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FDA follows EMA with approval of Merck’s Ebola vaccine

First to be approved in the US

Ebola Vaccine

The US Food and Drugs Administration (FDA) has approved its first-ever Ebola vaccine, just over a month after the European Medicines Agency (EMA) gave it the green light. 

The Ervebo shot – previously known as V920 – is marketed by Merck & Co and was developed by NewLink Genetics. It has been cleared for the prevention of Ebola virus disease, caused by Zaire ebolavirus, in individuals aged 18 years and older in the US.

Although cases of the deadly disease are extremely rare in the US, infections have been acquired by those travelling to the country from affected areas, and health care workers who have fallen ill after treating people with Ebola.

The FDA approval of Ervebo was based on a study conducted in Guinea, West Africa during the 2014-2016 outbreak – the largest outbreak of Ebola to date. Ervebo was determined to be 100% effective in preventing cases of Ebola, with symptom onset greater than ten days after vaccination.

The Democratic Republic of the Congo (DRC) is currently experiencing the world’s second largest outbreak of the disease – in 2018, the World Health Organization (WHO) and the DRC began use of Ervebo as an investigational vaccine under an expanded access programme.

The epidemic in the DRC has caused the deaths of over 2,000 people, with 3,000 confirmed infections since the outbreak began in August 2018.

To date, hundreds of thousands of people have been vaccinated against Ebola in the country, either with Merck’s vaccine or another investigational shot from Johnson & Johnson – Ad26.ZEBOV.

J&J submitted marketing authorisation applications with the EMA at the beginning of November for its own Ebola vaccine – this comprises a two-dose regimen of Ad26.ZEBOV and MVA-BN-Filo. Merck could have an advantage over J&J with its dosing, given that it is a single-dose injection.

“The FDA’s approval of Ervebo is a major advance in helping to protect against the Zaire ebolavirus as well as advancing US government preparedness efforts,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“The FDA is committed to continuing our work across the US government and with our international partners to prevent future Ebola outbreaks and mitigate the current outbreak in the DRC, reflecting our nation’s commitment to preparing for and responding to biological threats, like Ebola,” he added.

Merck will now be able to qualify for a tropical disease priority review voucher – this is an incentive meant to encourage pharmaceutical companies to develop treatments for diseases that might be neglected by the industry because they lack substantial financial returns.

Merck can either use the PRV to fast-track an FDA review of one of its own products, or sell it on to another company.

Article by
Lucy Parsons

20th December 2019

From: Regulatory



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