Merck plans to seek FDA approval for Ebola vaccine in 2019

Excerpts from media

Next year, Merck plans to seek approval of the vaccine from the U.S. Food and Drug Administration, based on previous studies of the shots.

One problem remains the lengthy, complex and expensive process of getting new vaccines licensed by Western regulators, like the U.S. Food and Drug Administration (FDA).

Merck – whose vaccine was originally developed by the Public Health Agency of Canada and then handed to NewLink Genetics NLNK.O, before Merck took it on in 2014 – does not expect to be ready to seek an FDA marketing authorisation licence for VSV EBOV until 2019.

This is in part due to “unforeseen facility and engineering issues” at a manufacturing plant being built in Germany, Merck’s spokeswoman Pamela Eisele said. “We … are focused on getting vaccine manufacturing on-line as quickly as possible.”

The company could get a pay-off when the vaccine is finally licensed, in the form of an FDA priority review voucher, which can be used with another product of its choice or sold on.

The FDA issues such vouchers for innovative drugs or vaccines tackling neglected or rare diseases, including Ebola, and past examples have been sold for up to $350 million.

The only licensed Ebola vaccines come from separate groups in Russia and China. Their products have been approved by local regulators only on the basis of limited clinical data. An FDA licence is widely regarded as the definitive stamp of approval.

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