Flu crisis crisis!
The UK regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), has suspended Chiron Corporation's license to manufacture Fluvirin influenza virus vaccine in its Liverpool facility for three months.
The UK regulatory body, the Medicines and Healthcare Products Regulatory Agency (MHRA), has suspended Chiron Corporation's license to manufacture Fluvirin influenza virus vaccine in its Liverpool facility for three months.
This will prevent the company from releasing any of the product during the 2004-2005 influenza season, throwing the UK Government's flu vaccination programme into crisis.
There have been claims that as many as three million vulnerable people, who would normally have the jab, will be unable to do so this year.
Chiron, who has not released any Fluvirin into any territory, and therefore is no having to recall or withdraw any vaccine, supplies around 20% of the UK demand for the vaccination. The Government says it is buying in vaccinations from other sources, but experts believe there will not be enough to cover demand.
'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 confirmatory 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. Chiron had anticipated that the regulatory review process would be satisfactorily completed in time to allow release of Fluvirin in early October. However, MHRA has asserted that the company's manufacturing process does not comply with UK Good Manufacturing Practices regulations and 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. As a result of the license suspension, Chiron does not expect to record any sales of Fluvirin for the 2004-2005 season.