News highlights on health security threats and countermeasures curated by Global Biodefense
This week’s selections include a guide to a Pandemic Treaty, good data in NHP models for remdesivir against aerosolized Ebola virus, Gov. Newsom breaks out the veto on a biosecurity bill, and a recall for Ellume’s rapid COVID-19 tests.
POLICY + INITIATIVES
A Guide to a Pandemic Treaty
This guide aids preparatory work towards the special session of the World Health Assembly in late November 2021 to consider a treaty or other international instrument for pandemic preparedness and response. The WHO’s only experience in negotiating and adopting an international convention (FCTC) dates back to the early 2000s, and the current generation of health diplomats and negotiators were largely not part of it. A future instrument on pandemics would be informed by international legal regimes existing in other fields, such as human rights, environment, trade and security, not sufficiently known in health circles. The presence of such a large body of international law relevant to health often also prompts questions on why the health domain itself is regulated by a handful of legal instruments only, and why there is hesitation to international legal clarity even when it comes to confronting global health risks of this magnitude. Graduate Institute Geneva
Pfizer Asks F.D.A. to Authorize Its Covid-19 Vaccine for Children 5 to 11
Pfizer and BioNTech asked federal regulators today to authorize emergency use of their coronavirus vaccine for children ages 5 to 11, (approx. 28 million people in the US). Pfizer has proposed a pediatric dose of one-third of the adult dosage. The agency has promised to move quickly on the request and has tentatively scheduled a meeting at the end of the month to consider the data. NY Times
UK Vaccine Advisory Committee Must Be More Transparent About Decisions, Say Researchers
The UK Health Security Agency has rejected a freedom of information request to release the minutes of the 3 September meeting in which its vaccine advisory committee decided not to recommend vaccinating all children ages 12-15 against Covid-19. The agency argued that it was in the public interest to withhold the information until it could be released in a “simultaneous, coordinated manner” and that disclosing the minutes before they were finalized could “result in a false impression of the contents of the meeting.” The decision is being appealed. The BMJ
UNODA Launches Project to Strengthen National Implementation of Biological Weapons Convention in the Caribbean
On 16 September, the Implementation Support Unit (ISU) of the Biological Weapons Convention (BWC) launched a new project for the Caribbean to assist the region with developing national legislation to implement the BWC and with preparing and submitting confidence-building measures (CBMs). UN Office for Disarmament Affairs
A Biodefense Fusion Center to Improve Disease Surveillance and Early Warnings to Enhance National Security
The COVID-19 pandemic has also shown crucial U.S. national security vulnerabilities and shortfalls in our response capability, and our adversaries have likely taken note. Intelligence gathering that includes disease surveillance is an important early warning tool that strengthens decision-making capability and national security. We must enhance threat awareness by developing a global Biothreat Common Operating Picture (BioCOP) in coordination with national and international defense, public health, homeland security, and intelligence agencies. Daniel K. Inouye Asia-Pacific Center for Security Studies
U.S. Leads Effort to Press Russia on Chemical Weapons Use at the Organization for the Prohibition of Chemical Weapons Executive Council Meeting
Western countries on October 5 gave a list of questions to Russia at a meeting of the Organization for the Prohibition of Chemical Weapons (OPCW), the global body responsible for implementation of and compliance with the Chemical Weapons Convention (CWC). “The U.S. and many in the international community have long sought clarity on Russia’s attempted assassination of Mr. Navalny with a chemical weapon on August 20, 2020, and whether it intends to cooperate with the OPCW. Given its status as a State Party to the CWC, Russia’s continued lack of transparency and cooperation surrounding the poisoning is particularly concerning.” The CWC requires Russia to provide its response within 10 days. U.S. Department of State, RFERL
