Global & Disaster Medicine

Archive for the ‘Bioterrorism’ Category

Emergent Biosolutions gets Health Canada approval for Botulism antitoxin

Emergent

Emergent BioSolutions Inc.  today announced that Health Canada has approved the company’s New Drug Submission (NDS) for its botulism antitoxin, BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)]. BAT is indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients…….

Emergent has an existing ten-year contract, executed in 2012, to supply BAT to the Canadian Department of National Defense as well as the Public Health Agency of Canada and individual provincial health authorities. In addition, Emergent has been supplying BAT to the U.S. Strategic National Stockpile as part of a $450 million contract with the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. BAT, which was licensed by the U.S. Food and Drug Administration in 2013, is the only botulism antitoxin available in the U.S. for treating naturally occurring, non-infant botulism, and for administering to patients under emergency conditions…..”

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A government investigation of lab incidents involving incomplete pathogen activation at US high-containment labs since 2003 turned up 11 events that weren’t reported and identified problems with identifying and tracking such instances.

GAO

The 21 identified incidents involved a variety of pathogens and laboratories, as shown below:

 


The National Institute of Allergy and Infectious Diseases (NIAID) of NIH has exercised an option to fund animal efficacy and toxicology studies for Soligenix’s RiVax ricin vaccine as a bioterror preparedness measure

Ricin Vaccine 

CDC:  Facts about Ricin

 


The first blood test for anthrax that could show results within minutes at a doctor’s office or ER will take the final steps in development

HHS

May 9, 2016

Contact: HHS Press Office
202-690-6343
media@hhs.gov
HHS sponsors point-of-care anthrax diagnostic test
Simple, fast finger-prick blood test could aid in medical response to bioterrorism attack.

The first blood test for anthrax that could show results within minutes at a doctor’s office or emergency room will take the final steps in development with support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).

Under an 18-month $2.5 million agreement with ASPR’s Biomedical Advanced Research and Development Authority (BARDA), SRI International of Menlo Park, California, will conduct studies necessary to ensure the test accurately detects anthrax infections in blood samples; the studies are needed to apply for clearance to market the device from the U.S. Food and Drug Administration. The contract can be extended for up to a total of three years and $7.8 million.

The test being developed is based partly on a similar version developed at the Centers for Disease Control and Prevention (CDC). Anthrax diagnostic tests available today require sending samples to a laboratory for analysis, with results available in days.

The test SRI is developing uses blood samples on small cartridges; after 15 minutes, the cartridge is placed in a reader, and results are displayed. This compact system fits into the palm of a hand and can be used in locations close to the patient, such as hospital emergency rooms, local health clinics, and potentially at the patient’s bedside or by first responders.

Having the results immediately available will help doctors make fast decisions about the appropriate care and treatment for patients who may have been exposed to anthrax, particularly after an anthrax bioterrorism attack. Anthrax is an acute disease caused by Bacillus anthracis bacteria, and if untreated can be deadly. The inhaled form can cause death in a matter of days.

SRI International will work with DCN Diagnostics of Carlsbad, California, and Web Industries of Holliston, Massachusetts, on regulatory, design, and manufacturing studies of the anthrax diagnostic test.

BARDA, CDC and other federal agencies coordinate as a Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) to prioritize medical countermeasures – drugs, vaccines, and diagnostics – needed in public health emergencies, identify promising medical countermeasures, and transition products from early development to advanced development with the goal of FDA approval.

Protecting health after an anthrax attack requires preventing, detecting, and treating anthrax infections. To meet this national health security need, BARDA’s portfolio includes development of three anthrax antitoxin drugs that have been approved by FDA. BARDA also is supporting advanced development of vaccines to prevent illness after exposure to anthrax as well as improvements on the only vaccine licensed for use prior to exposure so that fewer doses are needed to protect health.

BARDA is seeking additional proposals for advanced development of new drugs and products to diagnose, prevent, treat, and protect health against chemical, biological, radiological or nuclear threats. Proposals are accepted through the Broad Agency Announcement BARDA-CBRN-BAA-13-100-SOL-00013, available on fbo.gov.

ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

To learn more about ASPR and BARDA, as well as preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, phe.gov and the HHS emergency medical countermeasures website, medicalcountermeasures.gov.

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NYC: Department of Homeland Security scientists are releasing (nontoxic) gases and particles on crowded subway platforms, beginning a week-long airflow study aimed at measuring the impact of a nightmarish chemical or biological terrorist attack.

New York Magazine

 

 


Man Gets 16 Years for Attempting to Purchase Ricin

FBI

Shipment Containing Fake Ricin Sent to Cheng Le

04/19/16

It was a very scary scenario: Chinese national Cheng Le, living in New York City, attempted to order ricin through the so-called dark web.

Ricin, of course, is a highly potent and potentially fatal toxin with no known antidote. And the dark web includes a number of extensive, sophisticated, and widely used online criminal marketplaces that allow participants to buy and sell all kinds of illegal and often dangerous items, including drugs, firearms, and hazardous materials, like ricin.

