One of the principal goals of the initiative known as Project Equal Immunization Policies & Practices (EQUIPP) is to help gain approval for the preventive vaccination of civilian emergency responders against anthrax. Since 2008, this grassroots campaign has fought vigorously to eradicate the disparity of access to the only vaccine licensed by the U.S. Food and Drug Administration for anthrax prophylaxis. More specifically, Project EQUIPP has and continues to reverse the upside-down status quo wherein only the second wave of federal WSD-CST (Weapons of Mass Destruction Civil Support Team) personnel – rather than local civilian responders – are preventively immunized.
As a result, some important milestones have been reached. One example is that the anthrax vaccine adsorbed (AVA) is now included as a covered countermeasure in the U.S. Department of Health and Human Services’ 2008 Public Readiness and Emergency Preparedness (PREP) Act. This status provides not only important injury compensation awards but also the appropriate indemnification mechanisms needed for the manufacturing, distribution, delivery, administration, and receipt of AVA.
In addition, equal policy guidance supporting the preventive vaccination of emergency responders is now in place, thanks to the publication (in 2010) of the 2009 report on the Final Recommendations from the U.S. Centers for Disease Control & Prevention (CDC) Advisory Committee on Immunization Practices (ACIP). Although these CDC guidelines do not specifically call for the routine pre-exposure vaccination of all emergency responders, they do affirmatively state that “responder units engaged in response activities that might lead to exposure to aerosolized Bacillus anthracis spores may offer their workers voluntary pre-event vaccination.”
Continuing Inequality But With a Ray of Hope
In retrospect, increased understanding of the dangers posed by an anthrax “weapon” attack – combined with additional information on the supply, safety, and acceptance of AVA – can be credited as having been particularly helpful in advancing this ongoing policymaking process. In that context, there are three key points of particular importance worth emphasizing:
- In the context of an attack with a weapon or device carrying antibiotic-resistant anthrax bacteria, post-exposure antibiotics will fail and the infected victims will almost always succumb before AVA can confer immunity. As is the case with all types of vaccines, the best and, realistically, only time to immunize is prior to exposure.
- Since 2008, approximately 500,000 AVA doses in the Strategic National Stockpile (SNS) have been destroyed every month because of expiration dating. It has been estimated that more than 20 million doses of AVA have been wasted in various ways since the October 2007 Government Accountability Office (GAO) admonishment to the U.S. Department of Health and Human Services (HHS) on its management of the SNS materiel. Obviously, therefore, using surplus AVA before its expiration date to immunize civilian emergency responders who meet the ACIP criteria mentioned earlier could protect hundreds and perhaps thousands of other personnel who might well be needed to help cope with a future anthrax WMD attack.
- In an unpublished 2009 survey carried out by the Missouri State Emergency Management Agency, with a group of 223 emergency responders (73 of which were randomly selected to be asked the question on their willingness to be immunized with the anthrax vaccine), it was determined that approximately two thirds of the civilian emergency responders participating said that they do want to have the option of receiving a voluntary pre-exposure vaccination against anthrax.
Unfortunately, two years after the report on the Final ACIP Recommendations was published, equality in the practice of providing anthrax immunization for local civilian emergency responders has still not been mandated. However, there is a ray of hope from the written testimony delivered by Dr. James Polk, Deputy Chief Medical Officer of the U.S. Department of Homeland Security (DHS), to the Subcommittee on Emergency Preparedness, Response, and Communications of the House Committee on Homeland Security. In the testimony released on 17 April 2012, Polk commented on 2011 discussions between CDC-SNS and the DHS Office of Health Affairs about “theea of working collaboratively to determine a use for anthrax vaccine with a short shelf life rather than disposing of the unused vaccine.”
“Our national response capability to a wide-area anthrax attack,” Polk also said, “would be enhanced by having pre-vaccinated responders, able to deploy immediately and confident that they have been afforded as much protective status as possible for these activities.” The “pre-event vaccination of these responders,” he further asserted, “will increase the [federal government’s] ability to save lives, maintain social order, and ensure continuity of government after a wide-area anthrax attack.”
Polk also commented on the creation of a federal interagency working group to discuss the key decision points of a DHS/CDC-SNS program designed to evaluate the possible provision of soon-to-expire AVA to federal departments and agencies as well as to some state and local jurisdictions. In addition, twelve different federal departmental subject matter experts discussed the scientific medical data and policy implications involved, and also developed AVA prioritization guidance for immunization in the event that the vaccine supply available could not fully meet the demand.
