Chiron Promises U.S. Flu Vaccine Safe and Available

By Maggie Fox, Health and Science Correspondent 

WASHINGTON (Reuters) - This year's U.S. flu vaccine will be safe and 
will be distributed on time, Chiron Corp. President and Chief 
Executive Officer Howard Pien pledged on Tuesday. 

Pien also said the company was working hard to develop a better and 
more efficient way to make influenza vaccine so it can adapt to 
epidemics that change as the virus mutates every year. 


Last month Chiron said it would delay shipment of its FluVirin 
vaccine because lots containing 4 million doses of the vaccine did 
not meet sterility standards. 


"We expect that in the next few days we can make shipment plans," 
Pien told a hearing of the Senate Committee on Aging. 


He said 48 million doses of the company's vaccine, nearly half the 
total U.S. supply, would be shipped to distributors in October and 
November. 


"This is only our second year as a supplier of flu vaccine to the 
United States but nonetheless we have increased output by 50 
percent," Pien said. 


Influenza typically kills 36,000 Americans a year and 500,000 
worldwide. 


Pien said a few batches of the company's vaccine being prepared for 
the upcoming flu season seemed to be contaminated, so the company 
halted production to check it out. 


This created concern because last year there was a shortage of flu 
vaccine, but Pien said the checks were needed to guarantee that the 
vaccine was pure and safe. 


"In our situation we determined that some small number of batches of 
product that were being made ... appeared to have contamination," 
Pien told the hearing. 


"Testing procedures and protocol calls for a program to confirm 
this. The first thing is to retest all of the product that we have 
made. The second is to look at all possible hypotheses as to why 
there might have been contamination." 


Then the root cause has to be found. Pien said the company was now 
working with the Food and Drug Administration (news - web sites) to 
clear the vaccine for shipment. 


"We hope that in due course, the next few days, we will make an 
announcement," he said. 


The formula for the influenza vaccine is changed every year to 
include the most common strains circulating at the time. It them 
takes months to grow the three strains in specially prepared chicken 
eggs and prepare the vaccine. 


Last year 83 million doses were made. This year the Centers for 
Disease Control and Prevention (news - web sites) says the companies 
that make flu vaccine will have 100 million doses available. 


The CDC recommends that 185 million Americans get vaccinated against 
flu every year including the elderly, chronically ill, babies and 
their caregivers. But in reality not everyone does and often vaccine 
is thrown out at the end of the season. 


Pien said Chiron was going to step up production. 

   



"We will make the investment to the tune of about $100 million for 
this year and next to upgrade manufacturing capacity, to obtain more 
equipment and machinery, to train our work force even better," he 
said. 

"It is our deep and ardent commitment that we are going to do better 
and be a reliable and consistent supplier." 

Chiron shares were up 56 cents or 1.3 percent at $44.15 on the 
Nasdaq on Tuesday afternoon. 






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