Posted on 02/08/2003 4:02:33 AM PST by Jim Noble
The U.S. Centers for Disease Control and Prevention have failed to properly reassure the American public of the safety of the smallpox vaccination plan, leading to a growing backlash by health care providers who want nothing to do with it, an expert at Boston University charges.
``The CDC has not fairly laid out how it can be done safely and what the real historical risks are,'' said William Bicknell, a smallpox expert at the BU School of Public Health.
Since the plan was announced, a growing number of hospitals, doctors and nurses have said they will not participate, citing safety risks.
In Massachusetts, Cooley Dickinson Hospital in Northampton has opted out of the plan, and several more are on the fence. The Massachusetts Nurses Association also has said it will urge its members not to be vaccinated.
Bicknell, who testified on the subject before Congress this week, blamed the CDC for the growing opposition to the plan. He said the agency let potential volunteers develop exaggerated fears, failed to assure them they would be protected from liability in case of bad reactions and did not publicize the positive experiences of the Israeli and U.S. military vaccination programs, which have had few problems.
Bicknell said that to ensure the success of the program, the Bush administration at the highest levels ``must make it clear to providers that this is very important to do.''
In addition, Congress must address the liability issue and the CDC must ``far more accurately and realistically represent the risk, which it has not done. They overplay the risk dramatically, and that scares the crap out of people.''
Bicknell said healthy adults have nothing to fear, and the chances of a health care worker passing infection on to a sick patient are also slim.
Although Bicknell backs the Bush plan, he has argued the case for mass inoculation before an outbreak, rather than waiting for an outbreak to occur. Such a plan would involve vaccinating millions of Americans.
In 1976, a decision was taken to immunize the US population against swine influenza. This decision was very well-founded, although the feared epidemic did not materialize.
The result was that many promising public health careers were ruined, as the politicians hid behind the furniture and hung their CDC and PHS employees out to dry.
If (and I have no knowledge about this) there is a credible threat of smallpox bioterrorism, then the current vaccination process is woefully inadequate.
The national political leadership must be much more assertive if they want adequate vaccine coverage in advance of an attack. The post-attack plans are very good, almost as good as they could be, I think-but no plan survives contact with the enemy. Vaccinating 300 million people in ten days is vulnerable to various disruptions, not even including enemy action.
My bottom line is that for 150 years we vaccinated everyone at an acceptable risk and cost, and we can do it again, without 30-page consent forms and a laundry list of cautions.
What I don't know is the risk of an attack. Because this risk is unknown to almost everyone in the planning process, their opinions about our political leadership become important in determining their individual actions.
Highly parsed innuendo & fevered imaginations are not the same as actionable information, of which I've seen none.
Very well stated objection.
Of course, the fact that you have not been given that information does not affect the risk of you dying from a smallpox attack at all.
It affects how you feel about it-but it doesn't change the underlying reality.
There is evil in this world, people. They have their own fears which may delay them in employing such tactics, but they might easily find themselves emboldened to carry out such an attack. The threat is very real.
And I have been designing real clinics that follow (more or less) those guidelines since 11/6/02, as have many other of our colleagues. Whether they can operate as planned under an attack scenario remains to be seen.
As I alluded to previously, all sorts of horrible events can be imagined, but in matters of life, death, or debility one must balance the risks of each. The risks of vaccination are known - a certain number, however small, will die. The risks of contraction are not known with precision, but based on the best evidence I've seen, they're much closer to zero.
I agree with most of what you are posting.
But I think it is a fallacy (common, but a fallacy) to think that, because you don't have risk information, that the risk is low.
It may be low.
It may be zero.
My point was, in the absence of risk information, the smallpox program is in "let a hundred flowers bloom" mode, which is not conducive to widespread vaccination.
You've made a very important point, and one I certainly had not considered before, namely, that extra-medical considerations are really the controlling factor here. We private individuals (or even agencies) obviously cannot know all of the details of the threat, so it comes down to a decision to trust that our leadership has acted rightly in deciding that smallpox is a threat in the first place. And as with Iraq, there are many people who simply will not accept anything the Bush administration does, and prefer to think that, for some mysterious reason, the government would like to embark on a large expensive program simply on a whim and with no grounding in fact.
The fact that the Germans are currently trying to acquire smallpox vaccine in massive quantities indicates that the threat is known beyond our borders and is a real one. But even that is not be enough to convince people who do not want to believe it.
Thanks! Your point is well-taken, and unless I'm reading you incorrectly, we're in agreement.
International Society for Infectious Diseases http://www.isid.org
Date: 6 Feb 2003 From: ProMED-mail promed@promedmail.org Source: CDC. MMWR Morb Mortal Wkly Rep 2003; 52(05): 88-89, 99 (7 Feb) [edited] http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5205a5.htm
Smallpox vaccine adverse events monitoring and response for the first stage of the smallpox vaccination program
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Smallpox vaccination of civilian volunteer health care workers began on 24 Jan 2003. As of 4 Feb 2003, a total of 37 states and counties have received shipments of smallpox vaccine, and 18 states and counties have begun smallpox vaccination; no serious adverse events have been reported. To monitor the occurrence of adverse events associated with vaccination, both those expected on the basis of previous experience and possible new unexpected adverse events, the Centers for Disease Control and Prevention (CDC) and state health departments have established the Smallpox Vaccine Adverse Events Monitoring and Response System. The system also will be used to monitor the effectiveness of contraindication screening, identify new contraindications, and coordinate the distribution of vaccinia immune globulin (VIG) and cidofovir to the civilian population. This notice describes the components of the system, delineates roles and responsibilities, and explains how data from the system will be compiled and communicated.
