Merck & Co expects to complete production of the first batches of Ervebo – its newly EC-licensed Ebola vaccine – at its Burgwedel plant by late 2020.
The European Commission (EC) granted Ervebo conditional marketing authorization for the active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus this week.
The decision was based on data submitted for accelerated assessment in March.
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Merck – which is known as MSD outside the US and Canada – said: “Given the unique manufacturing requirements for ERVEBO, this approval allows MSD to initiate manufacturing of licensed doses in Germany, which are expected to start becoming available in the third quarter of 2020.”
A Merck spokesperson confirmed the production schedule, and told us “the manufacturing site is located in Burgwedel, Germany.”
He went on to say there are no plans to make the vaccine elsewhere, explaining “MSD has examined alternative options, and continue to consider all options, but currently no faster option exists.”
In related news, the World Health Organization (WHO) said it has prequalified Ervebo in a bid to accelerate “licensing, access and roll-out in countries most at risk of Ebola outbreaks.”
The status means member states and procurement agencies – like Gavi and the Vaccine Alliance – can buy it for immunization programs.
It also means Ervebo will undergo regular retesting and the WHO will investigate reports of adverse events.
Manufacturing
Ervebo consists of a live attenuated recombinant Vesicular Stomatitis Virus (rVSV) in which the gene encoding the envelope has been replaced by one encoding the Zaire Ebola virus (ZEBOV) surface glycoprotein.
As a result, the vaccine provides immunity against the Zaire Ebola virus by inducing a response that helps protect against the disease.
Ervebo was created by the Public Health Agency of Canada’s National Microbiology Laboratory.
Originally it was licensed to NewLink Genetics, however, Merck was granted development, production and distribution rights in 2014.
US priority review
The European Commission decision follows a recommendation by the EMA’s committee for medicinal products for human use (CHMP) that Ervebo be approved last month.
It also comes weeks after the US FDA accepted a BLA for Ervebo. The US regulator set a PDUFA target date of March 14, 2020.
At the time NewLink said “approval of this Ebola vaccine would trigger the issuance of a priority review voucher owned by Merck and in which NewLink Genetics has a substantial economic interest.
“Thereafter, NewLink would have the right to monetize its share of interest in the voucher.”