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Merck Wins European Approval for World’s First-Ever Ebola Vaccine

November 11, 2019, 11:13 PM UTC

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Happy Monday, readers! I hope you enjoyed your weekend.

This week started off with some pretty remarkable news: The world’s first-ever Ebola vaccine has been approved in Europe.

The European Commission, following a recommendation from the European Medicines Agency (EMA), Europe’s Food and Drug Administration (FDA) analogue has granted drug giant Merck marketing approval for Ervebo. This is a pioneering treatment against the deadly infectious virus, which has claimed more than 2,100 lives in the Democratic Republic of Congo in less than a year-and-a-half.

This particular vaccine is urgent because of how deadly the strain it tackles is. Death rates from Ebola Zaire, the strain making its way round the Congo, can reach 67%, whereas earlier outbreaks have ranged from 25% to 90% (depending on the specific incident). Merck’s vaccines were already being used on an experimental and compassionate basis in the region last year following Ebola’s re-emergence following the deadly 2014-2016 outbreak in West Africa.

“After recognizing the need and urgency for an Ebola Zaire vaccine, many came together across sectors to answer the global call for outbreak preparedness,” said Merck CEO Kenneth Frazier in a statement.

The situation in the Congo has been complicated by regional warfare. And containing an infectious disease this dangerous is inherently complicated work. Merck will now look to an expected 2020 FDA approval and licensing of Ervebo—developed in conjunction with plenty of partners, including public academic institutes in the U.S. and Canada—in order to expand its reach.

That could be particularly significant since marketing authorizations from the E.U. and the U.S. could help make it easier for the affected populations to get the Ebola vaccine.

Read on for the day’s news.

Sy Mukherjee
sayak.mukherjee@fortune.com
@the_sy_guy

DIGITAL HEALTH

WSJ: Google, Ascension team up to collect personal health data from millions. The Wall Street Journal reports that one of the nation's largest health systems, Ascension, has teamed up with Google on a typically esoteric initiative called "Project Nightingale." This is an effort to mine personalized health data as tech companies vie to establish the biggest footprint in the medical industry. According to the Journal, the data-sharing ranges from lab tests to hospitalization data to actual diagnoses—though the non-disclosure to patients about the collection of this data between a hospital and a third party may be acceptable under current law. More on this soon. (Wall Street Journal)

Genetically engineered pigs to be used for human skin transplants. Emily Mullin of OneZero brings the bacon on this story: a Food and Drug Administration (FDA) cleared experiment will be the first of its kind to use skin from genetically modified pigs in order to help treat burn victims. This is part of a larger effort to use modified pigs, which have striking biological symmetry with human, to facilitate organ transplants. (OneZero)

INDICATIONS

Roche sets up rival to Biogen, Novartis spinal muscular atrophy drugs. Roche's experimental treatment risdiplam is shoring up its clinical bona fides in a battle against first-to-market spinal muscular atrophy (SMA) drugs from Biogen and Novartis. That latter two companies' Spinraza and Zolgensma, respectively, are among the costliest drugs (by list price) in the world, treating a devastating genetic disorder that afflicts young patients. Roche's hope is to submit for FDA approval later this year. (Reuters)

THE BIG PICTURE

A tribute to late health care visionary Bernard Tyson, Kaiser Permanente CEO. The medical industry mourned the loss of a giant this weekend. Bernard Tyson, CEO of Kaiser Permanente and ardent advocated for health care equity, unexpectedly passed away in his sleep at age 60 on Sunday. I'd had the pleasure of meeting him on multiple occasions and can say he's one of the kindest, most sincere executives I'd ever met. My colleague and our editor-in-chief Clifton Leaf has a beautiful remembrance of him here: "To say that Bernard Tyson was good-natured, which surely he was, would miss the point, however. His nature, simply put, was good—and he felt an obligation to be candid about where the world felt short in that respect," writes Cliff. "He was bold and forthright, on matters ranging from the cost of health care (“It was unaffordable, period,” he’d say) to homelessness (“The narrative that it’s okay to keep stepping over the homeless and going about our business in the richest country of the world is just something we cannot accept.”) to what it’s like to be black man in America." (Fortune)

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