Tag: DPRK

Happy fall! It’s finally time to enjoy all things pumpkin spice free of judgement. We will save the judgement for professional matters. Speaking of which…does a pandemic end when the US president says it does? Nope! We kick off this week discussing why the COVID-19 pandemic may be ending but is certainly not over. We also discuss new US export limits on fentanyl to Russia, highlights from the UNGA, and more.

When Does a Pandemic End?

Early this week, President Biden stated that “The pandemic is over,” on “60 Minutes.” He continued by saying “We still have a problem with COVID. We’re still doing a lot of work on it…but the pandemic is over. If you notice, no one’s wearing masks. Everybody seems to be in pretty good shape. And so I think it’s changing.”

“Everybody” is definitely not “in pretty good shape.” There were 25,202 American COVID-19 patients in hospitals across the country the day that President Biden made this statement. The week before his appearance on the show had a 59,856 case 7-day average in the United States, down 71,190 from the week before. This number is also likely low given how many in the US now use at-home testing without reporting positives to public health authorities. Worse, the US averaged 358 COVID-19 deaths that 7-day period, with our national total sitting at 1,047,020 Americans dead from COVID-19 as of September 14. According to estimates by Brookings, around 16 million working-age Americans suffer from long COVID right now, bringing potentially devastating economic and social impacts. While the situation today is better off than the US was with COVID-19 earlier in the pandemic, it is far from over.

Politico wrote of the president’s statement “White House officials on Sunday downplayed Biden’s comments as simply an attempt to reflect where the U.S. is at now, according to Adam— that is, still dealing with Covid but not gripped by a pandemic that is all-consuming. But whether Biden’s phrasing was a gaffe or intentional, the president’s precise words matter for pandemic policy and public health messaging as the U.S. continues its battle with Covid.”

Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children’s Hospital and dean of the National School of Tropical Medicine at Baylor College of Medicine, told CBS “It didn’t make sense from a policy perspective…I don’t want to take away from the fact that the president overall has done a good job as the leader fighting Covid. But you can’t really say the statements are just careless because he said it — I mean, I listened to it — he made a point of saying it twice.”

Politico continued, writing “His remarks also won’t help with the country’s already-struggling booster uptake, Hotez said. The FDA and CDC just authorized a new Covid booster shot, and the White House has pushed Americans to roll up their sleeves for the Omicron-specific vaccine. Earlier this summer, Covid shots became available for young children, but the vaccination rate remains abysmal: Just under 325,000 young children are fully vaccinated across the U.S., according to the CDC.”

The US has also experienced a surge in cases driven by a new variant each winter since 2020. While the US has rolled out bivalent vaccines ahead of the coming winter, only time will tell if this trend will continue, an especially concerning fact given the likelihood of an especially bad flu season on the horizon for the northern hemisphere. Experts like Dr. Hotez remain especially concerned that a new variant is coming and will again wreak havoc in the US.

Hotez and others have also pointed out this is not going to help the president secure the $22.4 billion in additional COVID-response funding the administration is seeking. Predictably, Biden’s declaration triggered partisan response in Congress, with some members demanding that this statement should end measures like DoD’s vaccination requirements and pandemic student loan relief. “This is not a statement you make when you’re trying to persuade the Congress to allocate funds,” Hotez said. “For public health, scientific, policy reasons — not the way to go. He hit the trifecta.”

However, some experts do agree with President Biden’s statement, arguing the US is no longer in the emergency state it was earlier in the pandemic. NPR wrote of Biden’s statement, “It is a reasonable thing to do as we collectively move on from this emergency footing that we’ve been on for the last couple of years, and try to navigate a new normal,” said Dr. Bob Wachter, chair of UCSF’s Department of Medicine. “It’s an appropriate way of thinking about the threat as it stands today.”

