NY Times

“….The Office of Public Health Preparedness and Response, which tracks outbreaks of disease, would be cut by $136 million, or 9.7 percent. The National Center for Emerging and Zoonotic Infectious Diseases — a branch of the Centers for Disease Control and Prevention that fights threats like anthrax and Ebola — would be cut by $65 million, or 11 percent.

The C.D.C.’s Center for Global Health would lose $76 million, or 18 percent. Its Emergency Operations Center, which conducts real-time monitoring of outbreak responses, and its Select Agents Program, which sets regulations in lethal toxin labs and helps researchers stay ahead of bioterrorists, face unspecified cuts as well…..”

TFAH

Ready or Not? examines the nation’s ability to respond to public health emergencies, tracks progress and vulnerabilities, and includes a review of state and federal public health preparedness policies. Some key findings include:

• 26 states increased or maintained funding for public health from Fiscal Year (FY) 2014-2015 to FY 2015-2016.
• Just 10 states vaccinated at least half of their population (ages 6 months and older) against the seasonal flu during the 2015-2016 flu season (from July 2015 to May 2016).
• 45 states and Washington, D.C. increased the speed of DNA fingerprinting using pulsed-field gel electrophoresis (PFGE) testing for all reported cases of Shiga toxin-producing E. coli O157, a measure of a state’s ability to detect foodborne outbreaks.
• 10 states have a formal access program or a program in progress for getting private sector healthcare staff and supplies into restricted areas during a disaster.
• 30 states and Washington, D.C. met or exceeded the overall national average score (6.7) of the National Health Security Preparedness Index (as of 2016).
• 32 states and Washington, D.C. received a grade of C or above in States at Risk: America’s Preparedness Report Card, a national assessment of state-level preparedness for climate change-related threats – which have an impact on human health.

In addition, the report examined trends in public health preparedness over the last 15 years, finding successes and ongoing concerns.

• One-third of funds for health security and half of funds for healthcare system preparedness have been cut: Health emergency preparedness funding for states has been cut from $940 million in fiscal year (FY) 2002 to $660 million in FY 2016; and healthcare system preparedness funding for states has been cut by more than half since FY 2005 – down to $255 million.
• Some major areas of accomplishment: Improved emergency operations, communication and coordination; support for the Strategic National Stockpile and the ability to distribute medicines and vaccines during crises; major upgrades in public health labs and foodborne illness detection capabilities; and improvements in legal and liability protections during emergencies.
• Some major ongoing gaps: Lack of a coordinated, interoperable, near real-time biosurveillance system; insufficient support for research and development of new medicines, vaccines and medical equipment to keep pace with modern threats; gaps in the ability of the healthcare system to care for a mass influx of patients during a major outbreak or attack; and cuts to the public health workforce across states.

The Ready or Not? report provides a series of recommendations that address many of the major gaps in emergency health preparedness, including:

• Requiring strong, consistent baseline public health Foundational Capabilities in regions, states and communities-so that everyone is protected.
• Ensuring stable, sufficient health emergency preparedness funding to maintain a standing set of foundational capabilities alongside a complementary Public Health Emergency Fund which would provide immediate surge funding during an emergency.
• Improving federal leadership before, during and after disasters – including at the White House level.
• Recruiting and training a next generation public health workforce with expert scientific abilities to harness and use technological advances along with critical thinking and management skills to serve as the Chief Health Strategist for a community.
• Reconsidering health system preparedness for new threats and mass outbreaks by developingstronger coalitions and partnerships among providers, hospitals, insurance providers, pharmaceutical and health equipment businesses, emergency management, and public health agencies.
• Prioritizing efforts to address one of the most serious threats to human health by expanding efforts to stop Superbugs and antibiotic resistance.
• Improving rates of vaccinations for children and adults – which are one of the most effective public health tools against many infectious diseases.

Ready or Not? was released annually from 2003-2012, and more recently, TFAH has released Outbreaks: Protecting Americans from Infectious Diseases, from 2013-2015.The report was supported by a grant from the Robert Wood Johnson Foundation (RWJF).

Score Summary:

A full list of all of the indicators and scores and the full report are available on TFAH’s website. For the state-by-state scoring, states received one point for achieving an indicator or zero points if they did not achieve the indicator. Zero is the lowest possible overall score, 10 is the highest. The data for the indicators are from publicly available sources or were provided from public officials.

10 out of 10: Massachusetts

9 out of 10: North Carolina and Washington

8 out of 10: California, Connecticut, Iowa, New Jersey, Tennessee and Virginia

7 out of 10: Colorado, Delaware, Florida, Indiana, Maryland, Michigan, New Hampshire, New Mexico, New York, North Dakota, Oregon, Rhode Island, South Carolina, Utah and Wisconsin

6 out of 10: Arizona, Arkansas, District of Columbia, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Maine, Minnesota, Mississippi, Montana, Nebraska, Ohio, Pennsylvania, Texas and Vermont

5 out of 10: Alabama, Missouri, Oklahoma, South Dakota and West Virginia

4 out of 10 Nevada and Wyoming

3 out of 10: Alaska and Idaho

NY Times

• “…..President Trump’s budget would cut funding for the National Institutes of Health by 18 percent.
• It would cut the State Department and the United States Agency for International Development, a key vehicle for preventing and responding to outbreaks before they reach our shores, by 28 percent.
• And the repeal of the Affordable Care Act would kill the billion-dollar Prevention and Public Health Fund, which provides funding for the Centers for Disease Control and Prevention to fight outbreaks of infectious disease.
• (While the budget also calls for the creation of an emergency fund to respond to outbreaks, there is no indication that it would offset the other cuts, or where the money would come from.)
• We are already witnessing an outbreak of influenza in birds — the H7N9 strain, in China — that could be the source for the next human pandemic. Since October, over 500 people have been infected; more than 34 percent have died. Most victims had contact with infected poultry, yet three recent clusters appear to be from person-to-person transmission. Will H7N9 mutate to become easily transmitted between humans? We don’t know. But without sufficient supplies of a vaccine, we are not prepared to stop it…….”

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…..”

GAO

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

Ricin Vaccine 

CDC:  Facts about Ricin

HHS

May 9, 2016

New York Magazine

FBI

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 phony pill sent to Le glows under ultraviolet light, just as real ricin would.

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

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.