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Merck’s Ebola vaccine wins approval in four African countries

Follows approvals in US and Europe last year

Ebola vaccine

Merck & Co/MSD has won approval for its Ebola vaccine Ervebo in four African countries, including the Democratic Republic of the Congo (DRC), one of the countries worst affected by the disease. 

Merck became the first drug developer to win approval for an Ebola vaccine last year, from both the US Food and Drug Administration and the European Medicines Agency.

Now, Ervebo has been registered by National Health Authorities in the DRC, Burundi, Ghana and Zambia. The pharma company also said it expects approvals in additional countries in Africa in the near future.

According to the World Health Organization, which granted Ervebo prequalification status just 90 days ago, the licensing of the vaccine in these countries will allow Merck to stockpile and widely distribute the vaccine in African countries at risk of Ebola outbreaks.

Merck said it will initiate manufacturing of licensed doses and expects these to become available in approximately the third quarter of 2020.

The company is already working with WHO and partners to make the vaccine available in support of international outbreak response efforts in the DRC and neighbouring countries.

Hundreds of thousands of people have already been vaccinated in the worst affected countries, either with investigational Ervebo (also known as V920) or Johnson & Johnson’s Ad26.ZEBOV.

Ervebo was studied in a major trial involving 11,841 people in Guinea in 2015, during the height of the 2014-2016 West Africa outbreak.

Among the 5,837 people who received the vaccine, no Ebola cases were recorded ten days or more after the vaccination, compared to 23 cases ten days or more after vaccination in the placebo group.

The worst Ebola outbreak to date – in West Africa – resulted in 28,600 cases and over 11,000 deaths, with the urgency of the crisis leading to a number of major pharma companies to begin the development of vaccines to tackle the disease.

The DRC is currently experiencing an outbreak of Ebola, with more than 2,200 live lost and 3,300 confirmed infections since the outbreak began on 1 August 2018.

As well as Merck, J&J has submitted marketing authorisation applications with the EMA for its own Ebola vaccine, which comprises a two-dose regimen of Ad26.ZEBOV and MVA-BN-Filo.

The regimen is delivered through a first dose of Ad26.ZEBOV and MVA-BN-Filo as the second dose, approximately eight weeks later. The latter vaccine is based on Danish biotech Bavarian Nordic’s technology.

Article by
Lucy Parsons

18th February 2020

From: Regulatory



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