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Contents
FEATURED
Inside the Effort to Repurpose a Manufacturing Platform to Produce COVID-19 Vaccines
When used in combination with ultraviolet light of specific wavelengths, riboflavin can alter genetic material, whether RNA or DNA, of infectious pathogens in the blood, making them unable to transmit disease, but preserving the viral proteins in order to produce effective antibodies. This experimental vaccine construct, called SolaVAX, is undergoing animal testing and further laboratory characterization, such as studying the nature of the damage to the viral RNA that this process induces and its immunological effect when given to animals. READ MORE
WVU Center for Inhalation Toxicology Unmasks Effective N95 Alternatives
WVU iTOX research engineers have developed two alternative face coverings that are as effective at blocking novel coronavirus as those highly-coveted N95 masks. You may even have some of the materials to make them: a home furnace filter and a 3D printer. READ MORE
New COVID-19 Data Tools Coming Online to Help Tackle Pandemic
As researchers and organizations grapple with enormous amounts of data, more and more portals and dashboards are coming online. EMBL-EBI has launched a new COVID-19 data portal; WHO has overhauled their dashboard and released a mobile friendly version; UC Davis released a data visualization tool…(more at link)… READ MORE
CDC Coronavirus Test Kit Failure Due to Contamination
The CDC facilities that assembled the kits violated sound manufacturing practices, resulting in contamination of one of the three test components. Fallout from the agency’s failed rollout of national coronavirus kits two months ago continues to haunt U.S. efforts to combat the spread of the highly infectious virus. READ MORE
POLICY + INITIATIVES
SAFE Act Introduced to Improve Strategic National Stockpile
Under current law, the SNS cannot accept donation of equipment or medical countermeasures without going through a complex transaction with HHS and GSA. In practice, very few of these donations are accepted because of this complexity. The Stockpiling for America’s Future Endeavors (SAFE) Act would allow the Secretary of HHS to authorize these donations directly and place them into the stockpile for disbursement. READ MORE
Disease Containment Policies Much Harder to Implement in Dense Communities That Lack Running Water
Disease containment policies are much harder to implement for communities that lack running water, are made up of overcrowded township housing, and entirely rely on informal and in-person work. A single 20-second wash plus wetting and rinsing uses at least two liters of water, more than half a gallon—an unimaginable luxury in much of the world. READ MORE
+ Google Releases COVID-19 Community Mobility Reports
+ HHS Announces Ventilator Contract with Philips under Defense Production Act
+ A National Plan to Enable Comprehensive COVID-19 Case Finding and Contact Tracing in the US .pdf
FRONTLINE RESPONDERS
Designing Face Shields to Protect Medical Staff During Critical Supply Shortages
A team of Montreal medical experts has partnered with a 3D printing company to design and distribute face shields to protect healthcare workers as they treat patients with this life-threatening disease. The researchers have published their open source, adapted design files for anyone to use. READ MORE
NIST Tool Could Help Hospitals Repurpose Rooms for Disinfecting N95 Masks
A new tool from the National Institute of Standards and Technology (NIST) can help hospitals and medical professionals determine which rooms should be used to disinfect N95 masks using vaporized hydrogen peroxide. The tool estimates the amount of VHP masks would receive and suggests that larger rooms containing fewer objects, with less-reactive surfaces and slower ventilation, maintain VHP concentration the best. READ MORE
+ DuPont to Produce up to 4.5 Million TYVEK Protective Suits for U.S. Healthcare Workers
MEDICAL COUNTERMEASURES
JPEO-CBRND, BARDA Partner with SAb Biotherapeutics to Develop COVID-19 Therapeutic
The therapeutic, called SAB-185, is part of a new class of immunotherapies that relies on SAb’s platform technology to produce fully human polyclonal antibodies as the basis for the drug. This technology produces the antibodies without the need for blood donations from people who have recovered from the virus; this approach produces greater quantities of the drug than the traditional human antibody donor methods. READ MORE
HHS Facilitates Development of Immunotherapies for COVID-19 Patients
BARDA will collaborate with multiple non-government organizations on the development of convalescent plasma and hyperimmune globulin immunotherapies, providing support to the American Red Cross; Emergent BioSolutions of Gaithersburg, Maryland; Grifols USA of Los Angeles, California, and SAb Biotherapeutics, Inc. of Sioux Falls, South Dakota. READ MORE
Ridgeback Receives UK Clearance to Begin Human Testing of Antiviral for COVID-19
