Global & Disaster Medicine

Archive for the ‘Anthrax’ Category

FDA issues final guidance for drug companies to use for developing pre-exposure prophylaxis for inhalational anthrax.

FDA

FDA In Brief: As part of a longstanding program encouraging the development of medical countermeasures; new FDA policy promotes innovation to thwart inhalational anthrax

May 23, 2018

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  Tara Rabin
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“The FDA has long played an important role preparing our nation for potential bioterrorism threats, providing guidance and support around the development of medical countermeasures that can be used safely, effectively and reliably during public health emergencies,” said FDA Commissioner Scott Gottlieb, M.D. “Since the 2001 anthrax attacks, the U.S. government’s efforts to protect the nation from bioterrorism threats have continued to evolve. We now know that a comprehensive preparedness plan for potential anthrax threats must account for both pre- and post-exposure scenarios. That’s why the FDA has taken steps to modernize its guidance on inhalational anthrax to advance the development of new drugs for prophylaxis, prior to exposure. This builds upon the treatments that are currently available for inhalational anthrax and advances the agency’s longstanding commitment to the development of a full suite of medical countermeasures as part of its established programs.”

The U.S. Food and Drug Administration today issued final guidance, Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax, which is designed to assist in the development of drugs for prophylaxis (prevention) of inhalational anthrax for individuals who may be potentially exposed to or have inhaled aerosolized Bacillus anthracis (B. anthracis) spores, but who have not yet displayed related signs and symptoms.

While there are FDA-approved drugs for treatment of anthrax and for post-exposure prophylaxis of inhalational anthrax, situations can arise where starting therapy immediately before the anticipated or potential exposure can reduce the risk of illness and death (for example, first responders who anticipate an imminent risk of exposure to B. anthracis spores).

The FDA’s final guidance is the result of a multi-year effort to advance its policy framework for the development of treatments targeting inhalational anthrax. The final guidance revises the indication to “prophylaxis of inhalational anthrax” for the reduction of disease risk in those who have inhaled, or are likely to inhale, aerosolized B. anthracis spores, but who do not yet have established disease.

Clinical trials in humans cannot be conducted since naturally occurring inhalational anthrax is extremely rare and it would be unethical to deliberately expose healthy human volunteers to B. anthracis spores. Therefore, the final guidance clarifies that drugs developed for the prophylaxis of inhalational anthrax can rely on evidence from animal studies (known as the Animal Rule) to support approval when the criteria under the Animal Rule have been met.

The FDA encourages drug developers to reference the final guidance issued today when designing studies to appropriately establish the safety and effectiveness of drugs for prophylaxis of inhalational anthrax.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


4/2/1979: The world’s first anthrax epidemic begins in Sverdlosk, Russia eventually killing 62 and incapacitating another 32

History Channel

“…..workers at the Ekaterinburg weapons plant failed to replace a crucial filter, causing a release of anthrax spores into the outside air. The wind carried the spores to a farming area and infected people and livestock in the area….”

 


South Korean sources: Pyongyang is conducting heat and pressure resistance tests to see whether anthrax germs can survive at temperatures of 7,000 degrees or higher, the level an ICBM encounters when it re-enters Earth’s atmosphere.

Asahi Simbun

Slideshow image 1: The type of illness a person develops depends on how anthrax spores enter the body. All types of anthrax can cause death if they are not treated with antibiotics.

CDC


Safety of inadvertent anthrax vaccination during pregnancy: An analysis of birth defects in the U.S. military population, 2003–2010

 

Vaccine

Highlights

Anthrax vaccination is compulsory for certain United States military personnel.

Assurance of anthrax vaccine safety in pregnancy is important for military members.

Infants inadvertently exposed to anthrax vaccine in the 1st trimester are not at higher risk for birth defects.

Infants inadvertently exposed to anthrax vaccine are not at increased risk for any specific individual birth defects.

Study findings are not only relevant to military populations but also to civilian populations for bioterrorism preparedness.

 


Anthrax research: Estimating the post-exposure period for effective treatment of human inhalational anthrax.