So, when does a pandemic end? It definitely isn’t when the US president suddenly says it does, but the answer is still complicated. A pandemic can be considered over when the disease becomes endemic, but that transition isn’t well defined and there is no clear authority to make that judgement call. A pandemic happens when a disease spreads across large regions or world wide, so there is no single leader in charge of declaring it over. Furthermore, the WHO recently refused to say whether or not it will formally recognize an end to the COVID-19 pandemic. A WHO spokesman told CNN “”WHO does not have a mechanism for declaring or ending a “pandemic…’ Instead, he said, WHO will continue to assess the need for the public health emergency, and an expert committee meets every three months to do that.” While the WHO says the world is nearing the end of the COVID-19 pandemic, the Director General still stressed this week that “being able to see the end, doesn’t mean we are at the end.”

This is reflected in US health policy, even as officials stress the country is no longer in the emergency stage. “We are no longer in the emergency phase of the pandemic…we haven’t yet defined what endemicity looks like,” Dr. Ashwin Vasan, NYC Health Commissioner, said at an event with HHS Secretary Xavier Becerra this week. Ultimately, while the situation in the United States is undoubtedly better and improving, this is not the time to let up on the gas.

US Limits Exports of Fentanyl to Russia…and Well Plates?

The US Department of Commerce’s Bureau of Industry and Security (BIS) announced last week that the bureau is applying further restrictions on Belarus and Russia. This move also “…strictly limited the export of fentanyl and related chemicals to Russia, saying that they “may be useful” as chemical weapons to support Russia’s “military aggression,” The Washington Post reports. Under this new rule, fentanyl sales to Russia and Belarus will now require special licensing. This echoes actions taken by the EU this summer to control exports of fentanyl and other related exports to Russia. The 2002 Nord-Ost siege, when Chechen terrorists seized the Dubrovka Theater, culminated with Russian forces filling the theater with an aerosol made from carfentanil and remifentanil, both fentanyl derivatives. This action killed over 100 hostages in the theater in addition to the insurgents, and demonstrated Russia’s interests in these weapons.

In addition to measures controlling quantum computing-related hardware and other matters, the rule released last week specifically “Expands the scope of the Russian industry sector sanctions to add items potentially useful for Russia’s chemical and biological weapons production capabilities and items needed for advanced production and development capabilities that enable advanced manufacturing across a number of industries.” This includes export restrictions on a number of kinds of laboratory equipment that BIS has determined are not manufactured in Russia. The report explains this logic, reading “Therefore, the implementation of restrictive export controls on this equipment by the United States and our allies will economically impact Russia and significantly hinder Russia’s CBW production capabilities.” This list includes items like fermenters and compressors ‘‘specially designed to compress wet or dry chlorine,
regardless of material of construction,” but also well plates and PCR instruments, offering interesting insight into the state of biotech and life sciences research in Russia.

United Nations General Assembly Highlights

The UN General Assembly wraps up its 77th session today following several days of high level engagement, including a speech from President Volodymyr Zelensky of Ukraine. Here are some global health security-related highlights from this session:

Food Security– During a side event on Tuesday, leaders from across Europe, the Americas, and Africa called for immediate funding and action to address the growing food security crisis that has been worsened by Russia’s war in Ukraine. AP reports that “Speaking at a Global Food Security Summit on the sidelines of the annual U.N. General Assembly, the leaders demanded an end to the war, with each calling it a needless “aggression” and Spain’s prime minister accusing Russian President Vladimir Putin of trying to “blackmail” the world with hunger by causing severe disruptions in the export of Ukrainian grain.”

““Russia must end its illegal war against Ukraine, which has certainly been an essential source of the world’s food supply,” Spanish Prime Minister Pedro Sanchez told the gathering. “The truth is that Putin is trying to blackmail the international community with a large part of the world’s food needs. We cannot combat hunger without peace. The world is expecting much from us. Let’s act together, and let’s act now.””

The Global Fund– The Global Fund to Fight AIDS, Tuberculosis and Malaria hosted its replenishment conference this week with President Biden, seeking to close its $18 billion funding gap for the next few years. However, the Fund only accumulated $14.25 billion in pledges, though the organization stated it expects the gap will close as more donations come in. The UK and Italy notably delayed their pledges. Sarah Champion discussed this in The Guardian, writing “As the Independent Commission for Aid Impact, the UK’s aid watchdog, stated in its recent report: the Global Fund is the project covered by the government’s Overseas Development Assistance (ODA) that has the greatest value for money. With this in mind, it is hard to believe that the government is choosing to ignore the facts and not fully commit to this cause.”

