Global & Disaster Medicine

Archive for the ‘Anthrax’ Category

Tunisia: 31 people to death over the 2014 terrorist attack and a possible anthrax attack in 2019

Asharq Al-Awsat

“……19 letters containing potentially deadly toxins addressed to prominent journalists, politicians and trade unionists, have been intercepted by police at the central Post Office in Tunis and taken for testing.

The National Unit of Investigation for Terrorist Affairs and Organized Crime revealed that the toxic substance was made in Tunisia inside a laboratory.

The Ministry of Interior indicated that it is monitoring the movements of the terrorist cells that plotted the attack, especially that the deadly poison was made with local Tunisian expertise and required huge financial support. …..”

 


Tunisia: Envelopes delivered to politicians, journalists and syndicate members contained the Anthrax toxin.

Asharq Al-Awsat

“……Twenty public figures were targeted in this horrifying terrorist plot, including 10 prominent politicians, seven journalists and activists in syndicates and human rights, they continued.

Moreover, they said that the terrorist groups have shifted their tactics after security measures against them have limited their activity.

For years, they have relied on armed attacks, but they are now forced to resort to poisoning their victims, said the security agencies…..”

Types of Anthrax(https://www.cdc.gov/anthrax/basics/types/index.html)


An enhanced-delivery anthrax vaccine formulation

Weir GM, MacDonald LD, Rajagopalan R, et al. Single dose of DPX-rPA,
an enhanced-delivery anthrax vaccine formulation, protects against a
lethal _Bacillus anthracis_ spore inhalation challenge. npj Vaccines,
Abstract
——–
Anthrax is a serious biological threat caused by pulmonary exposure to
aerosolized spores of _Bacillus anthracis_. Biothrax® (anthrax
vaccine adsorbed (AVA)) is the only Food and Drug
Administration-licensed vaccine and requires 5 administrations over 12
months with annual boosting to maintain pre-exposure prophylaxis. Here
we report the evaluation of a single intramuscular injection of
recombinant _B. anthracis_-protective antigen (rPA) formulated in the
DPX delivery platform. Immune responses were compared to an alum-based
formulation in mice and rabbits. Serological analysis of anti-rPA
immunoglobulin G and toxin neutralization activity demonstrated higher
responses induced by DPX-rPA when compared to rPA in alum. DPX-rPA was
compared to AVA in rabbits and non-human primates (NHPs). In both
species, DPX-rPA generated responses after a single immunization,
whereas AVA required two immunizations. In rabbits, single injection
of DPX-rPA or two injections of AVA conferred 100% protection from
anthrax challenge. In NHPs, single-dose DPX-rPA was 100% protective
against challenge, whereas one animal in the 2-dose AVA group and all
saline administered animals succumbed to infection. DPX-rPA was
minimally reactogenic in all species tested. These data indicate that
DPX-rPA may offer improvement over AVA by reducing the doses needed
for protective immune responses and is a promising candidate as a
new-generation anthrax vaccine.

Emergent BioSolutions Inc. announced that Health Canada has approved the company’s New Drug Submission (NDS) for its anthrax vaccine, BioThrax® (Anthrax Vaccine Adsorbed).

Emergent BioSolutions

  • BioThrax is indicated for active immunization for the prevention of disease caused by Bacillus anthracis, in individuals 18 through 65 years of age, whose occupation or other activities place them at risk of exposure, regardless of the route of exposure.
  • BioThrax is administered in a three-dose primary schedule (0, 1 and 6 months) with boosters at three-year intervals recommended thereafter.

 


Current Emergency Use Authorizations

Emergency Use Authorization, with Emergency sign

FDA

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), which was enacted in March 2013

Current EUAs

The tables below provide information on current EUAs:


A Dual Vaccine against Anthrax and Plague

Pan Tao, Marthandan Mahalingam, Jingen Zhu, Mahtab Moayeri, Jian Sha, William S. Lawrence, Stephen H. Leppla, Ashok K. Chopra, Venigalla B. Rao
“…..We engineered a virus nanoparticle vaccine using bacteriophage T4 by incorporating key antigens of both B. anthracis and Y. pestis into one formulation. Two doses of this vaccine provided complete protection against both inhalational anthrax and pneumonic plague in animal models. This dual anthrax-plague vaccine is a strong candidate for stockpiling against a potential bioterror attack involving either one or both of these biothreat agents. Further, our results establish the T4 nanoparticle as a novel platform to develop multivalent vaccines against pathogens of high public health significance……”
Plague ecology in the U.S. infographic.

A simple, rapid, and specific early detection of anthrax infection

PLOS

Suryadi K, Shine N (2018) Design and use of a novel substrate for simple, rapid, and specific early detection of anthrax infection. PLoS ONE 13(11): e0207084. https://doi.org/10.1371/journal.pone.0207084

“……Bacillus anthracis is a major biological warfare threat. The inhalation form of infection can kill quickly. While antibiotic treatment is effective, if diagnosis is delayed, the rapidly produced toxin may already be present in lethal amounts. This report describes a fast, sensitive, specific and accurate method for detection of active infection by Bacillus anthracis in plasma…..”

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.

 

 

 


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

Media Inquiries

  Tara Rabin
  240-402-3157

“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


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