Wednesday, January 20, 2016

Merck's Ebola Vaccine Efforts Rewarded With GAVI Contract Support -- To Secure Global Approvals

My regular readers will recall that just over a year ago, HHS granted Merck's Ebola vaccine candidate so-called "PREP Act" suit-immunity, which essentially provides that Kenilworth won't ever face US claims -- for having been a Good Samaritan, here -- in producing the vaccine candidate, to respond to last year's devastating West African epidemic. Now, Merck will likely be at least cash neutral, as it seeks various global regulatory approvals -- from the commitments in this initial GAVI contract.

Until those approvals are secured, though, the vaccine may only be used to quell contact flare-ups, on an emergency basis. That is happening this week, in Sierra Leone, for just over 100 contacts of the latest reported victim of the virus. But in time, Merck might secure governmental/W.H.O. funding -- for wide scale vaccinations, in threatened populations. We shall see -- this could actually be a slightly profitable franchise -- even though that was not the original primary objective.

The newly-proactive global health approach -- from a wide array of interested parties -- is quite gratifying. Here's a bit from Reuters overnight, out of Davos, Switzerland -- but do go read it all:

. . . .If approved, Merck's so-called VSV-ZEBOV live attenuated Ebola Zaire vaccine would become one of the world's first licensed Ebola shots and Gavi would be able to start buying it to create a stockpile for future outbreaks, it said in a statement issued at the World Economic Forum in Davos.

"The suffering caused by the Ebola crisis was a wake-up call to many in the global health community," said Gavi's chief executive Seth Berkley.

"New threats require smart solutions and our innovative financing agreement with Merck will ensure that we are ahead of the curve for future Ebola outbreaks."

The deal was agreed on the understanding that the vaccine will be submitted for a license by the end of 2017.

Speaking to Reuters in Davos, Berkley said the advance commitment should give a positive signal to drugmakers developing products that may not have an immediate market

"It's critical that we give confidence to companies that when they make this type of effort, there is somebody to buy it," he said.

As part of the agreement, Merck will ensure that 300,000 doses of the vaccine are available from May 2016 to be used in expanded use clinical trials as well as for emergency use as needed while development work on the shot continues. . . .

Good news for all concerned. Enjoy the softly wheeling snowflakes around much of the mid-nation, this morning. . . smile. . . .

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