Managing these moving parts requires patience and a vision for the future. It often takes a decade or more for an innovation to go from concept to reality to execution.
Using science to advance herd health
Feeding a growing population more efficiently and safely is at the heart of innovation. With the public keeping a closer eye on animal welfare, food safety and the judicious use of antibiotics, there is more on us as animal scientists to develop preventive therapies. Immunology provides solutions to many of those challenges.
One such example is how an innovative new product went from an idea to reality (Once PMH® IN). This product was introduced in 2014 as the first intranasal vaccine to deliver dual bacterial pneumonia protection in cattle, including calves as young as 1 week of age.
For decades it was believed vaccinating young animals would be ineffective because of maternal antibody interference. It was also known that vaccines administered subcutaneously had serious side effects in young animals. Scientists were looking for ways to bypass maternal interference in order to shorten the window newborn calves were susceptible to disease.
In 2006, our team met Dr. Philip Griebel, Ph.D., professor and research chair in neonatal mucosal immunology at the University of Saskatchewan School of Public Health. At a symposium, he presented information from a study in which lambs in utero were given antigens orally during the second trimester of gestation. At birth, when the vaccine was re-administered, it was discovered that the offspring had memory of being immunized in utero.
The lengthy approval process begins
This study, as well as work our team of researchers was conducting, revealed young animals could respond to vaccines. The information put in motion the lengthy process of introducing an innovative product to dairy producers that advances herd health.
After meeting with our internal research and development team and proposing a proof-of-concept study to the USDA, the process of taking the antigens from a popular line of vaccines and developing an intranasal vaccine began.
After being told for decades that bacterial antigens would not respond orally or intranasally, there was delight to learn it worked better than anticipated. Once success was demonstrated and replicated, an approval project plan was developed with the USDA.
In order to gain the USDA’s approval, efficacy trials were conducted to assure antigens provided protection and did not interfere with one another’s ability to provide efficacy when administered in combination. The vaccine was in combination, but individual trials were run to demonstrate efficacy of each fraction.
Another set of two trials was completed to confirm the attenuated bacteria in the vaccine didn’t revert to a virulent form and cause disease.
For the intranasal vaccine, the USDA required an overdose safety study that delivered the vaccine at 10 times the labeled dose and a field safety trial at three different geographic locations. In the field safety trial, one-third of the animals represented the youngest age of expected use, which was 3-day-old calves or younger.
The USDA requires that efficacy trials be completed on colostrum-deprived calves. While this is an important step in seeking their approval, there was a need to determine how the intranasal product performed in a realistic environment. This took more time, but provided the answers that were needed.
Also, duration of immunity (DOI) trials were not required for licensure, but can be conducted to determine how long the vaccine would be effective. Time points that match a critical production time and are convenient for producers were selected. DOI trials provide guidance to veterinarians how long immunity will last, which means animals need fewer vaccines, resulting in product and labor cost savings for dairy farms.
This fascinating process of bringing a new product to market requires collaboration between the private and public sectors. Both sides need each other in order to be successful and bring advancements to dairies. Companies are continually canvassing universities and public agencies, reviewing the work that is being done. It’s a prime example of both sides working together to reach a unified goal.
Peeking into the crystal ball
Animal health companies seek out problems and solve them with science, which is constantly changing. It’s important to remain vigilant as the industry faces constant evolving threats and new pathogens. As a result, there’s more focus on disease prevention. That will come from a variety of places, including innovative vaccine tools as well as better animal husbandry and different approaches in managing livestock.
As the ability to manipulate pathogens continues to improve, the ability to deliver products that stimulate a more superior immune response will also improve. New products reflect the knowledge we are gaining now, like how to administer vaccines in a variety of ways. The lessons that are learned in bringing new products to dairies contribute to constant improvement in herd health protocols. 
References omitted but are available upon request. Click here to email an editor.
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Scott Nordstrom
- Director of New Product Discovery and Development for U.S. Cattle
- Merck Animal Health
- Email Scott Nordstrom
