The World Health Organization (WHO) has prequalified an Ebola vaccine for the first time, a critical step that will help speed up its licensing, access and roll-out in countries most at risk of Ebola outbreaks. This is the fastest vaccine prequalification process ever conducted by WHO.
Prequalification means that the vaccine meets WHO standards for quality, safety, and efficacy. United Nations agencies and Gavi, the Vaccine Alliance, can procure the vaccine for at-risk countries based on this WHO recommendation. “This is a historic step towards ensuring the people who most need it are able to access this life-saving vaccine,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General.
“Five years ago, we had no vaccine and no therapeutics for Ebola. With a prequalified vaccine and experimental therapeutics, Ebola is now preventable and treatable.”
“The development, study, and rapid prequalification of this vaccine show what the global community can do when we prioritize the health needs of vulnerable people.”
The injectable Ebola vaccine, Ervebo, is manufactured by Merck (known as MSD outside the US and Canada). It has been shown to be effective in protecting people from the Ebola Zaire virus and is recommended by the WHO Strategic Advisory Group of Experts (SAGE) for vaccines as part of a broader set of Ebola response tools.
The decision is a step towards greater availability of the vaccine in the future, though licensed doses will only be available mid-2020. This announcement comes less than 48 hours after the European Commission’s decision to grant conditional marketing authorization for the vaccine, following the recommendation from the European Medicines Agency (EMA).
Due to the urgent public health need for a prequalified Ebola vaccine, WHO accelerated prequalification by reviewing safety and efficacy data as the information became available. Representatives from the prequalification team participated in the EMA evaluation process to address programmatic suitability for at-risk countries in Africa.
“The development, study, and rapid prequalification of this vaccine show what the global community can do when we prioritize the health needs of vulnerable people,” said Dr. Tedros. WHO is also facilitating licensing of the vaccine for use in countries at risk of Ebola outbreaks, based on the reviews and positive outcomes by the EMA. WHO, with the support of EMA, has worked closely with many African regulators who have indicated they will quickly license the vaccine following the WHO recommendation.
The Ebola virus was introduced into Nigeria on 20 July 2014 when an infected Liberian man arrived by airplane into Lagos, Africa’s most populous city. The man, who died in the hospital 5 days later, set off a chain of transmission that infected a total of 20 people, of whom 8 died (case fatality rate of 42.1%).
The Democratic Republic of the Congo is currently battling the world’s second-largest Ebola epidemic on record, which began in 2018 and has so far seen 3168 confirmed cases and 2191 deaths as of 6 November 2019.
The Ebola virus which takes from 2-21, but mostly 8-10 days to show symptoms has been the cause of thousands of deaths.
The first known outbreak of EVD was identified only after the fact. It occurred between June and November 1976, in Nzara, South Sudan (then part of Sudan), and was caused by Sudan virus (SUDV). The Sudan outbreak infected 284 people and killed 151.
The other was in Yambuku (the Democratic Republic of the Congo), a village near the Ebola River from which the disease takes its name. EVD outbreaks occur intermittently in tropical regions of sub-Saharan Africa. Between 1976 and 2013, the World Health Organization reports 24 outbreaks involving 2,387 cases with 1,590 deaths. The largest outbreak to date was the epidemic in West Africa, which occurred from December 2013 to January 2016, with 28,646 cases and 11,323 deaths.
Ebola first appeared more than three decades ago, but there was no cure or vaccination for the disease, in part because the dangerous nature of the virus makes it difficult to study. This is why the WHO’s prequalification of an Ebola vaccine is exciting news as it gives people a fighting chance.
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