FDA approves new FluMist plant in England

Jan 3, 2006 (CIDRAP News) – A new facility built in England to produce MedImmune's intranasal flu vaccine, FluMist, has gained the US Food and Drug Administration's approval, the company announced last week.

The facility in Liverpool will increase the company's production capacity to about 90 million bulk doses per season, MedImmune said in a news release.

The company's existing bulk production plant, also in Liverpool, can produce up to 18 million to 20 million bulk doses per season, according to MedImmune spokeswoman Clarencia Stephen in Gaithersburg, Md.

MedImmune made about 3 million doses of FluMist, a live-virus vaccine, for the US market for this flu season. The company shipped about 800,000 doses in the third quarter of 2005, Clarencia told CIDRAP News. Figures for the last quarter of the year were not yet available.

Bulk FluMist is made in Liverpool and shipped to Philadelphia (Pa.), where it is blended and packaged, Stephen said.

In MedImmune's news release, Bernardus N.M. Machielse, senior vice president for operations, said the new facility "provides the capacity for manufacture of increased supply of FluMist and our investigational, next-generation influenza vaccine, known as CAIV-T (cold adapted influenza vaccine, trivalent). The facility could also be used to produce vaccine year round in the event of an influenza pandemic."

The new plant has 10 times the square footage of the existing facility and has larger testing and storage facilities, the company said.

MedImmune hopes to start production in the new plant sometime this year, Stephen said. Because FluMist is sold only in the United States, the facility is not facing any British regulatory hurdles, she said.

Stephen said it was too early to suggest what effect the plant may have on the supply of FluMist in the United States.

MedImmune recently announced favorable preliminary results in a phase 3 study of CAIV-T, a new FluMist formulation that can be stored in liquid rather than frozen form. "It provides greater accessibility and added convenience for healthcare providers, because it no longer needs to be stored in a freezer and it can be administered fairly quickly after it's taken out of the refrigerator," Stephen said.

FluMist is currently licensed for use only in healthy people between the ages of 5 and 49 years. The aim of the phase 3 study of CAIV-T was to provide the "pivotal data" to seek approval for use of the vaccine in children down to the age of 6 months, the company said.

The trial included about 8,500 children between the ages of 6 and 59 months, including children with a history of asthma and wheezing. Compared with an injectable flu vaccine, CAIV-T yielded a significant 55% reduction in illness caused by any flu strain, MedImmune said. Participant who received the injectable vaccine had an 8.6% rate of flu, versus 3.9% for those who received CAIV-T.

The trial results have not yet been reported in a scientific journal, Stephen said.

See also:

Dec 27 MedImmune news release on FDA approval of British plant

Dec 12 MedImmune news release on the CAIV-T trial

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