News highlights on health security threats and countermeasures curated by Global Biodefense
This week’s selections include highlights from a rash of health security Executive Orders from the Biden administration; more delays for the National Bio and Agro-Defense Facility; and the clinical case report for Navalny’s novichok poisoning.
POLICY + GOVERNMENT
National Security Directive on U.S. Global Leadership to Advance Global Health Security and Biological Preparedness
This NSS reinforces the Biden Administration’s intent to treat epidemic and pandemic preparedness, health security, and global health as top national security priorities; orders a review of funding for COVID-19 response and global health security and biodefense; reverses U.S. decision to withdraw from W.H.O.; asserts U.S. intent to support the Access to COVID-19 Tools (ACT) Accelerator and join the multilateral global vaccine distribution facility, COVAX; orders planning for strengthening international biosecurity cooperation and health diplomacy; orders development of protocols for coordinating and deploying a global response to emerging high-consequence infectious disease threats; and orders a review of existing sanctions to evaluate whether they are unduly hindering COVID-19 pandemic response. WhiteHouse.gov
Executive Order on Establishing the COVID-19 Pandemic Testing Board and Ensuring a Sustainable Public Health Workforce
This EO establishes a national COVID-19 testing and public health workforce strategy with oversight from a new COVID-19 Pandemic Testing Board; works to expand test supply, laboratory capacity, and test manufacturing capacity in the U.S.; supports screening testing for schools and priority populations and clarity of messaging about no-fee testing and insurance coverage; and outlines the growth plan for a U.S. Public Health Job Corps. WhiteHouse.gov
Executive Order on Ensuring a Data-Driven Response to COVID-19 and Future High-Consequence Public Health Threats
Guides agencies to coordinate pandemic data sharing with COVID-19 Response Coordinator; provides for an HHS review of the effectiveness, interoperability, and connectivity of public health data systems supporting the detection of and response to high-consequence public health threats, such as the COVID-19 pandemic; and orders OSTP to develop a plan for advancing innovation in public health data and analytics in the U.S. WhiteHouse.gov
Executive Order on a Sustainable Public Health Supply Chain
This order prescribes actions to secure supplies necessary for responding to the pandemic; calls for immediate inventory of critical materials such as PPE, vaccine and testing supply components; requires a comprehensive status report on the Strategic National Stockpile; and provides post-assessment for appropriate action to fill shortfalls using all available legal authorities, including the Defense Production Act. The EO also gives 180 days for development of a long-term pandemic supply chain resilience strategy for future threats. WhiteHouse.gov
Executive Order on Ensuring an Equitable Pandemic Response and Recovery
The lack of complete data, disaggregated by race and ethnicity, on COVID-19 infection, hospitalization, and mortality rates, as well as underlying health and social vulnerabilities, has further hampered efforts to ensure an equitable pandemic response. An COVID-19 Health Equity Task Force will work with agency heads to assess pandemic response plans and policies to determine whether personal protective equipment, tests, vaccines, therapeutics, and other resources have been or will be allocated equitably; and strengthen equity data collection, reporting, and use. WhiteHouse.gov
Executive Order on Supporting the Reopening and Continuing Operation of Schools and Early Childhood Education Providers
This EO directs development of a Safer Schools and Campuses Best Practices Clearinghouse; provide technical assistance to schools during the pandemic; requires data collation from agencies to inform and respond to challenges of in-person and online learning and safe re-opening; ensures equitable allocation of COVID-19-related supplies to schools, child care providers and Head Start programs to support in-person care and learning; supports contact tracing to facilitate safe reopening and operation of education and care centers; requires strategies to address the impact of the pandemic on educational outcomes. WhiteHouse.gov
Executive Order on Protecting Worker Health and Safety
This EO gives the Department of Labor’s Occupational Safety and Health Administration (OSHA) to get revised guidance to employers on COVID-19 workplace safety within 2 weeks; assess and coordinate emergency temporary standards such as masks in workplaces and issue those measures NLT 15 March; conduct a review of OSHA enforcement of safety measures and ensure equity in worker protection with emphasis; conduct a multilingual outreach campaign to inform workers and their representatives of their rights under applicable law, emphasizing communities hardest hit by the pandemic. WhiteHouse.gov
