RISKY MERCK VACCINE HAS FAILED TO GAIN REGULATORY APPROVAL IN THE USA SO FAR, PLANS FOR END 2017


Merck’s ($MRK) candidate is the furthest along in the quest for an Ebola vaccine, having posted interim Phase III data showing 100% efficacy last July. Now, the Big Pharma has won $5 million from Gavi, the global vaccine alliance, to help see its candidate through late-stage trials, licensure and prequalification by the WHO, and plans to submit the vaccine for regulatory approval by the end of 2017.

Gavi committed $5 million in an advance purchase commitment, with the understanding that Merck will submit the candidate for licensure in 2017, Gavi said in a statement on Wednesday. If it’s approved, Gavi will build a stockpile of the vaccine for future outbreaks.

Merck has filed an emergency use application with the WHO. If it’s approved, the experimental vaccine will be available for use if there is another outbreak before the it is licensed. The company will provide 300,000 doses starting in May this year for use in clinical trials or emergency situations, Gavi said.

http://www.fiercepharma.com/regulatory/merck-to-submit-ebola-vaccine-for-regulatory-approval-2017

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