News highlights on health security threats and countermeasures curated by Global Biodefense
This week’s selections include the shifting sands of ‘gain-of-function’ research; Ebola vaccines for workers at designated special pathogen treatment centers; and the data for COVID-19 vaccines for 5-11 year olds.
POLICY + INITIATIVES
Twenty Years After the Patriot Act, What Is the Future of Biosecurity?
Within the realm of biosecurity, the legislation sought to make it harder for states, terrorists, extremist groups, and lone-wolf actors to acquire dangerous biological materials, while also protecting biological research facilities from insider threats such as disgruntled employees and people with a grudge against biological research. The implementation of the Patriot Act has triggered a series of unintended negative consequences on the life sciences, greatly disrupting who participates in science, where science is done, and how it is conducted. Issues in Science and Technology
The Shifting Sands of ‘Gain-Of-Function’ Research
Some virologists can envisage valuable experiments with SARS-CoV-2 that could be considered GOF. For example, experiments to look for mutations that make SARS-CoV-2 resist vaccines or treatments could be beneficial, so that scientists can be better prepared if such variants emerge. And as scientists attempt to make vaccines that work on all coronaviruses, it might be useful to test the vaccines’ abilities to protect against infection by chimeric viruses that incorporate spikes from various wild specimens. The ongoing political debate has meant that some virologists dare not even propose research that might be deemed GOF. Nature
US Court Blocks Biden’s Vaccine Mandate for Companies
A US appeals court has temporarily blocked President Joe Biden’s plans for a vaccine mandate for businesses. If enforced, the ruling by the fifth US circuit court of appeals would be a blow to the Biden administration’s sweeping measures to extend vaccination. Five Republican-led states – Texas, Louisiana, Mississippi, South Carolina and Utah – as well as private companies and religious groups, have filed legal challenges against the mandate. BBC News
A Hub for Zoonotic Disease Research
The new Institute for Infectious and Zoonotic Diseases, launched by the School of Veterinary Medicine, leans on Penn’s strengths in immunology and infectious disease to prepare for emerging threats to animal and human health. One roadmap for determining the structure and scope of the Institute can be found within the school itself: The Center for Host-Microbial Interactions (CHMI), launched in 2013. Penn Today
New USAID Director Aims to Shake Up 60-Year-Old Aid Agency. Here’s Her ‘New Vision’
Former U.S. ambassador to the United Nations Samantha Power has set out her ideas to transform USAID, one of the largest foreign aid agencies in the world, including “establishing a new and dedicated USAID Emergency Response Unit to lead on infectious disease outbreaks.” NPR
Rochelle Walensky Said She Would ‘Fix’ The CDC, But Nine Months In, She’s Faltering
Even the CDC’s staunchest supporters acknowledge that the agency has experienced numerous setbacks since Biden took office. Some have pinned recent stumbles on the agency and its politically inexperienced director Walensky, while others say that the White House’s own actions have made the CDC’s full revival impossible. STAT
G-20 Announces New Global Body to Respond to Future Pandemics, But Stops Short of Committing Funds
The new Joint Finance-Health Task Force would improve planning among the wealthiest nations to respond to pandemics with additional health-care resources and financing measures. But the announcement came without a pledge of any new funding, inviting criticisms from those already furious that the rich nations of the world are doing too little to help poor countries still being ravaged by the coronavirus. Washington Post
African Medicines Agency to Begin in November
More than a decade after the idea for the African Medicines Agency (AMA) was broached at the 60th session for the World Health Organization Regional Committee for Africa, the agency will officially begin operating Nov 5 under the African Union (AU). Instead of acting as a stand-alone regulatory body, it will coordinate national and regional regulatory efforts, support local manufacturing and pharmacy, and act against substandard and falsified medicines. CIDRAP
WHO Director-General Tedros Unopposed for 2nd Five-Year Term
A former health and foreign minister from Ethiopia, Tedros has been a leading voice urging wealthy countries with large COVID-19 vaccine stockpiles and the big pharmaceutical companies that make them to do more to improve access to the jabs in the developing world — a call that has largely gone unheeded. AP News
MEDICAL COUNTERMEASURES
ACIP Makes Recommendations on Hep B, Orthopoxvirus, Ebola Vaccines
The orthopoxvirus recommendation related to the Bavarian Nordic vaccine against monkeypox and smallpox, which the FDA approved in 2019. In a five-part vote, the group recommended it as an alternative to the first-generation vaccine (ACAM2000). ACIP also recommended the VSV-EBOV vaccine for preexposure prophylaxis for health workers at special pathogens treatment centers and those who work at Laboratory Response Network facilities. CIDRAP
The ACIP Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5–11 Years — United States, November 2021
