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Radiation Injury Biomarkers, Germline Gene-Editing Moratorium, FMD Vaccine Stockpile

Credit: Shutterstock, modified

See what we’re reading this week at Global Biodefense on topics including: how the government’s failure to reauthorize the Pandemic and All Hazards Preparedness Act hampers the measles outbreak response; proposed rules for germline gene-editing; and an update on radiation injury biomarkers.

Quick Index

POLICY + INITIATIVES

Kadlec Testifies on Ebola Outbreak in the DRC and Other Emerging Health Threats

Video recording of HHS Assistant Secretary for Preparedness and Response Dr. Robert Kadlec’s testimony on 14 March before the Senate Appropriations Subcommittee on the Departments of Labor, Health and Human Services, and Education and Related Agencies on Ebola and other emerging health threats. Senate.gov

WHO Unveils ‘Triple Billion’ Health Security Targets

Wide-ranging reforms announced last week aim to modernize and strengthen the organization to support countries in achieving: one billion more people benefitting from universal health coverage (UHC); one billion more people better protected from health emergencies; and one billion more people enjoying better health and well-being. World Health Organization

The World’s Second-worst Outbreak of Ebola is Underway in Congo. Where is the Concern?

One major challenge is a lack of White House leadership. President Barack Obama created a special National Security Council team to oversee epidemic preparedness and response on a permanent basis. Trump retained the unit during his first year in office, but on the day that John Bolton took over as national security adviser in 2018, he dismantled the unit and ousted its leader, the widely respected Rear Adm. Timothy Ziemer. Perhaps fighting epidemics didn’t fit Bolton’s “hard power” view of security. Washington Post

Germline Gene-Editing Research Needs a Moratorium and Rules

“All ethically vetted and approved basic research studies that use gene-editing tools in human embryos and gametes, including those aimed at assessing efficacy and safety, should be deposited in an open registry. Second, researchers need to develop a system that allows early recognition of any research that risks overstepping predefined boundaries. A useful model to follow could be the WHO guidance for regulating research with a potential biosecurity risk. The system should include a mechanism — perhaps affiliated with the open registry — that allows researchers to flag up potentially dangerous research.” Nature

Measles Response Hampered by Emergency Programs Lapse at HHS

State and local health officials can’t be reassigned to tackle the measles outbreak because Congress let a health emergency program lapse, the head of HHS’s response teams told Bloomberg Law this week. The Pandemic and All Hazards Preparedness Act authorization expired Sept. 30, 2018. Bloomberg Law

Why the Scientific Debate Over a UW Bird Flu Study Isn’t Going Away

Yoshihiro Kawaoka is a virologist and professor at the UW School of Veterinary Medicine and the University of Tokyo who has figured prominently in Wisconsin’s long-term central role in flu research. Kawaoka’s work has been the focus of fierce debate ever since he announced in 2011 that his lab had successfully altered the H5N1 subtype of the influenza A virus to be transmittable through the air among ferrets. His research is now set to resume.  Global Biodefense

PREPAREDNESS + RESPONSE

Preparedness Field Assignee Program

The CDC program places PFAs in Public Health Emergency Preparedness (PHEP) recipient jurisdictions around the country to serve three-year terms. PFAs become embedded staff, assisting jurisdictions with public health preparedness planning and response efforts using the framework of the 15 Public Health Emergency Preparedness and Response Capabilities. Since the program’s inception in 2012, 45 field assignees have served in 22 states, three large metropolitan areas, and one U.S. territory. CDC State and Local Readiness

U.S. Government Beefs Up Presence Near Congo’s Ebola Epicenter

The CDC will be assigning about a dozen health experts to work in the DRC for a year and positioning at least some of them much closer to the epicenter. The last time U.S. personnel traveled anywhere near the outbreak zone in August 2019, when a team of three CDC experts and one USAID staffer arrived in the town of Beni. Days later a rebel group attacked a nearby military base and the U.S. State Department immediately ordered the U.S. team out. NPR

Preparing for a Potential Domestic Ebola Outbreak

ASPR outlines measures taken since the 2014 Ebola outbreak to improve preparedness including: providing $214 million to help establish a nationwide, regional treatment network for Ebola and other highly infectious diseases; enhanced training to NDMS personnel; and conducting the largest biocontainment patient movement exercise in HHS history. ASPR Blog

FAO, OIE, and WHO Launch a Guide for Taking a One Health Approach to Addressing Zoonotic Diseases

The Tripartite Zoonoses Guide (TZG) provides principles, best practices and options to assist countries in achieving sustainable and functional collaboration. It is flexible enough to be used for other health threats; for example, food safety and antimicrobial resistance (AMR). Options for monitoring and evaluating the function and impact of these activities are additionally included to support countries in their efforts to make improvements in their zoonotic disease frameworks. World Organisation for Animal Health

OUTBREAK NEWS + THREAT SURVEILLANCE

Ebola Epidemic in Congo Could Last Another Year, CDC Director Warns

Returning from a trip to the Democratic Republic of Congo, the agency chief also worried that vaccine supplies could run out. Dr. Redfield’s outlook was less optimistic than that of the director general of the World Health Organization, Dr. Tedros Adhanom Ghebreyesus, who said at a news conference on Thursday that his goal was to end the outbreak in six months. More than 87,000 people have received the vaccine, which is being donated by its manufacturer, Merck. So far, Merck has donated 133,000 doses and committed to keeping a stockpile of 300,000 doses, which it replenishes by making more vaccine whenever doses are deployed for outbreaks. NY Times

