Vaccination

The Co-Infection Conundrum: How Bad Can Bad Get?

Fri, 05 Sep 2025 18:35:15 GMT

For years, the swine industry has talked at length about multiple pathogens and multiple infectious agents. JD Fiechtner, senior key account veterinarian for Boehringer Ingelheim, says only recently has the industry begun to fully realize the impacts of two infections affecting the pig at the same time.

“For a long time, we thought of them separately, as just a one plus one – an additive component,” Fiechtner explains. “What the industry is realizing now is that we are seeing worse outcomes from these infections when they’re together than when we just considered them independent of each other.”

Two recent studies back up the compounding impact pigs face when hit with more than one pathogen at a time. Scientists looked at the impact of co-infections of porcine reproductive and respiratory syndrome (PRRS) plus Lawsonia intracellularis and PRRS plus porcine circovirus type 2d (PCV2d).

“Most everybody is dealing with PRRS infections, and there is not any one answer to manage that disease,” Fiechtner says. “It’s very common, and it’s very common to be frustrated with it.”

A Dynamic Discovery
In the first study, scientists evaluated the highly virulent PRRS 1-7-4 strain in combination with PCV2d . The study revealed that giving a PCV2d vaccine as prevention or protection results in better economic outcomes in co-infected PRRS pigs. Not only did they see a decrease in mortality, but they also saw a decrease in the number of pigs treated for health challenge signs that would require an antibiotic or other supportive therapy.

“We call this dynamic pig health, because it is a dynamic system within the pig,” he says. “It’s not just one issue. You have to consider all the aspects of disease. That’s why looking at the overall pig and the overall challenges when making your intervention strategies is very important.”

The second study evaluated PRRS with Lawsonia intracellularis . Typically, studies don’t connect the respiratory component of the PRRS virus with a gut infection like Lawsonia.

“We usually don’t think about a common tie between those two organ systems – enteric and respiratory,” Fiechtner says. “But in this study, we proved that even with subclinical (or less than obvious infection of Lawsonia), there was increased mortality and decreased average daily gain — worse than what was expected.”

Fiechtner believes most people who work in the pork industry have a gut feeling about the deeper impact of co-infections.

“These studies put some facts to what many who work in swine health assumed and helped us predict some economic costs and/or benefits of tailoring your approach to mitigate co-infection concerns,” he says.

Strategize Solutions
Working with a herd veterinarian is key, Fiechtner says. Find a veterinarian who is informed on pathogens present in the industry and is connected to the diagnostic labs.

“Diagnostic labs have made great improvements in the last decade on testing and specifics of disease pathogens,” he points out. “This allows you to tailor vaccination strategies or treatments to obtain the best outcomes economically from these pigs.”

For example, with PCV2d, Fiechtner says there have been good vaccines available for a number of years. The challenge is that the predominant genotype has shifted from PCV2a to PCV2d. Most systems will still say they have good coverage with their vaccines, but some are seeing impacts that they don’t like, that are negatively impacting herds. This knowledge allows them to tailor a specific vaccine to approach a “d” problem to obtain a better outcome.

One of the challenges with PRRS plus Lawsonia is that subclinical Lawsonia is hard to “see” in barns, he explains.

“Lawsonia is a silent thief,” Fiechtner says. “In economic studies from Iowa State, it costs anywhere between $3 and $10 a pig with subclinical Lawsonia, and up to $17 a pig with a clinical infection. There are some big dollars that can be lost here.”

That’s why it’s important to understand your herd’s health in order to strategize prevention. Although there is not one perfect method, he cautions against underestimating biosecurity.

“If you can prevent entry of any disease to your herd, that would be the best mechanism,” he says. “But a lot of these pathogens I’m talking about are endemic, which means they’re already present so you can’t exclude them. But you can minimize their impacts.”

To stay in business to provide healthy, nutritious protein to the global population, producers must be able to do so in a reasonable, economic and sustainable manner.

“Nothing trumps health when you want the best outcomes for your pig production systems,” Fiechtner says. “Prevention is the key. Work with your herd veterinarian who is familiar with your system and health challenges to tailor your interventions and preventions to obtain the best outcomes possible.”

Bottom line? Have a plan on how to deal with disease, minimize impacts, mitigate problems and obtain support from trusted advisers.

Iowa Secretary of Ag Weighs In on The H5N1 Battle, Vaccine Potential And Trade Sensitivities

Wed, 29 Jan 2025 13:53:38 GMT

Eggs continue to be a hot topic in the news as supplies are down, prices are up – and expected to go even higher – and consumers are understandably concerned.

At the center of the issue, fanning the on-going problem for poultry and dairy producers as well, is the Highly pathogenic H5N1 avian influenza A virus (HPAI H5N1).

AgriTalk Host Chip Flory broached the topic with Iowa Secretary of Agriculture Mike Naig on Tuesday.

At the heart of their conversation was a two-part question – how does the U.S. address the virus and, in the process, prevent any potential negative ramifications on trade?

Naig says the federal government is taking what he described as a three-legged stool approach to addressing the problem in both industries.

He described the three legs of the stool as being USDA’s Animal and Plant Health Inspection Service (APHIS), individual state animal health officials and industry.

“We work very closely with APHIS on this, meaning that they’re the ones that are providing the indemnity payments to producers. They are providing the disposal and cleanup assistance, but they must work in close collaboration with the states and state animal health officials,” Naig says. “And then, of course, you’ve got to have the third leg, which is industry.”

Biosecurity Measures
Naig noted that while the virus hit the poultry industry hard in 2015, it struck even harder in 2024.

“It’s not just in the Midwest or West, it’s been really all across the country now, affecting the egg laying industry, broilers and turkey production,” Naig says.

A significant positive, Naig says, is that biosecurity measures in the poultry industry appear to be preventing farm-to-farm spread. “The industry continues to get high marks for that, which wasn’t the case in 2015, which was so devastating because we didn’t have those strategies in place.”

“I believe, and our experience has been, that our USDA partners in this regard have been very strong,” he adds.

As Naig addressed the three-legged stool approach the U.S. is taking to addressing the virus in dairy, he says the three partners have more work to do.

“Frankly, there’s been a lot of criticism to share around the three legs, if you will, on how states have reacted, or how strongly USDA should have reacted, and what the industry is doing to try to contain that virus. So, I would say on the dairy side of things, it’s a different story (than in poultry). There’s a lot more work that’s yet to be done to even understand how that virus is impacting those (dairy) herds.”

What Is The Role For Vaccines?
Flory asked Sec. Nagy whether he believes a vaccine could be part of the solution to the virus or whether that would set up too many trade barriers. Flory also asked whether the virus is stable enough for a long enough period of time for a vaccine to be developed that would work effectively.

Both are questions the U.S. is grappling with as it tries to get ahead of the virus in dairy and poultry.

Earlier this month, Reuters reported the U.S. will rebuild a stockpile of avian influenza vaccines for poultry that match the strain of the virus circulating in commercial flocks and wild birds, citing the Department of Agriculture.

Naig told Flory that he believes a vaccine could be developed, with regard to poultry specifically, and its use negotiated into trade agreements.

“Those are challenges, and yet those are things that can be worked on and can be done, but it’s not easily done. I would want to put a flag there,” Naig says.

“I’m supportive of developing … we should try to figure out whether this can be an effective tool. If you’re in the broiler business or if you’re in the turkey meat business or if you’re in the egg business or maybe you’re in the genetics business, those are very different in terms of how you view that vaccine.”

Naig explains part of the different viewpoints on vaccine use have to do with the difference between poultry business segments.

“We need to recognize that those sectors are different in how they’ll view and potentially use a vaccine,” Naig says.

“Don’t treat them all the same. It’ll make way more sense for some than others.”

Naig did not weigh in on vaccine development for the dairy industry specifically.

The full conversation between Naig and Flory on AgriTalk is available below.

Your next read: Think Egg Prices Are Already Too High? USDA Says Retail Egg Prices Could Jump Another 20% in 2025

Livestock and mRNA Vaccines: What You Need To Know

Fri, 27 Sep 2024 01:56:42 GMT

As misinformation regarding the use of mRNA vaccines in livestock filter through social media, there are facts begging to be set straight.