What did Le plan to do with the ricin? Nothing good. According to U.S. Attorney for the Southern District of New York Preet Bharara, “In Le’s own words, established at trial, he was looking for ‘simple and easy death pills’ and ways to commit ‘100 percent risk-free’ murder.”

While on a particular dark web marketplace in early December 2014, Le asked, “This might sound blunt but do you sell ricin?” Fortunately, the individual at the computer on the other end was not a trafficker in lethal poisons—instead, it was an undercover FBI employee.

For the next couple of weeks or so, Le and the undercover employee exchanged more than 20 encrypted messages. Some of Le’s communications included:

  • “If [the ricin’s] good quality, I’ve already had buyers lining up.”
  • “Does ricin have an antidote? Last I check there isn’t one, isn’t it?”
  • “The client would like to know…if it is wise to use ricin on someone who is hospitalized…Injection will leave needle holes on the body which could be found in regular forensic examinations. But hospitalized people already have needles in them so it wouldn’t be suspicious…”
  • “I’ll be trying out new methods in the future. After all, it is death itself we’re selling here, and the more risk-free, the more efficient we can make it, the better.”
  • “Also, besides that one bottle of pills with one poisonous pill in there, can you send some extra loose powder/liquid ricin? I’d like to test something.”

Sometime during these exchanges, Le revealed to the undercover employee that he had a specific victim in mind: “Someone middle-aged. Weight around 200 pounds.”

Ultimately, Le placed his order, paying with bitcoins, a virtual currency. Bitcoins themselves are not illegal and have known legitimate uses. However, they are also a common form of payment for illegal goods and services on the dark web because of the anonymity they provide.

On December 18, 2014, Le directed his contact to send a quantity of ricin to a rented postal box at a Manhattan shipping store (investigators later determined that Le had rented the postal box using the name of an individual whose identity he had stolen).

The Bureau prepared a mock shipment exactly as Le had requested—with one small difference: the “ricin pill” concealed in a pill bottle and the loose “ricin powder” were fake. And on December 23, the sham shipment was delivered to the requested postal box. Le, wearing latex gloves, retrieved the package, opened it, and took it to his apartment. Agents, armed with a search warrant, entered the apartment, collected the evidence, and arrested Le.

Le was tried by a federal jury and convicted in August 2015 of, among other things, attempting to possess a biological toxin for use as a weapon and aggravated identity theft in relation to a terrorism offense. Last month, he was sentenced to 16 years in prison, a term that had been enhanced by the aggravated identity theft charge.

And as a result of yet another successful joint law enforcement investigation—this one by the FBI, New York Police Department, and U.S. Postal Inspection Service—a criminal who posed a deadly threat to the public is behind bars.


FDA: A new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis for people 18 through 65 years of age in conjunction with recommended antibiotic treatment.

FDA

The U.S. Food and Drug Administration today approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease. The vaccine’s new use is approved for people 18 through 65 years of age in conjunction with recommended antibiotic treatment. BioThrax was initially approved by the FDA in 1970 for the prevention of anthrax disease in persons at high risk of exposure.

Anthrax disease, especially the inhalation form, is often fatal if not promptly treated. Anthrax is considered one of the more likely agents to be used in a biological attack, primarily because its spores are very stable and easy to disperse. Although it is rare, people may contract anthrax disease through natural exposures, such as contact with infected animals or contaminated animal products.

“With today’s approval of BioThrax, we now have a vaccine that can be used, together with antibiotic treatment, to prevent disease after exposure to anthrax spores,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

BioThrax is the first vaccine to receive approval based on the Animal Rule. The Animal Rule allows animal efficacy data to be used as a basis for approval when human efficacy studies are not ethical or feasible.

Protective antibody levels, which were determined in rabbit and monkey studies, were used to predict efficacy in humans based on an assessment of the extent of antibody response achieved in human study participants. A 70 percent probability of survival in animal models from inhalational anthrax disease was deemed a reasonable level of protection and likely to provide reasonable benefit in humans.

The ability of BioThrax to increase the probability of survival after stopping post-exposure antibiotic treatment was assessed in rabbits. Rabbits treated with both antibiotics and BioThrax had a survival rate of 70 to 100 percent, depending on the vaccine dose administered. In contrast, in two studies of rabbits that received only antibiotic treatment, survival rates were 44 and 23 percent respectively.

The safety and antibody responses to BioThrax in humans were evaluated in a multi-center study conducted in the United States. Subcutaneous (under the skin) injections were given to 200 healthy adults in three doses at zero, two, and four weeks. The majority of study participants generated antibody responses that correlated to a 70 percent probability of survival that was observed in animal models.

The observed adverse reactions were comparable with those observed when BioThrax is used for pre-exposure disease prevention. The safety profile for BioThrax is well-established, with the majority of localized adverse events reported as tenderness, pain, swelling, and redness at the injection site, as well as limited movement of the injected arm. The most common systemic adverse reactions were muscle aches, headache, and fatigue.

BioThrax is manufactured by Emergent BioDefense Operations Lansing LLC, based in Lansing, Michigan.


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