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.
Statement from the Department of Health and Human Services Regarding Chiron Flu Vaccine
Clearly, the loss of the Chiron flu vaccine poses a serious
challenge to our vaccine supply for the upcoming flu season. Chiron was to
produce between 46-48 million doses of influenza vaccine for the United States.
The Department has begun pursuing contingencies for this loss of supply.
We currently anticipate having approximately 54 million doses of influenza
vaccine from Aventis and about another 1-2 million doses of FluMist nasal spray.
HHS had planned for a vaccine supply of about 100 million doses this season,
after a demand of about 87 million doses last flu season.
Our immediate focus will be on making sure that the supply we do have reaches
those who are most vulnerable. The Centers for Disease Control and Prevention is
convening its Advisory Committee on Immunization Practices to prioritize its
recommendations on who should get the flu vaccine for this season based on the
new vaccine supply information.
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