Recently, a claim was made saying producers are required to inject livestock with mRNA vaccines.

According to USDA spokesperson, Marissa Perry says, “There is no requirement or mandate that producers vaccinate their livestock for any disease. It is a personal and business decision left up to the producer and will remain that way,” in response to the claim, Associated Press shared in an article .

National Pork Board’s Director of Consumer Public Relations, Jason Menke echoed the statement to AP, noting that the decision to use vaccines and other medical treatments to protect animal health and well-being are made by the farmer under the direction of the herd veterinarian.

To further explain mRNA vaccines and shed light on controversies, Dr. Kevin Folta, a molecular biologist and professor at the University of Florida, shares his viewpoint and experience with the technology.

What are mRNA Vaccines?

First introduced to the population through the COVID-19 vaccines, mRNA (messenger ribonucleic acid) vaccines have been in development for decades, says Folta in a recent AgriTalk segment.

He adds that the technology’s potential in human health makes it a likely candidate to have a place in animal health as well. However, “the technology is being maligned in social media, and is now shaping decisions at the level of state legislature,” Folta says. This leads to the growing importance that producers and consumers become more educated on the topic.

What Folta believes began in January of this year, based on claims with very little data, certain advocates against mRNA vaccines are concerned that mRNA vaccines are in use and development in livestock. Additionally, these vaccines may then be present in the food these animals provide.

Why mRNA Vaccines Are Not Present in Food

“It’s not in your food. It’s a vaccine for the animal that, just like any vaccine, protects the animal from disease,” Folta says.

Current mRNA vaccines being used in swine are injected into the muscle, Folta explains, which causes the development of the immune response protein to then stimulate the body to work against the virus.

“In the absence of the virus, it’s kind of like giving the virus or giving the body a ‘wanted’ poster that says, ‘when this individual comes along, and this virus comes along, work against it,’ and it’s all gone within hours,” he adds.

The mRNA never leaves the cells from where it was injected. RNA is a very unstable molecule that must be kept cold, buffered and in solvent, to remain viable, Folta explains.

Additionally, any licensed vaccine comes with a minimum time before that animal can enter the food chain, also known as the “withdrawal time,” says Alan Young, professor in the Department of Veterinary Biomedical Sciences at South Dakota State University and founder of protein platform (non-mRNA) vaccine company Medgene.

The Animal’s Genes Are Not Altered

While mRNA vaccines include genetic code, Folta says the use of a mRNA vaccines does not alter the animal’s genes in any way.

“This [mRNA] is an intermediate between the gene itself and the products that the gene encodes. So, it’s like having a blueprint and a house. The mRNA is like the construction worker. It takes the blueprint and manufactures the house. In the case of the cell, it takes the DNA blueprint and then takes a little bit of that information to build part of the final structure. The mRNA is just that intermediate, it does not change the genes. It doesn’t change the DNA itself,” he explains.

What are the Benefits of mRNA Vaccines?

More flexibility and faster response to new disease, Folta describes as reasons why mRNA vaccines are becoming more popular.

Traditional vaccines require large amounts of a virus to be raised and purified before being injected to elicit an immune response, he adds. Meanwhile, mRNA encourages the body to make a little piece of protein to elicit the desired immune response.

“It’s much cleaner, much easier. If you’re moving parts in this machine, to make this product that induces an immune response, it’s so good in so many ways,” Folta says.

In pork production specifically, researchers are working with mRNA vaccines that will work this way against porcine reproductive and respiratory syndrome (PRRS), which is a viral disease that causes economic loss totals around $664 million per year in the U.S. (Holtkamp et al., 2013).

Additionally, the use of mRNA technology adds another tool to the toolbox, which may be helpful in combating diseases, such as African swine fever (ASF), avian influenza and other food-animal diseases.
“This stands to be a revolutionary technology if we don’t get in the way,” Folta adds.

Are There Risks to mRNA Vaccines?

Folta says everything has some sort of risk, but it’s important to weigh the benefits against the risk.
As seen with the COVID-19 vaccines, in rare cases, people experienced side effects from the vaccine. However, Folta is encouraged by the initial results in livestock.

“If you look in animals where these [vaccines] have been used, there have been no unusual effects noted. Everything potentially has risk, but it’s monitored, and especially in large animal populations, we can look very carefully at that for surveillance,” he explains.

mRNA Enters State Legislation

While some consumers spread misinformation about the use of mRNA vaccines, the ideas have also crept into state legislation.

The Missouri House Bill 1169 , with a special hearing set for Apr. 19 on the matter, aims to require a label be used on meat from animals treated with an mRNA vaccine, identifying the “potential gene therapy product.”
This bill falsely claims that mRNA vaccines would modify the genes of the organism, Folta explains.

mRNA vaccines are simply another modality that can protect animal health, which results in healthy animals producing the best and safest food products, Folta says, and provides producers with more options to help combat disease.

“To have affordable food, we need to have continual innovation in the animal, medical, veterinary space and mRNA vaccines are safe and an effective way to treat the animal that does not change the final product,” he adds.

The COVID-19 pandemic simply “broke the seal” to the development of these new modalities that will change the way human and animal diseases will be treated in the years to come.

More on Vaccines:

Genvax Technologies Secures $6.5 Million to Advance Novel Vaccine Platform

Cattle Veterinarians Have New Vaccination Guidelines

Don’t Assume That Old Refrigerator Is Good Enough To Store Vaccines

OTC Livestock Antibiotics Will Require Prescription June 11

Canada To Develop a Foot and Mouth Disease Vaccine Bank

Wed, 11 Sep 2024 14:24:47 GMT

The Government of Canada is continuing to advance its work of protecting animal health by establishing a foot and mouth disease (FMD) vaccine bank, according to a news release from the Canadian Food Inspection Agency (CFIA).

The vaccine bank is a key part of Canada’s response plans to control and ultimately eliminate an outbreak of FMD should it be detected in Canadian animals, CFIA said.

In late August, a Request for Proposal (RFP) was issued by Public Services and Procurement Canada, on behalf of the CFIA, to supply vaccine products to the FMD vaccine bank.

The successful bidder(s) would provide concentrated FMD vaccines that could be rapidly transformed into usable vaccines. Information about the RFP including requirements, criteria, processes and timelines is available to interested bidders on CanadaBuys.

“It’s vitally important that we continue to take steps to protect livestock, and the livelihood of our hardworking farmers, against the threat of animal disease. By creating a dedicated foot and mouth disease vaccine bank, we’re working to reduce the spread of the disease and the impact that a potential outbreak would have on market access for Canadian producers. The announcement marks another step forward in the on-going work of supporting our animal disease preparedness efforts,” said Lawrence MacAulay, Canada Minister of Agriculture and Agri-Food, in the release.

The vaccine bank would help protect Canada from the emerging threat of FMD, maintain public confidence in the Canadian food supply, and help reduce the spread of the disease, should an outbreak occur. An effective and efficient response, including vaccination, will also help mitigate prolonged market disruptions to trade.

Quick Facts

Budget 2023 committed $57.5 million over five years, with $5.6 million ongoing, to the CFIA to establish an FMD vaccine bank for Canada, and to develop FMD response plans.
FMD is a severe, highly communicable viral disease of cattle and swine. It also affects sheep, goats, deer and other cloven-hoofed ruminants but not horses. Many affected animals recover, but the disease leaves them weakened and debilitated.
Canada has been free from FMD since 1952, and strict measures are in place to prevent the disease from entering Canada. FMD is not a public health risk and is not considered a food safety issue.
The CFIA would use a vaccine only in the event of an outbreak to protect animals and help stop the spread of disease. This complements Canada’s current access to vaccines through the North American Foot and Mouth Disease Vaccine Bank (NAFMDVB) ensuring readily available vaccines for Canadian producers.
In Canada, FMD is a reportable disease under the Health of Animals Act, and all suspect cases must be reported to the CFIA.
The CFIA monitors the status of FMD worldwide and has emergency preparedness and response plans ready.

