News highlights on health security threats and countermeasures curated by Global Biodefense
This week’s selections include shorter isolation and quarantine for COVID-19; new rapid at-home test approvals; the struggle to keep up with demand for monoclonal therapies in areas with low vaccination rates; and new Marburg vaccine candidate data.
POLICY + INITIATIVES
C.D.C. Shortens COVID Isolation Period for Health Care Workers
The agency recommended that health care workers who are asymptomatic return to work after seven days and a negative test, adding that “isolation time can be cut further if there are staffing shortages.” CDC additionally said that those workers who had received all recommended vaccine doses, including boosters, do not need to quarantine at home following high-risk exposures. The new guidelines apply to all health care facilities that are directly involved in patient care. That would include hospitals, nursing homes, dental offices and other medical sites. New York Times
OSHA Withdraws Non-Recordkeeping Portions COVID-19 Emergency Temporary Standard Protections for Healthcare Workers
OSHA is withdrawing the non-recordkeeping portions of its ETS for COVID-19 focused on health care workers. The federal agency took the little publicized action Dec. 27, one week after it allowed the six-month emergency temporary standard to expire without establishing permanent standards to replace them. “OSHA’s assertion that it ‘intends to work expeditiously to issue a final standard that will protect health care workers from COVID-19 hazards’ is welcome but wholly insufficient until such a standard is actually promulgated and has the force of law,” noted National Nurses United President Zenei Triunfo-Cortez. As of 22 Dec, at least 4,702 health care workers have died of COVID-19 and more than 1 million have been infected, including 14,696 in the last month alone. U.S. Department of Labor, Bloomberg Law
Beneath a COVID Vaccine Debacle, 30 Years of Government Culpability
Looking forward at medical countermeasure infrastructure by examining how Emergent BioSolutions became the dominant player in a little-noticed corner of Washington bureaucracy — “the Lockheed Martin of biodefense”. Three times over the past three decades, presidential administrations explored plans for a vaccine overhaul like the one President Biden is now considering, only to be thwarted by pharmaceutical lobbying, political jockeying and cost concerns. New York Times
The Seattle Flu Study: When Regulations Hinder Pandemic Surveillance
Despite the severity of the SARS-CoV-2 Delta and Omicron variants, many people are seeking to move on and re-establish life as they knew it before the COVID-19 pandemic. But public-health policymakers cannot move on unless and until a sustainable surveillance system is in place. The Seattle Flu Study (SFS) represents a case study in what can go right — and wrong — even when such a surveillance system exists. Nature Medicine
Gain-of-function Research Advances Knowledge and Saves Lives
With the push to negotiate and pass the U.S. Innovation and Competition Act, which includes language that would have harmful ramifications on viral gain-of-function research, it is imperative that Congress modifies the act before the landscape of research is altered for decades to come. To be sure, some gain-of-function research on pathogens requires a higher level of review given its ramifications for biosafety and biosecurity. But to label all gain-of-function research as worrisome and requiring stringent oversight is misguided. Doing so may lead to inappropriate limitations on important work that reveals fundamental mechanisms of the cell or helps create new technologies that save lives. STAT News
Congress is Weighing Cuts to the Pentagon Disease-Fighting Budget
The Pentagon, under both President Joe Biden and former President Donald Trump, has asked Congress to scale back funding for the Biological Threat Reduction Program, despite successes that include funding a lab in Thailand that in January 2020 first detected the coronavirus outside of China. Roll Call
Measurability and Inclusivity: Challenges for the New Global Health Security Fund
Public health institutions and governments will grapple with the consequences for years to come, yet one fact is indisputable: the institutions, norms, and policies in place during January 2020 were insufficient to prevent and combat a pandemic. A new financing mechanism from the Biden administration presents a unique opportunity to repair and strengthen these public health institutions. Georgetown Journal of International Affairs
