Merck Still Struggles With Adult Hepatitis B Vaccine
3 CommentsBy Ed Silverman // July 30th, 2010 // 7:38 am
In early 2009, Merck disclosed that manufacturing issues would disrupt supplies of its Recombivax hepatitis B vaccine for adults. Supplies of other vaccines have also been constrained. For instance, orders placed for the Zostavax shingles vaccine after mid-May won’t be filled until November or December. But Recombivax for adults continues to confound the drugmaker.
Previously, Merck indicated Recombivax would ship in mid-2010. But the drugmaker just updated its supply status page on its web site, indicating that availability isn’t expected at all this year. Merck has struggled with vaccine production issues for more than two years, in fact. The FDA issued a warning letter in April 2008 (see here) after an inspection found a ” number of significant objectionable conditions relating to your firm’s compliance” with good manufacturing practices. Recombivax was among the products cited.
To cope, Merck is in the process of adding production in Durham, North Carolina; Carlow, Ireland; Elkton, Virginia; and Mirabel, France; and upgrading production in West Point, Pennsylvania. “It is a top Merck priority to resolve any outstanding supply issues as quickly as possible,” a Merck spokeswoman tells us. Indeed, Merck could use the money. Meanwhile, GlaxoSmithKline tells the Journal of the Canadian Medical Association that it’s scrambling to fill the void (see here).
SFM
But wait - I thought pharma companies didn’t really make money from vacccines? They just produce them out of the goodness of their hearts!
Eyes rolling . . .
Condor
Actually, I suspect this old Hep B vaccine is VERY low margin, in Canada and the EU, SFM.
Not a loser, but clearly no Isentress.
In fact, a few days ago, I speculated that MAYBE Merck is planning a “silent exit” from the Hep B vaccine space — leaving it to GSK, thus:
Given that Merck stopped manufacturing its Hep B (not Hep C) Recombivax HB® vaccine over a year and a half ago, and is now talking about allocating that production away from West Point, PA (a union facility) to Durham, NC (a non-union facility), could it be that New Merck actually intends to surrender this market space to GSK? [As a side issue, is Merck permitted to do so, under the recently-ratified USW Local No. 10-86 three year collective bargaining agreement? I dunno. . . .]
Great stuff, Ed!
Namaste
Former SP
Merck earnings waaaaaaay down! Biggest reason was costs related to separation from former SP employees. They could have saved about $500 - 600 MM if they didn’t let Fred and cronies rob them blind! In addition ,they’ve kicked thousands of others out on the street - many of them good hard-working people who didn’t deserve it. Merck management has rocks for brains!