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The Truth About mRNA Vaccines in the Animal Health Industry

Mon, 11 Dec 2023 15:39:48 GMT

The animal health industry continues to face challenges of new and emerging diseases as well as improvements in current commercial vaccines. Mike Roof, chief technology officer for the State of Iowa Bioscience initiative, believes the industry needs to ensure all relevant technology can be used to best support animal health today and in the future.

“Vaccines in the animal health industry play an important role in disease control, economic production, animal welfare and control of zoonotic agents. Despite the broad range of vaccines available to veterinarians today, there are still unmet needs and gaps in available tools,” Roof said during a presentation at the 2023 Allen D. Leman Swine Conference in St. Paul, Minn.

Proposed legislation on mRNA vaccine use in animals in some states, if successful, could limit the tools available now and in the future for veterinarians, he pointed out.

“In some cases, these discussions are not based on scientific facts or an understanding of the USDA’s Center for Veterinary Biologics (CVB) regulatory policy and so it is important that veterinarians and stakeholders in the animal health industry help educate the public and interested stakeholders,” Roof said.

Here are 5 things Roof wants people to know about mRNA vaccines:

1. mRNA is the template which cells use to make proteins required for cell function and viability. mRNA has a short half-life (seconds-hours) which is an evolutionary trait to ensure cells don’t overexpress and a mechanism of biological balance and control, Roof said.

2. COVID vaccines, such as those developed by CureVac, use modified nucleotides and complex methods to stabilize such as nanoparticles and lipids, he explained. Despite this advanced technology, these vaccines still require storage at -70 Celsius or they would degrade to the point of non-functional.

3. mRNA does not incorporate into the genome of the host and there are no “Frankenstein” creations of new genetic material or altered host genomes, Roof explained.

4. Unlike synthetically produced mRNA vaccines used in humans (COVID), there are currently no mRNA vaccines licensed by the USDA/CVB. The Sequivity product licensed and commercialized by MERCK is categorized by CVB as an RNA particle. In practical terms, Roof said this is derived from an alphavirus (Venezuelan equine encephalitis vaccine strain TC-83) virus that is defective. Like a MLV vaccine virus product, it can infect and delivery a viral payload, but the platform is defective and cannot create viable virus particles and so a non-replicating platform.

5. Vaccine approval and use is already regulated by highly skilled and competent experts at CVB, Roof said. Further legislative policy may not serve the animal health industry. He said this is true not only of mRNA vaccines, but all vaccines and all future vaccine technology. The CVB process considers not only host animal safety and efficacy, but also issues like shed, spread, environmental and human safety.

Read More:

Livestock and mRNA Vaccines: What You Need To Know

mRNA Conspiracy Theories: Ranch Group Offers ‘Fearmongering’ and ‘Misinformation’

New Center at Kansas State University to Drive Innovation in Animal Vaccines and Antimicrobial Alternatives

Fri, 07 Jul 2023 19:50:20 GMT

Launching the new Center on Vaccine Evaluation and Alternatives for Antimicrobials, or CVEAA, Kansas State University’s College of Veterinary Medicine aims to support animal vaccine development and usage, says a recent release.

The new center will provide innovative services to global partners and customers by conducting safety and efficacy evaluations of vaccines for transboundary animal diseases, helping animal vaccine buyers manage product specification and quality evaluation, and leading feasibility analysis and policy advocacy on vaccines as alternatives for antimicrobials used in animal production, says the release, with Jishu Shi, professor of vaccine immunology and one of the university’s leading researchers on infectious swine diseases to serve as the center’s director and one of three primary faculty members.

“The Center on Vaccine Evaluation and Alternatives for Antimicrobials is a research and service center designed to meet a series of unmet needs in the development and usage of animal vaccines around the world,” Shi says in the release.

The center will focus on U.S. Department of Agriculture and Department of Homeland Security supported research projects and work closely with animal health industry partners in the following areas, says the release:
• Safety and efficacy testing of experimental vaccines for African swine fever, classical swine fever and porcine reproductive and respiratory syndrome.
• Co-development of novel adjuvants for animal vaccines.
• Evaluations of diagnostic tools for swine infectious diseases, novel antiviral compounds against swine viral pathogens, and novel disinfectants against African swine fever virus and other swine viral pathogens.

“Dr. Shi’s research expertise in helping control the spread of African swine fever and his experience in building coalitions between a wide variety of partners in private industry and government agencies makes him uniquely qualified to lead this new center,” says Bonnie Rush, Hodes family dean of the College of Veterinary Medicine, in the release.

The primary faculty members at the center will include Shi. Lihua Wang, research assistant professor of virology and vaccine immunology, and Rachel Madera, senior research scientist in anatomy and physiology, as well as a team of the following collaborating principal investigators from K-State’s veterinary college: Jianfa Bai, Santosh Dhakal, Natasha N. Gaudreault, Tae Kim, Waithaka Mwangi, Roman M. Pogranichniy, Jürgen A. Richt and Dana L. Vanlandingham.

“The need to evaluate safety and efficacy of experimental vaccines for high consequence transboundary animal diseases has increased significantly since 2018, but the availability of suitable high-level biosecurity research facilities and associated expertise in public and private domains is very limited,” Shi explains in the release. “Vaccines for transboundary animal diseases are frequently procured by international aid agencies. However, these agencies have very limited resources on ‘fit for purpose’ analysis and quality evaluation of the vaccines before they are purchased.”

Additionally, Shi notes the “One Health” initiative, which aims to promote vaccines as alternatives to antibiotics in food animal production practice — has faced multiple challenges, including the efficacy, availability and affordability of current commercial bacterial vaccines, Shi believes new policies and public-private partnerships are needed to accelerate targeted research and development of new vaccines to improve animal health and reduce antibiotic consumption and antimicrobial resistance risk.

Vaccines Using mRNA Can Protect Farm Animals Against Diseases Traditional Ones May Not

Fri, 19 May 2023 18:52:21 GMT

By David Verhoeven , Iowa State University

While effective vaccines for COVID-19 should have heralded the benefits of mRNA vaccines, fear and misinformation about their supposed dangers circulated at the same time. These misconceptions about mRNA vaccines have recently spilled over into worries about whether their use in agricultural animals could expose people to components of the vaccine within animal products such as meat or milk.

In fact, a number of states are drafting or considering legislation outlawing the use of mRNA vaccines in food animals or, at minimum, requiring their labeling on animal products in grocery stores. Idaho introduced a bill that would make it a misdemeanor to administer any type of mRNA vaccine to any person or mammal, including COVID-19 vaccines. A Missouri bill would have required the labeling of animal products derived from animals administered mRNA vaccines but failed to get out of committee. Arizona and Tennessee have also proposed labeling bills. Several other state legislatures are discussing similar measures.

I am a researcher who has been making vaccines for a number of years, and I started studying mRNA vaccines before the pandemic started. My research on using mRNA vaccines for cattle respiratory viruses has been referenced by social media users and anti-vaccine activists who say that using these vaccines in animals will endanger the health of people who eat them.

But these vaccines have been shown to reduce disease on farms, and it’s all but impossible for them to end up in your food.

Traditional Animal Vaccine Approaches

In food animals, several types of vaccines have long been available for farmers to protect their animals from common diseases. These include inactivated vaccines that contain a killed version of a pathogen, live attenuated vaccines that contain a weakened version of a pathogen and subunit vaccines that contain one part of a pathogen. All can elicit good levels of protection from disease symptoms and infection. Producing these vaccines is often inexpensive .

However, each of these vaccines has drawbacks .

Inactivated and subunit vaccines often do not produce a strong enough immune response, and pathogens can quickly mutate into variants that limit vaccine effectiveness . The weakened pathogens in live attenuated vaccines have the remote possibility of reverting back to their full pathogenic form or mixing with other circulating pathogens and becoming new vaccine-resistant ones. They also must be grown in specific cell cultures to produce them, which can be time-consuming.

There are also several pathogens – such as porcine reproductive and respiratory syndrome virus, foot and mouth disease virus, H5N1 influenza and African swine fever virus – for which all three traditional approaches have yet to yield an effective vaccine.