Non-Communicable Diseases– WHO Director General Dr. Tedros Adhanom Ghebreyesus also released a new report, “Invisible Numbers: The true extend of noncommunicable diseases and what to do about them,” urging world leaders to take action on NCDs, which annually are responsible for 17 million premature deaths and cause nearly three quarters of all global deaths. The report’s description explains “Noncommunicable diseases (NCDs) – chief among them, cardiovascular diseases (heart disease and stroke), cancer, diabetes and chronic respiratory diseases – along with mental health, cause nearly three quarters of deaths in the world. Their drivers are social, environmental, commercial and genetic, and their presence is global. Every year 17 million people under the age of 70 die of NCDs, and 86% of them live in low- and middle-income countries (LMICs).”

Sudan Strain Responsible for Ebola Outbreak in Uganda

Uganda has reported the probable Ebola-related death of a one-year-old , with 11 more suspected cases, one confirmed case, and six more probable cases identified in the country. The WHO reported that Uganda declared an outbreak after a 24-year-old man died after showing symptoms. Samples taken from him were later identified as the relatively rare Sudan strain of Ebola virus, marking the first time this strain has been found in the country. Uganda borders the Democratic Republic of Congo, which recently reported a new case after experiencing its fourteenth outbreak earlier this year. Uganda’s last Ebola outbreak was driven by the Zaire strain in 2019, though the country’s deadliest Ebola outbreak came in 2000, leaving over 200 dead.

The WHO released a statement from Dr. Matshidiso Moeti, WHO Regional Director for Africa, in which she explained “Uganda is no stranger to effective Ebola control”, she said. “Thanks to its expertise, action has been taken to quickly to detect the virus and we can bank on this knowledge to halt the spread of infections.” The WHO also explained that “Existing vaccines against Ebola have proved effective against the Zaire strain but it is not clear if they will be as successful against the Sudan strain,” in its statement.

“FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing”

The HHS Office of Inspector General released this report this week on FDA’s use of its EUA authority to authorize COVID-19 tests early in the pandemic. The OIG report found that:

“The failure of the Centers for Disease Control and Prevention (CDC)’s first test rollout revealed vulnerabilities in the Federal approach to testing early in the COVID-19 pandemic. It is typical for CDC to be the first to receive an EUA, and FDA expected that the CDC’s test would meet the early testing needs of the nation. However, CDC’s first test was unusable for many for weeks while no other test was authorized. Furthermore, due in part to its limited engagement with the public health labs that were using CDC’s test, FDA was slow to realize that testing by public health labs was far more limited than it initially expected. To address problems with the first authorized COVID-19 test, FDA worked with CDC, including allowing CDC to modify the terms of its original EUA. However, preventing a similar problem from occurring in future emergencies would require actions outside of FDA’s authority alone.

In using its EUA authority, FDA also made calculated decisions to increase availability of COVID-19 testing, but these decisions often came at a potential cost to test quality. FDA authorized tests using lower levels of evidence to support developers struggling to access clinical samples. FDA’s policies allowed diagnostic and serology tests to get on the market quickly; however, that resulted in some problematic tests on the market, requiring further action by FDA.

FDA’s decision to accept all EUA requests resulted in a record number of submissions-often low-quality and from developers lacking experience with FDA’s processes. In response, FDA took steps to support developers and ease its workload, which included issuing EUA guidance, updating templates (submission guides for developers requesting EUA), and adjusting its EUA review process, among others. Some developers still reported being frustrated and confused.”