UK Health Security Agency Launches with a Relentless Focus on Keeping the Nation Safe
Public Health England is officially superseded. The UK Health Security Agency (UKHSA), the nation’s new public health body focused on health protection and security, become fully operational as of 1 Oct. GOV.UK
A Public–Private Partnership Model For COVID-19 Diagnostics
To meet the testing challenges of the pandemic, many academics and research institutes around the world set up their own ad hoc testing facilities, and governments rapidly established funding mechanisms for diagnostics development. Here, we report on another approach: the creation of an ad hoc public–private consortium that was able to rapidly design, develop and implement a high-throughput diagnostic platform for SARS-CoV-2, enabling testing on a massive scale in the Netherlands. This consortium may provide a model for other countries seeking to rapidly build capacity in diagnostic testing for COVID-19 and for other infectious diseases. Nature Biotechnology
California Governor Vetoes AB70 Bill for “Gene Synthesis Providers”
Because it costs time and money to perform biosecurity screening, responsible companies that voluntarily conduct screening are at a competitive disadvantage. Requiring all providers in the synthetic DNA market to participate in biosecurity measures levels the playing field. This bill was hoped to be the first legally binding biosecurity measure for the synthetic biology industry in the U.S. and become the de facto standard for the U.S. Approximately half of the nation’s SynBio companies are in California. CA Office of the Governor .pdf
MEDICAL COUNTERMEASURES
A ‘Historic Event’: First Malaria Vaccine Approved by W.H.O.
Malaria kills about 500,000 people each year, about half of them children in Africa. The new vaccine isn’t perfect, but it will help turn the tide, experts said. By one estimate, it will save tens of thousands of children each year. NY Times, STAT
Remdesivir is Efficacious in Rhesus Monkeys Exposed to Aerosolized Ebola Virus
Remdesivir treatment initiated 4 days after exposure was associated with a significant survival benefit, significant reduction in serum viral titer, and improvements in clinical pathology biomarker levels and lung histology. These observations indicate that remdesivir may have value in countering aerosol-induced Ebola virus disease. Scientific Reports
Scientists, Biotechs Look to Unlock the Potential of Phage Therapy
The high specificity that phages have for their bacterial hosts is a double-edged sword. “On the one hand, you have these precision missiles that can go and take out a particular pathogen without disturbing the rest of the body and the rest of the microbiome. But on the other hand, if it’s so specific that you have trouble accessing a wide range of bacterial isolates of any particular pathogen, then that makes your task really difficult.” CIDRAP
Moderna to Build State-of-the-Art mRNA Facility in Africa to Manufacture up to 500 Million Doses Per Year
The company today announced it will build a state-of-the-art mRNA facility in Africa with the goal of producing up to 500 million doses of vaccines each year at the 50 µg dose level. The new facility is expected to include drug substance manufacturing with the opportunity for fill/finish and packaging capabilities at the site. While this is positive news, it is unlikely the facility will be up and operational for a few years. The announcement also comes as the company faces increasing pressure to share more knowledge or doses to accelerate pandemic vaccination efforts given the U.S. government co-developed the mRNA vaccine and invested some $8B. Windfall pandemic profits helped 3 from the company crack the Forbes 400 Richest list this week. Moderna
A Pan-Serotype Dengue Virus Inhibitor Targeting the NS3–NS4B Interaction
Dengue virus causes approximately 96 million symptomatic infections annually, manifesting as dengue fever or occasionally as severe dengue. Data from this early-stage study suggest that an antiviral compound prevents the interaction between two viral proteins (NS3 and NS4B) that play an important role in the replication process of a virus, thereby stopping the ability of the virus to reproduce. This represents an entirely novel mechanism of antiviral action. Nature
Merck’s Molnupiravir Will Be a Blockbuster Drug During Pandemic. What About Endemic COVID-19?