Another major drawback for all three of these vaccine types is the time it takes to test and obtain federal approval to use them. Typically, animal vaccines take three or more years from development to licensure by the U.S. Department of Agriculture. Should new viruses make it to farms, playing catch-up using traditional vaccines could take too long to contain an outbreak.

Advantages of Animal mRNA vaccines

All cells use mRNA, which contains the instructions to make the proteins needed to carry out specific functions. The mRNA used in vaccines encode instructions to make a protein from a pathogen of interest that immune cells learn to recognize and attack. This process builds immunological memory , so that when a pathogen carrying that same protein enters the body, the immune system will be ready to mount a quick and strong response against it.

Compared to traditional vaccines, mRNA vaccines have several advantages that make them ideal for protecting people and farm animals from both emerging and persistent diseases.

Unlike killed or subunit vaccines, mRNA vaccines increase the buildup of vaccine proteins in cells over time and train the immune system using conditions that look more like a viral infection. Like live attenuated vaccines, this process fosters the development of strong immune responses that may build better protection. In contrast to live attenuated viruses, mRNA vaccines cannot revert to a pathogenic form or mix with circulating pathogens. Furthermore, once the genetic sequence of a pathogen of interest is known, mRNA vaccines can be produced rather quickly .

The mRNA in vaccines can come in either a form that is structurally similar to what is normally found in the body, like those used in COVID-19 vaccines for people, or in a form that is self-amplifying, called saRNA . Because saRNA allows for higher levels of protein synthesis, researchers think that less mRNA would be needed to generate similar levels of immunity. However, a COVID-19 saRNA vaccine for people developed by biopharmaceutical company CureVac elicited less protection than traditional mRNA approaches.

Merck’s Sequivity is currently the only saRNA vaccine licensed for use in animals, and it is available by prescription to protect against swine flu in pigs.

Persistance of mRNA Vaccine Components

All mRNA vaccines are made in the laboratory using methods that were developed decades ago . Only recently has the technology advanced to the point where the body doesn’t immediately reject it by activating the antiviral defenses intrinsic to each of your cells. This rejection would occur before the immune system even had the chance to mount a response.

The COVID-19 mRNA vaccines used in people mix in modified nucleotides – the building blocks of RNA – with unmodified nucleotides so the mRNA can hide from the intrinsic antiviral sensors of the cell. These modified nucleotides are what allow the mRNA to persist in the body’s cells for a few days rather than just a few hours like natural mRNAs.

New methods of delivering the vaccine using lipid nanoparticles also ensure the mRNA isn’t degraded before it has a chance to enter cells and start making proteins.

Despite this stability, mRNA vaccines do not last long enough within animals after injection for any component of the vaccine to end up on grocery store shelves. Unlike for human vaccines, animal vaccine manufacturers must determine the withdrawal period in order to obtain USDA approval. This means any component of a vaccine cannot be found in the animal prior to milking or slaughter. Given the short lifespan of some of the agriculture animals and intensive milking schedules, withdrawal periods often need to be very short.

Between the mandatory vaccine withdrawal period, flash pasteurization for milk, degradation on the shelf and the cooking process for food products, there could not be any residual vaccine left for humans to consume. Even if you were to consume residual mRNA molecules, your gastrointestinal tract will rapidly degrade them .

Several mRNA vaccines for use in animals are in early stages of development . Merck’s USDA-licensed Sequivity does not use the modified nucleotides or lipid nanoparticles that allow those vaccine components to circulate for slightly longer periods in the body, so long-term persistence is unlikely.

Like in people, animal vaccines are tested for their safety and effectiveness in clinical trials. Approval for use from the USDA Center for Vaccine Biologics requires a modest level of protection against infection or disease symptoms. As with all animal vaccines, future mRNA vaccines will also need to be fully cleared from the animal’s body before they can be used in animals for human consumption.

mRNA Vaccines for More Farm Animals

Whether mRNA vaccines will displace other vaccine types for livestock is yet to be determined. The cost of manufacturing these vaccines , their need to kept very cold and warm up before use to avoid degradation, and the efficacy of different types of mRNA vaccines all still need to be addressed before large-scale use can take place.

Traditional vaccines for food animals have protected them against many diseases . Limiting the use of mRNA vaccines right now would mean losing a new way to protect animals from pesky pathogens that current vaccines can’t fend off.

(Farm Journal)

Article written by David Verhoeven , Assistant Professor of Vet Microbiology and Preventive Medicine, Iowa State University

This article is republished from The Conversation under a Creative Commons license. Read the original article .

mRNA Conspiracy Theories: Ranch Group Offers ‘Fearmongering’ and ‘Misinformation’

Mon, 24 Apr 2023 20:23:57 GMT

Misinformation and conspiracy theories regarding the use of mRNA vaccines in livestock continue, despite efforts of the scientific community, the Animal Health Institute and government agencies.

Last week Drovers and AgWeb reported about a bogus claim on social media that producers are required to inject livestock with mRNA vaccines. USDA spokesperson Marissa Perry said, “There is no requirement or mandate that producers vaccinate their livestock for any disease.”

Further, the mRNA vaccines are not even available for cattle in the United States, and the National Cattlemen’s Beef Association issued a statement indicating such in an effort to tamp down the internet falsehoods.

University of Florida professor Kevin Folta appeared on AgriTalk confirming to host Chip Flory that no mRNA cattle vaccine is approved in the U.S., but researchers are working on an mRNA vaccine for swine to battle porcine reproductive and respiratory syndrome (PRRS).

“It’s (mRNA) a vaccine for the animal that, just like any other vaccine, protects the animal from disease,” Folta said. And, “It’s not in your food.”

Despite Folta’s and assurances from many others in the scientific community, false accusations about the safety of meat and milk continue. Late last week one ranch group issued a press statement followed by a commentary, both filled with inaccuracies about mRNA and frosted with a coating of fear for consumers.

In the press release, R-CALF USA said after a briefing from its Animal Health Committee Chair, who “spoke with medical doctors and a microbiologist” who were unnamed, the group’s board passed a motion to bring the issue before the full membership at its next annual meeting to determine policy direction. Until then, R-CALF says mandatory country-of-origin labeling (COOL) must be adopted, because without COOL, “The American consumer has no way of knowing if the beef they are buying is coming from a country using this debatable mRNA technology in their cattle health management.”

R-CALF CEO Bill Bullard went even further in his commentary , calling the mRNA vaccine “an injection.” Additionally, he claimed that mRNA “hijacks living cells, tricking them into producing some level of immunity against human viruses.”

But the most egregious statement from Bullard seems to cavalierly tarnish beef’s safety image.

“There is great concern that living cells excrete the mRNA over time and the mRNA can then be transferred to animals and humans that have never received the mRNA injection,” Bullard wrote. “It is believed, for example, that humans can contact (sic) mRNA by eating meat from livestock that have received the injection.”

All of that is false, of course. To obtain confirmation we reached out to Dr. Jeff Savell, Vice Chancellor and Dean, Agriculture and Life Sciences at Texas A&M University, who is also a Distinguished Professor, Meat Science. He promptly put us in contact with a faculty expert.

That would be Dr. Penny Riggs, associate professor of animal science at Texas A&M. More of her credentials later. But first, after reviewing the R-CALF releases she called them “fearmongering and misinformation.”

Quoting directly from the email Drovers received from Dr. Riggs:

“First. No mRNA vaccines are currently available for beef cattle. I understand that there are a couple of vaccines against respiratory disease and rotavirus for swine.”

“Second. No food safety risk exists for meat from animals that have received any vaccination.” [Regardless of vaccination type, proper withdrawal times should be ensured. Specified withdrawal times are based on the specific vaccine and its formulation components.]

“Third. mRNA from a vaccine will NOT be passed along in meat.”

So what about Dr. Riggs’ credentials? Start with a BS in Biology, and then a Masters in Cytogenetics from Purdue University. Then a PhD in molecular genetics from Texas A&M.

(Here’s a crash course in just what mRNA is and the important job it does, authored by Dr. Riggs for The Conversation.)