“Health Care and the Climate Crisis: Preparing America’s Health Care Infrastructure”

The House Ways and Means Committee recently released its report analyzing responses to an RFI sent to hospitals, health systems, and health care providers to “better understand how climate events have impacted the health sector, as well as steps the health care industry is taking to address its role in mitigating the climate crisis.” The committee explains that “Health Care and the Climate Crisis: Preparing America’s Health Care Infrastructure includes an overview of the role the U.S health system plays in the climate crisis. Part One provides an overview of the problem, description of Chair Neal’s 2022 Request for Information (RFI), and summary statistics from an analysis of survey respondents. Part Two examines how the climate crisis and the prevalence of extreme weather events impact health care organizations. Part Three describes how health care organizations are assessing their climate impact and working to reduce their respective carbon footprints. Part Four summarizes findings and provides a discussion of implications. Part Five is an appendix with survey methodology, limitations, and supplemental tables.”

“Strengthening the Biological Weapon’s Convention’s Contributions to Global Health Security”

This Think Global Health piece discusses false Russian BW allegations and the recent invocation of Article V of the BWC. The authors explain “Russia’s disinformation regarding Ukrainian biological laboratories is intended to distract and divide global attention concerning its reprehensible actions in Ukraine and to generate post hoc justification for its invasion. Russian invocation of Article V risks tainting the BWC consultation mechanism and abusing it to air political grievances and foment distrust. And, like the 1997 consultations, BWC parties reached no consensus, highlighting major challenges to the mechanism in the face of complex geopolitical tensions.”

“Harnessing the Power of Science and Technology Communities for Crisis Response”

The RAND Corporation recently released this Perspective, co-authored by Dr. Daniel M. Gerstein, a Biodefense PhD Program alumnus, discussing DHS’s “…ability to leverage science and technology communities to support the use of science, technology, innovation, and analytical capabilities during crisis response.” The abstract explains, “RAND researchers conducted a literature review and discussions with subject-matter experts to understand how these capabilities have been used during past national security crises and how they could be used in the future. In this Perspective, the researchers offer a conceptual framework for employment of the science and technology communities’ capabilities during crisis response. They also present five imperatives that should be considered for providing technical support during a crisis and a concept for how to institutionalize that support. These critical elements form the basis for providing quality technical support to crisis leadership.”

“What is the Future of the Global Health Security Agenda?”

The Pandemic Action Network released this piece last week discussing the future of GHSA, explaining “The GHSA is now at an inflection point. While GHSA has built a strong community, the COVID-19 pandemic has also stress-tested domestic and global health systems and raised questions about the reach, relevance, and impact of this partnership. Despite its success as a forum for collaboration and incubator for health security concepts and networks, GHSA has been less visible as part of the global response to the COVID-19 pandemic, missing an important opportunity to activate its coordination mechanisms to support global policy discussions on the future of the global health security architecture.”

What We’re Listening To 🎧

This Podcast Will Kill You “Episode 105 Down in the Mumps”

From TPWKY: “We’ve covered measles, we’ve taken on rubella, and now we’re finishing up the classic MMR vaccine by exploring the other M: mumps. To some listeners, mumps may be a painful childhood memory while to others it’s just a letter in a vaccine they were too young to remember getting. But by the end of this episode, we promise that you’ll all be much more familiar with this strange little virus. How does the mumps virus make you sick and give you that classic swollen face look? What is so bad about the mumps that Maurice Hilleman decided to snag a mumps sample from his sick daughter to make a vaccine? Where do we stand with mumps today and what do declining vaccination rates have to do with those not-so-great numbers? Tune in to hear our take on all these questions and many more in this classic TPWKY episode.” Listen here.

National Biodefense Science Board Public Meeting

The National Biodefense Science Board (NBSB) is hosting its next public meeting on September 29 at 11 am ET. “This public meeting of the NBSB will focus on several topics, including the collection, analysis, and sharing of operational health data and/or development and implementation of systems to ensure the availability of virtual healthcare (telehealth, telemedicine, etc.) during a disaster. The NBSB is particularly concerned with the impacts of COVID-19 on rural and underserved communities, including the ways in which those communities succeeded or were challenged in conducting a public health response, and ways in which HHS can support strengthening of systems, technologies, and partnerships that will lead to improvements in data collection and virtual care during disasters.” Learn more and register here.

