[NVIC] Contaminated Flu Vaccine

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July 12, 2006

Today's Headline: Contaminated Flu Vaccine

:: <#leftarticle1>Flu vaccine problems possible this fall

:: <#rightarticle1>FDA waits for vaccine maker's response to warning

" Compans, a virologist and chairman of the Department of

Microbiology and Immunology at Emory University School of Medicine, said

the current egg-based vaccine technology has been used at least since the

1950s.

" It involves inoculating large numbers of fertilized chicken eggs with a

virus preparation, and harvesting the fluid from these infected eggs and

putting the vaccine through a purification procedure, " he said. " There is

potential for introducing contaminants, particularly at the stage of

inoculating eggs and harvesting material from the eggs. "

BL Fisher Note:

The CDC wants every man, woman and child in America to get a flu shot every

year. But the CDC has not been honest with the people about the fact that

only 20 percent of all respiratory-like illness is caused by flu viruses

and the flu vaccine has never been more than 80 percent effective in

preventing flu. Now we find out that the manufacturing process using

chicken eggs has always been inherently risky. With all this talk about

bird flu caused by infected chickens infecting humans, how risky has it

been to use chicken eggs to produce flu vaccine since the 1950's?

Flu vaccine problems possible this fall

The Atlanta Journal-Constitution, July 10, 2006

The Atlanta Journal-Constitution, July 10, 2006

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By BILL HENDRICK

The Atlanta Journal-Constitution

The Centers for Disease Control and Prevention has " heightened concern "

that the nation will not receive all the seasonal influenza shots it needs

this fall after the Food and Drug Administration's stern warning over

contamination issues against Sanofi Pasteur, the country's largest flu

vaccine maker.

Sanofi, which is producing 50 million doses of injectable influenza vaccine

at its Swiftwater, Pa., manufacturing plant, was slapped by FDA last week

for what the regulatory agency called " a number of significant

objectionable conditions " at the plant. Among them were findings that 11

lots of Fluzone concentrate used to make the seasonal flu doses were

contaminated with an unnamed microbe, out of 250 to 300 lots needed to make

the promised vaccine.

" We are concerned, " said Dr. Lance Rodewald, director of the CDC's

immunization services division. " We are always concerned. Now, concern is

heightened. "

Since problems have hit the nation's seasonal flu vaccine program in four

of the last six years, Rodewald said CDC is watching Sanofi " very closely, "

not just because the firm is America's largest producer, but because it

also produces vaccine for children under age 4, one of the groups at

highest risk for seasonal influenza.

The FDA would not identify the contaminant but agreed with Sanofi that the

problem appeared unlikely to prevent Sanofi Pasteur from making its 50

million doses. That amount is about 40 percent of the 120 million total flu

shots expected for the United States this year.

" With regard to the upcoming influenza season, we are confident that we

will meet our manufacturing goal of approximately 50 million doses of

influenza vaccine for the U.S. market, " said Sanofi spokesman Len Lavenda.

" ... The amount of material impacted is minimal relative to our overall

manufacturing capacity, and none of this material has been or will be used

in the manufacture of this year's vaccine. "

Sanofi's problems were reminiscent of the 2004 contamination issues at a

Chiron Corp., flu vaccine plant in Liverpool, England, which cost the

United States 48 million of the 100 million doses it expected that year.

The unexpected shortfall stunned public health officials and physicians

across the country, created sharp demand for vaccine and caused the CDC to

reorder its priorities for who should get vaccinated.

Chiron first reported contamination of vaccine lots at its Liverpool plant

in late August 2004. CDC said at the time that it expected only delays in

Chiron's production — and U.S. health officials assured the public in late

September that close FDA monitoring showed the rest of the expected supply

was fine and that there would be no shortage. Two weeks later, on Oct. 5,

British health authorities suspended Chiron's entire production because of

the contamination, identified as potentially fatal Serratia bacteria.

Sanofi first discovered its contamination in March and notified the FDA,

which sent inspectors to the Pennsylvania plant from April 18 to April 28.

In addition to problems with influenza vaccine, the FDA also found issues

with vaccines against meningococcal disease, diphtheria and tetanus.

Sanofi officials said they could not calculate how many flu vaccine doses

the 11 affected lots would have produced.

Seasonal flu vaccine is grown in fertilized chicken eggs, a process that

takes six months, with vaccine deliveries expected in late August and early

September each year. Rodewald said Sanofi has time to fix its problems and

fulfill its expected production, but he would not rule out production delays.

When it comes to flu vaccine, any uncertainty is unsettling, said Dr.

Lance, the epidemiologist in the Georgia Department of Human Resources'

Division of Public Health. She suggested that Sanofi's problems may be

chicken-related.

