News highlights on health security threats and countermeasures curated by Global Biodefense
This week’s selections include GAO recommendations to course-correct vaccination efforts; investigations into misspending biopreparedness funds; and the challenges of forensic attribution of engineered biothreats.
POLICY + INITIATIVES
Critical Vaccine Distribution, Supply Chain, Program Integrity, and Other Challenges Require Focused Federal Attention
In this report, GAO is making 13 recommendations to federal agencies to improve the ongoing response and recovery efforts in the areas of public health and the economy. As the new Congress and administration establish their policies and priorities for the federal government’s COVID-19 response, GAO urges swift action on these 13 recommendations, as well as on the additional recommendations that GAO has made since June 2020 (27 of GAO’s 31 previous recommendations remained unimplemented by the prior administration as of Jan 2021). GAO
WHO Team in Wuhan Departs Quarantine for COVID Origins Study
A World Health Organization team emerged from a 14-day in-country quarantine period in Wuhan on Thursday to start field work in a fact-finding mission on the origins of the virus that caused the COVID-19 pandemic. The mission has been plagued by delays, concern over access and bickering between China and the U.S., which has accused China of hiding the extent of the initial outbreak and criticized the terms of the visit, under which Chinese experts conducted the first phase of research. Associated Press and Reuters
HHS Authorizes Retired, Former Health Care Workers to Administer COVID-19 Vaccines to Expand Vaccinator Workforce
An amendment to the PREP Act issued today authorizes any active healthcare provider who is licensed or certified in a state, or provider with an expired license/certification within the past 5 years and in good standing at the time of expiry, to and administer COVID-19 vaccines in any other state or U.S. territory. All must complete CDC COVID-19 Vaccine Training, and those with expired licenses require an on-site observation period by a currently practicing professional. HHS.gov
Disclosure of Wrong-Doing: HHS Misused Millions of Dollars Intended for Vaccine Research, Emergency Preparedness
HHS OIG report generated after a whistleblower complaint contains evidence that ASPR used BARDA’s research funds to pay for myriad expenses unrelated to the mission. The report reveals that the practice of using BARDA funds for non-BARDA purposes was so common, there was even a name for it within the agency: “Bank of BARDA.” HHS OIG determined that ASPR had “violated the Purpose Statute” and “potentially violated the Antideficiency Act.” U.S. Office of Special Counsel
Millions Earmarked for Public Health Emergencies Were Used to Pay for Unrelated Projects, Inspector General Says
The Obama administration’s top emergency-preparedness official, who was named in the report, defended the agency’s use of BARDA funds as appropriate. “All expenditures were done in a routine way,” said Nicole Lurie, who led the umbrella office known as ASPR at the time. “BARDA was part of ASPR and had a shared mission and used common resources,” Lurie added, noting that the OIG faulted spending decisions — such as using BARDA funds to pay for ASPR contracting officers — that she said helped the agency expedite dozens of medical products to help fight public health emergencies. Washington Post
The Pandemic Paradox: Hope and Hardship, in Equal Measure
Today the world will exceed 100 million confirmed COVID-19 cases. Continued high rates of transmission and emerging COVID-19 variants of concern, have raised the urgency of the task to vaccinate priority groups. The increasing expectation of science, and vaccine development, production and equitable distribution, is not being met quickly enough. World Health Organization
House Opens Investigation of Pandemic Ventilator Purchases Overseen by White House
A House subcommittee is investigating a government deal to buy $70 million worth of ventilators for the coronavirus pandemic response that a Washington Post investigation found were inadequate for treating most covid-19 patients.