Introducing the Global Guidance Framework for the Responsible Use of the Life Sciences: Mitigating Biorisks and Governing Dual-Use

The WHO is offering this open webinar on 3 October 2022, 13:30-14:30 CEST, where an expert panel will introduce the recently released global guidance framework for the responsible use of the life sciences: mitigating biorisks and governing dual-use research and discuss its applications for different stakeholders. The panel will include a number of WHO experts as well as Drs. Anita Cicero and Filippa Lentzos. Learn more and register here.

Interested in Studying Biodefense? Come to Our Information Session!

Are you a Pandora Report reader who just can’t get enough? Consider applying to the Schar School’s Biodefense Program, which offers several graduate certificates, an MS in Biodefense (both in-person and online), and a PhD in Biodefense if you’re really into this. On October 11 at 12 pm ET you can join us virtually to learn more about admissions for the MS and graduate certificates, including info on the application process, student experiences, and graduate outcomes. Register here.

iGEM Responsibility Conference: Navigating the Future of Synthetic Biology

“For the first time ever, iGEM’s Responsibility Program is running a dedicated Responsibility Conference on the margins of this year’ s Grand Jamboree. The theme is ‘Navigating the future of synthetic biology’. The event is taking place from 26-27 October 2022 at the Paris Expo, Porte de Versailles, Paris, France. Join policy makers, technical experts, and other experts from around the world in exploring: Safe, secure, & responsible synbio beyond containment; Negotiating competing ideas of doing good; Applied biosafety & biosecurity; Lessons for governance of emerging technologies. If you are interested in taking part in this exciting new event, please register your interest online here, or contact us directly at responsibility@igem.org.”

Pathogens Project Launched

This week, “a group of scientists and public health leaders, convened by the Bulletin of the Atomic Scientists, launched an international taskforce to consider trends and oversight of high-risk pathogen research. This follows the WHO’s recent release of the “Global guidance framework for the responsible use of the life sciences: mitigating biorisks and governing dual-use research.”

“Over the next few months, the initiative on “Creating the Framework for Tomorrow’s Pathogen Research” will discuss risk assessment and mitigation, including lab-based outbreak risks.   A public-facing conference in Geneva, Switzerland on April 19-21, 2023, will include task force members, policy leaders, journalists, scientists, and civic leaders, among others, and will produce a summary report with recommendations for a comprehensive global approach to management of extremely high-risk biological research.”

Read more about the project here.

It has been a busy week and this issue reflects that! We kick this issue off with updates on the conclusion of the Biological Weapons Convention Article V Formal Consultative Meeting in Geneva before getting into everything from the United States’ inclusion on the WHO’s list of countries with circulating vaccine-derived polio (yikes) and new US government health security leadership and funding. As always, there are enough new publications, podcasts and upcoming events to keep you way too busy until next Friday.

BTWC Consultative Meeting Wraps Up

Last Friday, the Biological Weapons Convention Article V Formal Consultative Meeting requested by Russia concluded in Geneva. The meeting was held in response to Russia’s claims that the US supports biological weapons development in Ukraine. The US State Department issued a statement accusing Russia of abusing the consultative meeting process by using it as an international stage to further spread disinformation. The statement reads in part, “The United States delegation, led by Special Representative Kenneth D. Ward, effectively exposed Russia’s disinformation tactics and dispelled Russia’s spurious allegations seeking to malign peaceful U.S. cooperation with Ukraine.”

“In the presence of delegations from 89 countries, the United States and Ukraine presented a thorough, in-depth series of presentations that strongly refuted Russia’s absurd and false claims of U.S. biological weapons development and bio-labs in Ukraine. Technical experts from the U.S. and Ukrainian delegations unambiguously explained their cooperation and U.S. assistance related to public health facilities, biosafety, biosecurity, and disease surveillance as part of the broader U.S. Cooperative Threat Reduction Program. The United States and Ukraine also highlighted how such activities are consistent with—and further support—the provisions of the BWC, particularly Article X, which promotes cooperation and assistance by States Parties. States Parties affirmed and supported the United States in this regard, with over 35 of the 42 countries that spoke noting the importance of such work.”