The first step in this process, according to Polk, would be to pilot a pre-event AVA vaccine distribution program on a relatively small and manageable scale with the goal of eventually building a full-scale program that would be safe, reliable, functional, and sustainable. The pilot would: (a) include two federal departments or agencies and two state or local jurisdictions; and (b) continue for at least 18 months, time enough to accommodate the lengthy “priming” vaccination series anticipated.
The Future of Pre-Event Vaccination
Despite Polk’s testimony that planning began more than a year ago, no publicly discoverable information has been released, and there have been no pre-solicitations or solicitations. Moreover, recent inquiries submitted earlier this year to the DHS Office of Health Affairs by Project EQUIPP, and by at least one state that has volunteered as a pilot location, have yielded no response.
There are several possible reasons for this official silence. It could be, perhaps, that any further action by DHS and CDC-SNS would require an examination of the potential benefits from pre-event/pre-exposure vaccination weighed against the probable resource requirements to implement and maintain the vaccination schedule in the context of the potentially adverse events associated with vaccination. Another possibility is that the unexplained delays can be attributed to a contrarian position that: (a) mandates the presence of a “calculable risk” before changing the modus operandi; and (b) is not satisfied with a programmatic decision based solely on an estimated/presumed risk-benefit assessment.
A third possibility is that the yet unexplained opposition and/or reluctance to make a firm decision is fueled by the belief that, depending on the occupational activities of the vaccine recipient(s), pre-event or pre-exposure vaccination might not completely eliminate the need for the purchase and distribution of appropriate personal protective equipment and post-exposure antibiotics.
Despite the above rationale, it seems reasonable to suggest that the final release of the 26 January 2012 National Response Team Emergency Responder Health Monitoring and Surveillance (ERHMS) Technical Assistance Document would acceptably serve as a safe harbor, if not a catalyst, for a pre-event vaccination program. The ERHMS documentation provided from the National Institute for Occupational Health and Safety is a product of significant consultations with not only the U.S. National Response Team but also a large number of federal agencies, state health departments, labor unions, and volunteer emergency responder groups. In addition to the operational benefits described above, that same document would also:
Provide the guidelines needed to protect emergency responders operating over a full range of emergency types and settings;
Serve as an invaluable resource for all who are involved in the deployment and protection of emergency responders – including but not limited to incident management and response organization leaders as well as health, safety, and medical personnel – and the emergency responders themselves; and
Legally defines the anthrax vaccine as an immunization that is appropriate to provide to emergency responders.
In a community of emergency response professionals who courageously charge toward the danger – while others in the vicinity are running for their lives – the selfless actions of these professionals speak louder than words. The threat is real. The solution, or at least a significant part of it, is known. Now is the time to deliver.
For additional information on: U.S. Public Readiness and Emergency Preparedness (PREP) Act, 6 October 2008, visit http://www.gpo.gov/fdsys/pkg/FR-2008-10-06/html/E8-23547.htm
CDC’s “Use of Anthrax Vaccine in the United States Recommendations of the Advisory Committee on Immunization Practices (ACIP),” 23 July 2010, visit http://www.cdc.gov/mmwr/PDF/rr/rr5906.pdf
U.S. Government Accountability Office’s “Actions Needed to Avoid Repeating Past Problems with Procuring New Anthrax Vaccine and Managing the Stockpile of Licensed Vaccine,” 23 October 2007, visit http://www.gao.gov/products/GAO-08-88
Written testimony of Dr. James Polk for a House Committee on Homeland Security, Subcommittee on Emergency Preparedness, Response, and Communications hearing, 17 April 2012, visit http://www.dhs.gov/news/2012/04/17/written-testimony-office-health-affairs-house-homeland-security-subcommittee
The ERHMS “National Response Team Technical Assistance Document,” 26 January 2012, visit http://www.cdc.gov/niosh/topics/erhms/document/
Thomas K. Zink
Thomas K. Zink, M.D., is an adjunct associate professor of community health in the Institute for Biosecurity at Saint Louis University and a healthcare/biodefense consultant. He graduated from the University of Missouri – Kansas City School of Medicine – and is now an accomplished quality improvement professional, a successful health policy strategist, and an experienced vaccinologist with special expertise in viral hepatitis, pertussis, anthrax, and botulinum toxin. A retired emergency physician, he also is the Founding Director of Project Equal Immunization Policies & Practices (EQUIPP), an organization that has been a catalyst in the formulation of CDC recommendations to support the pre-event anthrax vaccination of U.S. civilian emergency responders.