“Riggs’ research focuses on analyses of gene, RNA and protein expression, function, and signaling that regulate or influence aspects of beef quality, skeletal muscle traits, and developmental processes in beef cattle, as well as whole genome sequencing of bacterial pathogens. She has additional interests in genome technologies and genetic modifiers of disease susceptibility and in the role of animal agriculture and biotechnology in ensuring food and nutritional security,” according to her A&M profile.

And for good measure, Riggs “conducted postdoctoral work in the radiation biophysics lab as a Texas Aerospace Fellow at the University of Houston and the NASA Lyndon B. Johnson Space Center.”

Regarding the misinformation about the safety of meat contained in the R-CALF releases, Riggs called it “unfortunate.” As agriculturalists, “we should be celebrating the advances in technology that enable more precise and effective strategies for ensuring animal health and well-being in order to continue producing the nutritious and safe meat, milk, and other animal source products that sustain life and good health.”

Riggs went on to address the commentary and press release specifically, noting they both contain numerous factual errors. The following are Riggs’ verbatim comments to Drovers:

1. mRNA itself is neither a vaccine, nor an injection. Specific mRNAs are produced in every cell of every living organism as the first step for every biological function. The mRNA is a specific and relatively short-lived nucleotide message that is translated into the proteins in our cells. The messages are destroyed in the cell after sufficient protein is made for each biological task (minutes to hours).

2. A vaccine is a derivative of a pathogen—such as a modified virus, a killed virus, part of a virus, or a specific mRNA copy of a small part of a virus—that can function as an antigen. That means that when the vaccine is delivered, often by injection, our bodies recognize that antigen and respond to it by making antibodies, enabling development of immunity to that original pathogen. What makes an mRNA vaccine different is that it is the minimal amount of sequence needed for eliciting an immune response. Viruses tend to mutate rapidly, so mRNA is an advantage for speedy vaccine production because the sequence can be revised as needed. Also, this type of vaccine doesn’t have to be grown – so there are fewer ingredients in the formulation that could have potential to elicit an allergic reaction. In short, the mRNA vaccine is a new tool that is very precise and can be formulated rapidly as threats emerge.

3. What does the mRNA in a vaccine do? THE mRNA from a vaccine DOES NOT rewrite instructions from the body’s DNA. The mRNA does not hijack the cell.

When the mRNA enters the cytoplasm of the immune system’s sentinel cells, the normal protein-making “machinery” present in the cytoplasm reads the message and generates a protein product that is then recognized as the foreign antigen. Then, our immune system is stimulated to produce antibodies, just like any other vaccine does.

4. Potential risks are very low for humans and livestock. Although vaccines are very safe and help protect people and animals from harmful viruses and other pathogens, they function by eliciting an immune response. Rarely, that triggering of the immune response may be harmful, or a person may have an allergic reaction to the materials used to formulate the vaccine – for example, people allergic to eggs should not receive a vaccine developed in eggs. So far, data only exists for the mRNA vaccines developed to protect again COVID-19 and the limited swine vaccinations. From data collected to date, the risk of adverse events compared to other types of vaccines is very low, achieving zero risk for anything is almost impossible.

5. NO, there is NOT “great concern that living cells excrete the mRNA over time and the mRNA can then be transferred to animals and humans that have never received the mRNA injection.”

6. NO it is NOT TRUE that “for example, that humans can contact [sic] mRNA by eating meat from livestock that have received the injection.”

This is false. These statements are unfounded fearmongering. Every morsel of food we eat that comes from plants or animals is loaded with the DNA, RNA (mRNA, rRNA, miRNA, etc), along with proteins and other contents of the cells from source organisms – no matter if it is spinach or steak. People can enjoy a great meal, digest the meat, and none of its DNA or RNA will be transferred to them. It’s just not physically possible for that to occur.

7. mRNA vaccines have been “in development” for a couple of decades, but mRNA is unstable and difficult to deliver as a vaccine. As a result of U.S. investments during COVID, the last hurdle was overcome – how to deliver the specific mRNA and keep it from being destroyed long enough for an immune response to occur. This is still expensive technology, but the big breakthrough enables highly specific vaccines to be formulated rapidly and deliver only what is required. However, tests have shown that even these types of mRNA molecules can’t survive very long in the cell – an estimate is that 50% of the mRNA from a vaccine is gone in about 20 hours, and completely destroyed within a few days.

8. NO, the COVID-19 mRNA vaccines that contain a portion of the Sars-CoV2 spike protein will not deliver mRNA to consumers who drink milk if it is injected into dairy cows. Yes, there are ways to genetically engineer animals to deliver protein products in milk – this was done in dairy goats many years ago, but it CANNOT be accomplished by an mRNA vaccine.

9. NO, people who eat meat from an animal treated with an mRNA vaccine, CANNOT absorb the mRNA from the vaccine in the intestinal tract.

In conclusion, Riggs wrote, “These outlandish claims are nothing more than fearmongering to push other agendas. The various state and federal proposed bills are not based on any kind of rational scientific evidence.”

Don’t Assume That Old Refrigerator Is Good Enough To Store Vaccines

Mon, 13 Mar 2023 17:32:44 GMT

There is a scenario with used refrigerators that occurs routinely across farm country: The old refrigerator is pulled out of the family kitchen when a new and improved version is installed. The old appliance is then moved to a garage, machinery shed or barn and repurposed. It might be responsible now for chilling a variety of items ranging from pharmaceutical products to employee lunches.

That’s fine if the refrigerator is up to the task. But that’s often not the case, according to research conducted by Emmanuel Rollin, DVM and clinical associate professor, College of Veterinary Medicine at the University of Georgia*.

“It might be OK to store a Coca-Cola, but I wouldn’t want to leave my sandwich in some of them,” he says.

Rollin and team evaluated the performance of 20 refrigerators during a five-month period from July through November 2021. While the bulk of the refrigerators were household appliances, mini-refrigerators and a couple of commercial grade refrigerators were also evaluated.

“Our main objective for the study was to go out into the real world and see how vaccines and other refrigerated pharmaceuticals are actually being stored on the farm and whether they are staying at the temperature recommended on the product labels,” he says.

To maintain product integrity in refrigeration, the recommended temperature interval (RTI) for most biologics, including vaccines, is between 35°F and 45°F, according to Grant Dewell, DVM, associate professor and beef Extension veterinarian, and Troy Brick, DVM, assistant professor of vet diagnostic and production animal medicine, Iowa State University.

Not Up To Snuff

During the study, Rollin and team recorded the internal temperature of each refrigerator every 10 minutes, using a data logging device to accomplish that [Specifically, an InTemp Bluetooth temperature with glycol bottle (VFC/CDC) Data Logger that retails for about $175. It’s available here: link ] While only 20 refrigerators were in the study, the team collected about a million data points.

As suspected, the team found refrigerator performance was subpar in many cases. Results showed that household refrigerators were outside the recommended temperature interval 37% of the time, mini-refrigerators 27% of the time and commercial refrigerators 2% of the time.

Rollin says he was surprised the mini refrigerators, like those found in dorm rooms, performed as well as they did. Not surprising was that commercial units scored the best in the evaluation process.

“Because they’re designed for commercial spaces and have better quality components, they have a way to dial-in and maintain the temperature. They also may have fans to keep the air flowing to improve circulation and minimize hot and cold spots,” Rollin says.

Similar Findings Elsewhere
Rollin’s findings are much like those found by the University of Arkansas Cooperative Extension Service in a 2008 study**. It evaluated 191 refrigerators used by producers, retail stores and veterinary clinics. Data loggers were used to record temps at 10-minute intervals over 48 hours.

Of 191 refrigerators tested, 76% were unacceptable for storing pharmaceuticals, because temperatures were not consistently maintained between 35°F and 45°F.

Refrigerator type and age were not critical factors in performance. However, refrigerator location did matter. The refrigerators in barns maintained the coldest (often freezing) temperatures. Refrigerators located in temperature-controlled environments performed better.

Rollin and team looked at similar factors:

They considered the location of the refrigerator and whether the temperature of the room affected its ability to cool products. The short answer in many cases was yes.

The cooling power or style of the refrigerator and its age were noted.

Researchers inventoried the types of items that were kept in the refrigerator. “That was interesting,” Rollin says. “Some of the refrigerators were packed. We saw everything from $100 worth of (product) inventory up to $15,000 of inventory in the refrigerators.”

