New group helps US monitor swine flu shot safety
By LAURAN NEERGAARD
WASHINGTON (AP) - Independent health advisers begin monitoring
safety of the swine flu vaccine on Monday, an extra step the
government promised in this year's unprecedented program to watch
for possible side effects.
Decades of safe influenza inoculations mean specialists aren't
expecting problems with the swine flu vaccine, because it's made
the same way as the regular winter flu vaccine. But systems to
track the health of millions of Americans are being tapped to make
sure - to spot any rare but real problems quickly, and to explain
the inevitable false alarms when common disorders coincide with
inoculation.
U.S. health officials have spotted no concerns to date, Dr.
Bruce Gellin, head of the National Vaccine Program Office, told The
Associated Press.
A specially appointed working group of independent experts will
track the vaccine's safety, too. Although the group will deliberate
in private meetings, starting Monday, its charge is to raise a red
flag if members feel the feds miss anything.
``Given the rapidity with which this particular vaccine was
rolled out, there seems to be an extra-special obligation to make
sure things remain as uncomplicated as they have in the past,'' Dr.
Marie McCormick of the Harvard School of Public Health, who chairs
the working group, told the AP.
Vaccinations against the new flu, which scientists call the 2009
H1N1 strain, have begun more slowly than the Obama administration
had hoped, with long lines for the nearly 27 million doses divided
around the country so far. More is on the way, even as swine flu
cases and hospitalizations continue to rise.
How many ultimately line up depends in part on public confidence
in the vaccine's safety. While vaccine side effects always are
monitored, the H1N1 inoculations are getting extra scrutiny in part
because the last mass vaccinations against a very different swine
flu, in 1976, were marred by reports of a rare paralyzing
condition, Guillain-Barre syndrome.
A report in The Lancet British medical journal on Friday said
the intense monitoring will be crucial for an additional reason:
separating normal disease rates from real vaccine risks. For
example, 2,500 miscarriages occur every day in the U.S., and about
3,000 heart attacks - and some are sure to coincide with
vaccination yet not be caused by it.
Monday, McCormick's group will hear safety data from studies of
the swine flu vaccine in more than 10,000 people, some conducted by
the government and others by manufacturers.
``To date, no serious adverse events have suggested any safety
signals with H1N1 vaccines,'' says a summary of the data - although
it cautions that the studies aren't large enough to rule out any
very rare risk.
That's where the additional monitoring comes in.
Initial reports to a beefed-up government database - where
anyone can report any symptom, and serious ones get intense
investigation - showed nothing unusual after the first 10 million
vaccinations, Gellin said. Most reports were of sore arms and
fever, plus some flu symptoms that suggested people already were
infected when they got the shot, too late for it to help.
Gellin said one report of a death turned out to be caused by
swine flu itself, not vaccine.
Other monitoring includes linking large insurance databases to
state vaccine registries to track who visits a doctor and why after
the shot, a program covering about 20 million people. Plus, there's
specially targeted tracking of pregnant women, and work to tell if
the risk of Guillain-Barre - which regularly strikes about 1 in
every 100,000 people - really is increased slightly by flu vaccine
or not.
If serious problems were to crop up, federal law makes vaccine
manufacturers and health officials immune from lawsuits. But it
allows for a compensation fund for proven serious side effects,
just as happens today with routine child vaccinations. Health and
Human Services officials are developing such a program for swine
flu vaccine, just in case it's needed, spokesman Bill Hall said.
11/02/09 00:40
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