Jan 21, 2003 (CIDRAP News) The Institute of Medicine (IOM) has urged the federal government to move slowly and carefully on its pre-event smallpox vaccination program, with a pause after the initial phase to assess the vaccine's safety before moving to a broader inoculation campaign.
In a report dated Jan 17, the IOM advised the Centers for Disease Control and Prevention (CDC) to conduct active surveillance for adverse reactions during the first phase and analyze the data before moving to the second phase. The report also urges the CDC to work to resolve the question of compensation for adverse reactions and to tell potential vaccinees whether compensation is available or not. Also, the IOM advised the CDC to test screening materials on people from different backgrounds before starting the first round of vaccinations.
CDC Director Julie Gerberding, MD, said Jan 17 that the CDC will work to address the IOM's concerns but that the campaign must go forward because of its importance for national security (see related story). Gerberding said 11 states have requested a total of more than 50,000 doses of vaccine for the first round of shots, involving smallpox response teams in hospitals and public health agencies. The CDC will begin shipping the vaccine to states this week, she said.
The initial round of voluntary vaccinations is expected to include about 500,000 hospital and public health workers around the nation and could begin as soon as Jan 24, the date when federal liability protection takes effect for vaccine manufacturers and those who administer the program and give the shots. In the second phase, the voluntary program is to be extended to as many as 10 million other healthcare and emergency response workers. President Bush announced the program Dec 13, 2002, as a precaution against the possible release of smallpox virus by terrorists.
In a news release, the IOM stated, "Broader vaccination of health care workers and others [the second phase] should begin only after adequate evaluation of the immunization of the first round of recipients has occurred." The institute also said the CDC should allow more time in the first phase to educate vaccine recipients and train vaccine workers and other healthcare providers.
The IOM prepared the report in response to the CDC's request last fall for advice on how to run the pre-event vaccination program. The 44-page report was produced by a 15-member IOM committee chaired by Brian Strom, MD, MPH, a professor of public health and preventive medicine at the University of Pennsylvania School of Medicine.
The committee made several recommendations regarding an evaluation after the first round of vaccinations. The panel said CDC should collect safety data in phase 1 and, before starting phase 2, analyze the data in relation to differences in implementation of the vaccination program among hospitals and health departments. Further, CDC should assess the effects of the current recommendation against administrative leave for vaccinees and decide whether that recommendation should be changed before phase 2, the committee said. (The CDC's Advisory Committee on Immunization Practices [ACIP] said last fall that healthcare workers don't need to go on leave after getting a smallpox shot because the risk of transmitting the virus to patients is very low if the inoculation site is properly covered.)
The IOM also advised the CDC to use active surveillance for adverse events and analyze the results before starting the second phase. "The committee strongly recommends that active surveillance for adverse reactions be employed, rather than relying exclusively on the passive surveillance systems that already exist," the report states. The committee urged the CDC to use its Pre-Event Vaccination System (PVS), a secure Internet-based system to collect information on those receiving smallpox shots, to collect adverse-event reports. CDC should use the PVS data to do case-control studies before starting phase 2, the report says.
Regarding compensation for adverse reactions to the vaccine, the report notes that the Homeland Security Act sets up "a federal mechanism to compensate vaccinees who are injured due to negligent manufacture or administration of the smallpox vaccine," but this would not help those with vaccine-related costs or injuries unrelated to negligence. State workers' compensation programs may help vaccinees with costs such as lost work time or medical expenses, but there is much uncertainty about the circumstances in which those provisions would apply. Therefore, the report recommends that the CDC and state and local public health agencies immediately work to clarify the situation in each state. In addition, the CDC is urged to support administrative and legislative efforts to ensure that compensation for adverse events will be available.
CDC should also pretest its educational and screening materials on peoplw with different educational, socioeconomic, and cultural backgrounds before using the materials in phase 1 of the campaign, the IOM said. If the time frame prevents this, the materials should be evaluated after the first phase and modified before the second phase.
The IOM also expressed concern about the independence of a board, called the Data and Safety Monitoring Board (DSMB), that will monitor the safety of the vaccine for the CDC. The report says it appears that the DSMB will operate as a working group of the ACIP. The board's close connection to the CDC and the Department of Defense "violates one of the key attributes of all DSMBsboth real and perceived independence from the organizing group," the report says. A perception that the CDC controls the monitoring board could endanger the vaccination program. "If CDC is unable to assure this independent functioning of the DSMB, the committee recommends that the proposed organizational arrangement be reconsidered," the report states.
In other recommendations, the IOM said the CDC should:
- Determine and communicate the types and rates of adverse reactions that would trigger reconsideration of the ACIP recommendations on vaccine contraindications, screening, care of the vaccination site, and administrative leave
- Include in consent documents a statement that the risks of the smallpox vaccine are higher than those associated with other vaccines and that the benefit is presently unknown
- Develop educational materials for household contacts of potential vaccinees
- Collect data on the reasons potential vaccinees choose not be vaccinated
- Identify one credible person with a strong scientific background to serve as the spokesperson for the vaccination program
- Evaluate each state's capacity for managing adverse reactions before signaling that a state is ready to begin vaccinations
Jan 17 IOM letter report