Factors Not Evaluated
Since the completion of the study, Rollin says the most common question he has received from people is whether the refrigerated vaccines and other products are any good, once they’ve been stored outside a manufacturer’s prescribed temperature range for any length of time.

Because the study didn’t address that particular question, the University of Georgia study has no specific insights to offer.

“Every vaccine is different and has different adjuvants, so how far it can get away from the ideal temperature zone and for how long that can happen before impacting the product’s efficacy, we just don’t know that,” Rollin says.

Dewell and Brick say, in their experience, vaccines that have “undergone temperature cycles above or below the recommended storage temperature (over time) will have reduced efficacy and may be completely worthless due to deactivation.” They detail proper vaccine handling practices in this online article, Vaccines: Handle with Care

Where To From Here?
Rollin recommends that livestock producers along with their veterinarians consider how refrigerator performance on the farm can impact the efficacy of animal health products stored in them. Here are some of his recommendations next steps:

For existing refrigerators, set the refrigerator temperature correctly for the pharmaceutical products it contains, he advises. Use a data logging device for monitoring, if possible.

“Even a cheap $5 dial thermometer you can find in the cooking section at the grocery store is better than nothing,” he says. “It will give you the temperature at the specific time you check it.”

For between $20 and $30 Rollin says producers can purchase a digital thermometer, which can provide temperature highs and lows in the refrigerator over a 24-hour period.

If the producer is building a new office or farm building or has the resources, Rollin recommends purchasing and installing a commercial refrigerator.

Likewise, if financial resources are tight, producers can check with their veterinarian or product distributor to see if they will supply a thermometer, says Fred Gingrich, DVM and executive director of the American Association of Bovine Practitioners (AABP).

“When I was in practice I had these little USB data loggers I’d throw into clients’ fridges to monitor the temperature,” Gingrich recalls.

Keep the refrigerator organized and manage the inventory. “We saw a lot of refrigerators where products were just piled into them along with human food and human drinks, too,” Rollin says. “Keeping the refrigerator organized is going to make it quicker for somebody to reach in and get what they need and close the door rather than having it open for 10 minutes while they’re looking for something.”

“Those are all things that veterinarians can do to help producers,” Rollin adds. “A lot of times we’re selling these products and relying on them to work. So, I believe it’s our role to help producers make sure that those products are actually able to have their intended use of preventing disease.”

Recently, Rollin spoke with Dr. Gingrich about the refrigerator study on a ‘Have You Herd’ podcast, which is available for free at aabp.org. You can access it here: https://www.buzzsprout.com/814177/

References:

*Fallness, C. A., Rollin, E., Heins, B. D., & Berghaus, R. D. (2022). Maintenance of the last step of the cold chain: on-farm refrigerator storage and performance. The Bovine Practitioner, 56(2), 62–69. https://doi.org/10.21423/bovine-vol56no2p62-69

**“The Temperature Variability of Refrigerators Storing Animal Health Products”, T.R.Troxel, PAS, B.L.Barham, PAS, University of Arkansas, Division of Animal Health, Cooperative Extension Service.

PRRS-resistant pigs an industry "game-changer"

Thu, 22 Sep 2022 04:15:02 GMT

Since the Porcine Reproductive and Respiratory Syndrome (PRRS) virus first appeared in the U.S. in 1987, it has cost the U.S. pork industry roughly $10 billion.

PRRS causes severe pneumonia or respiratory problems in newborn piglets and young pigs, resulting in a 20 percent to 80 percent mortality rate, and reproductive failure in sows.

Now, teams of researchers from the University of Missouri and Kansas State University have collaborated with experts from Genus plc to develop the first generation of pigs resistant to PRRS.

Randall Prather, a distinguished professor of animal sciences at the University of Missouri and one of the study’s researchers, explained the science behind PRRS itself.

“Once inside the pigs, PRRS needs some help to spread; it gets that help from a protein called CD163,” he explained. “We were able to breed a litter of pigs that do not produce this protein, and as a result, the virus doesn’t spread. When we exposed the pigs to PRRS, they did not get sick and continued to gain weight normally.”

Raymond “Bob” Rowland, professor of diagnostic medicine and pathobiology at Kansas State University and another researcher on the project, praised the discovery, stressing that it not only will significantly improve animal well-bring but will also save hundreds of millions of dollars each year. In the U.S. alone, PRRS leads to annual losses of approximately $664 million.

“In the decades that we have had the PRRS virus, we have looked at vaccines, diagnostics and other strategies and we have never been able to eliminate the disease,” Rowland said. “This is the first time that we have established the potential to eliminate this devastating disease.”

The collaborative research appears in Nature Biotechnology in the article, “ Gene-edited pigs are protected from porcine reproductive and respiratory syndrome virus .”

“The demonstration of genetic resistance to the PRRS virus by gene editing is a potential game changer for the pork industry,” said Jonathan Lightner, Chief Scientific Officer and Head of R&D of Genus plc. “There are several critical challenges ahead as we develop and commercialize this technology; however, the promise is clear, and Genus is committed to developing its potential. Genus is dedicated to the responsible exploration of new innovations that benefit the well-being of animals, farmers, and ultimately consumers.”

Related Links

From the University of Missouri: Pigs that are Resistant to Incurable Disease Developed at University of Missouri
From Kansas State University: Research develops breakthrough technology to address devastating pig disease PRRS
From Genus plc: Genus tackles major pig disease with breakthrough technology

Genvax Technologies Secures $6.5 Million to Advance Novel Vaccine Platform

Wed, 10 Aug 2022 20:39:46 GMT

Genvax Technologies, a startup dedicated to bringing advances in self-amplifying mRNA (saRNA) vaccine production to animal health, has secured $6.5 million in series seed funding.

United Animal Health led the financing with participation from Johnsonville Ventures, Iowa Corn Growers Association, Summit Agricultural Group and Ag Startup Engine. This investor coalition represents animal health, nutrition, feed, meat packers and consumer products in the fight against existing and emerging threats to the food supply chain.

“The threat posed to producers and consumers by foreign animal diseases like African swine fever (ASF) and constantly mutating variants of swine influenza is extraordinary,” Joel Harris, CEO and co-founder of Genvax Technologies, said in a release. “The goal is to develop a vaccine that matches 100% to the specific strain when a disease outbreak occurs.”

This funding moves the company a step forward to USDA and international regulatory approval of its vaccines in anticipation of any foreign animal disease outbreak, Genvax said in a release.

“For ASF, Genvax’s vaccine could be an important tool for eradication efforts and may alleviate any concerns with trading partners abroad. In addition, the financial and public support of multiple stakeholders like United Animal Health and others in the food industry is a huge validation of this technology’s promise,” Harris said in a release.

The company’s proprietary saRNA platform allows for rapid development of herd-specific vaccines matched 100% to the variant strain circulating in an animal-production operation. By inserting a specific transgene or “gene of interest” (GOI) matched to the variant strain into the platform, the saRNA can generate an antibody response without requiring the whole pathogen, Genvax explained.

“United Animal Health sees Genvax and self-amplifying mRNA vaccines as the cutting edge of technology to protect the industries we serve,” Scott Holmstrom, Ph.D., senior vice president, research and development of United Animal Health, said in a release. “These technologies are critical to food security and protein availability. We are excited to be offering our innovation and research farms to work carefully with Genvax in developing these future products.”

In April 2022, Genvax received more than $145,000 in grant funding from the USDA-Agricultural Research Services Plum Island Animal Disease Center and the Foundation for Food and Agriculture Research (FFAR) to develop a saRNA vaccine for ASF virus. Genvax, founded in February 2021 by animal health serial entrepreneurs Joel Harris and Hank Harris, DVM Ph.D., has raised $1.9 million in a pre-seed round of funding, the release said, in addition to the USDA and FFAR grant.

ASF is a deadly virus of pigs that can cause up to 100% mortality in pigs and could decimate the income of U.S. pork producers and force layoffs, significantly reducing rural employment. Economic models estimate the worst case scenario of an ASF outbreak in the U.S. would result in a $50 billion loss to the domestic pig industry.

