USDA Approves Merck Animal Health’s NOBIVAC® NXT Canine Flu H3N2 – The First and Only RNA-Particle Technology Vaccine for Canine Influenza

Rhea-AI Summary

Merck Animal Health announced the USDA approval of NOBIVAC® NXT Canine Flu H3N2, the first and only canine influenza vaccine utilizing RNA-particle technology. This innovative vaccine is designed to offer a precise immune response, improving protection against the prevalent canine flu virus in the United States. The nonadjuvanted, low volume vaccine is indicated for dogs eight weeks and older and will be available nationwide by late summer. NOBIVAC NXT marks a significant milestone in Merck's commitment to veterinary innovation and preventive care.

Positive

• USDA approval of NOBIVAC® NXT Canine Flu H3N2, enhancing Merck's product portfolio.
• First canine influenza vaccine using RNA-particle technology, a breakthrough in veterinary medicine.
• Vaccine availability set for late summer, expected to generate early revenue streams.
• Supports Merck's long-standing commitment to preventive veterinary care.

Negative

• Potential challenges in widespread veterinary adoption of new RNA-particle technology.
• Market competition with existing canine influenza vaccines.

Insights

Veterinary Vaccine Expert

The approval of Merck Animal Health’s NOBIVAC® NXT Canine Flu H3N2 represents a significant step forward in veterinary medicine, particularly in the field of canine respiratory health. RNA-particle technology, which this vaccine utilizes, is a relatively new and sophisticated approach allowing for a more precise immune response. Traditional vaccines often use inactivated viruses or proteins to stimulate immunity, but RNA-particles can prompt the body to produce antigens directly, potentially leading to a more effective and safer vaccine.

For veterinarians, this advancement means a potentially lower risk of adverse reactions and a more robust immune response in dogs, which can translate into fewer cases of canine flu and better overall pet health. However, it's essential to monitor the real-world effectiveness of this new technology once it is widely administered.

Market Research Analyst

From a market perspective, the introduction of NOBIVAC® NXT Canine Flu H3N2 has the potential to solidify Merck Animal Health's position as a leader in the veterinary vaccine market. The use of cutting-edge RNA-particle technology sets this vaccine apart from competitors, which could drive significant market share growth. Pet owners are increasingly willing to invest in advanced healthcare options for their pets, particularly in the wake of high-profile outbreaks of canine influenza.

Financially, this product may contribute to higher revenues for Merck in the animal health segment, given the year-round nature of canine influenza and the recommendation for annual vaccination. This could lead to a steady stream of income, helping to balance the seasonal fluctuations seen in other parts of the business.

Innovative technology represents a breakthrough scientific achievement for highly contagious respiratory disease

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), announced today the U.S. Department of Agriculture (USDA) approval of NOBIVAC^® NXT Canine Flu H3N2, a next-level solution to help safeguard dogs against the ongoing threat of canine influenza. The product is expected to be available at veterinary clinics and hospitals nationwide late this summer.

Merck Animal Health has a long-standing commitment to discovering and developing innovative preventive medicines that support veterinary healthcare teams and improve the lives of pets. NOBIVAC NXT is a revolutionary, first-of-its-kind vaccine technology for companion animals that leverages RNA-particle technology, allowing for a precise immune response to protect against a wide range of viral and bacterial pathogens.

"On behalf of Merck Animal Health and our NOBIVAC brand, we are beyond proud to introduce our latest vaccine using ‘NXT-level’ technology. This is a groundbreaking advancement in our vaccine pipeline designed to meet the evolving needs of veterinarians and pet owners alike,” said Christine Royal, DVM, vice president, companion animal and equine business unit, Merck Animal Health. “With over 70 years of innovation and commitment to animal health, our new NOBIVAC NXT technology will continue to lead the way in providing breakthrough solutions for the prevention of disease in animals.”

NOBIVAC NXT Canine Flu H3N2 is the first and only canine influenza vaccine built on Merck Animal Health’s RNA-particle technology platform to deliver optimized protection against the most prevalent canine influenza virus circulating in the United States. NOBIVAC NXT Canine Flu H3N2 is a nonadjuvanted, low volume 0.5 mL dose vaccine that harnesses the natural ability of the immune system to generate a robust response without compromising comfort or safety. The product is indicated for the vaccination of healthy dogs eight weeks of age or older against canine influenza H3N2.