Belarus, China, Cuba, Nicaragua, Russian Federation, Syrian Arab Republic, Venezuela, and Zimbabwe also submitted a joint statement on Friday, showing that the Russians just aren’t ready to give this up-“We have to conclude that the questions as to the military biological activities conducted by the United States in the context of the functioning of biological laboratories on the Ukrainian territory still remain unresolved. We have not received exhaustive explanations that could completely allay the doubts concerning the said activities and thus straighten out the situation that had prompted the Russian side to convene the Consultative meeting under BTWC Article V. This is regrettable.”

The statement later continued, “In addition, given the outcomes of the Consultative meeting as well as to facilitate the resolution of the existing situation, we call for making use of all opportunities available within the framework of the BTWC, including the mechanism under Article VI of the Convention.”

Article VI of the convention is the provision of “Right to request the United Nations Security Council to investigate alleged breaches of the BWC, and undertaking to cooperate in carrying out any investigation initiated by the Security Council.”

Though China’s Xi Jinping has yet to officially back Russia’s claims, his representative at the consultative meeting, Li Song, said “China was “deeply concerned” about the allegations and called for an independent international investigation of the United States’ activities involving biological research,” according to the New York Times. “My delegation believes that a series of specific questions raised by Russia have not yet received pointed response from the U.S.,” Li said in a statement provided by the UN Office of Disarmament Affairs.

What Purpose Does This Disinformation Serve?

While Soviet and, later, Russian disinformation surrounding US BW programs (or the lack thereof) is nothing new, it is important to understand what purposes it serves. With Russian claims about supposed US BW work in Ukraine doing everything from developing an ethnic bioweapon to target Russians to training birds to deliver biological weapons, these claims are broad and have far-reaching consequences. For starters, these claims help the Russians justify and legitimize the invasion of Ukraine to their people by offering a threat to the homeland that justifies the severe cost this has had for the country.

However, claims like this also damage public health, especially since the facilities targeted by this disinformation, both in Ukraine and other countries assisted by the United States’ Cooperative Threat Reduction program, are those with important public health missions. This was the case when allegations were aimed at the Richard G. Lugar Center for Public Health Research in Tbilisi, Georgia, home to the Georgian National Center for Disease Control and Prevention and US Army Medical Research Directorate-Georgia. The Lugar Center was instrumental in Georgia’s management of the COVID-19 pandemic in 2020, shoring up diagnostic capability for the country. Targeting facilities with such important missions, especially when they are well-documented to be working on strictly peaceful work, undermines their legitimate service to the public and their role in protecting health security globally.

Furthermore, the RAND Corporation’s John V. Parachini explains, “It’s tempting to write off such claims as cartoonish propaganda. But Russia is also making similarly outrageous claims to the United Nations and other international forums, and that’s more serious. Such maneuvers could dangerously undermine international arms control agreements.” He also explains of Russia’s Permanent Representative to the UNSC Vassily Nebenzia’s claims about Ukraine that “What the ambassador failed to mention was that Russian scientists visited these same laboratories in the past and never noted anything like what Russian officials now claim. Moreover, the United States had been collaborating with Russia in the same way—providing similar assistance to Russia to refocus the activities of former Soviet biological weapons laboratories, until Russia pulled out of the program in 2014, the same year it invaded Crimea.”

United States Added to WHO’s List of Countries with Circulating Vaccine-Derived Poliovirus

At one point in the 1940s, polio disabled an average of over 35,000 Americans annually. However, thanks to a robust vaccination push, the Pan American Health Organization announced in 1994 that “…three years had passed since the last case of wild polio in the Americas. A three-year-old Peruvian boy, Luis Fermín, had the last registered case there.” There have been no cases of polio originating in the US caused by wild poliovirus since 1979. However, wild poliovirus has been brought into the country by travelers, with the last occurrence in 1993.