Rubinson L, Corey A, Hanfling D. Estimation of Time Period for Effective Human Inhalational Anthrax Treatment Including Antitoxin Therapy. PLOS Currents Outbreaks. 2017 Jul 28 . Edition 1.

doi: 10.1371/currents.outbreaks.7896c43f69838f17ce1c2c372e79d55d.

“…..Results: For antibiotic sensitive infections, treatment with antibiotics alone ≤4 days after spore exposure prevents toxemia. Administration of raxibacumab together with antibiotics protects ≥ 80% of subjects for 3 additional days (7 days post exposure). In the setting of antibiotic resistance, raxibacumab would be protective for at least 6 days post exposure.
Conclusions: Although the animal model of disease does not reflect the potential impact of supportive care (e.g. fluid resuscitation received by critically ill patients) on PA kinetics and raxibacumab PK, the simulations suggest that administration of antitoxin in combination with antibiotics should provide a longer postexposure window for effective treatment than for antibiotics alone. In addition, raxibacumab administration soon after exposure to an antibiotic resistant strain should provide effective treatment…..”

 

  • Raxibacumab, an IgG monoclonal antibody against protective antigen (PA);
  • For inhalational anthrax, protective antigen (PA) drives much of the mortality
  • Raxibacumab is an anti-PA monoclonal antibody
  • The anthrax toxin is a tripartite toxin: lethal factor (LF) and edema factor (EF) have enzymatic activities, while PA binds to cell receptors. PA binds and translocates LF and EF into the cell. Inhibition of PA binding to cell receptors blocks binding and internalization of LF and EF.

4/2/1979: The world’s first anthrax epidemic begins in Sverdlosk, Russia. By the time it ended 6 weeks later, 62 were dead and another 32 survived serious illness.

History Channel


Epidemiology of Human Anthrax in China, 1955−2014

EID

Using national surveillance data for 120,111 human anthrax cases recorded during 1955−2014, we analyzed the temporal, seasonal, geographic, and demographic distribution of this disease in China. After 1978, incidence decreased until 2013, when it reached a low of 0.014 cases/100,000 population. The case-fatality rate, cumulatively 3.6% during the study period, has also decreased since 1990. Cases occurred throughout the year, peaking in August. Geographic distribution decreased overall from west to east, but the cumulative number of affected counties increased during 2005−2014. The disease has shifted from industrial to agricultural workers; 86.7% of cases occurred in farmers and herdsmen. Most (97.7%) reported cases were the cutaneous form. Although progress has been made in reducing incidence, this study highlights areas that need improvement. Adequate laboratory diagnosis is lacking; only 7.6% of cases received laboratory confirmation. Geographic expansion of the disease indicates that livestock control programs will be essential in eradicating anthrax.

Li Y, Yin W, Hugh-Jones M, Wang L, Mu D, Ren X, et al. Epidemiology of Human Anthrax in China, 1955−2014. Emerg Infect Dis. 2017;23(1):14-21. https://dx.doi.org/10.3201/eid2301.150947

Anthrax postexposure prophylaxis (PEP) was recommended to 42 people after a laboratory incident & 3/4 didn’t finish taking it. How come?

Health Security

Postexposure Prophylaxis After Possible Anthrax Exposure: Adherence and Adverse Events.  Nolen Leisha D., Traxler Rita M., Kharod Grishma A., Kache Pallavi A., Katharios-Lanwermeyer Stefan, Hendricks Katherine A., Shadomy Sean V., Bower William A., Meaney-Delman Dana, and Walke Henry T.. Health Security. December 2016, 14(6): 419-423. doi:10.1089/hs.2016.0060.

“…..At least 31 (74%) individuals who initiated PEP did not complete either the recommended 60 days of antimicrobial therapy or the 3-dose vaccine regimen. Among the 29 that discontinued the antimicrobial component of PEP, most (38%) individuals discontinued PEP because of their low perceived risk of infection; 9 (31%) individuals discontinued prophylaxis due to PEP-related minor adverse events, and 10% cited both low risk and adverse events as their reason for discontinuation. Most minor adverse events reported were gastrointestinal complaints, and none required medical attention……”

 


40 now hospitalized after anthrax outbreak in Yamal, more than half are children

The Siberian Times

 


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