News highlights on health security threats and countermeasures curated by Global Biodefense
This week’s selections include legal challenges to vaccine mandates; a case of monkeypox in the U.S.; the global syringe shortage (and health care worker shortage); EUA filing for COVID-19 antiviral; and bird flu on the rise in several countries in EU and Asia.
POLICY + INITIATIVES
Federal Appeals Court Affirms Stay on Biden Vaccine Mandate for Businesses
A federal appeals court has upheld its stay on President Biden’s vaccine-or-test mandate for companies with at least 100 employees. In a 22-page ruling on Friday, the 5th U.S. Circuit Court of Appeals said the mandate was “fatally flawed,” and barred the Occupational Safety and Health Administration (OSHA) from enforcing the mandate “pending adequate judicial review” of a motion for permanent injunction. The Hill
Official Introduction of Cures 2.0 – Incentives for New Antimicrobial Solutions
There is a lot to like in Cures 2.0: this major legislation is divided into sections that cover Public Health, Patient-Caregiver issues, FDA, CMS, and Research. From the perspective of the AMR community, the big news is Sec. 105. entitled “Developing Antimicrobial Innovations” which includes the PASTEUR Act (Pioneering Antimicrobial Subscriptions to End Up surging Resistance). This policy would establish a subscription model to pay for critically needed novel antimicrobial drugs delinked from the sales or use of those newly-developed antibiotics, to ensure a predictable return on investment and improve appropriate use of the drug. AMR Solutions
Utah Rep. Chris Stewart Introduces Bill Targeting Dr. Fauci and Federal Research in China
Republican Rep. Chris Stewart has introduced a bill in the U.S. House of Representatives that, the congressman says, would ban federal funding for “gain-of-function” research in China. The proposed legislation was named the Fairness and Accountability Underwriting Chinese Institutions Act — or the FAUCI Act — after National Institute of Allergy and Infectious Disease Director Dr. Anthony Fauci, a frequent pandemic scapegoat of former President Donald Trump and his supporters. Salt Lake Tribune
The US Must Separate Nuclear Deterrence From Biological Weapons
Today, the U.S. nuclear posture positions nuclear weapons as a leading means of deterring strategic-level biological weapons activities. As the 2018 Nuclear Posture Review described, the roles of U.S. nuclear forces currently include acting as a “hedge against the potential rapid growth or emergence of nuclear and non-nuclear strategic threats, including chemical, biological, cyber, and large-scale conventional aggression.” Defense News
OSHA, South Dakota Pork Plant Settle Coronavirus Complaint
Smithfield’s Sioux Falls plant was one the nation’s worst COVID-19 hotspots during the early days of the pandemic. By June 16, 2020, four workers were dead and nearly 1,300 had tested positive for the virus. Under the agreement, Virginia-based Smithfield Foods will develop a plan to prevent infectious diseases at meatpacking plants nationwide and pay a $13,500 fine. The president of the local United Food and Commercial Workers union, B.J. Motley, derided the settlement and $13,500 fine as a “slap on the wrist for Smithfield and a deeply troubling betrayal of the men and women who have already sacrificed so much in this pandemic.” AP
Biden Taps Califf to Head FDA — An Agency Where He Has Plenty of Unfinished Business
A cardiologist by training, Califf previously served as FDA commissioner for nearly a year at the tail end of the Obama administration — winning Senate confirmation by a wide margin despite the objections of a handful of Democratic senators. The White House is counting on Califf to once again garner broad bipartisan support within the divided chamber, casting him as a deeply experienced researcher and policymaker who has long worked with both sides of the aisle. STAT, Politico
Oklahoma National Guard Rejects Pentagon’s Coronavirus Vaccine Mandate
Brig. Gen. Thomas Mancino, appointed this week by Gov. Kevin Stitt (R) as adjutant of the state’s 10,000 National Guard soldiers and airmen, on Thursday notified those under his command that they are not required to receive the vaccine and won’t be punished if they decline it. It’s an extraordinary refusal of Pentagon policy by the general and follows Stitt’s written request to Defense Secretary Lloyd Austin seeking suspension of the requirement for Guard personnel in the state. Washington Post
Air Force is First to Face Troops’ Rejection of Vaccine Mandate as Thousands Avoid Shots
The vast majority of active-duty airmen, more than 96 percent, are at least partially vaccinated. But up to 12,000 Air Force personnel have rejected federal orders to get fully vaccinated against the coronavirus despite the Pentagon mandate, and officials say it is too late for them to do so by the Tuesday deadline, posing the first major test for military leaders whose August directive has been met with defiance among a segment of the force. Washington Post
MEDICAL COUNTERMEASURES
