This Is Good News For Merck -- But May Take A Few Years To Become... Material. Pfizer Basically Owns The Pneumococcal Vaccine Market With Its Prevnar® Line, At Present...

To be sure, it will be wonderful to have a meaningful competitive force in the US markets for vaccines. Pfizer has ruled the roost for over a decade now, in the US (by far the largest global marketplace for such vaccines).

Even so, this Merck clinical was a "non-inferiority" trial (meaning each works approximately equally well) -- so it will take some time to cut into Pfizer's perhaps 90 percent market share. But Merck clearly has the pre-existing cap ex investment base, in high through-put vaccine plant facilities -- to make millions of doses in under two to three years' time, from the date of a likely coming FDA approval. [Prior backgrounder from September 2021 -- on patent spats between the two, on these vaccines.]

And with drug price negotiations front and center, at the US government payor windows, now. . . it will likely come down to keeping the Merck V116 vaccine at or below what Prevnar 20^® costs, after all rebated amounts. Same with private pay insurance plans. So it will take a bit to be a material contributor (maybe three to five years from FDA approval), but clearly good news for Rahway. Here's the well-thought out scoop from FierceBiotech, this morning:

. . .[Merck posted] data from a phase 3 trial designed to knock Pfizer’s pneumococcal vaccine off its perch. The vaccine candidate matched Prevnar 20 [the successor to Prevnar 16] for shared serotypes and performed better for 10 of its 11 unique serotypes, positioning Merck to file for approvals around the world.

Pfizer is the dominant force in the adult U.S. pneumococcal vaccine market, with Prevnar 20 holding a 95% share in the third quarter, but Merck believes its V116 candidate provides broader protection than the competition. The drugmaker shared top-line data from a phase 3 trial of V116 in July and followed up Tuesday with a closer look at the results at the World Vaccine Congress West Coast.

In adults aged 50 years and older, V116 elicited non-inferior immune responses compared to PCV20, the generic name for Prevnar 20, for all 10 serotypes common to both vaccines. The immune responses in recipients of V116 were superior for 10 of the 11 serotypes that are included in Merck's asset but not in Prevnar 20. . . .

At base, this is really about offering prescribers a meaningful choice in vaccines -- and price point possibilities. We shall see how it plays out. But not materially important to this year, or next, at either Merck or Pfizer -- up or down. Onward.

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