Getting Vaccines -- On A "Millions Of Doses Scale", Into Vials, Flawlessly... Is A Daunting Engineering Challenge: Gardasil® Manufacturing Contract Delays, For Gavi '24

After running into Gardasil^® supply shortfalls in both 2018 and 2019, Merck made a large capital expense / expansion downstroke in its rural Elkton, Virginia facilities -- to double manufacturing capacity. [We covered that, here, in real time.]

But now Merck may be (in part) a victim of its own marketing successes, in Europe, and the US and Japan -- as even its overall expanded capacity -- between Durham, West Point and Elkton is being sorely tested. More doses are being sold than expected, in high margin geographies.

And so, this morning, we read in the NYT that Rahway will be about 1.2 million doses short, on its 2024 delivery contract with the global non-profit alliance that immunizes young African girls against HPV, which after infection and remaining dormant for years in the human body, may -- later in life -- manifest itself as several forms of cancers.

So the jabs are critical -- and approved for all girls at the age of 12. Being even a year late in getting it (if a girl is sexually active), may mean that we've missed the window. Once you've contracted the HPV virus, obviously, the vaccine is of no real use. So here's to hoping Merck is able to resolve the "manual inspections" snag, and rapidly so. [The company doesn't make any real profit on the Gavi contract -- but makes very high profits on EU, UK and US dosings of the Gardasil vaccine.]

Here's the bit from the NYT:

. . .Nearly 1.5 million teenage girls in some of the world’s poorest countries will miss the chance to be protected from cervical cancer because the drugmaker Merck has said it will not be able to deliver millions of promised doses of the HPV vaccine this year.

Merck has notified Gavi, the international organization that helps low- and middle-income countries deliver lifesaving immunizations, and UNICEF, which procures the vaccines, that it will deliver only 18.8 million of the 29.6 million doses it was contracted to deliver in 2024, Gavi said. . . .

Patrick Ryan, a spokesman for Merck, said the company “experienced a manufacturing disruption” that required it to hold and reinspect many doses by hand. He declined to give further details about the cause of the delay. . . .

Perhaps some of the "high margin" inventory in Europe might be temporarily diverted to the African continent, until the glitch is straightened out? Perhaps -- as I suspect Merck has enough on hand to cover its higher profit geographical contract commitments. But I'm just a natural-born cynic, in that way. Onward -- sorta' gray morning here.

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