Biden Administration Meets with European Commission on COVID-19 and Global Health Security
Statement on 22 Dec meeting with senior White House officials covering ongoing efforts to donate and deliver more than a 1.9 billion vaccine doses around the world; coordinating initiatives to boost global production of COVID-19 vaccines and critical supplies; and cooperating on joint health threat assessments and R&D. WhiteHouse.gov
Europe Spat Will Weaken Research – Science Leaders
Scientific leaders have urged the government not to abandon talks to enable the UK to participate in a €100bn European research program. The UK’s continued participation in the EU’s Horizon program was agreed in principle just before Christmas 2020 in the Brexit withdrawal agreement. But the signing of a formal agreement on the UK’s associate membership has dragged on for a year. The delay is creating problems, because funding cannot be released to UK collaborators until there is a formal agreement. If it becomes apparent that agreement will take many more months, EU researchers will not include UK scientists in their projects. BBC News
MEDICAL COUNTERMEASURES
Merck, Ridgeback Clinch FDA’s 2nd Emergency Nod for a COVID-19 Antiviral Pill
Pfizer wasn’t the only drugmaker to score an early Christmas present from the FDA this year. A day after Paxlovid’s blessing as the first oral COVID-19 treatment, Merck & Co. and Ridgeback Biotherapuetics’ molnupiravir entered the fray as the second antiviral pill authorized in the U.S. Molnupiravir may not see as much widespread use compared to Pfizer’s oral antiviral Paxlovid, however, given the latter’s superior profile of safety and efficacy. Fierce Pharma, New York Times
J&J’s Booster Shot Provides Strong Protection Against Severe Disease From Omicron, A Study Says.
A Johnson & Johnson booster shot provided strong protection against the Omicron variant, greatly reducing the risk of hospitalization, according to a clinical trial in South Africa. The study, which compared more than 69,000 boosted health care workers with a corresponding group of unvaccinated South Africans, found that two shots of the vaccine reduced the risk of hospitalization from Omicron by about 85 percent. New York Times
Omicron Extensively but Incompletely Escapes Pfizer BNT162b2 Neutralization
“We isolated and sequence confirmed live Omicron virus from an infected person in South Africa and compared plasma neutralization of Omicron relative to an ancestral SARS-CoV-2 strain, observing that Omicron still required ACE2 to infect. For neutralization, blood samples were taken soon after vaccination from participants who were vaccinated and previously infected or vaccinated with no evidence of previous infection. Neutralization of ancestral virus was much higher in infected and vaccinated versus vaccinated only participants but both groups showed a 22-fold escape from vaccine elicited neutralization by the Omicron variant.” Nature
Children Develop Robust and Sustained Cross-Reactive Spike-Specific Immune Responses to SARS-Cov-2 Infection
Here researchers compare antibody and cellular immunity in children (aged 3–11 years) and adults. Antibody responses against spike protein were high in children and seroconversion boosted responses against seasonal Beta-coronaviruses through cross-recognition of the S2 domain. Spike-specific T cell responses were more than twice as high in children and were also detected in many seronegative children, indicating pre-existing cross-reactive responses to seasonal coronaviruses. Importantly, children retained antibody and cellular responses 6 months after infection, whereas relative waning occurred in adults. Spike-specific responses were also broadly stable beyond 12 months. Therefore, children generate robust, cross-reactive and sustained immune responses to SARS-CoV-2 with focused specificity for the spike protein. Nature Immunology
Long-Term Stability and Protection Efficacy of the RBD-Targeting COVID-19 mRNA Vaccine in Nonhuman Primates
Following development of a novel COVID-19 mRNA vaccine candidate, ARCoV, based on lipid nanoparticle-encapsulated mRNA (mRNA-LNP) encoding the receptor-binding domain (RBD) of SARS-CoV-2, researchers here report the protection efficacy of ARCoV in nonhuman primates and the long-term stability under normal refrigerator temperature. Signal Transduction and Targeted Therapy