Washington Post
MEDICAL COUNTERMEASURES
Adenovirus-Vectored Johnson & Johnson SARS-CoV-2 Vaccine: Reassuring Initial Results
In a phase 1–2 trial, a single dose of the Ad26.COV2.S vaccine (which uses a replication-incompetent adenovirus) appeared safe and immunogenic. After vaccine administration in 805 participants (both cohorts) the most frequent adverse events were fatigue, headache, myalgia, and fever. Reactogenicity was lower in older individuals (cohort 3) and in those receiving the low dose. Neutralizing antibodies were present in 90% of participants on day 29 after the first dose (irrespective of dose and cohort) and reached 100% by day 57. NEJM Journal Watch
COVID-19 Monoclonal Antibody Treatments: Using Evolving Evidence to Improve Care in the Pandemic
Monoclonal antibodies (mAbs) for COVID-19 had shown promising results in limited trials, but new findings from ongoing trials in combination with previous data solidify the key role of therapeutic antibodies to reduce death and disability from COVID-19. Trials studying four mAbs manufactured by Eli Lilly and Regeneron show fewer complications leading to hospitalization or death for patients early in the course of illness and before they progress to breathing problems or other significant symptoms. Duke Margolis Center for Health Policy
Is Drug Repurposing Worth the Effort? Lessons from the Pandemic
While several drugs received emergency use authorizations by the US Food and Drug Administration, just one drug—Gilead Sciences’ antiviral remdesivir—has been approved globally to treat COVID-19. But even that one repurposing success story comes with caveats. Chemical & Engineering News
Coronavirus: Germany Set to Limit AstraZeneca Jab to Under-65s
Germany’s vaccine committee has said AstraZeneca’s Covid jab should only be given to people aged under 65. The committee cited “insufficient data” over its efficacy for older people. The European Medicines Agency is to decide on Friday whether to approve the vaccine for use across the EU. The German announcement comes as the EU is in dispute with leading manufacturers over a shortage of vaccines on the continent. BBC News
Novavax Says Its Covid-19 Vaccine Is 90% Effective, Except on Variant First Found in South Africa
In its 15,000-volunteer U.K. trial, Novavax said, the vaccine prevented nine in 10 cases, including against a new strain of the virus that is circulating there. But in a 4,400-volunteer study in South Africa, the vaccine proved only 49% effective. In the 94% of the study population that did not have HIV, the efficacy was 60%. STAT News
Potential Solutions to the COVID-19 Oxygen Crisis in the United States
During COVID-19 surges, parts of the U.S. experienced shortages of wall oxygen in hospitals as well as portable oxygen (cylinders and concentrators) in hospitals and medical facilities and for at home and emergency use. Lessons learned and remaining gaps are identified in this paper. JHSPH Center for Health Security
In A Major Setback, Merck to Stop Developing Its Two Covid-19 Vaccines
Results from a Phase 1 trial had resoundingly disappointing immune response results. Work will continue on at least one of the vaccines to see if using an oral or intranasal administration route improves how effective it is. STAT News
Sanofi to Produce 100 Million Pfizer/BioNTech Vaccine Doses
As Sanofi and its British partner GlaxoSmithKline have delayed the launch of their shot to late 2021, the French company decided to approach Pfizer “in order to be helpful as of now”, CEO Paul Hudson said, adding that an agreement with the U.S. company had been reached to produce more than 100 million doses by the end of the year. Reuters
India Is at Centre Of Global Vaccine Manufacturing, But Opacity Threatens Public Trust
With the second largest population and one of the biggest pharmaceutical manufacturing capacities in the world, India has a central role in the covid-19 vaccination effort. But hurried approval of its own vaccine, Covaxin, threatens to undermine domestic trust. BMJ
Hacking the Skin Microbiome to Fool Mosquitos and Prevent Malaria
Long-lasting protection is the goal of DARPA’s ReVector project, which seeks to design a safe repellent that will prevent mosquito bites for up to two weeks after a single application by temporarily modulating the skin microbiome to adjust a person’s ‘odor plume’ – the olfactory cues that guide female mosquitoes to their mark. NeoLife
BIOSECURITY + BIOPREPAREDNESS
Time to Double Down on DoD Investments in Platform Technologies for Combating Biological Threats
Within the DoD’s Chemical and Biological Defense Program (CBDP), support for platform-based approaches has waxed and waned over time. In 2006, the Transformational Medical Technology Initiative was created to start shifting the Pentagon away from the slow, inflexible and expensive strategy of tailoring medical countermeasures to specific, identified biothreats, often referred to as a one-bug, one-drug approach. The initiative has had some success in moving the DoD towards a faster, more flexible, and more cost-effective response to reducing biothreats. A significant part of the effort was devoted to platform technologies. Council on Strategic Risks
Public Health Systems Still Aren’t Ready for the Next Pandemic
Understaffed and hobbled by data systems that relied on telephones and fax machines to manage an avalanche of testing and new patient information, many state, city and county public health agencies fumbled. Public health agencies must now fill empty positions in a politically fraught environment, carry out a massive vaccination program that’s off to a rocky start and continue to manage ongoing crises such as substance use disorders and chronic diseases. Pew Charitable Trusts