On October 29, 2021, FDA issued an EUA amendment for a new formulation of Pfizer-BioNTech COVID-19 vaccine for use in children aged 5–11 years, administered as 2 doses (10 μg, 0.2 mL each), 3 weeks apart. The body of evidence regarding immunogenicity, efficacy, and safety for this approval was primarily composed of data from one randomized, double-blind, placebo-controlled phase II/III clinical trial that initially enrolled 2,268 participants aged 5–11 years, randomized 2:1 to receive vaccine or saline placebo. Interim findings from this clinical trial were based on data from participants with a median follow-up of 3.3 months. MMWR
Vaccines For 5-11 Year Olds: FDA Meeting Cliff Notes
In the U.S., more than 1.9 million 5-11 year olds have been infected by COVID-19 during the pandemic. During Delta, there was a sharp increase in cases; this age group represented 10.6% of cases in the week of Oct 10 (they make up 8.7% of the population). There have been >8300 COVID-19 hospitalizations in children ages 5-11, with over 30% of those not having any underlying condition. Once hospitalized, 1/3 kids ended up in the ICU. Your Local Epidemiologist
U.S. Cancels Multimillion-Dollar Deal with Emergent BioSolutions
The decision marks a stark reversal of fortune for the politically connected contractor, Maryland-based Emergent BioSolutions, and an abandonment by the government of a deal that was supposed to be a centerpiece of Operation Warp Speed. New York Times, Fierce Biotech
Molnupiravir: Another Covid-19 Treatment, Another Opportunity to Recognize Inequity
For molnupiravir to be effective, it apparently must be taken within five days of symptom onset. This requires that an individual:
- recognize they have symptoms indicative of Covid-19
- secure a Covid test
- get the test results back in a timely manner
- make an appointment with a doctor
- get a prescription from the doctor for molnupiravir
- buy the medication
Approximately 33 million U.S. adults under age 65 lack health insurance. Those in racial and ethnic minority groups are more likely to be uninsured than white Americans. And about 25% of Americans don’t have a primary care provider. STAT
Why is Delta So Infectious? New Lab Tool Spotlights Little Noticed Mutation That Speeds Viral Spread
A new lab strategy that makes it possible to quickly and safely study the effects of mutations in SARS-CoV-2 variants has delivered one answer: a little-noticed mutation in Delta that allows the virus to stuff more of its genetic code into host cells, thus boosting the chances that each infected cell will spread the virus to another cell. Science
Covid-19: UK Stockpiles Two Unapproved Antiviral Drugs for Treatment at Home
The government has purchased 480,000 courses of molnupiravir (Merck) and 250,000 courses of the combination of PF-07321332 and ritonavir (Pfizer), neither of which have been approved by the UK’s regulator of medicine. The government’s previous record on stockpiling of antivirals had proved controversial, particularly oseltamivir (Tamiflu), stockpiled on a large scale after the 2009 H1N1 “swine” flu pandemic, despite a lack of evidence to support its use. The BMJ
BIOSECURITY + BIOPREPAREDNESS
How Biological Detective Work Can Reveal Who Engineered A Virus
The idea behind the Genetic Engineering Attribution Challenge was to challenge teams to develop techniques to predict, using machine-learning algorithms, which lab produced a certain genetic sequence with more than 80 percent accuracy, according to a new preprint summing up the results of the contest. Vox
HHS’s Medical Countermeasures Enterprise Should Be Re-envisioned Post-COVID-19
A new report from the National Academies of Sciences, Engineering, and Medicine identifies four priority areas for PHEMCE’s improvement: recommitting to its mission; revising its operations and processes; enhancing collaboration with nonfederal partners; and navigating legal and policy issues that have impeded PHEMCE objectives. NASEM
Public-Private Partnership is Essential in Preparing for Future Special Pathogen Outbreaks
The coordinating body must remain agile, as different special pathogen scenarios are highly variable depending on factors such as precaution/spread, lethality, geography, population movement, and demographics. For example, there are significant differences between the following scenarios: isolated cases of a special pathogen – such as Ebola; mid-sized special pathogen spread – such as a unique annual influenza outbreak in a nursing facility; early-stage outbreaks or epidemics such as – a regional outbreak of an unusual foodborne pathogen; and a whole-of-system pandemic – such as COVID-19. Health Affairs
Mentoring as a Vehicle for Implementing Sustainable Health Security in Africa
The International Federation of Biosafety Association (IFBA) South-to-South Global Mentorship Program has demonstrated its ability to form crucial links between frontline biosafety professionals, laboratory workers, and policy- and decision-makers across several implicated sectors. By supporting regionally relevant peer mentorship programs, the gap between health security policy development and implementation may be narrowed. One Health Outlook
SURVEILLANCE + DETECTION
How the Hunt for Nipah Virus Shaped the Search for Coronavirus’s Origins
