Pandora Report 6.22.2018

 US Military Asks – What Would A SynBio Weapon Look Like?
A new study ordered by the DoD seeks to evaluate the potential for synthetic biology to be a biodefense threat. The report, Biodefense in the Age of Synthetic Biology, was issued by the National Academies of Sciences, and provides an actual ranking of national security threats that genetic engineering technology, like CRISPR, pose. “’Synthetic biology does expand the risk. That is not a good-news story,’ says Gigi Gronvall, a public health researcher at Johns Hopkins and one of the report’s 13 authors. ‘This report provides a framework to systematically evaluate the threat of misuse’.” The report includes a framework for assessing synbio capabilities as well as concerns related to the production of chemicals or biochemicals, bioweapons that alter the human host, pathogens, etc. The report also includes a section on related developments that impact the ability to effect an attack using a synthetic biology-enabled weapon, where the authors note several mitigation challenges posed by synbio. Some of the challenges to deterrence and prevention include accessibility of biotechnology, pointing to DIY biohackers, the iGEM competition, and traditional pathways like academic laboratories. Regarding the challenges in recognizing and attributing an attack, they note that “synthetic biology could also confound the ability to identify the causative agent in a biological attack. Despite the breadth and depth of available repository resources, there would not always be a reference specimen to use as comparator, particularly if the agent is markedly different from natural pathogens or toxins.” “According to the report, the US must now also track ‘enabling developments’ including methods, widely pursued by industry, to synthesize DNA strands and develop so-called chassis’ organisms designed to accept genetic payloads.” Consider the recent de novo synthesis of the horsepox virus by researchers in Canada that has opened up Pandora’s box regarding synbio and biosecurity. GMU Biodefense professor and graduate program director Gregory Koblentz noted that “Synthetic biology has provided the tools necessary to recreate the smallpox virus,” and “Safeguards against the misuse of those tools are weak and fragmented.”  “The US government should pay close attention to this rapidly progressing field, just as it did to advances in chemistry and physics during the Cold War era,” says Michael Imperiale, a microbiologist at the University of Michigan. The recent tabletop hosted by the Center for Health Security (Clade-X) even presented some real-world scenarios and gaps for dealing with a bioterrorism event that involved an engineered organism.

Gene Drives and Frank Discussions With CRISPR Scientists
Speaking of gene editing…GMU Biodefense professor Sonia Ben Ouagrham-Gormley recently sat down with Vox to discuss the good and bad side of gene drives in the context of genetically modified mosquitos and their place in the fight against malaria. Malaria kills hundreds of thousands a year and despite eradication efforts, it’s still a monumental task for public health. “We have eliminated malaria from the rich world; it used to be endemic to France just as it is to Mali today. And now, with CRISPR gene drives, we have the potential to wipe it out globally and save millions of lives. Gene drives allow humans to change the genetic makeup of a species by changing the DNA of a few individuals that then spread the modification throughout an entire population. In the case of malaria, the idea is to change the three species of mosquito most responsible for its transmission — Anopheles gambiae, Anopheles coluzzii, and Anopheles arabiensis — so that all their offspring would be male, effectively leading to the species’ extinction.” The debate though is that if gene drive was used poorly, it could cause irreversible changes in the ecosystem. Many worry about the potential for weaponization of gene drives or nefarious actors using it, but several biosecurity experts have pointed to the limitations of gene drive when it comes to making diseases more potent. “The biosecurity experts I talked to are deeply skeptical of those nightmare scenarios. Sonia Ben Ouagrham-Gormley, a professor in the biodefense program at George Mason University, says she doubts gene drives will be militarily effective in targeting rival countries’ harvests. ‘Animals and plants that are raised for food are generally monitored, and a gene drive can be easily detected in the genome of the animal,’ she explained. ‘Because of that regular monitoring, I don’t think gene drives would be a good tool for affecting a country via agriculture.’ Biosecurity experts like Ben Ouagrham-Gormley and Filippa Lentzos have concerns that are more social. “What happens if one of the few thousand fruit fly biologists around the world decides to act unilaterally and throws international talks on the matter into chaos? What if a grad student creates a gene drive that can’t reliably hurt people but can reliably terrify them?” If she wasn’t busy enough, Sonia Ben Ouagrham-Gormley recently returned from a research trip to China where she met with several CRISPR scientists and toured their laboratories. She discussed CRISPR developments in China and gave a talk at the University of the Chinese Academy of Sciences in Beijing (UCAS) on the technological, regulatory and technical challenges of CRISPR.

Summer Workshop on Pandemics, Bioterrorism, and Global Health Security
We’re less than a month away from the workshop on all things health security, are you registered? Since we’re on the topic of biotechnology and biosecurity, our workshop is a great chance to hear from Supervisory Special Agent Edward You of the FBI’s WMD Directorate, Biological Countermeasures Unit. “Mr. You is responsible for creating programs and activities to coordinate and improve FBI and interagency efforts to identify, assess, and respond to biological threats or incidents. These efforts include expanding FBI outreach to the Life Sciences community to address biosecurity. Before being promoted to the Weapons of Mass Destruction Directorate, Mr. You was a member of the FBI Los Angeles Field Office Joint Terrorism Task Force and served on the FBI Hazardous Evidence Response Team.” Don’t miss Mr. You’s talk on the bioeconomy and biosecurity threats during this three-day workshop on all things biodefense!

