The Obama administration is preparing to make unused federal stocks of anthrax vaccine available to certain nonmilitary emergency personnel in a trial effort that could lead to wider distribution of the countermeasure to first responders (see GSN, Oct. 23, 2008).
The initiative would offer select state and local officials the option to accept a federally funded course of anthrax vaccination doses and would consider broader distribution in part through demand from individual reponse personnel, senior medical officials with the Homeland Security Department and the Centers for Disease Control and Prevention told Global Security Newswire on Friday.
Planners from the White House and at least four federal departments weighed proposals to grant several other groups advance access to the vaccine, but ultimately settled on limiting its availability to emergency response personnel because they “will be the first people on the street” in the event of any outbreak, said Kathryn Brinsfield, who heads the Work Force Health and Medical Support Division at the DHS Health Affairs Office.
Anthrax frequently kills humans and animals that breathe in its long-surviving spores, and governments have sought to defend against use of the bacteria as a biological weapon. Spores mailed to U.S. political figures and media organizations in 2001 killed five people and highlighted the potential for the bacteria to be released deliberately, helping to precipitate a dramatic increase in preparations for comparable strikes.
The Homeland Security Department maintains a national warning mechanism for alerting first responders, other authorities and the public to any "credible, specific, and impending terrorist threat against the United States," such as a plot involving anthrax.
“First responders” can serve as shorthand for police, fire crews and emergency medical personnel, but Brinsfield said official participants in the upcoming trial could define it to also include certain infrastructure workers responsible for “making sure that the water runs, that the electricity stays on, that the streets are clear, to make sure that the operations to hand out medical countermeasures to the community can go on.”
State governments would have significant latitude in the trial to determine exactly who could receive the vaccine, provided their decisions fit within broad parameters hammered out by federal planners, she said.
Giving such personnel early access to the anthrax vaccine could bolster national capabilities for handling any deliberate release of the bacteria, according to one national security analyst.
“If a major city is hit with anthrax and it’s a dry powdered form or we think there’s a significant possibility of secondary aerosol invasion, we know we can send in the U.S. military to help out because they’re pretty well protected with vaccines,” said Randall Larsen, chief executive officer of the WMD Center in Washington. “Wouldn’t it be nice if we knew that the majority of the public health people in that city and law enforcement personnel were also protected?”
The CDC Advisory Committee on Immunization Practices opened a pathway for the initiative with its 2010 recommendation that emergency personnel have an option to receive the anthrax vaccine voluntarily if they are “engaged in response activities that might lead to exposure” to the bacteria through the air.
Brinsfield declined to estimate when the program would launch.
“I don’t think there’s any doubt it will move forward,” she said. “We’re certainly fast-tracking this as much as we can, but we also want to make sure as we’re rolling this out as fast as possible that we’re being really responsible about this.”
The program would draw from inventory that is within months of expiration in the U.S. Strategic National Stockpile of medical countermeasures. The federal government formally deems stockpiled anthrax vaccine to be unusable once it ages beyond its four-year shelf life, but officials have not ruled out the possibility that some lapsed material could remain sufficiently potent to distribute to the public if a shortage of unexpired stocks develops following an outbreak.
Federal authorities would ensure pilot participants could administer distributed vaccine before it lapses, said Daniel Sosin, deputy director and chief medical officer for the CDC Public Health Preparedness and Response Office, indicating the trial effort would draw from newer batches of the material as they near expiration.
Officials have yet to decide how much vaccine the initiative would offer, Sosin said. The national stockpile now includes roughly 18.2 million doses of vaccine, his agency said by e-mail on Wednesday; of that amount, nearly 2 million doses valued at approximately $48.3 million are due to expire within half a year.
Planners do not anticipate vaccine demand at four planned “pilot sites” exceeding available stocks, Sosin said. His agency was working with Homeland Security to recruit two federal offices and two state offices in the trial initiative.
A standard vaccination regimen would involve five shots over 18 months and yearly boosters to confer and sustain immunity. The trial is expected to hew roughly to the duration of the initial 18-month "priming series."
Asked if participants would receive access to the vaccine beyond the pilot’s duration, Brinsfield said “we’re looking at scheduling it out long term, in terms of both getting the whole five-dose series in and having the numbers include the boosters.”
She described receiving “largely positive” feedback since announcing the initiative at a February gathering of U.S. public health officials and specialists, though some state governments have raised questions over how they would internally execute elements of the plan. Emergency workers including police, firefighters and medical response personnel have provided input through a number of professional organizations.
“We’re reasonably confident at this point ... that we will get the number of communities to undertake a pilot activity where they will have constituents who want this and will go through the program,” Sosin said. “The issue of marketing … the vaccine should not be an issue for the pilot, and then we have to make different decisions if we go to a larger program.”
Sosin could not immediately specify what quantity of stockpiled vaccine has expired to date, but said the federal government retains lapsed material with an eye to potentially approving stores that remain sufficiently potent for fallback use in a crisis.
“We don’t know for sure if we needed to use this vaccine how we would go about the potency testing and assuring safety of the vaccine,” he said, adding it can be eliminated in line with procedures “the stockpile unfortunately is well versed in.”
