IAVI is pleased to announce that the first shipment of its Sudan virus (SUDV) vaccine arrived in Entebbe, Uganda, on Dec. 17. A World Health Organization (WHO) delegation received the 2,160 doses, shipped from Rockville, Maryland, just over 80 days after declaring a Sudan ebolavirus outbreak in Uganda. No SUDV vaccines have been approved to date, and existing Ebola vaccines and treatments are not effective against SUDV.
The IAVI vaccine candidate is one of three intended to be evaluated in a “ring vaccination” clinical trial being planned to assess vaccine effectiveness in preventing Ebola Sudan disease, should the outbreak in Uganda continue or recur. In November, a WHO-convened expert independent group ranked IAVI’s investigational SUDV vaccine candidate as the number one priority investigational vaccine for inclusion in the trial. As public health measures implemented in Uganda have fortunately been successful in limiting new cases of Ebola Sudan virus disease, it may not be possible to conduct a formal ring vaccination study. Even if the ring vaccination trial cannot be conducted as currently designed, IAVI will continue to move our program forward as expeditiously as possible. Alternative clinical studies are being considered that would contribute to the evidence base needed to bring promising vaccine candidates to regulatory approval and support their use to control future outbreaks. These studies will be co-sponsored by the Ministry of Health in Uganda and WHO, with support from other partners.
Merck, known as MSD outside the United States and Canada, produced and donated to IAVI vials of candidate vaccine from existing investigational drug substance to supplement IAVI’s ongoing SUDV vaccine development program. IAVI’s SUDV vaccine candidate is based on the same vesicular stomatitis virus (VSV) viral vector platform used in ERVEBO®, Merck’s single-dose Zaire ebolavirus (EBOV) vaccine that has achieved regulatory approval by the U.S. Food and Drug Administration, the European Medicines Agency, and several regulatory authorities in Africa.
Read more about IAVI’s plans to accelerate evaluation of its VSV-SUDV vaccine candidate.