Merck Animal Health Pioneers H3N2 Canine Influenza Vaccine

Innovative Addition Further Strengthens CIV Product Line

Nov 20, 2015, 16:01 ET from Merck Animal Health

MADISON, N.J., Nov. 20, 2015 /PRNewswire/ -- In response to the H3N2 canine influenza (CIV) outbreaks that impacted dogs in 241 states, Merck Animal Health (known as MSD Animal Health outside the United States and Canada) today announced the U.S. Department of Agriculture (USDA) has issued a conditional product license for a vaccine to protect against this newly identified strain of CIV. Canine Influenza Vaccine H3N2 will be available to U.S. veterinarians beginning Monday, November 23.

"We have a long history of bringing innovative products to the market that truly impact the health and well-being of animals, and this vaccine is another example of our deep commitment to animal health and veterinarians," said KJ Varma, BVSc, Ph.D., Diplomate ACVCP, Senior Vice President Global R&D, Merck Animal Health. "Building on our legacy of vaccine expertise, we are excited to be able to offer a cutting-edge product that will protect dogs against this virulent strain of CIV, and further strengthen our position as the leader in vaccines and canine influenza."

Since the outbreaks began in the spring, Merck Animal Health has been focused on creating greater awareness of this canine health threat, as well as supporting veterinarians and pet owners through information and education, to help protect the health of dogs and minimize any further spread.

"Early on, we suspected veterinarians were dealing with an outbreak of canine influenza and not kennel cough, which spurred us to implement the collection of nasal and pharyngeal samples from sick dogs that were tested by Cornell University," said Kathleen Heaney, D.V.M., Director, Companion Animal Technical Services, Merck Animal Health. "We came to realize what was actually unfolding was the transmission of an influenza strain – H3N2 – never before seen in the United States. Based on the highly contagious nature of the strain, the severity of clinical disease and the rate at which we were seeing newly diagnosed cases, we knew we needed to act fast – both to help veterinarians and pet owners contain the outbreaks and develop a vaccine to protect dogs against it."

According to clinical studies by researchers at the University of Wisconsin, the CIV H3N2 may be shed for an extended period of time – up to 24 days, which is far longer than what is seen with CIV H3N8.2 As a result, the infection can spread quickly among social dogs in inner cities, doggie daycares, boarding facilities, dog parks, sporting and show events and any location where dogs commingle.  

"Based on experimental studies in Asia and the rate of spread we've observed, I would estimate that H3N2 produces 10 times more virus than H3N8, which makes it far more contagious," said Edward Dubovi, Ph.D., Professor of Virology and Director, Virology Laboratory, Animal Health Diagnostic Center, College of Veterinary Medicine, Cornell University. "Preventing the transmission of the disease through vaccination is highly recommended for those dogs that have lifestyles that put them at greater risk."

Clinical signs of CIV H3N2 in dogs include coughing, fever, lethargy and interstitial pneumonia.3 CIV can be spread by direct contact with respiratory discharge from infected dogs, through the air via a cough or sneeze and by contact with contaminated objects such as dog bowls and clothing or by people moving between infected and uninfected dogs.2 According to the U.S. Centers for Disease Control (CDC), there is no evidence of transmission of the virus from dogs to people.

The Canine Influenza Vaccine H3N2 is recommended for healthy dogs 6 weeks of age or older as an aid in the control of disease associated with canine influenza virus H3N2 infection. The type A, subtype H3N2 virus has been chemically inactivated and combined with an adjuvant designed to enhance the immune response. The vaccine is conditionally licensed and there is a reasonable expectation of efficacy.

As part of our continuing support of science and healthy animals, Merck Animal Health will continue its work within the industry to help develop a better understanding of this disease, including its participation on the H3N2 task force created earlier this year, hosting educational webinars for veterinarians and providing informational materials on managing the outbreak for clinics and pet owners. For more information about CIV or to access CIV materials, please visit doginfluenza.com.

About Merck Animal Health
Today's Merck is a global healthcare leader working to help the world be well. Merck Animal Health, known as MSD Animal Health outside the United States and Canada, is the global animal health business unit of Merck. Through its commitment to the Science of Healthier Animals, Merck Animal Health offers veterinarians, farmers, pet owners and governments one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.merck-animal-health.com or connect with us on LinkedIn and Twitter at @MerckAH.

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This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

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1 Canine Influenza H3N2 Updates. Cornell University College of Veterinary Medicine website. https://ahdc.vet.cornell.edu/news/civchicago.cfm.
2 Updates in Canine Influenza Virus: Management, treatment and prevention of disease. VETgirl Webinar, July 27, 2015. Archived at www.vetgirlontherun.com.
3 Kang et al., H3N2 Canine Influenza Virus Causes Severe Morbidity in Dogs with Induction of Genes Related to Inflammation and Apoptosis, Veterinary Research 2013,44:92.

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