Wednesday, November 14, 2018

Merck's Rolling "Breakthrough" FDA Submission -- Its Ebola Vaccine -- Is Now Underway (Approval In Early 2019 Likely).


First, lots of the multi-year backstory here -- or just search "Ebola vaccine" in the upper left box.

We have followed this since early 2014, very closely. And now (overnight) we learn that Kenilworth has submitted an approval packet to US FDA staffers.

This all ought to go very quickly -- for all the reasons we mentioned -- and that is decidedly good news. However (less sanguinely), it now looks like the current Ebola outbreak in DRC (the most lethal in that country's history -- back to 1976) will last a minimum of another six months, due primarily to lost contact tracings. That, in turn, offers a real potential for the need to vaccinate NOT just "rings of contacts" -- but an entire urban population, in an 800,000-plus population city like Beni.

So. . . Merck may need to scale up -- and scale up rapidly (likely in Durham, NC), after the nearly certain FDA approval arrives. Now you know. Onward.

नमस्ते

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