FDA begins speed review of Mercks Ebola Vaccine


Merck&Co/MSD have become the first company to file for approval of an Ebola vaccine in the US, with a result expected in March next year after the FDA has given this case a priority review.

The vaccine has already been granted approval for use in emergencies by the World Health Organization (WHO) based on trials conducted during the 2014-16 Ebola crisis in West Africa, where it was found to have 93% protective efficacy.

It is now also under regulatory review in Europe with Merck eager to achieve registration and regulatory approval for its German manufacturing site, so that a licensed supply can be produced over time to support global public health preparedness and health security objectives.

This rapid move for approval stems from the recent outbreak in the Democratic Republic of Congo, where there has been a reported number of 3000 cases at the end of August, making it the second-largest epidemic of the virus ever. The death toll stands at nearly 1000, reminding us of the deadliness of the virulent strain.

More than 200,000 people have been vaccinated in the country either by Mercks product or by another experimental vaccine by J&J. The vaccines have been administered in a ring vaccination strategy, with the vaccination radiating out from those in contact with diagnosed cases of the infection in order to try and contain its spread in the absence of mass immunization.

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