“We’ve been impressed with Joel Harris and the Genvax team, in addition to the novel technology they are developing,” Kevin Ladwig, managing director of Johnsonville Ventures, said in a release. “As a stakeholder in the pork industry, we feel this is a necessary step in helping prepare for and protect against African swine fever and other emerging diseases.”

More from Farm Journal’s PORK:

One of the Most Important Questions Every Pig Farmer Should Ask

Wind, PRRS and Pig Farm Biosecurity: Learn from Our Outbreak

African Swine Fever: More Work Needs to Be Done, Swine Health Experts Say

Livestock Industry Praises USDA’s First Vaccine Bank Purchase

Fri, 20 Nov 2020 05:56:36 GMT

The USDA’s Animal and Plant Health Inspection Service (APHIS) announced Wednesday the initial purchase of vaccine for the National Animal Vaccine and Veterinary Countermeasures Bank (NAVVCB). With this purchase, APHIS will invest $27.1 million in foot-and-mouth disease (FMD) vaccine the Agency can use in the event of an outbreak to protect animals and help stop the spread of disease.

“While we are confident we can keep foot-and-mouth disease out of the country, as we have since 1929, having access to vaccine is an important insurance policy,” said Marketing and Regulatory Programs Under Secretary Greg Ibach in a press release. “Vaccines could be an important tool in the event of an incursion of the disease in the U.S, but their use will depend on the circumstances of the incursion and require careful coordination with the affected animal industries.”

As anticipated, the beef, dairy and pork industries were thrilled to hear this announcement which gives the U.S. livestock industry comfort in knowing adequate volumes of vaccine would be available to combat a foot and mouth outbreak should one occur. Currently, the USDA, which has prescribed vaccination for dealing with an FMD outbreak, does not have access to enough vaccine should an outbreak occur. FMD is an infectious viral disease that affects cloven-hooved animals, including cattle, pigs and sheep; it is not a food safety or human health threat.

“Today’s announcement is momentous, representing years of NPPC advocacy to ensure U.S. agriculture is protected should we have an FMD outbreak,” said National Pork Producers Council president Howard “AV” Roth, a hog farmer from Wauzeka, Wisconsin in a statement. “While U.S. pork producers and other farmers face significant challenges and uncertainty due to the COVID-19 pandemic, a solution to FMD preparedness is in our grasp. We thank USDA and especially Under Secretary for Marketing and Regulatory Programs Greg Ibach for proceeding with such an important effort and look forward to continuing to work with the agency to ensure the FMD vaccine bank is adequately stocked.”

The U.S. has not had an FMD outbreak since 1929. Still, recent foreign animal disease outbreaks in the U.S. of avian influenza and porcine epidemic diarrhea has focused attention on the importance of preparedness for other diseases, including FMD, for which outbreaks would have profound effects on international trade and animal health.

According to the National Milk Producers Federation (NMPF), this purchase culminates a multi-year effort by NMPF and other livestock organizations working with USDA to update U.S. preparedness for a FMD outbreak.

“NMPF appreciates the leadership shown by Congress in including FMD preparedness in the 2018 Farm Bill and USDA in moving forward with implementation,” said Jim Mulhern, president and CEO of NMPF. “A modernized vaccine bank signals appropriate vigilance against a threat that, while not a present danger, is always a potential risk.”

Similarly, the National Cattlemen’s Beef Association (NCBA) says this purchase is a great first step in building a national animal vaccine bank as authorized in the 2018 Farm Bill.

“We are pleased to see USDA is moving forward with creating a supply of FMD vaccines in the NAVVCB to ensure ranchers and farmers have timely access to a critical tool in the fight against foreign animal diseases, such as FMD. This is a promising first step forward to begin the work authorized in the 2018 Farm Bill; but, more action is needed to strengthen this newly created vaccine bank,” said NCBA Executive Director of Government Affairs, Allison Rivera in a press release. “NCBA will continue to work with USDA, Congress, and other stakeholders to secure future funding, making certain that the entire cattle industry is better prepared for a possible outbreak of FMD.”

USDA has awarded Boehringer Ingelheim (BI) a contract to help supply the vaccine to the vaccine bank.

According to a BI press release, the contract calls for the company to create and maintain a strategic reserve of frozen vaccine antigen concentrate that the company could quickly formulate into a vaccine for foot-and-mouth disease (FMD) in the event of an outbreak in the U.S.

“As a global leader in the storage and management of FMD vaccine banks, with FMD expertise dating back more than 70 years, Boehringer Ingelheim constantly monitors emerging disease threats,” said Steve Boren, Vice President of the U.S. Livestock Business at Boehringer Ingelheim Animal Health.

The NAVVCB is one component of a three-part program established by the 2018 Farm Bill to comprehensively support animal disease prevention and management.

Zoetis Establishes Vaccine Research Facility with Texas A&M University

Fri, 20 Nov 2020 05:52:42 GMT

Zoetis, the world’s leading animal health company, has signed an agreement with Texas A&M University’s Health Science Center for Innovation in Advanced Development and Manufacturing (CIADM) to establish a facility for accelerating the development of transboundary and emerging disease vaccines -- including those for Foot-and-Mouth Disease (FMD), a virus that can cause serious illness in cattle, pigs, and sheep. Working side by side with Zoetis scientists, CIADM staff will collaborate in the development of processes, assays, and formulations used to produce new vaccines.

As part of the agreement, Zoetis is setting up a 12,800-square-foot secure, biocontainment lab off-campus utilizing modular cleanroom technology. The Transboundary and Emerging Disease Vaccine Development Facility is expected to be operational mid-2020, pending approval by the U.S. Department of Agriculture (USDA) to receive strains of the Zoetis FMD vaccine platform that are non-infectious to cattle and other livestock – and therefore, cannot cause the disease. While FMD vaccines will be the initial focus of the center’s vaccine development, the facility can be expanded to accommodate vaccine development for other emerging diseases in the future.

“We are proud to be working with Texas A&M in the development of this critical vaccine to protect the health of livestock in the U.S. and markets around the world. FMD is one of the most serious diseases for livestock owners, and through an innovative vaccine platform, we can help them reduce the risk of an outbreak and avoid significant economic losses,” said Dr. John Hardham, Research Director in Global Biologics Research and Director of the Zoetis Center for Transboundary and Emerging Diseases. “By combining our internal innovation efforts with world-class research institutions such as Texas A&M, Zoetis is in the best position to bring veterinarians and livestock producers solutions to better predict, prevent, detect and treat disease in the animals under their care.”

Chancellor John Sharp with The Texas A&M University System echoed that sentiment: “The Texas A&M System is uniquely qualified to be on the front lines of protecting animal health care. By protecting animals, we are also protecting human health, our food supply and our economy.”

“I am pleased that Zoetis decided to establish a collaborative effort with CIADM to develop critical animal vaccines. Our combined efforts to bring critical foot-and-mouth vaccines to the veterinarian market utilizing the novel Zoetis platform will be of significant benefit to both Texas and livestock communities around the world,” said Dr. William Jay Treat, Chief Manufacturing Office for CIADM with the A&M Health Science Center. “It is an outstanding entrepreneurial opportunity for the A&M Health Science Center to play a key role in Zoetis’ vaccine efforts.”

As part of establishing the new facility, the CIADM program expects initially to hire up to eight staff scientists in College Station by the first quarter of 2020.

About FMD

While FMD is not harmful to humans, livestock animals worldwide are highly susceptible to FMD viruses. An unchecked spread of FMD could result in an economic impact of billions of dollars in the first year, devastate international livestock trade, and severely impact the livelihoods of farmers and ranchers. FMD does not affect horses, dogs, or cats, and is not a food safety threat.

As many countries across the globe are dealing with FMD in their livestock populations, the United States eradicated the disease here in 1929. The USDA’s Animal and Plant Health Inspection Service (APHIS) works to ensure the continued health of our nation’s livestock, including preventive steps to keep FMD from reentering the country.

