The World Health Organization (WHO) announced today that it has prequalified Merck’s Ebola vaccine, a move that comes just 1 day after the European Commission granted full approval for VSV-EBOV, which is in use on a compassionate basis and under further study in the current Ebola outbreak in the Democratic Republic of the Congo (DRC).
According to a statement sent to journalists, the WHO said prequalification means the vaccine meets the WHO’s quality, safety, and efficacy standards, paving the way for United Nations agencies and Gavi, the Vaccine Alliance, to buy the vaccine for use in at-risk countries.
Tedros Adhanom Ghebreyesus, PhD, the WHO’s director-general, said in the statement that prequalification marks a historical step toward ensuring that the people who most need the vaccine are able to receive it. “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,” he said.
Today’s WHO announcement made good on Tedros’s comments yesterday in the wake of the European Commission’s full licensure announcement, the world’s first for any Ebola vaccine. On Twitter, he said the WHO’s prequalification was expected within days.
In mid-October, the European Medicines Agency (EMA) conditionally approved the vaccine under the Ervebo brand name for active immunization of people 18 years and older to protect against Ebola.
To speed the WHO prequalification process, the group reviewed the vaccine’s safety and efficacy data as soon as they were available, and representatives from the WHO’s prequalification team were on hand for the EMA’s evaluation process to address program suitability for Africa’s at-risk countries.
In today’s announcement, the WHO said it is facilitating VSV-EBOV’s licensing in at-risk countries and, with support from the EMA, has worked closely with many African nations to quickly approve the vaccine following the WHO’s recommendation.
Step closer to global vaccine stockpile
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