The first stage of the vaccination program targets 1) smallpox response teams designated by terrorism and public health authorities to conduct investigation and follow-up of initial smallpox cases and 2) health care teams whose members are trained to provide medical care for initial smallpox patients (1). During this stage, the Institute of Medicine (IOM) has recommended active surveillance for adverse events following smallpox vaccination (2). To implement this recommendation among all vaccinees and their contacts, the system will track adverse events that require hospitalization or outpatient care, contraindications to vaccination among vaccinees or household contacts not identified at the time of vaccination, and vaccinia transmission to contacts of vaccinees. CDC also will collect data from people who experience commoner, nonserious adverse events in a telephone survey of about 10 000 vaccinees from at least 8 states and cities administered at days 10 and 21 following vaccination.
Successful monitoring of and response to adverse events following smallpox vaccination depends on the efforts of vaccination clinic staff, vaccination-site--care monitors at hospitals and other locations, health care providers, state health departments, and CDC. At smallpox vaccination clinics, a unique identifying number will be assigned to each vaccinee, and each vaccinee's vaccination information will be entered into an electronic tracking system (either the Pre-event Vaccination System (PVS) maintained by CDC or the state equivalent). In the days following vaccination, monitors at hospitals and other locations should assess vaccination-site care, symptoms reported by the vaccinees, and vaccine take (that is, response to vaccination). For hospital staff, monitors also should determine fitness for duty. CDC's web-based Hospital Smallpox Vaccine Monitoring System can be used to facilitate monitoring and to enter tracking data. Vaccination-site--care monitors and health-care providers should report adverse events associated with vaccination as they occur [table below]. When vaccination follow-up is completed (usually 21--28 days after vaccination), vaccination-site--care monitors should ensure that information about adverse events that require hospitalization or outpatient care, contraindications identified after vaccination, and contact transmission are documented for all vaccinees. CDC will provide a data entry mechanism linked to PVS for documenting this information.
Health care providers who need assistance with evaluating a smallpox vaccinee with a potential adverse event should contact their state health department or CDC's clinician information line, telephone 877-554-4625. Staffed by nurses 24 hours a day, 7 days a week, this information line is a source for general smallpox clinical adverse event information and for assistance with adverse event reporting. As needed for clinical consultation and release of VIG and cidofovir, callers to this line will be connected to CDC's Smallpox Vaccine Adverse Events Clinical Consultation Team, whose members are experts in infectious diseases, ophthalmology, and neurology, and have back-up from smallpox/vaccinia disease experts. For general information about diagnosis and management of smallpox vaccination--associated adverse events, health care providers should consult CDC's guidance for clinicians (3). Clinical evaluation tools to assist health-care providers in the diagnosis and management of smallpox vaccine adverse events also are available at .
Adverse events following smallpox vaccination should be reported to state health departments and the Vaccine Adverse Event Reporting System (VAERS), the national surveillance system for adverse events following the administration of US-licensed vaccines (4,5). Any adverse event that is of concern to the clinician or patient should be reported. In addition, certain events are recommended to be reported [table below]. Those adverse events that require VIG or cidofovir should be reported immediately (3). Other serious adverse events (those resulting in hospitalization, permanent disability, life-threatening illness, or death) should be reported within 48 hours after recognition. Reports may be submitted to VAERS at .
CDC's secure web-based communications network for public health investigation and response, the Epidemic Information Exchange (Epi-X) (), will be used for rapid and regular exchange of smallpox vaccine adverse events data among state and local health departments and CDC. These data will be tabulated regularly and reported on CDC's smallpox website and in MMWR. The reported rates of known serious adverse events will be compared with historically reported rates. If higher-than-expected rates of known adverse events or unexpected adverse events are detected from either active or passive surveillance analysis, further investigation will be conducted. A workgroup of the Advisory Committee on Immunization Practices will assess the data regularly. In addition, to ensure that the smallpox vaccination program is conducted safely and effectively, IOM will provide ongoing programmatic evaluation.
Table. Adverse events after smallpox vaccination that are recommended to be reported to the Vaccine Adverse Event Reporting System and to state health departments*
Eczema vaccinatum Erythema multiforme major or Stevens-Johnson syndrome Fetal vaccinia Generalized vaccinia Inadvertent inoculation Ocular vaccinia Post-vaccinal encephalitis or encephalomyelitis Progressive vaccinia Pyogenic infection of vaccination site Vaccinia transmission to contacts Vaccination of persons with a contraindication to vaccination Other serious adverse events (those resulting in hospitaliztion, permanent disability, life-threatening illness or death)
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*Any adverse event that is of concern to the clinician or patient should be reported.
References 1. Advisory Committee on Immunization Practices. Draft supplemental recommendations of the ACIP: use of smallpox (vaccinia) vaccine, June 2002. Available at .
2. Institute of Medicine Committee on Smallpox Vaccination Program Implementation. Review of the Centers for Disease Control and Prevention's Smallpox Vaccination Program implementation. Letter report #1. Washington, DC: Institute of Medicine, National Academy of Sciences, 2003. Available at .
3. CDC. Smallpox vaccination and adverse reactions: guidance for clinicians. MMWR 2003;52(Dispatch):1--29. Available at .
4. Chen RT, Rastogi SC, Mullen JR, et al. The Vaccine Adverse Event Reporting System (VAERS).Vaccine 1994; 12: 542-50.
5. Zhou W, Pool V, Iskander J, et al. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)-United States, 1991-2001. In: CDC surveillance summaries (January 24, 2003). MMWR 2003; 52(SS-1).
Whether they can operate as planned under an attack scenario remains to be seen.
Right. One can easily imagine a 'panic' that causes major difficulites in vaccination.
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