EIDD-2801, which has been shown to treat MERS and SARS, essentially tricks RNA viruses into including the wrong building blocks as it tries to reproduce itself. This leads to dramatically reduced levels of virus in animals infected with a wide variety of RNA viruses. READ MORE
Convalescent Plasma: Johns Hopkins Releases Guidebook, Penn Medicine and UChicago Start Trials
A team of Johns Hopkins experts has created a clinical guidebook to help hospitals and medical centers rapidly scale up their ability to deliver so-called convalescent plasma therapy. Among the protocols outlined in the guide are criteria for eligible donors of blood plasma, how hospitals can mobilize donors and work with local and national blood centers, methods for prescreening donors, and the risks and potential benefits of the therapy. READ MORE
Novartis to Start Large, Randomized Trial of Hydroxychloroquine in Hospitalized COVID-19 Patients
Novartis has reached an agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial with approximately 440 patients to evaluate the use of hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease. READ MORE
FDA Accepts for Priority Review for REGN-EB3 to Treat Ebola
The REGN-EB3 BLA is supported by data from the randomized, controlled PALM clinical trial conducted in the Democratic Republic of Congo. In August 2019, the trial was stopped early when preliminary results showed that REGN-EB3 crossed the pre-specified superiority threshold for preventing death compared to the control arm, ZMapp. REGN-EB3 demonstrated superior efficacy compared to ZMapp across multiple measures, including reduced mortality and fewer days until the Ebola virus was no longer detected in the bloodstream. READ MORE
+ FDA Approves Ridgeback Biotherapeutics to Begin Human Testing of Potential Treatment for COVID-19
+ INOVIO Initiates Phase 1 Clinical Trial of COVID-19 Vaccine Candidate
+ Alexion to Initiate Phase 3 Study of Rare Blood-Disorder Drug in Severe COVID-19 Patients
+ BARDA and Sanofi Prepare for Studies of COVID-19 Vaccine
+ Eli Lily Begins Clinical Testing of Rheumatoid Arthritis Drug for Potential Effect in COVID-19
+ Rapid Lab-Free PCR COVID-19 Test in Development by DnaNudge and Imperial College
+ BARDA and Genentech to Accelerate Phase 3 Clinical Trial of a Novel COVID-19 Therapeutic Treatment
+ Arrakis Therapeutics Enters Strategic Collaboration and License Agreement with Roche
SURVEILLANCE + DIAGNOSTICS
UK Launches Wide-Area Biosensor Competition
The Defence and Security Accelerator (DASA) competition is seeking innovative technologies for Phase 2 of a Wide-Area Biosensor program that aims to find an improved way to rapidly detect and locate hazardous biological agents in the field. The focus of this effort is on sensors and data processing/visualisation, not on hosting platforms (such as remotely controlled or unmanned systems) or the integration of existing sensors upon platforms. READ MORE
WashU Researchers Granted Federal Funding for Plasmonic-Fluor Rapid SARS-CoV-2 Test
Gold nanoparticles coated with conventional dyes create an ‘ultrabright flashlight’ nanolabel capable of detecting extremely small amounts of target biomolecules. The nanoprobe can also help in resource-limited conditions because it requires fewer complex instruments to read the results. READ MORE
Nanomix to Develop Both Rapid SARS-CoV-2 Diagnostic and Serology Assay with Boost from HHS
BARDA will support advanced development of the point-of-care diagnostic system for in vitro diagnostics assays. The platform consists of a hand-held reader and an integrated, self-contained, disposable, assay cartridge. READ MORE
OraSure Gains BARDA Backing for First Rapid COVID-19 Home Testing Kit
OraSure will use funding from BARDA towards developing and filing an EUA for a pan-SARS-coronavirus antigen rapid in-home self-test that uses oral fluid samples. OraSure has a well-documented history of success with in-home infectious disease testing; the Company’s oral fluid self-test for HIV has been used to diagnose millions of people around the world. READ MORE
Washington State Recalls 12,000 COVID-19 Test Kits Due to Possible Contamination
A small number of tubes of viral transport media alerted UW Medicine to a quality control issue, prompting the Washington State Department of Health to proactively recall thousands of test kits sent to local health jurisdictions, tribal nations and state agency partners. READ MORE
BARDA and Hememics Collaborate to Develop Rapid Diagnostic to Identify SARS-CoV-2
The test is being designed to detect SARS-CoV-2 antigen from nasal swab samples and associated antibodies in 60 seconds or less through a finger-prick. READ MORE
+ Abbott Launches Laboratory-Based Antibody Blood Test with Manufacturing Scaling Targets
+ Large Scale Testing Initiative Launched by UM School of Medicine
HEADLINES
- Nothing About NYC’s High Outbreak Numbers Was Inevitable
- Health Care Workers Seek Legal Immunity During Pandemic Response
- Hospitals Need Dialysis Equipment as Thousands of Coronavirus Patients Develop Kidney Problems
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