Comparative Effectiveness and Antibody Responses to Moderna and Pfizer-BioNTech COVID-19 Vaccines Among Five Veterans Affairs Medical Centers
Antibody levels were significantly higher among Moderna recipients than Pfizer-BioNTech recipients across all age groups and periods since vaccination; however, antibody levels among recipients of both products declined between 14–119 days and ≥120 days. Antibody levels in this age group were substantially lower than levels seen among younger, healthy volunteers or health care personnel in other studies. These findings from a cohort of older, hospitalized veterans with high prevalences of underlying conditions suggest the importance of booster doses to help maintain long-term protection against severe COVID-19. MMWR
BIOSECURITY + BIOPREPAREDNESS
The Global Health Security Index is Not Predictive of Vaccine Rollout Responses Among OECD Countries
Israel, ranked 34th in the world on the GHS index for pandemic preparedness, had the highest percentage of the population that was fully vaccinated against COVID-19 within 2 months of the global vaccine rollout. The findings suggest an absence of correlation between the GHS index rating and the COVID-19 vaccine rollout of OECD countries. International Journal of Infectious Diseases
Texas Runs Out of Monoclonal Antibody Treatment Effective Against Omicron
The Texas Department of State Health Services said that regional infusion centers in some of the state’s largest cities— Austin, El Paso, Fort Worth, San Antonio and The Woodlands— “have exhausted their supply of sotrovimab.” Other monoclonal antibodies have not shown to be effective against the Omicron variant, which now accounts for more than 90 percent of new cases. On Dec. 17, HHS released distribution determinations for sotrovimab, warning states that the government’s supply was “extremely limited” and treatments should be reserved for highest risk outpatients. The Hill
Florida Opposes Federal Government Over Monoclonal Antibodies — Again
In a Tuesday letter to Xavier Becerra, the secretary of the HHS, Florida Surgeon General Dr. Joseph Ladapo accused the federal government of “actively preventing the effective distribution of monoclonal antibody treatments in the U.S.” It’s the second time in three months that Florida officials have publicly disparaged federal officials over monoclonal treatments. Pushing COVID-19 treatments, including monoclonal antibodies, has been the centerpiece of DeSantis’ pandemic response since the summer surge. He and Ladapo have done far less to emphasize the importance of vaccination in their public messaging during that time. Tampa Bay Times
SELECT AGENTS + CBRNE THREATS
Discovery and Development of Novel Treatment Strategies for Filoviruses
This review summarizes identification, testing, and development of therapeutics based on the peer-reviewed scientific literature beginning with the discovery of filoviruses in 1967. Small molecules, antibodies, cytokines, antisense, post-exposure vaccination, and host-targeted therapeutic approaches are discussed. An emphasis is placed on therapeutics that have shown promise in in vivo studies. Expert Opinion on Drug Discovery
Proteomic Assessment of Humoral Immune Responses in Smallpox Vaccine Recipients
Data from this study indicate that poxvirus proteome microarrays can be valuable for screening and monitoring smallpox vaccine-induced humoral immune responses in large-scale serologic surveillance studies and prove useful in the guidance of developing novel smallpox candidate vaccines. Vaccine
Rapid and Durable Protection Against Marburg Virus with a Single-Shot ChAd3-MARV GP Vaccine
To support regulatory approval of the ChAd3-Marburg vaccine that has completed Phase I trials, here researchers show that a non-replicating chimpanzee-derived adenovirus vector with a demonstrated safety profile in humans (ChAd3) protected against a uniformly lethal challenge with Marburg-Angola. Protective immunity was achieved within 7 days of vaccination and was maintained through one year post vaccination, antigen-specific antibodies were a significant immune correlate of protection in the acute challenge model. BioRxiv pre-print
MAVS Mediates a Protective Immune Response in the Brain to Rift Valley Fever Virus
