Gene-Edited Pigs Engineered for Virus Resistance Nearing FDA Approval

Genus plc, a U.K. company specializing in breeding livestock, has achieved a significant milestone by engineering several commercial breeds of pigs to be resistant to a devastating virus affecting the swine industry. The pigs have been edited using the CRISPR genome editor to disable a receptor, CD163, on pig cells, making them resistant to the porcine reproductive and respiratory syndrome (PRRS) virus. Genus aims to obtain formal approval from the U.S. Food and Drug Administration (FDA) for human consumption by the end of the year, marking a historic approval for gene-edited animals.

The PRRS virus, causing significant economic losses in the pork industry, has been targeted with this gene-editing approach to enhance resistance in pigs. Although vaccines for PRRS exist, the gene-editing method offers a more robust solution, providing 100% protection compared to the vaccines. The modified pigs have their copies of the CD163 gene disabled, making them less susceptible to the virus.

However, the regulatory process for gene-edited animals is rigorous, with the FDA categorizing the DNA change made by CRISPR as an “investigational new drug.” Genus has to submit multiple applications to establish the safety, heritability, and stability of the altered gene, along with the resistance of the resulting pigs to the virus. Critics argue that the regulatory pathway is costly and unnecessary, given that the gene editing involves the pig’s own DNA without introducing foreign genes.

The CD163 modification offers benefits beyond economic gains for the pork industry, addressing food security concerns and the emotional toll on producers who have to euthanize infected pigs. While Genus awaits FDA approval, it is actively seeking regulatory clearance in other countries, including Colombia and China. The approval in multiple countries is crucial as the U.S. and other nations export pork globally. Once approved, the challenge will be gradual adoption, as producers integrate the modified pigs into their herds.

The development of gene-edited pigs resistant to PRRS signifies a groundbreaking achievement in the field of genetic engineering and holds promise for addressing challenges in the agriculture and livestock industries. However, market acceptance and regulatory considerations remain key factors in the widespread adoption of gene-edited animals.

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