Pneumonic Plague in Dog and Widespread Potential Human Exposure in Veterinary Hospital

In December 2017, a dog that had pneumonic plague was brought to a veterinary teaching hospital in northern Colorado, USA. Several factors, including signalment, season, imaging, and laboratory findings, contributed to delayed diagnosis and resulted in potential exposure of >116 persons and 46 concurrently hospitalized animals to Yersinia pestis. Emerging Infectious Diseases

US Warship Quarantined at Sea Due to Virus Outbreak

One of the biggest threats to military readiness is contagious diseases. A US warship has essentially been quarantined at sea in the Persian Gulf region over two months and has been unable to make a port call due to an outbreak of a viral infection. Twenty-five sailors and Marines aboard the USS Fort McHenry amphibious warship have been diagnosed with parotitis, which causes symptoms similar to mumps. “Until CNN asked about the incident, the US military had not disclosed it.” The illness first broke out in December, with the most recent case being reported on March 9. All seven hundred and three military personnel aboard the ship have received measles, mumps and rubella (MMR) booster vaccinations.  CNN

MEDICAL COUNTERMEASURES

Are Animal Models a Necessity for Acute Radiation Syndrome Drug Discovery?

Animal models of acute whole body irradiation have a long history and have provided a platform for several key scientific discoveries. They are doing the same for radiation countermeasure drug development, and are currently irreplaceable for this purpose. Tthe use of other endpoints may delay the development of appropriate radiation countermeasures by inadvertently biasing research efforts towards non-classical or, worse, incorrect targets. Drug discovery focused within these models will also show how acute and late radiation diseases evolve over time and be of clinical value within and outside the field of countermeasures. Journal of Expert Opinion on Drug Discovery

Acute Radiation Syndrome: An Update On Biomarkers For Radiation Injury

Scientists in the radiation dosimetry field have reached a consensus that there is no perfect biomarker to assess absorbed radiation dose or associated injury under all conditions of exposure. A combination of complementary methods is needed to account for factors such whole-body, partial-body, and combined injury and effects from wounds or burns altering or complicating biodosimetric assessments. Journal of Radiation and Cancer Research

SLU Launches NIH-Funded Bird Flu Study

Saint Louis University continues the push to develop a vaccine for avian flu, amid concerns that the viruses could mutate to cause a potential pandemic. Funded by the National Institutes of Health, the research is part of the federal government’s pandemic preparedness strategy. Saint Louis University

Vaccitech Awarded BARDA Contract for Phase 2 Influenza A Vaccine Study

This new contract is for the advanced clinical development of its recombinant Modified Vaccinia Ankara (MVA) vaccine candidate for the prevention of seasonal and pandemic influenza A. The clinical trial will test the ability of the experimental vaccine to protect healthy adult study participants from a challenge with the A/Belgium/4217/2015 (H3N2) influenza virus strain and will commence in Q1 2019 at the SGS Life Science Services clinical site in Antwerp, Belgium. Precision Vaccinations

GAO Report Says USDA Should Up Its Game and Store More FMD Vaccine

“The United States is vulnerable to FMD transmission, given the large size and mobility of the U.S. livestock sector,” noted GAO. As of last year the U.S. had 94 million head of cattle, 74 million swine, 5 million sheep, and more than 2 million goats. Current vaccine supplies are only sufficient to protect about 14 percent of the cattle in Texas or 4 percent of Iowa’s swine, leaving all the rest in the country susceptible. It is not a new concern. The Agriculture Improvement Act of 2018 includes a provision to increase the FMD vaccine supply. Food Safety News

Bavarian Nordic Announces FDA Delay in the Review of the Biologics License Application for MVA-BN Smallpox Vaccine

The review of the company’s Biologics License Application (BLA) for the liquid-frozen formulation of the MVA-BN® smallpox vaccine will be extended by three months. The BLA was granted a priority review in December 2018, originally targeting a six months review process. However, the FDA has assessed that due the amount of data submitted during the review phase, the agency now requires more time and has extended the target PDUFA action date to September 2019. Bavarian Nordic

SPECIAL INTEREST

Gorilla Doctors Lead One Health Workshop on Ebolavirus in DRC

Gorilla Doctors recently convened a workshop as part of their USAID Emerging Pandemic Threats PREDICT project work to address the ongoing threat of the Ebola virus outbreak in the North Kivu Province of DRC to both people and gorillas. A group of frontline workers shared best practices in veterinary medicine and its significant contribution to disease monitoring and control using a One Health approach with a focus on the current Ebola outbreak. Gorilla Doctors

From Ricin to Fires to Fentanyl….How Can We Clean It Up?

At this year’s Preparedness Summit March 26-29 in St. Louis, EPA researchers will share decontamination methods, case studies, and demo emergency response tools that can be used in disaster response and remediation following acute environmental contamination incidents. NACCHO

Experiments Making Deadly Influenza Virus More Contagious In Mammals Are Resuming

Why the Scientific Debate Over a UW Bird Flu Study Isn’t Going Away

Non-Medical Obstacles (NMO) Impacting Public Health Responses

Non-Medical Obstacles Impacting Public Health Responses