July 11, 2002 - Smallpox Vaccination Recommendations

The American Society for Microbiology (ASM) would like to comment on the Advisory Committee on Immunization Practice (ACIP) recommendations on smallpox vaccination.

The ASM is the largest life science society with over 40,000 members and its principal goal is the promotion of scientific knowledge of microbiology for the benefit of human welfare. The ASM has worked with the Administration, the Congress and federal agencies on measures to protect against biological weapons and bioterrorism. ASM members are involved in research and public health initiatives aimed at eradicating the scourge of infectious diseases, which daily end the lives of thousands of Americans and tens of thousands around the world.

The ASM has consistently held that public health and biomedical policies should have strong scientific underpinnings. The ASM supports the ACIP recommendation that under current circumstances, with no confirmed smallpox, and as long as the risk of an attack is assessed as low, vaccination of the general population is not recommended, as the potential benefits of vaccination do not outweigh the risks of vaccine complications. The ASM is unable to judge the actual risk of an attack but notes that the Administration's presentation to ACIP indicated that there was no evidence to alter the assessment that the risk of an attack was low. The ACIP recommendation carefully takes into consideration the risks of widespread vaccination with the live smallpox (vaccinia) vaccine virus, which can be transmitted from person to person. Because this vaccine can cause adverse reactions in vaccinated persons and in the contacts of vaccinated persons it is prudent not to carry out mass vaccination as long as the threat of a smallpox bioterrorism attack remains low. Under those circumstances we feel that the ACIP is correct at not placing the lives of hundreds or thousands of Americans at risk.

ASM also agrees with the ACIP recommendation to provide vaccine to a limited number of individuals who would be involved in the front-line response to a smallpox attack. We agree that vaccinating selected personnel in facilities pre-designated to serve as referral centers to provide care for the initial cases of smallpox will assist with preparedness for a smallpox attack, even though such an attack is considered to have a low likelihood. We concur that this vaccination program should include a number of clinical microbiologists in each state who are involved in the laboratory diagnoses of bioterrorism events. Ensuring the readiness of the nation by preparing the first responders--including clinical microbiologists--is critical in this new age of terrorism.

The ACIP recognized that the implementation of the vaccination of even a limited number of health care workers requires addressing a number of issues, including provider and public education, health care provider training, availability of vaccine and VIG, developing the appropriate investigational new drug protocols, screening, strategies to minimize vaccine wastage, vaccine adverse event surveillance, and other logistical and administrative issues. It is important to recognize that health care workers come in contact with especially susceptible populations and will likely need to restrict their work activities for several weeks at the time of vaccination. Thus, extending vaccination to a high number of first responders will raise serious issues as to how to provide health care and other essential services while ensuring that those vaccinated do not infect others who are likely to develop adverse reactions. We, therefore, urge the Secretary to work with the States to ensure a phased implementation of the limited health care provider vaccination program so as to avoid disruption of public health and the delivery of essential medical services.

While the ASM supports the ACIP recommendation, it feels that in the event of a smallpox attack that the current ring vaccination strategy should be supplemented to allow for broader vaccination usage (e.g., community-based, target population based) to stop transmission as rapidly as possible if a smallpox case is confirmed. The ASM recognizes that "ring vaccination" was used successfully to eliminate naturally occurring smallpox. The ASM, therefore, recommends that the ACIP reexamine or redefine its limited "ring vaccination" plan to respond to a bioterrorism attack in which a broad spectrum of the potentially exposed population demand availability of vaccine and healthcare treatment. These recommendations should include plans for the rapid distribution of vaccine to large population bases.

While ASM agrees with the ACIP recommendation as long as the risk of an attack of smallpox remains assessed as being low, we believe that policies and plans need to be established now for dealing with the contingency that such an attack becomes probable. ASM would support a more widespread vaccination program if the likelihood of a smallpox attack became high. We would think it prudent to consider vaccination of larger portions of the general and military populations, for example, in the event of hostilities with a nation known to support terrorism and to be in possession of clandestine stocks of smallpox virus or if the intelligence community determined that a terrorism attack with smallpox virus was imminent. ASM, therefore, recommends that CDC work with the ACIP to develop a contingency plan for protecting the nation in the event that a smallpox attack becomes probable. We believe that this must be done now, when there is time to consult with the ACIP the and broader biomedical and public health communities to develop a scientifically credible strategy for dealing with the defense of the Homeland against the horrific threat of smallpox.

We hope these comments will be of assistance to the CDC and the HHS as the country moves towards a national policy on the smallpox vaccine.