Lawsuit Alleges Irregularities With Vaccine

April 3, 2004

3/31/04

U.S. IMMUNIZATION NEWS

"Lawsuit Alleges Irregularities With Vaccine"

Wall Street Journal (www.wsj.com) (03/31/04) P. C1; Hensley, Scott; McKay,

Betsy

Since its introduction to the market in 2000, the pneumococcal vaccine

Prevnar has grown in popularity as a protective barrier against the

bacteria, which can cause brain infections and even death, yet its maker

Wyeth has run into a string of production problems that have left the

company unable to meet demand and prompting the Centers for Disease Control

and Prevention to recommend delays in children's four-dose immunization

schedules so that infants can have at least some protection with two doses.

The vaccine takes a year to produce, so any improvement in Wyeth's

production abilities is delayed on the market for a year, leading to

continued shortages that are expected through the summer of 2004, though

the company claims that at that time, the troubles will be over. In a

twist, however, former Wyeth manufacturing manager Mark Livingston has

filed a lawsuit against the company and two employees, saying that in its

drive to get Prevnar to the market, Wyeth cut production corners that

violate Food and Drug Administration (FDA) rules and which could leave the

vaccine vulnerable to problems with quality control. Livingston brought up

his concerns at an FDA meeting in July 2003, but he said that because he

had not heard any development from the agency since that time, he would go

ahead with a civil lawsuit to bring more attention to the matter, claiming

that Wyeth's actions amount to fraud against its shareholders by not

revealing problems with Prevnar production.

Erin MBksfld, Ca

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