Merck to submit Ebola vaccine for regulatory approval in 2017

Merck's Ebola vaccine candidate is readied for Phase III trials in Sierra Leone.--Courtesy of CDC

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.

This approach contrasts with the candidate's development. After protecting 100% of monkeys in preclinical trials in 2005, researchers hoped to progress to human trials two years later and eventually submit a regulatory filing in 2010 or 2011. But the candidate didn't get pushed to human trials until the most recent Ebola outbreak.

According to Gavi, the most recent epidemic infected more than 28,600 people and killed more than 11,300. Just last week, the WHO announced no new Ebola cases had been reported in the three worst-affected countries for 6 weeks. But just a day later, Sierra Leone reported an Ebola-related death.

"The most recent Ebola-related death in Sierra Leone and the fact that we know the reservoirs of Ebola still exist, underline why we must learn lessons from the devastating impact of the crisis and ensure we are better prepared for infectious disease outbreaks," said Dr. Seth Berkley, Gavi CEO. The world is still worryingly underprepared for potential future health threats and a change of mindset is required to ensure we invest in research and development today to protect ourselves in years to come."

GlaxoSmithKline ($GSK), Johnson & Johnson ($JNJ) and Maryland-based Novavax ($NVAX) and Profectus BioSciences have Ebola candidates in clinical trials, and San Diego's Inovio ($INO) is leading a consortium to develop treatments and a vaccine for Ebola. Merck's Phase III trial is ongoing and follows a novel "ring" structure, in which people at risk for Ebola infection were vaccinated with rVSV-ZEBOV.

- here's the release

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