ERVEBO® [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Awarded Prequalification Status by the World Health Organization (WHO)
November 13, 2019 10:10 am EDT
KENILWORTH, N.J., Nov. 13, 2019—Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that ERVEBO [Ebola Zaire Vaccine (rVSVΔ-ZEBOV-GP live)] has been awarded prequalification status by the World Health Organization (WHO). ERVEBO is the first vaccine to be prequalified by the WHO for the prevention of Ebola Virus Disease. WHO prequalification follows the European Commission’s grant of a conditional marketing authorization to ERVEBO on Nov. 11, 2019, previously announced by Merck here https://www.mrknewsroom.com/news-release/ebola/mercks-ervebo-ebola-zaire-vaccine-rvsvdg-zebov-gp-live-granted-conditional-approv. ERVEBO is currently under Priority Review with the U.S. Food and Drug Administration (FDA) with a target action date of March 14, 2020.
WHO prequalification means that ERVEBO has met the WHO’s standards of quality, efficacy and tolerability, which, in conjunction with other criteria, offers guidance to the United Nations (UN) and other global health entities in making relevant vaccine decisions. Importantly, prequalification status allows a vaccine to be procured and purchased by the UN, now allowing ERVEBO to be considered as a vaccine to be included in a global Ebola vaccines stockpile being planned by the WHO, UNICEF, Gavi (the Vaccines Alliance), and others.
In addition to the submission to the FDA, Merck has also made submissions to selected African country National Regulatory Authorities in collaboration with WHO-AFRO and the African Vaccine Regulatory Forum (AVAREF), which, if approved, will allow the vaccine to be registered in those countries.
Merck’s Commitment to Infectious Diseases
For more than 100 years, Merck has contributed to the discovery and development of novel medicines and vaccines to combat infectious diseases. In addition to a combined portfolio of vaccines and antibacterial, antiviral and antifungal medicines, Merck has multiple programs that span discovery through late-stage development. To learn more about Merck’s infectious diseases pipeline, visit www.merck.com.
For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
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