http://www.nytimes.com/2004/10/20/opinion/20wed1.html?hp=&pagewanted=print&position=An Influenza Vaccine Debacle
It is almost unbelievable - and surely unacceptable - that the world's most medically advanced nation should suddenly find nearly half of its expected supply of influenza vaccine wiped out by manufacturing problems at a single plant in England. Yet that is the shocking reality that has panicky patients lining up for flu shots that are not available and has price gougers trying to profit from their misery.
American health officials had no clue that almost half of the nation's flu vaccine supply was about to be impounded.
The question that has to be explored is whether the F.D.A. was asleep at the switch. There had been hints of trouble in the past. An F.D.A. inspection of the plant in June 2003 found quality-control problems and bacterial contamination at an early stage of the production process, but those shortcomings were reportedly resolved, allowing Chiron to produce clean vaccine for last year's flu season. Now even more severe contamination has emerged in this year's production, forcing Chiron to the sidelines. Congressional committees will need to determine whether the federal drug agency pushed hard enough over the past year to ensure that the Liverpool plant could be relied on.
They will also need to investigate whether the F.D.A. responded fast enough after the first reports of contamination in August. Events leave the impression that the company deluded itself into thinking the problem had been isolated and that the drug agency more or less accepted its reassurances. We are left to guess whether more aggressive intervention by government experts might have helped the company surmount its difficulties.
<>Experts are pondering ways to induce more companies to make flu vaccine for the American market.
The issue is not that manufacturers are worried about lawsuits over liability, as President Bush has suggested. Litigation is seldom, if ever, cited in authoritative analyses of vaccine shortages. The main problem is that influenza vaccine needs to be reformulated every year, and
companies suffer huge losses if they overestimate the amount that will be needed because they end up having to destroy millions of doses. The administration needs to find a way to expand and stabilize the vaccine manufacturing base. The lesson of the Chiron debacle is that a diversity of supply is critical.