“Unless we were confident that [expired anthrax vaccine] maintained sufficient potency to be of value and would be safe to provide to the public, it would not be used,” the official said.
The Food and Drug Administration permits anthrax vaccine doses to be retained for one year after expiration, after which point the material must be eliminated, said a CDC spokesman who provided the information on condition of anonymity.
The government is now holding 1 million doses of expired vaccine in "quarantine," the spokesman said on Monday. The official confirmed that vaccine has been destroyed, but was unable to immediately specify what quantity.
The official added earlier that it is standard government procedure to administer anthrax vaccine nearing expiration but still within its approved service period. The Defense Department’s immunization program maintains an inventory of 2 million anthrax vaccine doses redesignated from the Strategic National Stockpile, typically when they are within a year of expiration.
A publicity push might ultimately prove necessary to tout the vaccine’s benefits, said Larsen, who described initially witnessing “real pushback” within the military as the Clinton administration instituted the program of mandatory anthrax immunizations for military personnel in the late 1990s.
“We were now entering the Internet age [with] these crazy rumors,” said Larsen, a former Air Force colonel who promoted the vaccine to troops. “I started looking at the Internet sites myself. My God, it had [former President George H.W. Bush] linked to Nazis and World War II in this whole conspiracy to give you an anthrax shot.”
Federal courts have presided over cases disputing the legality of the mandatory Pentagon vaccination effort (see GSN, March 3, 2008). Brinsfield stressed the voluntary nature of the initiative now being planned for emergency workers, but said its potential to expose the government to lawsuits was still under investigation.
The Centers for Disease Control and the DHS Health Affairs Office began planning the initiative last fall in consultation with the White House as well as the Justice and Defense departments, Brinsfield said in February at the Public Health Preparedness Summit in Anaheim, Calif.
She said then that participants in the process had floated three broadly defined groups in addition to emergency response personnel as potential candidates to receive vaccine in advance of an anthrax epidemic: individuals whose medical issues would prevent them from retrieving vaccine and drugs after an outbreak; people needed “to make sure that government continues”; and residents of locales in which a release of the bacteria constitutes a particularly significant threat.
Neither the White House nor the Pentagon responded to requests for details on their specific input in the planning process. The Justice Department confirmed it was involved in the discussion but declined to elaborate on its role.
The 2010 CDC recommendations call for more general distribution of the vaccine and certain antibiotics after an anthrax outbreak.
“It’s really important to look at this pilot as a pre-event pilot,” Sosin said. “Who, in advance of an event, is at sufficient risk and value to go ahead and take this vaccine?”
Larsen, though, said a preparatory anthrax vaccination effort that extends beyond the defense community should also incorporate political leaders at every level of government. Administering the vaccine to public officials, he said, would prove “critically important” to encouraging participation in a wider immunization program.
“How can you expect people who work for you to get it if you don’t?” asked the expert, who interpreted political leaders to fall under the “continuity of government” category described by Brinsfield.
Officials have yet to begin considering specific government participants for the pilot program, the DHS official said, adding that speculation on likely candidates “would be premature until every single potential … state that could apply has been equally notified.”
State governments are generally better equipped than local jurisdictions to oversee the trial’s implementation, but immunization management officials from various states have expressed differing preferences over how to manage the vaccine as it arrives, Brinsfield added.
“It seems like some of the states would prefer it centrally and some would prefer it not to be centralized,” she said.
Sosin added the pilot program could help inform plans to distribute the vaccine in greater quantities following an anthrax release, shedding light on key operational details such as refrigerating vaccine continuously during shipment.
Federal officials began planning the pilot program in the months after a series of successively higher-level aerial anthrax dispersal planning drills that concluded with a tabletop simulation at the White House. The 2011 exercise series, dubbed “Dark Zephyr,” was “unique” in its focus on response operations three days following a release of the bacteria, according to the justification for the Health and Human Services Department’s fiscal 2013 budget proposal.
According to a separate HHS document, “the health effects of the hypothetical attack overwhelmed hospital resources over a large area, and produced many cases of disease and many deaths.”
One issue highlighted by the simulation was “how much better prepared [we would have] been had we prevaccinated people,” according to Larsen, who reviewed after-action reports on the exercises. The exercises also drew attention to complications stemming from the bacteria's long-term persistence in the environment, he said.
Sosin said Dark Zephyr was “certainly not the only factor that led to the activity that we’re involved in right now, but it helped crystallize and increase the support for moving ahead.”
Making anthrax vaccine available to emergency personnel has been a goal in Congress. One bill introduced in the House of Representatives last year would direct the Health and Human Services Department to grant such workers access to federally stockpiled drugs and vaccines with “short shelf lives,” as well as such materials held in “surplus.”
The administration has yet to brief lawmakers on the proposal but would do so “very soon,” Brinsfield said.
A 1988 law enables the Federal Emergency Management Agency to distribute certain medications and other materials to state governments as "excess" property, the DHS official noted in February.
The Obama administration is preparing to make unused federal stocks of anthrax vaccine available to certain nonmilitary emergency personnel in a trial effort that could lead to wider distribution of the countermeasure to first responders.