The U.S. Aims to Lift Covid Vaccine Manufacturing to Create a Billion Doses a Year
The White House, under pressure to increase the supply of coronavirus vaccines to poor nations, plans to invest billions of dollars to expand U.S. manufacturing capacity, with the goal of producing at least one billion doses a year beginning in the second half of 2022. New York Times
Pfizer to File for Emergency Authorization for Its Covid-19 Pill
The step comes shortly after the company reported its pill, called Paxlovid, reduced hospitalizations by 89% among patients who started within three days of symptoms and also prevented deaths in a large, randomized study. The disclosure followed news from Merck that its own pill reduced hospitalizations by 50%. The Pfizer pill is given as a five-day course, and must be combined with a second medicine called ritonavir, which is made by AbbVie (ABBV). STAT
France, Germany Recommend Only BioNTech/Pfizer mRNA Vaccine for Under-30s
People aged under 30 in Germany should only receive the BioNTech/Pfizer COVID-19 vaccine as it causes fewer heart inflammations in younger people than the Moderna shot, an advisory committee determined last week. France’s public health authority also recommended that under-30s be given the Pfizer vaccine when available instead of the Moderna shot. They join Finland and Sweden who paused the use of the Moderna shot in young adults in early November due to rare heart-related side-effects. Reuters
What Went Wrong with Russia’s Sputnik V Vaccine Rollout?
Sputnik V has struggled to gain mass acceptance inside Russia, let alone in other countries where it is marketed as an alternative to vaccines developed by Western and Chinese pharmaceutical firms. Hovering over the vaccine’s commercial prospects are lingering questions about its safety and efficacy—as well as Moscow’s ability to deliver promised numbers of doses and navigate complicated global supply chains. Carnegie Endowment
Integrating 3Rs Approaches in WHO Guidelines for the Batch Release Testing of Biologicals
The UK National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs) and the World Health Organization (WHO) are collaborating on a project to review animal-based testing methods described in WHO manuals, guidelines and recommendations for biologicals to identify where updates can lead to a more harmonised adoption of 3Rs principles (i.e. Replacement, Reduction, and Refinement of animal tests) in batch release testing requirements. Biologicals
BIOSECURITY + BIOPREPAREDNESS
Commentary: Biological Weapons in the ‘Shadow War’
“The specter of mass casualty biological weapons attacks — whether by nations or terrorists — is unrealistic. The United States should not overreact to the threat of biological weapons. Although the threat from biological weapons has not vanished, it is, in fact, at one of its lowest points since the Cold War’s end. Biological weapons are primarily a tool of assassination — largely for purposes of ensuring regime security in authoritarian states — and special forces operations. U.S. policymakers should strengthen diplomatic and intelligence community efforts to protect the American people from this enduring — but manageable — threat.” War on the Rocks
Why Health-Care Workers Are Quitting in Droves
About one in five health-care workers has left medicine since the pandemic started. Since COVID-19 first pummeled the U.S., Americans have been told to flatten the curve lest hospitals be overwhelmed. But hospitals have been overwhelmed. The nation has avoided the most apocalyptic scenarios, such as ventilators running out by the thousands, but it’s still sleepwalked into repeated surges that have overrun the capacity of many hospitals, killed more than 762,000 people, and traumatized countless health-care workers. The Atlantic
Decontamination of Seawater in a Harbor: Case Study of Potential Bioterrorism Attack
In case of intentional discharge of ballast water containing Bacillus anthracis, a two-dimensional disinfection of the harbor’s seawater surface can be made using hydrophobic or surface-active disinfectant, by using humic acid with trimethylammonium groups, concentrating in the monomolecular layer on water–air interphase. It will prevent the formation and dispersion of the deadly bioaerosol to atmosphere after a bioterrorism attack in the harbor. Developments and Advances in Defense and Security
Biobanking of COVID-19 Specimens During the Pandemic: The Need for Enhanced Biosafety
Biological samples could be kept for indefinite periods, allowing for long-term retrospective research in the future. Laboratory infrastructure may need to be reviewed to promote the efficiency of COVID-19 biobanks. Inefficient handling and storage of specimens, information management systems, and communication modalities between sample handling and storage units of biobanks, as well as the commercialization of samples, will reduce the efficiency of biobanks. African Journal of Laboratory Medicine
IDSA Guidelines on Infection Prevention for Healthcare Personnel Caring for Patients with Suspected or Known COVID-19
