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European Medicines Agency Approves Expanded Indication for BOVILIS® ROTAVEC® CORONA for Subcutaneous Administration

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European Medicines Agency Approves Expanded Indication for BOVILIS® ROTAVEC® CORONA for Subcutaneous Administration

European Medicines Agency Approves Expanded Indication for BOVILIS® ROTAVEC® CORONA for Subcutaneous Administration

Vaccine can now be administered intramuscularly or through subcutaneous injection as well as at the same time as BOVILIS® CRYPTIUM®

Subcutaneous injections are generally well-tolerated by animals, can minimize pain and distress, and improve meat quality[i]

RAHWAY, N.J., October 15, 2024 – 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), today announce that the European Medicines Agency has approved BOVILIS® ROTAVEC® CORONA for the subcutaneous injection of pregnant cows and heifers to raise antibodies against E. coli adhesins F5 (K99) and F41, rotavirus and coronavirus.

BOVILIS® ROTAVEC® CORONA is given to the dam during pregnancy, which subsequently helps to passively protect the calf from diarrhea caused by rotavirus, coronavirus and E. coli. Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day, via the same route, but not mixed with BOVILIS® CRYPTIUM® to confer concomitant protection against Cryptosporidium parvum in calves. The vaccines should be given at different sites.

“Vaccine innovation is at the core of BOVILIS vaccine portfolio,” said Ruud Segers, associate vice president, R&D, Merck Animal Health. “BOVILIS ROTAVEC CORONA induces specific antibodies in the colostrum of the dam now offers two options for administration, providing more flexibility to vaccinate against bacteria and viruses that cause calf scours.”

Calf scours is the most common cause of death in calves. It accounts for most deaths in calves less than one month old.[i] Pathogens such as rotavirus, coronavirus, Cryptosporidium and E. coli are major causes of infectious calf scours. Most farms have one or all of these pathogens.[ii] Young calves are very vulnerable in the first weeks of life and multiple factors (e.g., nutrition, hygiene, stress, housing or weather conditions) can trigger calf scours.[iii] When the dam is vaccinated with the two Bovilis  products before calving, she will provide colostrum that gives the calf an extra boost of protection against rotavirus, coronavirus, E. coli and Cryptosporidium.

For more information about BOVILIS ROTAVEC CORONA visit https://www.bovilis.com/bovilis-rotavec-corona/.

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 LinkedInFacebookX (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. There can be no guarantees with respect to pipeline candidates that the candidates 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.

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).


[i] USDA, 2007, Dairy, part 1: Reference of Dairy Cattle Health and Management Practices in the United states, USDA-APHISVS, CEAH, #N480.1007. National Animal Health Monitoring System, Fort Collins, CO.

[ii] Bartels, C. J., M. Holzhauer, R. Jorritsma, W. A. Swart, and T. J. Lam. 2010. Prevalence, predic-tion and risk factors of enteropathogens in normal and non-normal faeces of young Dutch dairy calves. Prev. Vet. Med. 93(2-3):162-169.

[iii] Lorenz, I., Fagan, J., More, S.J., 2011. Calf health from birth to weaning. II.Management of diarrhea in pre-weaned calves. Irish Vet. J. 64, 9.

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