Texas Lawmaker Proposes $3 Billion State Plan to Fight Future Pandemics
State Sen. José Menéndez, D-San Antonio, has proposed creating a state agency – funded with up to $3 billion in taxpayer-backed bonds over 10 years – to provide grants for research into emerging infectious diseases and development of vaccines and other treatments for them. The idea is modeled on the state’s cancer-fighting agency, which voters approved a $3B bond for in 2007. Austin American-Statesman
The Apollo Program for Biodefense: Winning the Race Against Biological Threats
A large team of experts was consulted during four roundtables to brainstorm solutions for the following goals: “Ambitious pathogen biosurveillance innovations; Improving PPE and built environments; Advancing medical countermeasures to combat biological threats; and Ambitious improvements to microbial forensics and attribution.” Along with extensive research, the Commission used the input from these experts to outline core technology that the federal government would best prioritize to achieve these goals. Bipartisan Commission on Biodefense via HSDL
Having Pandemic Panic Attacks About Virus Variants? National Preparation is the Cure
The lesson that we should be drawing is the one that the pandemic keeps teaching, but that the world and, especially, the U.S., fails to learn. The response to the pandemic so far has been like a fractal pattern that repeats itself over and over again at a different scale. We’re disorganized, we’re not ready, we don’t heed warnings, we don’t plan ahead. STAT News
Pandemic Shows Need for Biological Readiness
As bad as this pandemic is, imagine if instead it were caused by the deliberate release of a sophisticated biological weapon. Less than 2 percent of those infected have died of COVID-19, while a disease such as smallpox kills at a 30 percent rate. A bioengineered pathogen could be even more lethal. Our failed response to the pandemic in 2020 has exposed a gaping vulnerability to biological threats, ranging from natural outbreaks to deliberate biological weapons attacks. Arms Control Association
First in the Nation: COVID-19 Initial Response After-Action Report
In late February 2020, first responders and health officials detected what appeared to be an outbreak of flu-like symptoms in a number of patients living in a long-term care facility in Kirkland, Washington. This report focuses on organizational impacts of the pandemic on City of Kirkland departments and the City’s ability to maintain general government operations and service provision. City of Kirkland, WA
SELECT AGENTS + CBRNE THREATS
Federal Select Agent Program (FSAP) Webinars
In 2020, due to the COVID-19 pandemic, the Federal Select Agent Program (FSAP) replaced its annual in-person workshop for Responsible Officials and Alternate Responsible Officials with a series of five webinars. Each webinar was designed to provide participants with information related to compliance with the select agent regulations, and updates from FSAP on a variety of topics. The presentations are now available for download. SelectAgents.gov
Antibodies Periodically Wax and Wane in Survivors of Ebola
Little is known about the immunological memory of past Ebola infection. Researchers tracked immunoglobulins in 115 Ebola survivors for up to 500 days after infection. They found a rapid decline in IgG levels after recovery. However, a substantial proportion of survivors experienced antibody resurgence approximately 200–300 days after recovery; the antibody levels then decayed again. This ‘decay–stimulation–decay’ pattern suggests new antigenic stimulation without overt disease or detectable levels of virus. Nature and The Scientist
New Algorithms Developed to Attribute Origins of Genetically Engineered DNA
To advance genetic engineering attribution, altLabs sponsored in partnership with the Johns Hopkins Center for Health Security, the Johns Hopkins University Applied Physics Laboratory, and the iGEM Safety and Security Program the Genetic Engineering Attribution Challenge. While the top algorithms from the competition were highly effective at identifying where genetically engineered sequences were designed, they could not identify whether a given sequence, or the microbe that contains it, was engineered in the first place. Center for Health Security
IARPA’s Bioweapon Detection Tools Have Difficulty Finding What They’re Not Looking For
The pandemic has also put the spotlight on the Intelligence Advanced Research Projects Activity’s (IARPA) Finding Engineering-Linked Indicators (FELIX) program, an effort launched in 2018 to develop tools that can detect the fingerprints of bioengineered organisms. One FELIX program participant, MIT-Broad Foundry, analyzed the publicly available SARS-CoV-2 genome to test the possibility that the virus had been engineered. Forbes
West Point Biochemist Warns About Threat of Bioweapons
In this episode of Intelligence Matters, host Michael Morell speaks with Dr. Ken Wickiser, a biochemist and associate dean of research at U.S. Military Academy West Point, about his piece “Engineered Pathogens and Unnatural Biological Weapons: The Future Threat of Synthetic Biology.” Wickiser describes the growing influence of synthetic biology and what can happen if misused. CBS News
Engineered Pathogens and Unnatural Biological Weapons: The Future Threat of Synthetic Biology