The IDSA guideline panel agreed on eight recommendations, including two updated recommendations on the use of PPE for conventional settings and aerosol-generating procedures. Clinical Infectious Diseases
COVID-19 Pandemic Brings Global Syringe Shortage Into Sharp Focus
More than 6.8 billion doses of COVID-19 vaccines are being administered globally per year, which is nearly double the number of routine inoculations delivered annually: “A shortage of syringes is unfortunately a real possibility and here’s some more numbers. That the global manufacturing capacity of around six billion a year for immunization syringes it’s pretty clear that a deficit in 2022 of over a billion could happen if we continue with business as usual.” UN News
SURVEILLANCE + DETECTION
Japan Confirms H5N8 Strain in Third Bird Flu Outbreak in the Country
Japan has confirmed today the highly pathogenic bird flu subtype H5N8 was detected at a poultry farm in the third outbreak of avian influenza in the country this winter. It comes as several outbreaks of severe bird flu in Europe and Asia have been reported to the World Organisation for Animal Health in recent days, in a sign the virus is spreading quickly again. Reuters
Fast Spreading Bird Flu Puts Europe and Asia on Alert
South Korea reported an outbreak at a farm of around 770,000 poultry in Chungcheongbuk-do. In Europe, Norway reported an H5N1 bird flu outbreak in the Rogaland region in a flock of 7,000 birds, the OIE said. The Guardian
US Flu Shows Another Small Rise, With 90% Of Cases in Young People
Though the nation’s flu activity is still at low levels, the number of detections has increased in recent weeks, mostly due to the H3N2 strain and with 90% of cases in people ages 5 to 24. Most flu markers remained below baselines, and the CDC notes that public health labs over the past 3 weeks have reported H3N2 in 7 of 10 of US regions. CIDRAP
Re-Emergence of Enterovirus D68 In Europe After Easing the COVID-19 Lockdown, September 2021
Enterovirus D68 (EV-D68) infections have been linked to Acute Flaccid Myelitis since a large outbreak associated with respiratory and neurological symptoms in children was described in North America in 2014. Although regular EV-D68 upsurges have been reported in Europe since 2010, they largely ceased in 2020 during the COVID-19 pandemic. Following relaxing of widespread COVID-19 mitigation measures in 2021, EV-D68 case numbers presented at levels exceeding what was reported during the most recent EV-D68 upsurge in 2019. Eurosurveillance
CDC Confirms Cases of Anthrax Pneumonia in Welders
The cases, one of which was fatal, were caused by the Bacillus cereus group of bacteria containing genes that are typically associated with the bacterium that causes anthrax, B. anthracis. B. cereus group bacteria are gram-positive facultative anaerobes, often toxin-producing, that reside naturally in soil and dust. Infectious Disease Special Edition
Monkeypox Virus Infection Confirmed in Maryland Resident Who Traveled To Nigeria
The Maryland Department of Public Health said the undisclosed resident recently returned from a trip to Nigeria, and is showing mild symptoms, and is recovering in isolation while not hospitalized. It’s the first reported monkeypox case in the United States since 47 cases were reported in 2003 in five midwestern states. WDEL
Infection, Recovery and Re-Infection of Farmed Mink with SARS-Cov-2
A large outbreak at a farm with15,000 mink was evaluated, documenting antibodies against the virus. The mink were allowed to recover and showed maintenance of antibodies against the virus. However, less than 3 months after the initial infection, they again identified the presence of virus in some dead mink from this farm and in many live mink. The initial round of infection in mink was insufficient to confer protection against re-infection. PLOS Pathogens
HISTORICAL REFLECTIONS
Bioarchaeological Insights Into the Last Plague of Imola (1630–1632)
Researchers analyzed the full skeletal assemblage of four mass graves at the Lazaretto dell’Osservanza (n = 133 individuals) covered by multiple layers of lime, which is characteristic for epidemic mass mortality sites, which date back to the outbreak of 1630–1632 in Imola. The paper describes differential aDNA preservation in a grave containing multiple layers of lime, which could be valuable information for designing a sampling strategy for similar environments. Scientific Reports
Academy Calls for Program to Divert Bioweaponeers (1997)
The National Academy of Sciences (NAS) released a report on Nov 7, 1997 calling on the DoD to launch a $38.5 million initiative to fund collaborations between Russian scientists once involved in research on biological weapons and U.S. infectious disease specialists. In the early 1990s, the Russian government drastically cut funds for civilian and military research, leaving many institutes scrambling to pay salaries and prop up a minimal level of science. To arms-control experts, the dwindling support was a double-edged sword: While work on many weapons projects ended, the analysts feared that Russian scientists might be lured to countries like Iraq and Libya. Science