Chiron has been given the nod to ship the first batch of its influenza vaccine Fluvirin by the US Food and Drug Administration, taking the firm a step closer to meeting its supply targets for the coming flu season.
The company said it would start shipping 1.5 million doses of the vaccine from its manufacturing facility in Liverpool, UK, which was forced to cease production of Fluvirin last year after serious contamination problems were uncovered at the plant [[06/10/04b]]. As a result, Chiron was unable to supply the vaccine for the 2004/05 flu season, leading to shortages, particularly in the USA where it had been contracted to deliver around half of the country’s total flu vaccine requirements.
Thankfully, a mild flu season and additional supplies of flu vaccine from other suppliers averted any major public health problems, but the financial impact on Chiron has been significant. The debacle caused a significant drop in the firm's 2004 net income - down from $304 million dollars the previous year to just $158 million [[28/01/05e]].
Since then, Chiron has been racing to get the facility back into compliance with the regulatory authorities, and was granted approval to resume production at the facility by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in March [[03/03/05a]]. Earlier this year, the company said that it was hoping to deliver 18-26 million doses of Fluvirin in the 2005/06 season, although this figure may be updated at the company’s forthcoming third-quarter results meeting on October 25.
Meanwhile, Sanofi-Aventis’ Sanofi Pasteur business, which also claimed about half the US market for flu vaccines before Chiron’s manufacturing problems, has ramped up production and is expected to supply around 60 million doses, while GlaxoSmithKline will supply 8 million doses of its Fluarix vaccine [[01/09/05b]] - fast-tracked through the US approval process because of the shortages - and MedImmune will contribute 3 million doses of its nasally-delivered FluMist vaccine.
The Centres for Disease Control in the USA has estimated that at least
75 million doses of flu vaccine will be needed this season. It has asked health authorities in the USA to reserve vaccinations for the most needy members of society until a clear picture of the availability of flu vaccine supplies emerges.