Smallpox Vaccination Followup: IOM Suggests Changes, Widespread Civilian Vaccinations to Begin
January 21, 2003: The first phase of voluntary civilian smallpox vaccinations -- for about 500,000 persons who will serve in first-response teams in case of a smallpox attack -- is expected to start in a few days; later, "phase II" will recommend voluntary vaccination for up to 10,000,000 healthcare workers and others. On January 17 the prestigious Institute of Medicine released a number of recommendations for changes in the program. The IOM report, which had been requested by the U.S. Centers for Disease Control and Prevention (CDC), is available at http://nationalacademies.org, along with a press release summarizing important concerns and recommendations.
People with HIV must not be vaccinated against smallpox (unless there is a smallpox attack, in which case the risks and benefits would have to be reconsidered -- or unless a safer vaccine is developed, which will take years). Many others should not be vaccinated as well. In fact, about 30 percent of the U.S. population is believed to have one or more contraindications, and should not be vaccinated. And since this vaccine contains a live virus, persons with HIV or other contraindications need to avoid close contact (especially household contact) with those who have been vaccinated recently, probably for two to three weeks.
Here are some of the concerns reflected in the IOM report that our readers should know about:
Compensation: Who will cover medical and other expenses in case of adverse reactions to the vaccine, or to catching the vaccinia virus from someone recently vaccinated? The Homeland Security Act of 2002 provides a Federal system of compensation for vaccine injuries, but only in cases of negligence in its manufacture or administration (thus shielding the manufacturer from liability). But in cases of adverse reactions where there is no negligence, currently each state is being left to decide about compensation, if any. The IOM report recommends that the CDC try to "clarify each state's workers compensation program's position on coverage for smallpox vaccine-related injuries and illnesses for workers covered under their programs" -- and in other ways to quickly resolve the compensation problem.
[In our view, the compensation issue shows a serious corruption in modern U.S. society -- that governments and corporations use their power to wash their hands of a public expense and leave it to those least able to pay, in this case the individuals who become ill from adverse reactions. The cost of adverse reactions in this Federal program is clearly a Federal responsibility. We do not need 50 different state systems of rules and litigations, designed under the pressure of the worst state budget crisis in 50 years. Private insurance also may find ways to evade responsibility, under "acts of war" or other clauses. Congress and the president can fix this problem, perhaps by amending the Homeland Security Act to deal with non-negligent vaccine injuries as well as negligent ones.]
The IOM report recommends that the CDC use an existing system to actively look for adverse events, instead of waiting passively for such reports to come in. It supports the use of a data safety monitoring board, which is currently planned, but wants it to be more independent of government agencies.
Consent forms must clearly explain the risks of vaccination, and the status of compensation in case of adverse events. (Current government planning is to leave consent forms as well as compensation up to the states.)
There should be a pause between phase I (500,000 vaccinated) and phase II (10,000,000 vaccinated), to allow for evaluation and corrections if necessary.
The CDC should prepare educational material for household contacts of persons to be vaccinated -- realizing that some of them will be unwilling to disclose contraindications such as HIV or pregnancy, and will need information on how to protect themselves. And those being vaccinated should have confidential opt-out provisions, like blood donors do, so that people will not be socially pressured to receive the vaccine, despite contraindications they are unwilling to disclose. (Blood donors who suspect they might have HIV or other undisclosed illness, but have been pressured to donate and are unwilling to opt out in front of others, can quietly check a box on a form and continue through with the donation process, knowing that their blood will never be transfused into anybody.)
Note: Healthcare Workers Vaccination, HIV Testing and Disclosure
On January 15 Lambda Legal, amfAR, and the Gay and Lesbian Medical Association issued a joint statement on HIV testing and disclosure during the vaccination program. It is available at: www.thebody.com/lambda/smallpox_vaccine.html.
ISSN # 1052-4207
Copyright 2002 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.
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