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Merck wins CHMP recommendation for Ebola vaccine

Has also been granted priority review by FDA

Merck

Merck/MSD has been granted a positive opinion recommending the approval of its investigational V920 Ebola Zaire vaccine from the Committee for Medicinal Products for Human Use (CHMP).

An approval from the European Medicines Agency (EMA) is likely to follow, and if approved the vaccine will be given the brand name Ervebo. It will be indicated for active immunisation of people over the age of 18 to protect against the deadly virus.

“This positive opinion from CHMP represents important progress towards licensure of a vaccine to provide protection from Ebola virus disease to people in areas affected by the Ebola Zaire virus,” said Roger M. Perlmutter, president, Merck Research Laboratories.

“Our work would not have been possible without the efforts of countless numbers of people, especially those from the World Health Organization and many other government and non-governmental organisations, who have worked tirelessly on the development of this important vaccine,” he added.

The V920 or vRVS-ZEBOV vaccine – which was licensed from NewLink Genetics – was granted breakthrough status by the FDA in the US in July 2016 and is currently under review.

It has already been approved for use in emergencies by the World Health Organization (WHO), based on trials conducted during the 2014-2016 Ebola epidemic in West Africa which suggested it had 93% protective efficacy.

The approval comes as the ongoing outbreak of Ebola Zaire in the Democratic Republic of the Congo saw the number of cases head to around 3,000, making it the second-largest epidemic of the virus recorded so far. The death toll is at approximately 2,000 deaths among those recorded cases.

More than 200,000 people have been vaccinated against Ebola in the country, either with V920 or another experimental vaccine from Johnson & Johnson.

However, Merck is most likely to be the first to obtain formal regulatory approval for an Ebola vaccine, as J&J’s Ad26.ZEBOV and another candidate called MVA-BN-Filo from Bavarian Nordic are still in clinical testing in Uganda.

Merck slashes 500 jobs in the US

In other news for the pharma giant, Merck has announced major layoffs of its sales personnel based in the state of Pennsylvania, US.

Approximately 500 people working at or with Merck’s offices in the suburban Philadelphia area of the state will lose their jobs, following a permanent reduction in the workforce.

“The roles being eliminated are located across all states, but for administrative purposes, the jobs are associated with Merck’s US headquarters in Upper Gwynedd,” said a company spokesperson.

According to Merck, the cuts "are part of ongoing company-wide efforts to sharpen Merck’s focus on innovative research and development”.

Article by
Lucy Parsons

18th October 2019

From: Regulatory

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