Friday, August 21, 2009

FDA Approves GSK's Influenza Hib Vaccine; Doctor Asks After Merck's Voluntarily-Withdrawn Product -- Still MIA?


Late in 2007, Merck voluntarily withdrew its version of the above vaccine from the market, due to manufacturing problems. Since then, there have been episodic shortages of the vaccine -- especially in pediatric booster doses.

FDA just approved Glaxo's competing vaccine, and as Frank Maliniowski, MD, PhD, of the Gerson Lehrman Group, a management consulting firm, indicates (do go read it all), that may mean Merck -- still not back in production -- may not even be making the vaccine, post merger. We shall see, but here is the snippet I found most-interesting:

. . . .The accelerated approval for Glaxo Smith Kline's vaccine is in stark contrast to the continued lack of availability of the Merck products (along with other Merck products such as MMR, according to their website). Clearly Merck's recent announcement of nearly $1 billion in quality and manufacturing of their vaccines is meant to address these vaccine manufacturing shortfalls but it seems that regulators may be hedging their bets about how quickly Merck can fix their problems. . . .

Unrelated note: More on the European animal health markets -- and the highly-concentrated Merial/Intervet/"New Merck" market shares -- in Italy particularly (market shares north of 60 percent) for dog and/or cat otitis (ear infection) treatments, coming shortly. My packet for transmission to the ECC on Monday just keeps growing and growing.

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