MSD Animal Health Receives Positive Opinion from CVMP for INNOVAX®-ND-H5 Vaccine for Use in Chickens
If approved by the European Commission, the vaccine will become an available tool for governments to consider as part of a holistic strategy to combat the spread of highly pathogenic avian influenza (HPAI) which may include additional vaccinations plus enhanced biosecurity and surveillance
Potentially the first centrally registered vaccine in the European Union against the currently circulating avian influenza virus strains of clade 2.3.4.4b
RAHWAY, N.J., April 24, 2024- MSD Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) issued a positive opinion for the INNOVAX®-ND-H5 vaccine for a marketing authorisation in exceptional circumstances in accordance with Article 25 of Regulation (EU) 2019/6. When approved by the European Commission (EC) it will be the first centrally registered vaccine in the European Union against the currently circulating Avian Influenza virus strains of clade 2.3.4.4b, which cause high mortality in poultry. Any use of vaccines for HPAI should be done in conjunction with rigorous biosecurity and surveillance programs and in line with Government regulations.
INNOVAX-ND-H5 is a single-dose product administered in ovo or subcutaneously at one day of age to reduce mortality, clinical signs and virus excretion due to infection with highly pathogenic Avian Influenza (HPAI) virus of the H5 type. In addition, the vaccine induces active immunity against Marek’s disease and Newcastle disease and data is available that the vaccine can safely be administered in combination with NOBILIS RISMAVAC®. This vaccine bolsters MSD Animal Health’s Avian Influenza portfolio, which consists of inactivated vaccines for the H5 and H9 hemagglutinin subtypes.
“As avian influenza continues to spread around Europe and the globe, MSD Animal Health is proud that the INNOVAX-ND-H5 vaccine is one step closer to being the first vaccine registered in the European Union against the currently circulating avian influenza virus strains of clade 2.3.4.4b,” said Maxim Nakhodko, Global Poultry Business Unit Lead, MSD Animal Health. “This would represent another tool for governments to consider in ongoing efforts to combat the spread of avian influenza, which could include other additional vaccines we currently have in development. MSD Animal Health strongly believe that vaccination, associated with a well-defined strategy of monitoring and strict biosecurity and surveillance, can significantly reduce the challenges raised by avian influenza and offer an optimized HPAI control system. We look forward to working with individual governments as they develop their respective avian influenza mitigation strategies.”
INNOVAX-ND-H5 was developed using MSD Animal Health’s HVT (herpesvirus of turkeys) vector platform technology. The HVT vector platform has been used to generate recombinant vaccines for avian diseases, such as Newcastle disease (ND), and infectious bursal disease (IBD). INNOVAX-ND-H5 forms part of our holistic Avian influenza solution strategy aiming to clinically protect poultry and minimizing or ideally eliminating avian influenza virus shed over the whole life cycle of the birds. Used alone INNOVAX-ND-H5 will provide a high level of clinical protection and reduce avian influenza viral shed.
According to the World Organisation for Animal Health (WOAH), avian influenza is a highly contagious viral disease that affects both domestic and wild birds. avian influenza viruses have also been isolated, although less frequently, from mammalian species, including humans. This complex disease is caused by viruses divided into multiple subtypes (i.e., H5N1, H5N6, H5N8 etc.) whose genetic characteristics can rapidly evolve. The disease occurs worldwide but different subtypes are more prevalent in certain regions than others. The 180+ countries of WOAH agreed in a 2023 Resolution that “conventional control measures of biosecurity, stamping out and movement restrictions…can be insufficient and unsustainable” and that “vaccination should be considered as a complementary disease control tool.”
Based on the CVMP’s recommendation, the EC is expected to issue a decision for marketing authorization in the European Union (EU) in mid-2024
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, 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. 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 X (formerly Twitter).
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