10-19-2005: Chiron Corporation announced that it has initiated the first delivery and release of FLUVIRIN(R) influenza virus vaccine to customers in the United States for the 2005-2006 influenza season. The company expects to continue to deliver shipments of FLUVIRIN vaccine throughout October and November and into December.
Chiron has received all necessary approvals from the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) to start supplying FLUVIRIN vaccine to the U.S. market. Continued shipments of FLUVIRIN vaccine will undergo corresponding internal release procedures and standard FDA influenza vaccine lot release procedures.
Chiron has not updated its guidance on total FLUVIRIN vaccine doses or 2005 financial results since its second-quarter earnings report on July 27, 2005. The company now expects that the total number of FLUVIRIN vaccine doses it will produce for the 2005-2006 influenza season will be below its previously stated range, due to production delays related to remediation as well as lower production output associated with adaptation to new processes and procedures implemented in remediation. Accordingly, Chiron expects that its financial results for 2005 will be below its previously stated guidance. Chiron expects to have more information on FLUVIRIN vaccine production totals and financial guidance in the weeks ahead.
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