Mark Luecke
Mark Luecke is the CEO of animal vaccine manufacturer Medgene Labs in Brookings, South Dakota.
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Bird flu. COVID-19. Swine fever. When it comes to animal diseases, it’s not a matter of if but when. Earlier this year, the U.S. Department of Agriculture announced the detection of highly pathogenic avian influenza, commonly referred to as bird flu, in the U.S. commercial bird flock. The disease affected 39 states and over 40 million birds as of August. Because of the threat to international trade and public health, the birds are being “depopulated,” which is to say they are being killed to eliminate the disease.
Influenza is perhaps the most common zoonotic disease. It impacts people, dogs, cats, horses, pigs, cows and yes, birds. Bird flu can be spread from birds to humans by simple exposure, and there are strains known to cause severe illness and death in people. In fact, both the United States and China reported cases of humans testing positive for bird flu this past spring.
We know all too well the public health and economic devastation caused by the world’s most notorious zoonotic disease, COVID-19. Even as life begins to get back to normal, we still do not have the virus contained, as new variants continue to emerge. Most recently, COVID-19 was shown to spread from white-tailed deer to humans in Canada.
While the USDA is spending $300 million to conduct COVID-19 surveillance in animals and an additional $500 million to prevent African swine fever from reaching the United States, the agency still has more weaponry in its arsenal to prevent such disease threats.
One weapon is the use of platform technologies. After a 2013 coronavirus (porcine epidemic diarrhea virus) pandemic killed over 7 million U.S. pigs, the USDA, under Secretary Tom Vilsack, took a hard look at how the agency was regulating animal vaccine development. They determined that viruses were mutating in the field faster than the vaccine approval process, which typically takes an average of five years. The USDA responded by issuing regulatory guidance allowing vaccines developed using platform technologies to be granted expedited approval. These “plug and play” platform technologies use a previously approved production outline that can be used with the most effective virus genetics to achieve the right immune response.
Leveraging this previously approved guidance and partnering with private-sector companies that develop platform technologies would have a powerful impact. The USDA could decide to establish a partnership with one or more of those companies through a Cooperative Research and Development Agreement, allowing them to deliver a bird flu or COVID-19 vaccine in a matter of weeks rather than months. The vaccine would be manufactured in a USDA-licensed facility using USDA-licensed technology, further supporting the U.S. manufacturing objectives of the Biden administration. The private sector could use discretion in whether to vaccinate or depopulate based on international trade objectives, as these new vaccines can be differentiated from infected animals.
It’s a win for the safety of animal and human populations as well as the USDA and U.S.-based vaccine manufacturers. The USDA should strongly consider this approach and allow private industry to help mitigate the threat of both known diseases and the deadly mutations we will inevitably face.