Thursday, September 16, 2010

Will We Learn More -- About Availability Of Merck's Recombivax HB® (Adult) -- On Tuesday?

Most recently, in early August, we updated you on the continuing unavailability of Recombivax HB®, Merck's Hepatits B vaccine, for adults. Most experienced observers now presume Merck will not be able to deliver adult Recombivax HB, in meaningful quantities, until sometime in mid-2011 -- or beyond.

There have been persistent manufacturing issues at the facility in West Point, PA, with the Hep B vaccine stock. Merck is addressing its production issues in several ways: by investing in manufacturing capabilities to increase capacity and create redundancy; by building new vaccine-production facilities in Durham, North Carolina. . . and by modernizing equipment and processes at its West Point facility, it says.

Now -- as luck would have it, FDA's Vaccines & Biologics Advisory Committee is scheduled to meet next Tuesday, September 21, 2010 -- and part of the afternoon is devoted to Hep B vaccine issues, thus:

. . . .3:10 PM | Overview Laboratory of Hepatitis Viruses | Stephen Feinstone, M.D., FDA

3:35 PM | Q&A. . . .

Let's hope that FDA has been seeking answers on these supply contsraints (as there are persistent rumors of ongoing FDA inspections -- inside West Point), and that there will be some small light shed on when (or whether) Merck will be back in the formularies with meaningful quantities of adult Recombivax HB. Until then, this entire marketplace is effectively owned by GSK.

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