 07 March, 2021


FDA approves genetically engineered pigs for medical and food use

Sunlight illuminates pigs in an indoor pigsty on a livestock farm in Ohrenbach Germany on Monday Jan. 20 2020. Despite its relatively small size compared with producers like China or the U.S. Germany is a heavyweight in the global pork trade- accou FDA approves genetically engineered animals as both food and for medical purposes for the FIRST time
Kristine Garrett | 18 December, 2020, 23:39

First-of-their-kind genetically engineered pigs have just been approved in the U.S. and could soon be making their way into drugs, onto dinner plates, and used for transplants.

Additionally, their organs and tissues are also suitable for transplants and other biomedical uses.

In a press release, FDA Commissioner Stephen M. Hahn said that the agency has awarded it "first-ever approval of an animal biotechnology product", which can be used for biomedical goal and for general consumption. "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 modernising our scientific processes to optimise a risk-based approach that advances cutting-edge innovations in which consumers can have confidence". They are not superpigs as the only difference between GalSafe and a natural pig is their lack of alpha-gal sugar. 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. The sugar is also found in red meat like beef and lamb.

The adjustment knocks out alpha-gal, a sugar molecule on the surface of cells, and could help minimize allergic reactions to pork and reduce the risk of organ rejection in transplant patients.

The US Center for Food Safety, a non-profit organisation, noted that the meat from the genetically-modified pigs had not yet been tested on people with the allergies. This includes the blood thinner medication heparin, which is created using pig intestines. Tissues and organs from GalSafe pigs may address the issue of immune rejection in patients receiving xenotransplants, as alpha-gal sugar is believed to be a cause of this rejection.

In the USA, the condition most often begins when a Lone Star tick bites someone and transmits alpha-gal sugar into the person's body.

The FDA said it had determined that the food from the GM pigs, known as GalSafe pigs, is "safe for the general population to eat", and suggested the meat might be sold by mail order.

FDA said the intentional genomic adjustment, or IGA, was the first of its kind and allows for pigs raised with it to be consumed as food and for therapeutic uses.

'The conditions under which GalSafe pigs will be kept are far more stringent than those for conventionally farmed pigs, ' the FDA shared.

The FDA approval marks just the second time a genetically modified animal has been approved for human consumption in the United States. United Therapeutics Corp. says the primary goal of the pig would be for medical products.

The FDA approved genetically modified salmon for consumption in 2015 but blocked the imports until just a year ago.

The US regulator granted approval of the IGA in GalSafe pigs to regenerative medicine company Revivicor Inc.

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