Airborne transmission of the virus causes severe inflammation of the brain, yet little is known about the immune response against the virus in this organ. Here researchers note that microglia, the resident immune cells of the brain, initiate a robust response to Rift Valley fever virus infection and identified a key immune pathway that is critical for the ability of microglia to respond to infection. When this immune pathway is rendered non-functional, mice have a dysregulated response to infection in the brain. BioRxiv pre-print
Ebola Virus Disease Nosocomial Infections in the DRC During the 2018-2020 Outbreak
Of 3481 cases of EVD, 579 (16.6%) were nosocomial. Of these, 332 cases occurred in women (57.3%). Patients and visitors accounted for 419 cases (72.4%), of which 79 (18.9%) were aged 6–≤18 years and 108 (25.8%) were aged ≤5 years. Health workers accounted for the remaining 160 (27.6%) nosocomial cases. The findings highlight challenges of sometimes non-specific early clinical presentation of EVD and need for rapid diagnostics; patient care-seeking behavior involving visits to several facilities; unsafe injection practices in some resource-limited settings. High CFRs in children highlight the need for a targeted IPC strategy for this group, including caregivers and families. International Journal of Infectious Diseases
Nipah Virus V Protein Binding Alters MDA5 Helicase Folding Dynamics
Like other paramyxoviruses, Nipah virus V proteins function as interferon (IFN) antagonists to inhibit host antiviral signaling and appears to be a major determinant of pathogenesis. To develop a better understanding of the role of NiV V in this process, here resewarchers characterized the interaction between NiV V and MDA5. Co-immunoprecipitation (co-IP) and in vitro pulldown assays demonstrated direct binding between NiV V and MDA5 proteins. The results support NiV V binding disrupts the MDA5 fold and is a potential mechanism for immune evasion by a highly pathogenic RNA virus. ACS Infectious Diseases
France Detains Suspect in Syria Chemical Weapons Probe
The dual French-Syrian national was arrested in the south of France while vacationing with his family and is being held on preliminary charges of complicity in war crimes and crimes against humanity. The man detained in France is suspected of having used a transport company in France and the United Arab Emirates to supply materials to Syria in violation of an international embargo. ABC News
Self-Detoxifying Wearable Filter for Development of Next Generation NBC Protective Gear
Research presented on a highly effective self-detoxifying filter consisting of in-situ immobilized Zirconium hydroxide over woven activated carbon fabric for removal of Chemical Warfare Agents (sarin and soman). Scientific Reports
New OPCW Self-Assessment Tool Enables Countries to Take Stock of Chemical Security Threats
The pilot project will be rolled out over the next few months to interested Member States, with assistance from the OPCW Technical Secretariat, to conduct self-assessments and joint evaluations, and develop measures to improve national protective programs to bolsters chemical safety and security at the regional and sub-regional levels. Organisation for the Prohibition of Chemical Weapons
PUBLIC HEALTH
Shortened CDC COVID Isolation Guide Draws Sharply Mixed Reviews
The CDC’s decision to reduce isolation and quarantine was ‘needed to prevent the collapse of critical infrastructure, with the nation poised to pass its previous COVID-19 peak, possibly reaching 1 million cases a day’. Some experts said the 5-day isolation period unpaired with a negative test is risky and not supported by data. CIDRAP
COVID-19 Contact Tracing Outcomes in Washington State, August and October 2020
In this two-month retrospective analysis, the median time elapsed from specimen collection to contact interview was 4 days in August and 3 days in October, and from symptom onset to contact interview was 7 days in August and 6 days in October. The delay between case symptom onset to contact interview (i.e., when the contact is first notified of their exposure and need to quarantine) suggests that at least some contacts may not be reached soon enough for contact tracing to effectively reduce onward transmission. Frontiers in Public Health
SURVEILLANCE + DETECTION
FDA Authorizes Two COVID-19 Home Tests Based on Data From NIH