After showing a 50% reduction in the risk of hospitalization or death, Merck & Co.’s antiviral looks on track to secure an FDA emergency use authorization and become a blockbuster. In terms of pricing, Merck already has a deal with the Biden administration to supply 1.7 million courses of molnupiravir to the U.S. government for $1.2 billion. That’s about $700 per course. Merck said it expects to make 10 million courses of the drug by the end of 2021, meaning $7 billion in revenue. Fierce Pharma
BIOSECURITY + BIOPREPAREDNESS
20 Years After the Anthrax Attacks, We’re Still Unprepared
The anthrax-letter attacks killed five people, sickened another 17, sent 30,000 people to doctors, put 10,000 of them on preventive antibiotics, and convulsed Capitol Hill and the New York media world. People who worked in public health in 2001 recall the shock of learning how patchy health communication was. Medical care was just starting to move health records into digital form, but systems weren’t interoperable. That made it impossible to automate alerts and find addresses for doctors in their jurisdictions. Twenty years later, public health is still struggling to get access to data that could help officials respond. That was evident during the early days of Covid, when the civilian-run Covid Tracking Project assembled a corps of volunteers to assemble case count and testing data faster than the CDC could publish it, when the HHS took responsibility for Covid hospital data away from the CDC, and when HHS’s own data diverged from that of the states sending information to it. Wired
We’re Already Barreling Toward the Next Pandemic
More Americans have been killed by the new coronavirus than the influenza pandemic of 1918, despite a century of intervening medical advancement. The U.S. was ranked first among nations in pandemic preparedness but has among the highest death rates in the industrialized world. It invests more in medical care than any comparable country, but its hospitals have been overwhelmed. It helped develop COVID-19 vaccines at near-miraculous and record-breaking speed, but its vaccination rates plateaued so quickly that it is now 38th in the world. COVID-19 revealed that the U.S., despite many superficial strengths, is alarmingly vulnerable to new diseases—and such diseases are inevitable. As the global population grows, as the climate changes, and as humans push into spaces occupied by wild animals, future pandemics become more likely. We are not guaranteed the luxury of facing just one a century, or even one at a time. The Atlantic
SURVEILLANCE + DETECTION
Ellume Issues Recall for Rapid Covid Tests Over Concerns of False Positives
Approximately 427,000 test kits, including some provided to the U.S. Department of Defense, were affected by the problem. Roughly half have already been used, he said, yielding about 42,000 positive results. As many as a quarter of those positives may have been inaccurate, Dr. Parsons said, although he stressed that it would be difficult to determine exactly how many. New York Times
Need a COVID-19 Test in Maryland? First You Need to Find One.
Like many parts of the U.S., the state closed many of its mass testing sites as health departments shifted to more focused vaccination efforts. Over-the-counter rapid, or antigen, tests are in short supply on store shelves and online (and cost too much when you can find them). And urgent care centers and pharmacies are overwhelmed with demand from surging cases linked to the more contagious delta variant. It is chaotic, time-consuming and expensive for many people to navigate what at this point in the pandemic should be a simple process. Baltimore Sun
WHO: Risk of Spread High in Nigeria’s Yellow Fever Outbreak
A year-long yellow fever outbreak in Nigeria has led to 1,321 suspected cases across all 36 of its states. Nigeria has gaps in immunity against yellow fever, with a 2020 estimate suggesting that national immunization coverage was 54%, well below the 80% threshold needed to protect against outbreaks. CIDRAP
Influenza Lineage Extinction During the COVID-19 Pandemic?
