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U.S. May Add Shots for Swine Flu to Fall
Regimen
By Kimberly Kindy and Ceci Connolly
Washington Post Staff Writers Wednesday, May 6, 2009
The Obama administration is considering an unprecedented fall
vaccination campaign that could entail giving Americans three flu shots -- one to combat annual
seasonal influenza and two targeted at the new swine
flu virus spreading across the globe [ or so they say ].
If enacted, the multibillion-dollar effort would represent
the first time that top federal health officials have asked Americans to
get more than one flu vaccine in a year, raising serious challenges
concerning production, distribution and the ability to track potentially
severe side effects.
Another option, said Dale Morse, chairman of the advisory
committee on immunization practices at the Centers for Disease Control and
Prevention, is adding to the seasonal flu shot an ingredient targeted at
the new virus.
Experts in and out of the administration are evaluating a
raft of complicated issues, including who ought to receive an inoculation
against the swine flu and whether private vaccine makers can
simultaneously manufacture the standard 180 million doses as well as up to
600 million rounds of a new vaccine.
"We are moving forward with making a vaccine," said Robin
Robinson, a director with the Department of Health and Human Services who
oversees pandemic response programs. Robinson said that although a formal
decision about the swine flu vaccine has not been made, if the government
goes ahead, it would probably produce two doses for all Americans. If the
threat diminishes, he said, health officials could decide to produce doses
for only a portion of the population.
Vaccine and pandemic experts are working with the
administration to determine how to produce, test, track and educate the
public about two different influenza vaccines in the same flu
season.
"They have never tried this
before, and there is going to be a great deal of confusion," said
William Schaffner, chairman of the Department of Preventive Medicine at
Vanderbilt University School of Medicine.
Memories of the nation's earlier experience with a swine flu
vaccine present another challenge. In 1976, hundreds of Americans
developed neurological disorders after they were vaccinated for a swine
flu strain. The public was asked to receive one of two vaccines developed
to combat the strain.
Health officials have asked manufacturers to ramp up
production of the seasonal vaccine scheduled for rollout this fall to make
way for the possible mass production of a swine flu vaccine.
A decision on whether to produce such a vaccine will have to
be made soon, because it typically takes five months to produce a new
vaccine and authorities would want it available for the next flu season.
Some medical experts said rolling out two vaccines would
present additional challenges in terms of testing and tracking adverse
reactions. Health officials and manufacturers will need to know what the
negative reactions might be for each vaccine on its own and in combination
with the other. Initial tests would be done on animals, and then clinical
trials would be conducted with people to determine side effects before
either vaccine is rolled out.
Harvey Fineberg, president of the Institute of Medicine, part
of the National Academy of Sciences, said officials will have to weigh the
risks of the time spent on testing.
"All this takes time, money and organization," said Fineberg,
who led an investigation into the government's handling of the 1976 swine
flu vaccinations.
The greater challenge will be tracking any adverse reactions
as millions of Americans
get multiple vaccinations in a matter of months this fall and
winter.
"There will be adverse effects to any vaccine. That's just
science," said Michael Hattwick, who ran the CDC's vaccine-tracking system
during the last swine flu scare.
Hattwick said a "real-time" tracking system would need to be
established to provide constant updates to the CDC about adverse
reactions. That information, he said, should include lot numbers for the
vaccines so health officials can trace each side effect to the
manufacturer and the date of production. Routine flu vaccinations are not
traced with such precision because reporting is voluntary and often
delayed, Hattwick said.
Anthony S. Fauci, director of the National Institute of
Allergy and Infectious Diseases, said he does not expect additional
adverse reactions with two vaccinations. The traditional flu vaccine is
designed to attack the three flu strains health officials believe to be
the greatest threats in a regular season, he said.
"In a regular seasonal flu, you get three
vaccines. Adding an additional one should not present a problem,"
Fauci said.
A record-keeping system would also need to be devised to
track which doses patients have received, health experts said.
Without such a system, patients could lose track of which of
the three shots they have received or could fail to get the second swine
flu inoculation at the proper time.
"We will have to keep them straight and separate,"
Vanderbilt's Schaffner said. "This will be an enormous challenge, and we
haven't figured out how to do it yet. That's one of the things we are
trying to sort out."
Staff researcher Madonna Lebling contributed to this report.
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