MERCK (NYSE: MRK), known as MSD (www.MSD.com) 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 November 11, 2019. 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, MSD 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.