In April 2018, as a first step toward FMD vaccine development for the U.S., the USDA granted Zoetis a select agent exclusion authorizing the company to develop vaccines using a modified, non-infectious FMD-LL3B3D vaccine platform in the U.S. Through its collaboration with Texas A&M, Zoetis is now moving forward to safely develop an FMD vaccine that is not infectious and cannot transmit among livestock in the U.S. With this vaccine platform, regulatory authorities and veterinarians may be able to distinguish between animals that have been vaccinated and those with natural FMD virus infection -- which would help protect export markets for U.S.-raised meat.

Full-scale manufacture of FMD-LL3B3D based vaccines is being considered but is not currently authorized in the United States.

Enhancing Rapid Response to Emerging Diseases

The Transboundary and Emerging Disease Vaccine Facility in Texas will be part of the Center for Transboundary and Emerging Diseases within Zoetis, which helps governments prepare for and protect against the threat of outbreaks of devastating diseases in animal health. As infectious diseases are occurring with greater frequency and geographic impact, the Center serves as a virtual hub that brings together Zoetis’ capabilities in surveillance and alliances with animal health centers of excellence worldwide -- such as Texas A&M -- along with expertise in vaccine development, regulatory affairs and flexible manufacturing capacity to effectively prevent and control infectious disease outbreaks.

Zoetis has been on the forefront of vaccine development to help combat many of the most significant infectious diseases including Bluetongue, classical swine fever, porcine epidemic diarrhea, and highly pathogenic avian influenza.

Low FMD Vaccine Bank Leaves U.S. Pigs and Cattle Vulnerable to Disease

Wed, 11 Nov 2020 05:07:24 GMT

A U.S. government watchdog’s latest report says America’s swine and cattle populations are vulnerable to the highly contagious, deadly foot-and-mouth disease (FMD).

According to the USDA, the agency may not have a sufficient supply of FMD vaccine to control more than a small outbreak because of limited resources to obtain vaccine, the Government Accountability Office report said. An epidemic could prove costly to not only the nation’s livestock industry, but also the federal government.

The current vaccine supply would be sufficient to protect about 14% of Texas’s cattle or about 4% of Iowa’s swine herd. These states’ cattle and swine populations are the nation’s largest.

FMD is a viral disease that is not harmful to humans, but can be fatal in younger animals. It causes painful lesions on the hooves and mouths of some livestock, making it difficult for them to stand or eat, thus greatly reducing meat and milk production. FMD is found roughly in about two-thirds of the world, but the U.S. hasn’t experienced an outbreak since 1929. The U.S. is vulnerable to FMD transmission, given the large size and mobility of the U.S. livestock sector.

“An FMD outbreak in the U.S. could have serious economic impacts, in part because trade partners would likely halt all imports of U.S. livestock and livestock products until the disease was eradicated,” the GAO said in the report published last week.

With exports of U.S. swine, cattle and dairy products totaling more than $19 billion in 2017, the GAO warned that those shipments after an outbreak “would likely stop or be sharply reduced. Moreover, in a widespread outbreak, the scale of federal compensation payments could be substantial.”

USDA Response to Outbreaks
In the event of an FMD or other foreign animal disease outbreak, USDA APHIS, in coordination with state and industry partners, would conduct surveillance, perform epidemiologic tracing and diagnostic testing, apply quarantines and stop-movement orders, employ biosecurity measures, stamp out infected animals and vaccinate uninfected animals, and compensate owners, the GAO report said.

Response strategies would likely change as an outbreak unfolds and might vary by region or type of animal affected, according to APHIS planning documents.

APHIS has taken important steps to mitigate challenges it may face in responding to an outbreak. For example, the agency has developed an extensive collection of strategy and guidance documents, held FMD preparedness exercises to practice response activities, and identified dozens of corrective actions and completed some of these actions. However, APHIS has not yet completed other corrective actions, including actions that have been identified multiple times, such as developing a process for prioritizing and allocating the limited supply of FMD vaccine.

“USDA’s Animal and Plant Health Inspection Service understands the importance of preparing for the possibility of a foot-and-mouth disease outbreak in the United States,” USDA said in a statement. “This disease would have a significant impact on our livestock industry and our farmers and ranchers.

Farm Bill Support for FMD Vaccine Bank
The 2018 Farm Bill signed into law in December by President Donald Trump included more funding for USDA’s animal health and disease preparedness programs, such as money for an expanded animal vaccine bank for FMD. The National Cattlemen’s Beef Association (NCBA) and the National Pork Producers (NPPC) Council, among others, were pleased to see authorization of a new FMD vaccine bank.

“The United States has been ill-prepared to deal with a foreign animal disease outbreak for quite some time,” says Dustin Baker, NPPC director of eco and domestic production issues. “The farm bill’s multifaceted approach to surveillance, diagnostics and vaccines is critical to safeguard the health and well-being of our animals, rural economies and the safety of the food supply.”

The GAO report faulted the USDA’s APHIS agency for failing to complete certain corrective actions that it said were identified multiple times, including “developing a process for prioritizing and allocating the limited supply of FMD vaccine. Because of the limited supply of vaccine and the potentially high demand for it, USDA would likely face the challenge of deciding how to allocate it in an FMD outbreak.”

With a vaccine that is matched to the appropriate FMD subtype, a single dose can protect cattle for 6 months, and two doses are required to provide the same protection to swine, the GAO said. APHIS’s 2016 FMD vaccination policy states that 25 million doses for each of 10 subtypes of the virus is an appropriate minimum target to have available. However, the U.S. currently has access to only 1.75 million doses of each subtype available in the vaccine bank, according to USDA documents.

With the large number of FMD subtypes present around the world, and because the FMD virus is constantly mutating, the GAO report said it is possible that an FMD subtype could be introduced in the U.S. that is not covered by vaccines currently in the vaccine bank.

According to a representative from an FMD vaccine manufacturer, producing a vaccine for a new subtype of FMD could take from 6 to 18 months, the GAO said.

“USDA faces challenges in obtaining vaccine and using it in a response effort because of scientific, procedural, and infrastructure challenges related to the vaccine and its production,” the GAO said.

Few vaccine manufacturers in the world have the capacity to produce most of the FMD vaccine subtypes and meet the quality standards required by the U.S., according to agency officials. In addition, there is no production capacity at this time for FMD vaccine in the U.S. because dedicated infrastructure is not in place to produce vaccines without live virus.

GAO Recommendations
The GAO report concluded that APHIS has taken important steps to prepare for an FMD outbreak and to mitigate challenges it may face in responding to one. However, more work is needed. Two recommendations were made to USDA. They include:

1. The Administrator of the Animal and Plant Health Inspection Service should follow the agency’s SOP to prioritize corrective actions for FMD preparedness.

2. The Administrator of the Animal and Plant Health Inspection Service should follow the agency’s SOP to monitor progress and track completion of corrective actions for FMD preparedness.

Greg Ibach, USDA Under Secretary of marketing and regulatory programs, said USDA agrees with GAO’s recommendations and will follow the agency’s SOPs to prioritize corrective actions and monitor progress and track completion of corrective actions for FMD preparedness.

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USDA/CVB Issues Notice on Senecavirus A in Biological Products

Wed, 11 Nov 2020 04:36:17 GMT

The USDA’s Center for Veterinary Biologics (CVB) recently issued CVB Notice 18-05 Detection of Senecavirus A (SVA) in Veterinary Biological Products to warn of potential contamination of swine vaccines.

According to CVB, Senecavirus A (SVA) is a single-stranded RNA virus belonging to the family Picornaviridae that causes blister-like lesions on the mouth, snout, and hooves in susceptible swine.

These lesions, they note, are clinically indistinguishable from those caused by exotic agents including foot-and-mouth disease, swine vesicular disease, vesicular stomatitis, and swine vesicular exanthema. This virus was uncommon in the U.S. prior to 2015, but has become more prevalent since then, and is found as a contaminant in porcine trypsin and serum.

The CVB intends its notice to help ensure that veterinary biological product manufacturers who use ingredients of animal origin derived from swine are aware of the issue and can prevent the use of material that does not meet acceptable standards for purity and quality in the manufacturing process.

The CVB is now testing all Master Seeds and Master Cell Stocks that have been produced using ingredients derived from swine for the presence of SVA.

Access the CVB notice for more information.