General public should only receive smallpox vaccination in limited settings, says IOM

Jane Berg

Aug 15, 2003 (CIDRAP News) The Institute of Medicine (IOM) Committee on Smallpox Vaccination Program Implementation issued a report earlier this week recommending that members of the general public who wish to receive a smallpox vaccination do so only in a clinical trial setting. The report states, "Vaccinating members of the general public beyond the key personnel states deem necessary for preparedness should proceed only under the aegis of smallpox vaccine clinical research trials or other well-structured clinical arrangements."

The report also recommended that the nation be more focused on preparedness in general and less focused on who and how many people are vaccinated against the disease. The report says, "Smallpox is not the only threat to the public's health, and vaccination is not the only tool for smallpox preparedness."

The IOM committee was formed in October 2002 to provide the Centers for Disease Control and Prevention (CDC) with advice on the implementation of the national smallpox vaccination program.

This is the fourth report on the vaccination program that the IOM has prepared at the request of CDC. The CDC is reviewing the latest report and will respond to the recommendations of the committee, according to Dr. Brian Strom, chair of the committee and faculty member at the University of Pennsylvania medical school. Strom told CIDRAP News that the CDC has been very responsive to the other reports and has implemented the "bulk of the recommendations."

One part of the smallpox vaccination program, as unveiled by President Bush in December 2002, was to provide smallpox vaccination to the general public at some time. Said Bush then, "We have decided not to initiate a broader vaccination program for all Americans at this time." He added, however, that some citizens might "insist on being vaccinated now" and that public health agencies would work to accommodate those requests.

Strom said the committee's feeling regarding vaccinations for the general public was unanimous. The recommendations, he said, were reached because the smallpox vaccine is different from others; it is for a disease that does not exist, the associated risks can be substantial, and there is potential to infect others because the vaccine uses a live virus. According to Strom, "The reason to use the vaccine is for biopreparedness. This is not a normal public health campaign. This is not a vaccine to prevent disease."

The IOM report also addressed the ethical considerations of giving the vaccine because of the poor risk-benefit balance. The report states that the balance is "particularly problematic" because other people, who have not consented to the risks associated with the vaccine, could be inadvertently infected by those who have chosen to bear the risks. Strom reiterated the ethical concerns in the CIDRAP News interview and said vaccination of the general public is against public health ethics that focus on the reasonable balance of the risks and benefits to an individual and to the entire population.

Dr. Ray Strikas, director of the smallpox preparedness response activity for the National Immunization Program at the CDC, told CIDRAP News that his group has been considering various options for providing the general public with smallpox vaccinations. He said the CDC and the IOM have a long history of working together on various issues involving policy implementation.

The CDC and the IOM committee will be meeting the first week of September. One objective of the meeting is to determine metrics that could be used to evaluate states' overall preparedness. All states have received funding for bioterrorism programs, but there has not been a standard set by the CDC, or other agency, to assess the adequacy of a state's preparedness plan.