“We know so much about Nipah. But there are so many unanswered questions. What we do know — that’s taken a long time. It’s much longer than any research grant. It’s longer than anyone’s tenure in a particular job.” Washington Post
Optical Biosensor Platforms Display Varying Sensitivity for the Direct Detection of Influenza RNA
In order to reduce the background noise associated with incomplete quenching of the molecular beacon fluorophore, this work uses a system with only nucleic acids and exonucleases, which removes the need for complex design procedures such as selecting aptamers or DNAzymes, designed nanoparticles, or fabricated electrodes. This simple system is compatible with a wide range of optical sensors, including qPCR thermocyclers, flow cytometry, and the optical biosensors. Biosensors
Prediction of Pandemic Risk for Animal-Origin Coronavirus Using a Deep Learning Method
Coronaviruses can be isolated from bats, civets, pangolins, birds and other wild animals. As an animal-origin pathogen, coronavirus can cross species barrier and cause pandemic in humans. In this study, a deep learning model for early prediction of pandemic risk was proposed based on the sequences of viral genomes. Infectious Diseases of Poverty
Integrated Point-of-Care Molecular Diagnostic Devices for Infectious Diseases
A review of the challenges of automated sample preparation solutions integrated with nucleic acid amplification and signal transduction for rapid and precise home diagnostics. Blood, nasal swab, saliva, urine, and stool are emphasized as the most commonly used clinical samples, with each showing unique properties and exclusive advantages for molecular diagnostics in specific situations. Accounts of Chemical Research
Paper-Based Airborne Bacteria Collection and DNA Extraction Kit
In this study, a paper-based airborne pathogen monitoring kit which can collect bacteria and extract DNA was fabricated. Researchers fabricated an inventive cabinet system which could regulate most factors in the closed setting of the air collection test. The entire process from sampling to obtaining the DNA analyte took 20 min, which can be reduced when the collection time is reduced. The collected samples and concentrated DNA on the paper kit can undergo PCR analysis after long-term storage during the shipping process. Biosensors
PUBLIC HEALTH
Why Scientists Worldwide Are Watching UK COVID Infections
England was among the first regions in Western Europe to lift almost all of its COVID-19 restrictions, following one of the world’s fastest vaccine roll-outs. It ended the legal requirements for social distancing and mask use on 19 July, with Wales and Scotland — which set their own public-health policies — lifting most of their restrictions on 7 and 9 August, respectively. Northern Ireland followed on 31 October. As one of the first countries to trust high vaccine coverage and public responsibility alone to control the spread of SARS-CoV-2, the United Kingdom has become a control experiment that scientists across the world are studying. Nature
Europe Could See ‘Another Half Million Covid-19 Deaths’ by February, WHO Warns
The number of new cases per day has been rising for nearly six consecutive weeks in Europe and the number of new deaths per day has been rising for just over seven consecutive weeks, with about 250,000 cases and 3,600 deaths per day, according to official country data compiled by AFP. With 78 million cases in the WHO’s European region—which spans 53 countries and territories and includes several nations in Central Asia—the cumulative toll now exceeded that of South East Asia, the Eastern Mediterranean region, the Western Pacific, and Africa combined. Over the past seven days, Russia has led the rise with 8,162 deaths, followed by Ukraine with 3,819 deaths and Romania with 3,100 deaths. France 24
How a Vaccine Mandate Divided a Rural Washington Hospital’s Staff
McGuire liked to refer to his small staff as a family, but it had been splitting in two since the beginning of the year, when exactly 50% of the hospital’s few hundred employees chose to be vaccinated and 50% refused. McGuire had lined up for the first dose he could get; his 25-year-old daughter, Jessica, an employee in the hospital clinic, decided she didn’t feel comfortable getting vaccinated for at least a year. His medical director told the staff that mass vaccination was “safe, wildly effective and absolutely necessary.” His director of nursing wrote that it was “government overreach and medical tyranny.” Seattle Times
SPECIAL INTEREST
TWiV 822: Viking Variola Variants
Review of the history of smallpox and the discovery of variola viral genomes in ancient DNA from human remains throughout Northern Europe, which pushes back the earliest date of smallpox virus infection to ~600–1050 CE, overlapping the Viking Age. This Week in Virology
Virologist Eddie Holmes Wins Prime Minister’s Prize for Science for Work on COVID-19 And Viral Evolution
Professor Holmes has been awarded the prestigious Prime Minister’s Prize for Science for his transformative role in the global response to the COVID-19 pandemic. Working with international collaborators at Fudan University in Shanghai, Professor Holmes was the first person to publicly share the entire genome of SARS-CoV-2. That act on 10 January 2020 marked the start of the global scientific fightback against the pandemic and it allowed for the rapid development of COVID-19 tests and vaccinations. ABC News