" We are always nervous, but we are a little more nervous this year, " she

said. " My understanding is it may have been internal contamination of the

eggs that are used to produce vaccine, grow the virus. Hens can pass

bacteria to the inside of the eggs. "

She said vaccine-making is inherently outdated, tricky, perhaps even

dangerous. There's consensus among U.S. scientists that new technology is

needed to produce " the best vaccines available " without using chicken eggs.

The CDC said it is hoping for 50 million injectable doses from Sanofi

Pasteur, 25 million to 30 million from GlaxoKline, and 40 million from

Novartis, which recently acquired Chiron. Another 3 million doses of

vaccine in an inhaled spray from MedImmune are expected.

Compans, a virologist and chairman of the Department of

Microbiology and Immunology at Emory University School of Medicine, said

the current egg-based vaccine technology has been used at least since the

1950s.

" It involves inoculating large numbers of fertilized chicken eggs with a

virus preparation, and harvesting the fluid from these infected eggs and

putting the vaccine through a purification procedure, " he said. " There is

potential for introducing contaminants, particularly at the stage of

inoculating eggs and harvesting material from the eggs. "

The FDA would not elaborate on the problems that triggered its warning

letter to Sanofi, which was issued after Sanofi was given an opportunity to

reply to the FDA's concerns and take corrective action. Failure to correct

what the FDA called " deviations " could result in suspension or revocation

of Sanofi's license, the agency said.

Dr. Walter Orenstein, associate director of the Emory Vaccine Center,

questioned whether the FDA knows the source of Sanofi's contamination

because he found the warning letter " too vague. "

" The big concern to me is whether Sanofi and FDA have an idea of what is

causing the contamination, " he said. " I don't know if they have suspicions,

or if they have no idea. "

Dr. Elder, the FDA's director of enforcement, said the warning letter

was intended to alert Sanofi that it needed " prompt corrections. "

Dr. Midthun, deputy director of the FDA's Center for Biologics

Evaluation and Research, said, " Sanofi hasn't fixed everything " but is

expected to do so. " We remain concerned with the overall quality issues ...

we cannot know for sure if the problem has been corrected, " she said, but

she added the agency is " contining to monitor the situation. "

she added the agency is " contining to monitor the situation. "

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FDA waits for vaccine maker's response to warning

USA Today, July 11, 2006

USA Today, July 11, 2006

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By Anita Manning

USA TODAY

A major flu vaccine maker says it has resolved concerns about the sterility

of a vaccine component that prompted a warning letter from the Food and

Drug Administration. An FDA official, however, says problems at the

company's plant in Swiftwater, Pa., are " systemic " and corrections have not

been verified.

Sanofi Pasteur reported to the FDA on March 31 that 11 batches of one of

three main components being produced for its annual flu vaccine had failed

sterility tests. The company is expected to produce 50 million doses this

fall, half of the nation's expected supply. FDA officials say they do not

expect problems at the Sanofi plant to cause any delay or shortfall in the

vaccine supply.

The FDA inspected the plant in April and informed the company of technical

and quality-control problems it needed to correct. Then it issued a warning

letter June 30, citing " significant deviations from current good

manufacturing practices, " and advising, " you should take prompt action. "

, Sanofi's director for scientific and medical affairs, says

the company has made changes and is confident there will be no delay in

production. " We found it early enough that we were able to make up for it

and will still be able to produce 50 million doses, " he says.

Flu vaccine contains three strains of flu virus. Each strain is grown

independently in eggs; then the virus is extracted, inactivated, filtered

to remove biological impurities that are naturally found in eggs and

combined with the other strains to create the vaccine. says the 11

failed batches from one of the virus strains were destroyed. " We believe we

have found the root cause " for the failure, he says. " It was in the

filtration process, and in particular, a filtration device. We have

corrected that problem. "

FDA official Malarkey says the agency has not yet received Sanofi's

official response to the warning letter, though talks with the company

continue. But the agency's concerns go beyond a single malfunctioning

filtration device.

" I can't speak to our internal discussions with the firm, but the warning

letter was issued because we found significant regulatory violations, " she

says. " These are issues that are far-reaching. "

The FDA's warning letter and inspection form cite problems involving

equipment maintenance and procedures to assure sterility and compliance

with technical specifications, not only for flu vaccine but also for other

vaccines made at the plant, including those for yellow fever, meningitis

and diphtheria-tetanus-acellular pertussis.

says changes are being made at the plant. " Many of the observations

made by FDA during their annual visit and subsequent report have already

been fully addressed, and for a number of the others, the FDA agrees with

our action plan, " he says.

Sanofi has until July 21 to respond to the warning letter. Once it is

received, Malarkey says, the FDA will " do whatever is necessary to verify

that corrections have been made, " which may include re-inspection of the

plant. She says the FDA is not expecting a flu vaccine delay. " We believe

it is a good sign the last failure occurred in April, " she says. " We expect

the company will meet its production goals. "

the company will meet its production goals. "

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Vaccination Information & Choice Network, Nevada City CA & Wales UK

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