The Vaccine Mess Alert

Medical Authors and Editors: Frederick Hecht, MD and Barbara K. Hecht, PhD

Oct 6, 2004 -- The sudden shortfall in flu vaccine has prompted the US Department of Health and Human Services to issue a press release. In it HHS admits that the situation presents "a serious challenge to our vaccine supply for the upcoming flu season."

We present the HHS press release (below) and our view of the situation.

A "Serious Challenge"

To say that the situation presents a "serious challenge" may be something of an understatement. Coming just as the flu season is starting, the loss of the Chiron flu vaccine means there will almost surely be a very significant shortage of flu vaccine this winter.

Tommy Thompson, secretary of HHS echoed the challenge theme at his news conference yesterday, saying: "This is very disappointing news that creates a serious challenge to our vaccine supply for the upcoming season."

What Happened

The Medicines and Healthcare Products Regulatory Agency in Britain has suspended Chiron's manufacturing license for making flu vaccine for three months because of a concern about sterility. What that means is that they found contamination.

In fact, back in August, contamination was found. It involved a type of bacteria called Serratia. This type of bacteria is commonly found in the environment. It occurs on plants, in soil, and in water.

Serratia

Serratia is normally not harmful to healthy people but it is what is known as an opportunistic pathogen. Given the opportunity, Serratia can spell trouble.

In people with a compromised (weakened) immune system, Serratia can cause infection of the blood (sepsis), wound infections, and infections of the endocardium (of the heart) and the urinary and respiratory tracts.

And part of the problem is that the high-risk groups for the flu who most need the flu vaccine are precisely those with a weakened immune system.

Another part of the problem is that the finding of Serratia in the vaccine is a red flag, It is a warning that who knows what else may be contaminating the vaccine.

A Coalition Problem

This is truly an Anglo-American coalition problem. The factory is in Liverpool (from whence came the Beetles). But the plant belongs to Chiron Corporation, an American biotech company based in Emeryville, California (in the San Francisco Bay area). Chiron acquired the British owner of the Liverpool plant, PowderJect Pharmaceuticals, last year and has reportedly invested heavily to increase the supply of the vaccine, called Fluvirin, to the US. About 90% of the vaccine produced by the plant was destined for the US.

Caught Off Guard

The suspension of Chiron's Liverpool license appears to have caught the US government by surprise. "We had no idea," Mr. Thompson said yesterday. "In fact we didn't get notified until this morning.''

Some Questions

Why was the US government caught off guard? The contamination with Serratia has been known since August. It is now October.

Was the US Food & Drug Administration remiss? The FDA licensed the Liverpool plant to supply the US. Is the FDA not responsible for overseeing the production of the vaccine there?

The Medicines and Healthcare Products Regulatory Agency in Britain did their job but did the FDA? Why were they not on the same page?

The Sum of the Matter

The new shortfall in flu vaccine is really nothing new. It is only the latest of many signs that the US supply of vaccines is in perilous shape. "The vaccine infrastructure is frail," said Dr. Paul Offit, chief of infectious diseases at CHOP (Children's Hospital of Philadelphia), according to the New York Times.

Since 1998, there have been shortages of 9 of the 12 vaccines for American children. Little wonder. Seven of the 12 vaccines for kids are made by a one company. And only a few companies make the majority of all vaccines for the US.

What is needed is for the US government to not just put a bandaid on the flu vaccine problem but to address the whole vaccine mess. Free market forces have failed to provide a reliable supply of vaccines. The government has got to do more than issue press releases.

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