Merck known as MSD Thursday said its 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 followed the European Commission’s grant of a conditional marketing authorisation to ERVEBO on November 11.
ERVEBO is currently under Priority Review with the US 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 allowed 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…
View original post 105 more words