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DRC approves use of unlicensed Ebola vaccine if needed
Officials in the Democratic Republic of the Congo recently approved a study protocol that would allow the use of an experimental Ebola vaccine to contain an outbreak in the country, according to Médecins Sans Frontiéres, or MSF, also known as Doctors Without Borders.
The experimental vaccine rVSV-ZEBOV will be shipped and used only in the Democratic Republic of the Congo (DRC) if the Ebola virus disease (EVD) outbreak spreads beyond the known contacts, an MSF representative told Infectious Disease News.
“All technical and operational planning and preparations for a possible vaccination are being completed in order to rapidly initiate a ring vaccination should an EVD laboratory-confirmed case be identified outside of the already defined contacts,” she said. “The international vaccine deployment and cold chain shipment to DRC is not advised by WHO at this point. Planning and arrangements should continue, however, and be in place for immediate deployment if necessary.”
Although the rVSV-ZEBOV vaccine is not licensed yet, it can be deployed in the event of an outbreak under the Expanded Access Framework. Its use requires a formal study protocol and informed consent, and it must be used in compliance with good clinical practice, the representative said. The recently approved protocol, submitted by MSF, meets these requirements, she added.
The vaccine, which was developed in Canada, was 100% effective at preventing the disease during a 2015 ring vaccination trial in Guinea, where the West African epidemic started. It targets the Zaire strain of the virus, which WHO said is causing the current outbreak in Congo.
According to WHO, there are currently two confirmed, three probable and 12 suspected cases of EVD in the DRC as of June 1, as well as one confirmed and three probable deaths. The last confirmed case was identified on May 11. The outbreak remains confined to the Likati Health Zone, Bas Uele Province, in the northeast region of the country. – by Gerard Gallagher and Stephanie Viguers
Perspective
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The approval of the protocol for possible ring vaccination by the government of the Democratic Republic of the Congo, their national regulatory authority and the Ethics Review Board of the DRC, and the quick coordination with many partners, including WHO, Médecins Sans Frontières and multiple others, is an admirable achievement that makes the DRC more prepared to use the vaccine, if indicated, when future laboratory-confirmed cases occur in the DRC, as they have eight times since 1976.
The DRC might be interested in sharing their lessons learned from reviewing and approving this vaccine protocol with other nations at risk for Ebola outbreaks, such as the Central African Republic, given their shared border near the DRC Ebola outbreak area.