~*Online WACOC News 2006 July 15*~


Women and Children of CFIDS
WACOC

~*A comment or two*~

A partial excerpt from:


NVIC Contaminated Flu Vaccine
http://www.nvic.org

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National Vaccine Information Center Newsletter e-NEWS

July 12, 2006
Today's Headline: Contaminated Flu Vaccine

:: Flu vaccine problems possible this fall
:: FDA waits for vaccine maker's response to warning




"Richard 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?

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Flu vaccine problems possible this fall

The Atlanta Journal-Constitution, July 10, 2006

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. Susan
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 GlaxoSmithKline,
and 40 million from
Novartis, which recently acquired Chiron. Another 3
million doses of vaccine
in an inhaled spray from MedImmune are
expected.



Richard 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. David Elder, the FDA's director of
enforcement, said the warning letter
was intended to alert Sanofi that it needed "prompt
corrections."



Dr. Karen 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."

Click here for the URL: -
http://rs6.net/tn.jsp?t=ohgr9wbab.0.7pgf7wbab.oblmlwbab.2805&ts=S0196&p=http%3A%2F%2Fwww.ajc.com%2Fhealth%2Fcontent%2Fhealth%2Fstories%2F0710fluvaccine.html

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FDA waits for vaccine maker's response to warning

USA Today, July 11, 2006


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."



David Johnson, 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. Johnson
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 Mary 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.



Johnson 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."

Click here for the URL: -
http://rs6.net/tn.jsp?t=ohgr9wbab.0.6pgf7wbab.oblmlwbab.2805&ts=S0196&p=http%3A%2F%2Fwww.usatoday.com%2Fnews%2Fhealth%2F2006-07-11-vaccine_x.htm

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