On December 24, 2021, FDA authorized an over-the-counter (OTC) COVID-19 antigen test, the first test where validation data were gathered through the FDA’s collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP). The SD Biosensor COVID-19 At-Home Test will be distributed by Roche Diagnostics and is an OTC COVID-19 antigen diagnostic test that delivers results in 20 minutes. On December 29, 2021, FDA authorized Siemens’ CLINITEST Rapid COVID-19 Antigen Self-Test, where validation data were gathered through FDA’s collaboration with the NIH ITAP. The CLINITEST Rapid COVID-19 Antigen Self-Test is an OTC COVID-19 antigen diagnostic test that delivers results in 15 minutes. U.S. Food and Drug Administration
From Delta to Omicron: Analyzing the SARS-Cov-2 Epidemic in France Using Variant-Specific Screening Tests
Researchers analyzed 131,478 SARS-CoV-2 variant screening tests performed in France from September 1st to December 18, 2021. Tests consistent with the presence of the Omicron variant exhibited significantly higher cycle threshold Ct values, which could indicate lower amounts of virus genetic material. The data suggests transmission advantage of the Omicron variant over the Delta is +105%. In their ‘optimistic’ scenario, the researchers assume a 3-fold reduction of Omicron virulence compared to Delta, a 75% vaccine efficacy against infection, and 95% against critical forms. In the more ‘pessimistic’ scenario, virulence is only divided by 2 compared to Delta, and vaccine effectiveness is only 40% against infection and 80% against critical forms. MedRxiv pre-print
SARS-CoV-2 in Hospital Air as Revealed By Comprehensive Respiratory Viral Panel Sequencing
Because of the lower biological load in ambient aerosol, detection of SARS-CoV-2 is challenging. In this study, a large volume of indoor aerosol samples from three major hospitals involved in COVID-19 care in Kuwait was collected. The results suggest that using CRVP on a large volume aerosol sample was a valuable tool for detecting SARS-CoV-2 in indoor aerosols of health care settings. Infection Prevention in Practice
Scientists Worry That Pools of Unvaccinated People Could Be a Source of New Variants
COVID-19 vaccine hesitancy has long been recognized as a problem in high- and middle-income nations. But in some of the world’s poorest countries, lack of access to vaccines has been a much bigger hurdle. Now researchers say that as doses are trickling in, resistance to getting vaccinated is also emerging as a major issue in those nations. Nature
What We Know So Far About This Winter’s Flu Season
Winter’s flu epidemic has started – primarily Influenza A(H3N2) is circulating in Europe, resulting in mostly mild illness, but which can sometimes lead to severe disease and death in older adults or immunocompromised patients. Fewer influenza A(H1N1)pdm09 or influenza B viruses have been detected to date, although the distribution of viruses usually changes over the course of the winter, so we might see this situation change. World Health Organization – Europe
‘Enormous Spread of Omicron’ May Bring 140M New COVID Infections to US in the Next Two Months
As the omicron variant continues to spread throughout the world, new modeling data shows the latest strain may cause millions more new infections per day in the U.S. but fewer hospitalizations and deaths compared to the delta variant. A study of real-world data published Wednesday by the Imperial College of London suggests that omicron cases have up to a 20% reduced risk of any hospitalization compared to the delta variant, and up to a 45% reduced risk of admitted overnight. A study of real-world data published Wednesday by the Imperial College of London suggests that omicron cases have up to a 20% reduced risk of any hospitalization compared to the delta variant, and up to a 45% reduced risk of admitted overnight. USA Today
SPECIAL INTEREST
USDA Seeks Nominations for Membership on Food Safety Advisory Committee
FSIS is soliciting nominations for membership to the National Advisory Committee on Meat and Poultry Inspection (NACMPI). USDA expects to appoint committee members in 2022. Persons in academia, state and local government officials, public health organizations, and industry and consumer organizations are invited to submit nominations. Self-nominations are welcomed. Nominations packages must be received by Feb. 18, 2022. USDA