Chiron Corporation announced yesterday that the UK regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), has temporarily suspended the company’s license to manufacture Fluvirin influenza virus vaccine in its Speke, Liverpool facility.
The temporary suspension prevents Chiron from releasing any of the product during the 2004-2005 influenza season. Chiron said in a statement that has not released any Fluvirin into any territory and there is no requirement to recall or withdraw any vaccine.
“Chiron deeply regrets that we will be unable to meet public health needs this season. We take our responsibility to protect human health very seriously,” said Howard Pien, president and CEO of Chiron. “Chiron believes in the value of influenza vaccination, and we are committed to taking all necessary actions to ensure an adequate vaccine supply for the 2005-2006 influenza season.”
As Chiron conducted its internal quality assurance testing in recent weeks, MHRA, in its capacity as the Liverpool production facility’s local regulatory authority, reviewed the test data and the manufacturing processes at the facility.
MHRA has asserted that Chiron’s manufacturing process does not comply with UK Good Manufacturing Practices regulations and has suspended the company’s Liverpool facility license to manufacture influenza vaccine for three months. Chiron has initiated discussions with the MHRA to determine the appropriate corrective actions.
In the United Kingdom, where Fluvirin accounts for approximately 20 percent of the influenza vaccine market, Chiron plans to make up a significant proportion of this supply with vaccines that are produced at its other European sites and approved for use in the United Kingdom.
Chiron currently expects pro-forma and GAAP earnings per share to be negatively affected by a range of $1.10-$1.15 as a result of yesterday’s announcement.