The COVID-19 pandemic has demonstrated that significant biological threats can and will emerge from nature without warning, demonstrating that a single viral strain can have a profound impact on modern society. It has also demonstrated that infectious diseases can rapidly spread throughout a population without human engineering making them the ideal substrates from which to develop engineered weapons. Combating Terrorism Center
Navalny Poison Squad Implicated in Murders of Three Russian Activists
Bellingcat extends their investigative journalism on members of a clandestine unit within the FSB’s Criminalistics Institute, linked to the chemical weapons poisoning of opposition leader Alexey Navalny, and matches the movements of the FSB’s ‘poison squad’ with the suspicious deaths of three public figures between 2014 and 2019. Bellingcat
Asymptomatic Infection of Marburg Virus Reservoir Bats Is Explained by a Strategy of Immunoprotective Disease Tolerance
These findings offer the first in vivo functional evidence for disease tolerance as an immunological mechanism by which the bat reservoir asymptomatically hosts MARV. More broadly, these data highlight factors determining disparate outcomes between reservoir and spillover hosts and defensive strategies likely utilized by bat hosts of other emerging pathogens. Current Biology
Purification of Crimean–Congo Hemorrhagic Fever Virus Nucleoprotein and Utility for Serological Diagnosis
CCHF is not monitored in most of the endemic countries due to limited availability of diagnostic assays and biosafety regulations required for handling infectious CCHFV. These results demonstrate the usefulness of a CCHFV NP-based ELISA for seroepidemiological studies. Scientific Reports
SURVEILLANCE + DETECTION
Virus Variant from South Africa Detected in US For 1st Time
A new coronavirus variant identified in South Africa has been found in the United States for the first time, with two cases diagnosed in different regions of South Carolina. Neither of the people infected has traveled recently. The Biden Administration imposed a travel ban on most non-U.S. citizens entering the country who had recently been in South Africa beginning 30 Jan. due to concerns about the variant. Associated Press
Evaluation of Endpoint PCR as a Diagnostic Technology for SARS-Cov-2
UK BioCentre Ltd (UKBC) evaluated EPCR molecular testing technologies, which are designed as high-sensitivity, ultra-high capacity (more than 150,000 tests per day, per instrument) diagnostic assays to detect SARS-CoV-2 RNA extracted from combined throat and nose swab specimens. GOV.UK
Abbott’s Panbio Antigen Test Obtains New EU Approvals for Mass COVID-19 Screening
Abbott has received new COVID-19 diagnostic approvals in Europe for its rapid Panbio antigen test, clearing it for self-performed screening under supervision as well as widespread use by people who have not shown symptoms of the disease. The Panbio lateral flow test, unavailable in the U.S., operates much like the company’s card-sized BinaxNOW nasal swab rapid antigen test. Fierce Biotech
Prevalence of SARS-CoV-2 Antibodies in First Responders and Public Safety Personnel, New York City
This serologic survey of 22,647 public service participants in New York City (conducted May-July 2020) showed 22.5% positive for SARS-CoV-2–specific antibodies. Seroprevalence for police and firefighters was similar to overall seroprevalence; seroprevalence was highest in correctional staff (39.2%) and emergency medical technicians (38.3%) and lowest in laboratory technicians (10.1%) and medicolegal death investigators (10.8%). Emerging Infectious Diseases
Bioaerosol Sampling For SARS-Cov-2 In A Referral Center with Critically Ill COVID-19 Patients
Previous research has shown that rooms of patients with COVID-19 present the potential for healthcare-associated transmission through aerosols containing SARS-CoV-2. However, data on the presence of these aerosols outside of patient rooms are limited. In this study, aerosolized SARS-CoV-2 outside of patient rooms was undetectable. Clinical Infectious Diseases
For SARS-CoV-2 Detection, Saliva Performed as Well as Nasopharyngeal Swabs
Assessing nasopharyngeal (NP) swabs with nucleic acid amplification testing (NAAT) is considered the gold standard for detecting SARS-CoV-2, but proper sample collection requires trained personnel and is uncomfortable. Saliva, by contrast, is easily self-collected. Systemic review and meta-analysis in this study showed that NAAT had >80% sensitivity for detecting SARS-CoV-2 in saliva samples. NEJM Journal Watch
A Review of Risk Factors of African Swine Fever Incursion in EU Pig Farming
The current epidemiological situation in the eastern part of Europe represents a constant threat to the EU livestock sector, particularly if the infection pressure remains high at the eastern borders of the EU. Although non-commercial farms can be a dead end in terms of disease spread, backyard units that sell animals at the local or regional levels can have a role in the spread of diseases. Pathogens
SPECIAL INTEREST
Health Security Net – Global Health Security Library
This publicly accessible, centralized library houses decades of documents related to pandemics—research, government reviews, expert analyses, and hearings— an invaluable resource for decisionmakers and others on threat and risk awareness for pandemic-prone diseases, and guidance on how to prepare for, plan, respond to, and recover from pandemics. The Georgetown University Center for Global Health Science and Security (GHSS) and Talus Analytics manage and maintain the resource. Health Security Net
JPEO-CBRND’s Change of Charter Highlights
Congratulations to Dr. Jason Roos, the new Joint Program Executive Officer for Chemical, Biological, Radiological & Nuclear Defense. (JPEO-CBRND), and his predecessor, Mr. Douglas Bryce, on his retirement. YouTube