Chiron Delays Fluvirin Influenza Virus Vaccine Shipments; Vaccine Doses Expected to Be Available in October Pending Additional Tests

EMERYVILLE, Calif. -- Chiron Corporation today announced that, in conducting final internal release procedures for its Fluvirin influenza virus vaccine, the company's quality systems have identified a small number of lots that do not meet product sterility specifications. While ongoing internal investigations into the root cause of the variance indicate no widespread issues with the manufacturing process, Chiron has delayed releasing any Fluvirin doses until it has completed additional release tests. Chiron currently expects that the

additional tests will delay product release until early October. 

"Chiron is committed to protecting people. These extra checks will ensure

that the quality, safety and effectiveness of our product meet our rigorous

standards," said John Lambert, president of Chiron Vaccines. "In our role as

a key supplier of an important public health product, we are working with the

FDA, the U.S. Department of Health and Human Services, and the CDC to meet the

projected demand for the upcoming influenza season. We currently expect

Fluvirin doses to be available in early October, in time to meet public health

needs for this influenza season, and we expect to provide even more Fluvirin

doses this season than last season."

In July, Chiron announced that it was on track to deliver an estimated

total of 50 million doses of Fluvirin to the U.S. market this season, an

increase from earlier projections, and that it had delivered its first 1

million doses to U.S. distributors.  Assuming satisfactory results from

ongoing release testing, Chiron now expects to deliver between 46 million and

48 million Fluvirin doses to the U.S. market beginning in October.  The

vaccine doses held at distributors are subject to the same internal release

criteria as those held at Chiron's FDA-licensed Liverpool manufacturing

facility, with release anticipated in October.  The planned late-season

delivery of 2 million Fluvirin doses for a national stockpile held by the U.S.

Centers for Disease Control and Prevention (CDC), not included in the totals

above, remains on schedule.

According to the CDC, about 10 to 20 percent of the U.S. population

contracts influenza each year.  Vaccination not only decreases the risk of

illness for the vaccine recipient but also helps prevent the spread of the

influenza virus and limits its role in the potential development of

life-threatening complications. CDC statistics show that, in an average year

in the United States, influenza causes 114,000 hospitalizations and kills

36,000 people, primarily in persons 65 and older.

Influenza, a contagious disease caused by the influenza virus, affects the

respiratory tract, often resulting in symptoms in the nose, throat and lungs,

as well as fever, headache, tiredness and body aches. It can also lead to

complications such as pneumonia, bronchitis, or sinus and ear infections or

exacerbate chronic conditions.

 Influenza vaccination provides protection from influenza within about two

weeks of administration and may last for as long as a year. The vaccine

protects 70 to 90 percent of vaccinated people from contracting influenza, and

vaccinated people who do contract influenza generally develop milder cases

than unvaccinated people. Influenza vaccines, the majority of which are made

from inactivated influenza strains, are updated each year to address

changes in the viruses. People who are allergic to eggs, who have had a severe

reaction to an influenza shot in the past, or who have previously developed

Guillain-Barre syndrome in the six weeks after receiving an influenza

vaccination should consult their doctors before receiving influenza

vaccination.

Source: Chiron Corporation