MSD Animal Health Receives Marketing Authorization from European Commission for BOVILIS® Nasalgen®-C Live Vaccine for Cattle

First vaccine for bovine coronavirus (BCoV), to protect newborn calves against respiratory disease

MADISON, NJ, APRIL 4, 2023 – MSD Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), announced today the European Commission granted marketing authorization for BOVILIS® Nasalgen®-C, a bovine coronavirus (BCoV) vaccine for cattle. The intranasal, live vaccine can be used for active immunization of calves from the day of birth onward to reduce clinical signs of upper respiratory disease and nasal viral shedding from infection with BCoV.

BCoV is a member of a family of viruses associated with both enteric and respiratory diseases in ruminants. BCoV is well-established as a cause of Neonatal Calf Diarrhea. Furthermore, when present in the respiratory tract of cattle, BCoV increases the risk for Bovine Respiratory Disease (BRD) complex, resulting in respiratory infections with histopathological lesions and clinical signs. BRD is one of the most common and costly diseases in calves.

“Preliminary results from a field study presented at the World Buiatrics Congress 2022 indicate that BCoV is commonly present in both the respiratory and enteric pathways in the dairy cattle population in Europe, with all herds being seropositive to the virus and the virus present in the respiratory pathway in 73 percent of the herds,” said Geert Vertenten, Ph.D., DVM, global technical director, ruminant biologicals, MSD Animal Health. “BOVILIS® Nasalgen®-C, the only EU-licensed vaccine against BCoV that can be administered at the first day of life, offers young calves the earliest protection against this worldwide endemic pathogen.”

BOVILIS® Nasalgen®-C allows farmers and veterinarians to safely and effectively administer protection against the BCoV family of viruses in a single intranasal vaccination that can quickly reach the site of action. Another benefit of intranasal vaccination with Bovilis® Nasalgen®-C is its effectiveness when administered to a newborn animal in the presence of maternal antibodies found in colostrum – which a calf ingests from its mother during its first days of life. The onset of immunity starts five days after administration, with a 12-week duration.

BOVILIS® Nasalgen®-C can be used concurrently with BOVILIS® Intranasal RSP® Live, which offers protection against both Bovine Respiratory Syncytial Virus (BRSV) and Parainfluenza-3 Virus (PI3). It is available in different pack size options of one, five and 20 doses, suitable for small and large herds. Details of the product described in the Summary of Product Characteristics (SPC) will be translated in all EU languages for publishing by individual regulatory authorities.

About MSD Animal Health

At MSD, known as Merck & Co., Inc., Rahway, N.J., USA in 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. MSD Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is the global animal health business of MSD. Through its commitment to The Science of Healthier Animals®, MSD Animal Health offers veterinarians, farmers, 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. MSD 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. MSD Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit www.msd-animal-health.com and connect with us on LinkedIn and Twitter.

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 the global outbreak of novel coronavirus disease (COVID-19); 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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