“As a leader in innovation and trusted advocate for disease prevention, Merck Animal Health uses its leadership and expertise in research and development to make medicines that help keep pets safe,” said Ian Tarpey, vice president, research and development, Merck Animal Health. “The NOBIVAC NXT innovation represents a major advancement in vaccine technology and furthers our commitment to animal care by helping veterinarians protect pets from significant disease and ultimately, improve their lives by preventing health issues.”

Canine influenza, or dog flu, is a serious respiratory illness that is easily transmitted from dog to dog. Canines are social creatures by nature and are at risk for infection when exposed to the virus. Moreover, unlike human flu, canine influenza is not seasonal; dogs are susceptible to it year-round, which is why it’s important to vaccinate every year.

“Vaccination is the best form of protection against this highly transmissible disease. When canine influenza does show up in large outbreaks, it can have a widespread impact,” said Meg Conlon, DVM, executive director, veterinary professional services, Merck Animal Health. “Pets have become part of the family and are integrated into so many aspects of our lives, which makes vaccination even more crucial. At Merck Animal Health, we continue to stress the importance of preventative care to keep our beloved pets healthy and protected from potential illness.”

Merck Animal Health has been leading canine influenza protection since launching the first canine influenza vaccine – NOBIVAC^® Canine Flu H3N8 – in 2009. When canine influenza H3N2 emerged as an epidemic in the U.S. in 2015, Merck Animal Health made its monovalent H3N2 vaccine available to protect dogs against the disease; and in 2016, the company was first to receive a fully licensed bivalent and monovalent H3N2 vaccine. In addition, the company has been advancing canine respiratory protection for decades with its intranasal, canine flu and oral respiratory vaccines that prevent the spread of pathogens and protect the respiratory health of dogs. Now, Merck Animal Health continues its legacy of innovation with the introduction of NOBIVAC^® NXT Canine Flu H3N2. For more information on canine influenza and options for protection, visit dogflu.com.

About Merck Animal Health

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than a century, we’ve been at the forefront of research, bringing forward medicines, vaccines and innovative health solutions for the world’s most challenging diseases. Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is the global animal health business of Merck. Through its commitment to The Science of Healthier Animals^®, Merck Animal Health offers veterinarians, farmers, producers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of connected technology that includes identification, traceability and monitoring products. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals and the people who care for them. 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 and connect with us on LinkedIn, Facebook, X (formerly Twitter) and Instagram.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, 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. 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.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

View source version on businesswire.com: https://www.businesswire.com/news/home/20240625531464/en/

Laurel.Mundth@merck.com

Source: Merck & Co., Inc.

FAQ

What is NOBIVAC® NXT Canine Flu H3N2?

NOBIVAC® NXT Canine Flu H3N2 is a newly USDA-approved vaccine for canine influenza, utilizing RNA-particle technology to provide optimized protection against the H3N2 influenza virus in dogs.

When will NOBIVAC® NXT Canine Flu H3N2 be available?

NOBIVAC® NXT Canine Flu H3N2 is expected to be available in veterinary clinics and hospitals nationwide by late summer.

How does NOBIVAC® NXT Canine Flu H3N2 differ from other canine flu vaccines?

This vaccine is unique as it leverages RNA-particle technology for a precise immune response, unlike any other canine influenza vaccine currently available.

What are the benefits of RNA-particle technology in NOBIVAC® NXT Canine Flu H3N2?

RNA-particle technology allows for a precise immune response, providing robust protection without compromising comfort or safety for the dog.

Is NOBIVAC® NXT Canine Flu H3N2 safe for all dogs?

The vaccine is indicated for healthy dogs eight weeks of age or older, ensuring wide applicability within the canine population.

Why is annual vaccination important for canine influenza?

Canine influenza is a highly transmissible, year-round risk for dogs. Annual vaccination is important to protect against potential outbreaks and maintain overall health.

How long has Merck Animal Health been involved in canine influenza protection?

Merck Animal Health has been a leader in canine influenza protection since 2009, continuously innovating with various vaccines including the new NOBIVAC® NXT Canine Flu H3N2.