WHO Releases New International Classification of Disease (ICD11)
The World Health Organization (WHO) released the latest ICD-11, which includes 55,000 codes for specific injuries, diseases, and causes of death. “The ICD is also used by health insurers whose reimbursements depend on ICD coding; national health programme managers; data collection specialists; and others who track progress in global health and determine the allocation of health resources. The new ICD-11 also reflects progress in medicine and advances in scientific understanding. For example, the codes relating to antimicrobial resistance are more closely in line with the Global Antimicrobial Resistance Surveillance System (GLASS). ICD-11 is also able to better capture data regarding safety in healthcare, which means that unnecessary events that may harm health – such as unsafe workflows in hospitals – can be identified and reduced.”

Ebola Virus Disease Outbreak Updates
The DRC has reported 5 more suspected cases in the Iboko health zone, which brings the total to 60 cases, included 28 deaths (38 confirmed, 14 probable, and 8 suspected) as of June 19th. The case fatality rate for this outbreak is at 47% and “‘The number of contacts requiring follow-up is progressively decreasing, with a total 1,417 completing the mandatory 21-day follow-up period,’ the WHO said. As of Jun 17, a total of 289 contacts were still being monitored.” WHO Director General Tedros Adhanom Ghebreyesus recently tweeted “Just over a month into the response in , further spread has largely been contained. In spite of progress, there should be no room for laxity and complacency until it’s finally over. This is a collaborative effort led by

 MERS Trends in Saudi Arabia – Hospitals and Households
Since January of this year, the WHO has reported 75 laboratory confirmed MERS-CoV cases and 23 deaths in Saudi Arabia. 21 of these cases were involved in four clusters (2 household and 2 healthcare) – “Cluster 1: From 2 through 4 February, a private hospital in Hafer Albatin Region reported a cluster of three (3) health care workers in addition to the suspected index case (four [4] cases in total). Cluster 2: From 25 February through 7 March, a hospital in Riyadh reported six (6) cases, including the suspected index. No health care workers were infected. Cluster 3: From 8 through 24 March, a household cluster of 3 cases (index case and 2 secondary cases) was reported in Jeddah. No health care workers were infected. Cluster 4: From 23 through 31 May, a household cluster was reported from Najran region with eight cases including the suspected index case. This cluster is still under investigation at the time of writing. As of 31 May, no health care workers have been infected and the source of infection is believed to be camels at the initial patient’s home.” The total number of MERS cases since 2012 is now 2,220. These clusters underscore the role of hospitals as amplifiers for MERS transmission during outbreaks and the importance of infection prevention efforts.

Infection Prevention Gaps Found Across Critical Access Hospitals
GMU Biodefense doctoral student Saskia Popescu addresses infection prevention failures and gaps within the United States and specifically in critical access hospitals. “These findings are not novel as staffing issues are problematic across the country in all types of hospital systems. The importance of having IPs within health care and ensuring they have access to training and the ability to focus on infection control activities—not just reporting tied to CMS reimbursement—is critical. IPs need time for activities such as education, rounding, antibiotic stewardship, and more. This study supports the notion that not only should hospitals be ensuring proper staffing and support for infection prevention programs, but that significant gaps exist across CAHs. In the areas where CAHs are the only health care patients may access, it is vital that infection prevention processes be supported and followed”

How Ready Is the United States For The Next Anthrax Attack?
This week the CDC reviewed their recommendations for mass vaccination in the event of an anthrax attack. “The way that people think about [nuclear weapons] is on a much, much grander scale than biological weapons, and I think that’s a misperception,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. “If you use a contagious infectious disease, you really could create havoc on a different scale.” The Amerithrax attack was in 2001 and since then we’ve seen SARS, MERS, and Ebola as potential infectious disease threats that reveal a rather large spectrum of avenues for microbial events. “But there’s still a long way to go in terms of preparedness, Redlener said, adding that no city is fully prepared. Questions remain about what dosage of the vaccine to use for children, the safety of the vaccine for the general public, delivery and distribution of the vaccine and medications. ‘I think a vaccination program would be a nightmare. Who would administer it? Who would pay for it? Who would manufacture it? The cost of complications that may occur. I don’t think it would be practical,’ Redlener said.”

Stories You May Have Missed:

  • Gene-edited Farm Animals – “The team edited the animals’ DNA to make them resist the deadly respiratory disease known as PRRS – a move that could prevent billions of pounds in losses each year. However, consumers have traditionally been reluctant to eat genetically altered animals and crops. This poses a significant barrier to farmers owning gene-edited pigs. And because genome, or gene, editing (GE) is relatively new, the absence of regulation currently prevents their sale anyway.”
  • FDA Releases New Food Defense Guidance – “Today the US Food and Drug Administration (FDA) released the first of three installments of draft guidance on the intentional adulteration (IA) rule, part of the Food Safety and Modernization Act (FSMA). The rule is meant to guide the food industry on reducing the risk of exposing food facilities to IA, such as acts of terrorism. Unlike other FSMA rules that address specific foods or hazards, IA will require preventive measures for reducing vulnerabilities at all domestic and foreign companies that are required to register with the FDA as food facilities.”

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