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Merck claims first-ever okay for Ebola vaccine, in Europe

Comes shortly after J&J filed its Ebola candidate with EMA

Vaccine

Merck & Co/MSD has secured the first approval in Europe for a vaccine to protect against Ebola, getting a green light for the Ervebo shot originally developed by NewLink Genetics.

The approval comes shortly after Johnson & Johnson filed its Ebola vaccine candidate (Ad26.ZEBOV, MVA-BN-Filo) with the EMA, setting up a possible approval next year, and ahead of a potential approval of Ervebo in the US due next March. Another vaccine – MVA-BN-Filo from Bavarian Nordic – is in late-stage testing in Uganda.

Ervebo – previously known as V920 (rVSVΔG-ZEBOV-GP) – has been cleared by the EMA for active immunisation of adults aged over 18 who are at risk of infection from the Ebola virus.

The vaccine has been approved as the Democratic Republic of the Congo (DRC) is grappling with the world’s second largest Ebola epidemic on record, with more than 2,000 lives lost and 3,000 confirmed infections since the outbreak was declared in August 2018, according to the World Health Organization (WHO).

The largest outbreak to date occurred in West Africa in 2014-2016, and resulted in more than 11,000 deaths. Ervebo has already been approved for use in emergencies by the WHO, based on trials conducted during that epidemic which suggested it had 93% protective efficacy.

To date, hundreds of thousands of people have been vaccinated against Ebola in the country, either with V920 or J&J’s Ad26.ZEBOV, and MSD says it has already provided more than 250,000 doses of V920 for use in the DRC outbreak.

“This vaccine has already saved many lives in the current Ebola outbreak, and the decision by the European regulator will help it to eventually save many more,” said Dr Tedros Adhanom Ghebreyesus, WHO director-general.

MSD says it will now start producing licensed doses of Ervebo at a facility in Germany that should become available in the third quarter of 2020, and in the meantime will continue to produce V920 to supply compassionate-use programmes in the DRC assisted by the WHO, US government and vaccine charity Gavi.

It has also applied to the WHO seeking prequalification status for the vaccine, as well as making marketing submissions to certain African country regulators with the help of African Vaccine Regulatory Forum (AVAREF).

MSD chief executive Kenneth Frazier said the approval “is the result of an unprecedented collaboration for which the entire world should be proud. It is a historic milestone and a testament to the power of science, innovation and public-private partnership”.

Article by
Phil Taylor

12th November 2019

From: Regulatory

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