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Flu Vaccine News Heating Up

But Chiron's problems don't stop there ...

The company announced that problems at another manufacturing facility in Marburg, Germany will prevent the production of its Begrivac flu vaccine for European markets as well.

A Resurfaced Problem

It seems quality tests have again discovered sterility problems for Chiron, this time in Germany.

Expected manufacturing of the Bergrivac vaccine has been reduced by some two-thirds (from 12 million to 4 million doses), disabling Chiron from supplying the vaccine to Germany and the United Kingdom for the coming flu season.

The dilemma raises concerns regarding whether the company will be able to resolve its manufacturing tribulations in time to provide the United States with the flu vaccine it needs. Food and Drug Administration (FDA) scientists are currently in the midst of conducting an inspection that will determine if Chiron will be allowed to sell its flu vaccine in the United States this fall.

Assistance from Elsewhere

Though aside from Chiron, the United States has a few flu vaccine providers up its sleeve:

Sanofi-Pasteur expects to produce as many as 60 million doses. Moreover, a new $150 million Sanofi-Pasteur factory--designed to boost the nation's precarious vaccine supply--is projected to be ready for production for the 2009 flu season.
MedImmune, also licensed to sell flu vaccine in the United States, may provide up to 3 million doses.
And if GlaxoSmithKline's application is approved by the FDA, the company could tack on 10 million more doses

Sources

USA Today, July 21, 2005