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
Source: Chiron Corporation