On Way Out the Door, Trump Proposes Big Cuts to Health Security Budget
The $27.4 billion in proposed cuts is known as a rescission request — a largely symbolic package of spending claw-backs that the White House presents to Congress. The package sent to lawmakers last week cut more than $4 billion in funding for GAVI, $2 billion for AIDS relief, $13 million for the National Institutes of Health, and $181 million for climate research programs at NOAA. Politico
HHS, FDA Dispute Spills Out Onto Twitter
Following media reports last week that (since resigned) FDA Commissioner Stephen Hahn refused to sign a memorandum of understanding that would cede FDA’s oversight of genetically modified animals to the USDA, HHS pushed ahead with the policy. In a stunning move, Hahn tweeted that FDA would not abide by the MoU, a rare public airing of a dispute between top administration officials. RAPS
Hahn Leaves Food and Drug Administration
Dr. Stephen M. Hahn, who became commissioner of the FDA just weeks before the COVID-19 pandemic began, resigned on Wednesday as the administration of President Biden began. Dr. Janet Woodcock, the longtime head of the F.D.A.’s Center for Drug Evaluation and Review, will serve as acting commissioner. New York Times
MEDICAL COUNTERMEASURES
Experts Warn of Vaccine Stumbles ‘Out of the Gate’ Because Trump Officials Refused to Consult with Biden Team
While health agencies’ career staff have been helpful, it was not until this week that Biden officials were allowed to attend meetings of Operation Warp Speed. They were also not invited to the two Warp Speed sessions when Trump officials decided on sweeping changes to try to speed up the sluggish vaccine rollout, Nor were they briefed on those changes in advance. Washington Post
Moderna Believes It Could Update Its Coronavirus Vaccine Without a Big New Trial
Covid vaccines reprogrammed to aim at emerging new strains of the virus could reach the market quickly, without going through large clinical trials, according to officials at Moderna Therapeutics and the US government. MIT Technology Review
Ebola Vaccines Stockpiled Against Future Outbreaks
The World Health Organization and partners are creating an emergency reserve stockpile in Switzerland of Merck’s Ebola vaccine to help stamp out future outbreaks. Other stockpiles managed by WHO and partners exist for diseases including yellow fever and meningitis. Associated Press
Russia Files Sputnik V Vaccine Registration in Europe
Registration has been filed for the Sputnik V COVID-19 vaccine in the European Union and it is expected to be reviewed in February, as Moscow seeks to speed up its availability worldwide. Emergency use approval of the vaccine was recently delayed in Brazil, after the country’s health regulator said documents supporting the application did not meet its minimum criteria. Reuters
BIOSECURITY + BIOPREPAREDNESS
National Bio-Defense Lab Completion Date Moved to October 2021
Federal officials say it will likely be October 2021 before a national biosecurity lab in Manhattan is substantially completed. Disruptions in supply chains and construction employee availability caused by the coronavirus pandemic delayed the opening planned for this month. KSN/AP
80 Questions for UK Biological Security
Many emerging biosecurity dilemmas, such as the malicious use of synthetic biology, require new approaches to biosecurity, including the engagement of social scientists and policy-makers in forecasting. This paper is a step in this direction by having a diverse group of scholars, practicioners and policy-makers collaboratively contemplate the most pressing current and future challenges in biosecurity. PLOS ONE
The Biosecurity Benefits of Genetic Engineering Attribution
Capabilities for detecting whether an organism has been genetically modified and, if modified, to infer from its genetic sequence its likely lab of origin could be developed into powerful forensic tools to aid the attribution of outbreaks, and thus protect against the potential misuse of synthetic biology. Nature Communications
Improper Influence in Federally Funded Fundamental Research
This report outlines how federally-funded research scientists, the universities at which they work, federal grantmaking agencies, and federal oversight and enforcement entities, seek to become more resilient to improper foreign influence by improving their ability to: Identify improper foreign government influence risks to federally funded fundamental research. Employ effective tools and processes to counter improper foreign government influence. MITRE
SELECT AGENTS + CBRNE THREATS
Navalny: Poisoned Opposition Leader Held After Flying Home
Kremlin critic Alexei Navalny has been detained after flying back to Moscow five months after he was nearly killed by a nerve agent attack last year. Mr Navalny, 44, was seen being led away by police at passport control. Big crowds earlier gathered at Moscow’s Vnukovo airport to greet his flight from Berlin but the plane was rerouted. BBC News
