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How is it, again, that they know there is no risk from the contamination? - SM

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 State considers action over vaccine blunders
 The Irish Examiner 17 Aug 2002
   

 

By Carl O'Brien, Political Correspondent

THE Government is considering suing the drug firm at the centre of the TB vaccine controversy after a series of contamination and production blunders. Department of Health officials are currently inspecting their contracts with the company and are determined to recoup some of the costs associated with the recall of tens of thousands of people who received ineffective or contaminated jabs.

 

The British-based firm Evans Medeva distributed a polio vaccine linked to the human version of mad cow's disease and a weakened form of the BCG jab which protects against tetanus.

 

The Government was forced to spend millions on recalling, testing and re-administering vaccines as a result of the controversies.

 

Health authorities insist there is no risk to health as a result of the vaccine blunders but say they are angry at the alarm caused by the drug company's actions.

 

One senior health official said: "All avenues are open to us and we'll take whatever action is necessary."

 

It is understood that a team of State health experts visited the Liverpool-based facility and were horrified at the practices they saw there.

 

The Irish Medicines Board moved quickly to suspend all supplies of the firm's vaccines produced at the plant and have sourced alternatives from other vaccine producers.

 

The Evans Medeva plant has in the past provided Ireland with vaccines against flu, tetanus, yellow fever and diphtheria.

 

Irish health authorities rely on safety assurances by drug firms and inspections by the country's health watchdog.

 

However, the Irish Medicines Board visited the facility earlier this summer with the authorisation of British health authorities because of concerns at the plant.

 

Investigators from the United States' Food and Drug Administration (FDA) also visited the plant two years ago and expressed concerns at production practices.

 

A week-long inspection by the FDA into the production of the flu vaccine Fluvirin at the plant found Evans Medeva had failed to clean equipment at appropriate intervals and had not maintained safeguards to prevent unacceptable levels of toxins contaminating the production process.

 

This flu vaccine was also distributed to Ireland but supplies were halted in June of this year,

 

Evans Medeva yesterday declined to comment on its production record or on likely legal action by Irish health authorities.

 

The production of the polio vaccine linked to CJD sparked major alarm in December 2000 when it emerged that tens of thousands of children had received the jab

 


 

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