The SARS-CoV-2 pandemic has seen a notable global reduction in influenza cases of both influenza A and B viruses. In particular, the B/Yamagata lineage has not been isolated from April 2020 to August 2021, suggesting that this influenza lineage may have become extinct, which may provide opportunities for improving availability and effectiveness of influenza vaccines. Nature Reviews Microbiology
PUBLIC HEALTH
King County Woman Confirmed to Have Died from Rare J&J Vaccine Complication
A 37-year-old Seattle died from a rare blood-clotting syndrome, thrombosis with thrombocytopenia syndrome (TTS), after receiving the J&J COVID-19 vaccine. The CDC temporarily paused its authorization of the J&J vaccine in April, after federal health officials found 15 cases of people who developed a rare blood clot after receiving the shot. All of the patients were women, most under age 50. Three died. After the pause was lifted, the FDA included a new warning in its recommendation of the J&J shot, noting that rare clotting events might occur after vaccination, primarily among women ages 18 to 49 years old. Seattle Times
Public Health, Technology, and Human Rights: Lessons Learned from Digital Contact Tracing
It is still unclear whether digital contact tracing and exposure notification apps effectively reduce the infection rate. Most countries were struggling to integrate digital solutions with other public health measures. Digital contact tracing and exposure notification have been a contentious technology worldwide for concerns over individual privacy. Short of a few successful implementations like those in Germany, Switzerland, and Ireland, most countries are hovering around 5% adoption rates. Harvard Carr Center for Human Rights Policy
Clusters of Science and Health Related Twitter Users Become More Isolated During the COVID-19 Pandemic
The science- and health-related super-community on Twitter was leading the discussion early in the pandemic. Over time, the attention shifted towards both national elites and political actors, paralleled by the introduction of country-specific containment measures and the growing politicization of the debate. Scientific super-community remained present in the discussion but experienced less reach and became more isolated within the network. Overall, the emerging network communities are characterized by an increased self-amplification and polarization. Nature
Emergency Drug Use in a Pandemic: Harsh Lessons from COVID-19
Vaccines and dexamethasone aside, other therapeutic interventions have had minimal impact on overall mortality from COVID-19. Further, in the chaotic early days of the pandemic, the principles of evidence-based medicine were often brushed aside. There was widespread duplication of research effort due to poor coordination, leading to wasted funding and time. Cell
SPECIAL INTEREST
Side Event During BWC Meetings of Experts Spotlights Youth Contributions to Responsible Innovation
UNODA spotlighted youth contributions to global biosecurity efforts in the margins of the Biological Weapons Convention (BWC) Meeting of Experts 2 (MX2) on the “Review of Developments in the Field of Science and Technology Related to the Convention”. This included winners of the 2020 Next Generation for Biosecurity Competition, who presented their joint paper on “Widening the Framework for Regulation of Dual-Use Research in the Wake of the COVID-19 Pandemic”. As the COVID-19 pandemic demonstrates, a skilled and prepared biosecurity workforce is key to addressing future biosecurity challenges. UN Office for Disarmament Affairs
Trevor Bedford: Two Astounding Awards for Virologist Who Raised Early COVID Alarms
Bedford and his collaborators have been instrumental in tracking and understanding SARS-CoV-2 in real-time; co-developed the open-source platform Nextstrain to provide a continually updated view of viral phylogenetics; and provided expert assistance to public health officials in multiple states and international organizations. For his efforts, Bedford has been named a MacArthur Fellow — the so-called “genius grant” that comes with a $625,000 grant paid out over 5 years. This is on the heels of an astounding financial award – a 7-year, $9 million grant from the Howard Hughes Medical Institute. NPR
Chikwe Ihekweazu on His Role Leading WHO’s New Pandemic Hub
The hub, based in Berlin and funded with an initial investment of $100m from the German government, will be led by Ihekweazu, an epidemiologist, director general of Nigeria’s Centre for Disease Control since 2016, and WHO’s new assistant director general of health emergency intelligence. “We’ve got great flu surveillance systems, great tuberculosis surveillance systems, but not necessarily systems that aren’t for specific diseases. One of the components of this hub is that it needs to be disease agnostic. If you think about systems that have been built in other sectors that work with uncertainty—weather forecasting systems, the systems around earthquakes—these are much further developed in the use of different data points to improve decision making.” The BMJ
Francis Collins, Who Guided N.I.H. Through Covid-19 Crisis, is Exiting
The agency’s director under three presidents, Collins was appointed head of NIH in 2009 by President Barack Obama after more than a decade leading the National Human Genome Research Institute, which is part of the NIH. Collins said he is planning to shift his focus back to the lab. Dr. Collins’s replacement will have to be confirmed in an evenly divided Senate. Collins reportedly considered stepping down last year but was urged not to do so over concerns of whom the Trump Administration might appoint to replace him. NY Times