Dorm Evacuated After Student Tries to Make Ricin
Police and firefighters evacuated a Creighton University dormitory after a student at the Nebraska school told emergency room staff that she had tried to make the poison ricin in her dorm room in an attempt to harm herself. There is no antidote for ricin poisoning. Rome Sentinel
Novichok Nerve Agent Poisoning: Case Report
Clinical case report of Alexei Nevalny poisoning: On Aug 20, 2020, a 44-year-old man who was previously healthy suddenly became confused and began to sweat heavily on a domestic flight in Russia approximately 10 min after departure; he vomited, collapsed, and lost consciousness. After an emergency landing, the man was admitted to the toxicology unit of a local hospital in Omsk, Russia. On Aug 22, 2020, the patient was transferred by a German air ambulance to the Charité-Universitätsmedizin Berlin at the request of his family. Severe poisoning with a cholinesterase inhibitor was subsequently diagnosed. The Lancet
SURVEILLANCE + DETECTION
Diagnostics for Biodefense: Flying Blind with No Plan to Land
Congress should amend the CARES Act to require a national plan for COVID-19 diagnostic testing; advance health security by upping reimbursement for POC and point-of-need diagnostics; and advance appropriations that cover multiple years rather than one year at a time for diagnostics R&D. Bipartisan Commission on Biodefense .pdf
A Troubling New Pattern Among Coronavirus Variants
Scientists now wonder whether the variants in South Africa and Brazil are spreading precisely because they have a slight advantage in overcoming previous immunity. Both variants were originally found in parts of the countries that have had high levels of COVID-19 infection—especially in Manaus, Brazil, where an especially large proportion of people have already had the virus. The Atlantic
Test Positivity Is a Bad Way to Measure COVID’s Spread
While test positivity may be more informative than raw case numbers, it brings along its own distortions. The ratio will vary with the availability of tests, who’s deciding to get tested, and whether they can get into test centers if they go. And some states offer free testing only to people with symptoms, a policy that is guaranteed to make the test positivity rate go higher. Wired
Technical Difficulties of Contact Tracing
Many states are still chasing the promise of coronavirus exposure notification apps. Last week, California rolled out CA Notify, joining 18 other states as well as Guam and the District of Columbia in deploying the Exposure Notification System developed by Apple and Google. Lawfare
Flushing Out Coronavirus: Universities, Cities and States Are Testing Wastewater For The Virus
Wastewater testing does not replace clinical testing but can be a great predictor of where the virus is and how rampantly it is spreading, detecting its presence in people who may never show symptoms. The tool allows the state to screen congregate settings for the virus without asking people to line up to take tests. Washington Post
COMMENTARY
‘Toxic Individualism’: Pandemic Politics Driving Health Care Workers From Small Towns
“People who had routinely buttonholed her for quick medical advice at church and kids’ ball games were suddenly treating her as the enemy and regarding her professional opinion as suspect and offensive.” A wave of departing medical professionals would leave gaping holes in the rural health care system, and small-town economies, triggering a death spiral in some of these areas that may be hard to stop. NPR
More Than 2,900 Health Care Workers Died This Year in the U.S. — And the Government Barely Kept Track
Fatalities from the coronavirus have skewed young, with the majority of victims under age 60 in the cases for which there is age data. People of color have been disproportionately affected, accounting for about 65% of deaths in cases in which there is race and ethnicity data. Many of the deaths — about 680 — occurred in New York and New Jersey, which were hit hard early in the pandemic. KHN
SPECIAL INTEREST
Service to America Medal: Q&A with Finalist Nancy Sullivan on Ebola Antiviral Development
Nancy Sullivan, chief of the Vaccine Research Center’s Biodefense Research Section at the National Institutes of Health, and her team developed an effective antiviral infusion treatment for the Ebola virus that saved nearly 90% of the patients who participated in clinical trials conducted in the Democratic Republic of the Congo in 2018. The results capped Sullivan’s two-decade effort to identify, administer and manufacture effective Ebola vaccines and treatments. Partnership for Public Service
IN MEMORIAM
Sharon Begley, Path-Breaking Science Journalist Who Spun Words Into Gold, Dies At 64
Over the course of her 43-year-career, at Newsweek, the Wall Street Journal, Reuters, and STAT, Begley made complex ideas accessible to anyone — and beautiful — through her articles and books, and in doing so, trained and inspired generations of science journalists. STAT
