WASHINGTON -- The United States wants to have a new anthrax vaccine ready for large-scale acquisition no later than the 2017 budget year, the Health and Human Services Department said on Monday in its implementation plan for a national health preparedness initiative.
Such a treatment could win government authorization for potential distribution during a crisis, but full licensure could take longer, Biomedical Advanced Research and Development Authority head Robin Robinson told Global Security Newswire. "We have four candidates that are in development right now, and the trajectory for being able to purchase those" would fall between 2014 and 2018, Robinson said, adding that two other possible vaccines are "under consideration."
The federal government has sought for years to develop a successor to BioThrax, the only anthrax vaccine licensed by the Food and Drug Administration. A new version of the vaccine -- which could be ready as soon as fiscal 2015 for inclusion in the Strategic National Stockpile of medical countermeasures -- might be suited for storage at room temperature for up to a decade, Robinson said. He added it could be capable of conferring immunity with fewer doses than the five required by the existing vaccine.
Efforts to facilitate development of a new anthrax vaccine have absorbed hundreds of millions of dollars to date. In one high-profile setback, Health and Human Services in 2006 canceled plans for preparation of a new anthrax vaccine by the biotechnology firm VaxGen. The current vaccine's shortcomings could complicate any emergency distribution, and they necessitate the costly replacement of stockpiled materials on an ongoing basis.
"It's an expensive undertaking but it's also risky, which is why we have a number of different candidates," Robinson said. The four developmental candidates have made varying degrees of progress toward animal and human testing.
Meanwhile, separate research activities would seek to augment the existing anthrax vaccine "through the development and testing of adjuvants that could enhance performance and reduce the doses necessary to achieve full immunity," says the plan for activities under the HHS Public Health Emergency Medical Countermeasures Enterprise. Certain augmenting agents under development promise to render the vaccine effective following exposure to the bacteria; the existing shot must be administered well in advance.
Anthrax has been identified as a leading bioterror threat. Five people died after exposure to spores dispersed through the U.S. postal system in 2001.
Robinson said "considerable progress has already been made" in pursuing goals outlined in the broader HHS implementation blueprint, which establishes time lines for completing medical preparations against a wide array of unconventional-weapon and natural disease threats. The paper calls for federal agencies to collaborate in prioritizing the development and acquisition of various medical countermeasures, refining rules for their use, establishing distribution plans and making arrangements for potential administration to minors and other "special populations."
"The next four years should be bountiful in the amount of preparedness afforded by this plan," the BARDA chief said.
The National Institutes of Health is set through fiscal 2017 to fund development of medical treatments for nerve agents and other chemical warfare materials, as well as hazardous substances from manufacturing processes. One developmental drug could aid in mitigating seizures produced by nerve agents, and officials hope to create a more potent, easier-to-administer countermeasure for cyanide.
National Institutes' personnel have identified nearly 100 potential treatments for various types of acute radiation syndrome and related ailments, and the government intends through fiscal 2014 to select promising candidates to receive BARDA funding.
No steps to develop nonmilitary vaccines for biological "material threats" other than anthrax and smallpox are included in the HHS document, which elaborates on development priorities established in a strategy document issued earlier this year. Both papers are slated for reassessment and revision at least every half-decade.
Health and Human Services development activities would receive support from several recently established scientific organizations comprised of experts from the academic and commercial biotechnology sectors, the new emergency preparedness document notes.