The next phase of the smallpox vaccination program should be put on hold
while health authorities investigate possible severe side effects, a CDC
advisory panel recommended Thursday.
The original plan, proposed by President Bush in December, called for health
care workers to be vaccinated first, followed by up to 10 million
first-responders - police officers, firefighters and emergency medical workers -
and then the general public.
The Advisory Committee on Immunization Practices, which meets several times a
year to recommend changes in vaccination policy to the Atlanta-based CDC, voted
unanimously to continue only current efforts to vaccinate public health response
teams and hospital workers and not expand the program. Nearly 38,000 health care
workers already have been vaccinated, but that figure is well short of the
500,000 called for in the original plan.
The panel cited the recently discovered occurrence of post-vaccination
myocarditis, an inflammation of the heart muscle, and pericarditis, inflammation
of the lining around the heart, as ``a new and unanticipated safety concern''
that mandates further investigation before expansion of the program should
continue.
``The committee has believed from the very beginning that we need to put
safety above and beyond any other issue,'' said Dr. John F. Modlin, a professor
of pediatrics and medicine at Dartmouth Medical School who chairs the committee.
``This will allow us to buy some time, and to perhaps better understand both
sides of the equation,'' he said, noting that further research is needed to
determine the health risks involved.
In a news conference Thursday, CDC Director Julie Gerberding said she and
Health and Human Services Secretary Tommy Thompson would consider the
committee's recommendations ``respectfully,'' while also weighing national
security concerns.
``We have traditionally held their advice in very high regard, and it does
have a very strong, persuasive impact on the decisions that we make,''
Gerberding said. ``But it is not the only source of advice that we receive, and
as we've been saying all along with smallpox, this is a situation where we are
balancing public health issues . . . with homeland security issues.''
Since the smallpox vaccination program began with military personnel in
December, nine people have had heart attacks after immunizations and three have
died, according to the CDC, but it is not clear whether the deaths were related
to the vaccinations.
All of the heart attack victims were middle-aged, and many of them had other
health problems, such as clogged arteries, diabetes or smoking, that probably
put them at risk.
Of the 454,856 military personnel who have received the smallpox vaccination,
at least 50 experienced possible myocarditis or pericarditis symptoms, Col. John
D. Grabenstein of the Military Vaccine Agency told the committee. At least 22 of
the 37,608 civilian recipients of the vaccine experienced symptoms, according to
Dr. Juliette Morgan of the CDC.
Morgan was one of several doctors and officials from the CDC to discuss the
smallpox vaccinations with the committee before the panel voted on the findings.
The precise wording of the committee's recommendations has not been
finalized, but CDC officials said the resolution probably would be passed on to
Gerberding today.
The committee also pointed out that surveillance, training of response teams
and careful planning at hospital, community and regional levels were important
parts of preparedness.
``The question of how broad the smallpox program needs to be is something
we've all paid careful attention to,'' Gerberding said.
``This is not about a number, it is not about should we have 40,000 people or
400,000 people or 4 million people,'' she said. ``It's about how do we get
prepared.''
``This is different than normal immunization policymaking, because you have
to consider more than public health issues,'' said Dr. Walt Orenstein, director
of the CDC's National Immunization Program.
Though many of the presenters at the meeting discussed the health risks
associated with smallpox vaccinations, CDC officials said overall health
problems occurring as a result of the vaccine were far lower than expected.
CDC officials also noted Wednesday that not enough health care workers have
been vaccinated.
``In some quarters, there is a perception that the threat of smallpox has
diminished,'' Dr. Raymond A. Strikas of the National Immunization Program told
the panel.
Last month, a committee from the Institute of Medicine made similar
recommendations to the CDC, advising a ``pause'' in the smallpox vaccination
program to ensure safety and evaluate preparedness in case of an attack.
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"A foolish faith in authority is the worst enemy of truth."
-- Albert Einstein, letter to a friend, 1901
"I know of no safe depository of the ultimate powers of the society but the people themselves, and if we think them not enlightened enough to exercise control with a wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education."
-- Thomas Jefferson, letter to William C. Jarvis, September 28, 1820
"What's the point of vaccination if it doesn't protect you from the unvaccinated?"
-- Sandy Gottstein
"Who gets to decide what the greater good is and how many will be sacrificed to it?"