fiercepharmaNovember 23, 2017
Tag: Merck , Ebola vaccine
Although having taken a great effort to develop Ebola vaccines through testing during a severe outbreak, Merck & Co. confirmed Tuesday that the company will delay its persuit to applying for the candidate to get FDA approval this year, but still aiming for next year.
While the company is "committed to developing and seeking approval for our Ebola vaccine as quickly as possible," Merck spokeswoman Pamela Eisele said via email, the drugmaker expects to file for approval at a "major regulatory agency in 2018." Merck is working with the FDA and European Medicines Agency on its filings, she added.
The delay could jeopardize a $5 million advance purchase commitment from Gavi, the global vaccine alliance, that was announced early last year. The deal was contingent on Merck filing for approval by the end of 2017, the organization said at the time. Gavi representatives couldn't immediately be reached to comment on the development.
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