This week, “CDC…announced that polioviruses found in New York, both from the case of paralytic polio in an unvaccinated adult in Rockland County and in several wastewater samples from communities near the patient’s residence, meet the World Health Organization (WHO)’s criteria for circulating vaccine-derived poliovirus (cVDPV) – meaning that poliovirus continues to be transmitted in Rockland County, NY, and surrounding areas.”

The press release continued, “CDC is working closely with WHO, the Pan American Health Organization (PAHO), and other international public health partner organizations. As previously reported, the virus’ genetic sequences from the patient from Rockland County, NY, and wastewater specimens collected in New York have been linked to wastewater samples in Jerusalem, Israel, and London, UK, indicating community transmission. The viral sequences from the patient and from three wastewater specimens had enough genetic changes to meet the definition of a vaccine-derived poliovirus (VDPV).  These two things – one individual with VDPV and at least one detection of a related VDPV in an environmental sample – meet WHO’s definition of cVDPV, and CDC submitted this data to WHO for inclusion on its list of countries with cVDPV. There are global recommendations for countries with cVDPV2 outbreaks to protect people from polio, and the United States is taking all appropriate actions to prevent new cases of paralysis.”

While polio spreading in wealthy countries is concerning, check out Leslie Roberts’ article in Science news-“Polio is back in rich countries, but it poses a far bigger threat to developing world”.

US Announces Investments in Bioeconomy and Commits to Improving Biosecurity…Sorta?

Late this week, the White House announced $2 billion in “new investments and resources to advance President Biden’s National Biotechnology and Biomanufacturing Initiative.” The funding aims to expand domestic biomanufacturing, help bring new bio-products to market, train future generations of biotechnologists, and “drive regulatory innovation to increase access to products of biotechnology,” among other goals. However, the fact sheet also discusses the goal to “reduce risk through investing in biosecurity innovations,” which states that “DOE’s National Nuclear Security Administration [(NNSA)] plans to initiate a new $20 million bioassurance program that will advance U.S. capabilities to anticipate, assess, detect, and mitigate biotechnology and biomanufacturing risks, and will integrate biosecurity into biotechnology development.”

This has drawn some criticism as $20 million towards biosafety is a small amount of the (1%) of the overall $2 billion in funding announced, particularly with the growing need to address gaps in global biosafety. Furthermore, its placement under the NNSA has brought some concern, particularly as the Office of Defense Nuclear Proliferation, which “works globally to prevent state and non-state actors from developing nuclear weapons or acquiring weapons-usable nuclear or radiological materials, equipment, technology, and expertise,” will be tasked with overseeing the program.

US Government Gets New Health Security Leadership

Dr. Renee Wegrzyn Appointed First Director of Advanced Research Projects Agency for Health (ARPA-H)

President Biden appointed Dr. Renee Wegrzyn, a biologist currently at Gingko Bioworks, to lead the recently created Advanced Research Projects Agency for Health (ARPA-H). Biden proposed the creation of the Advanced Research Projects Agency for Health to “improve the U.S. government’s ability to speed biomedical and health research. Public Law 117-103 was enacted on March 15, 2022, authorizing the establishment of ARPA-H within the U.S. Department of Health and Human Services.”

STAT reports, “Wegrzyn, 45, currently works at Boston-based Ginkgo Bioworks, a company focused on biological engineering, but has prior experience in two government agencies Biden has said he hopes to emulate with ARPA-H — the Pentagon’s Defense Advanced Research Projects Agency and the Intelligence Advanced Research Projects Activity.” STAT also explains that “Wegrzyn is one of four former DARPA officials that STAT reported in July had been interviewed for the ARPA-H job by White House science adviser Francis Collins. She will not need Senate confirmation for her role but is sure to face scrutiny from lawmakers who have questioned the need for a new health agency, arguing it could replicate efforts at the National Institutes of Health.”

FDA Names Dr. David Kaslow New Director of Office of Vaccines Research and Review

Dr. David Kaslow, Chief Scientific Officer for Essential Medicines and Head of Center for Vaccine Innovation and Access at PATH, will become the FDA’s new director of the Office of Vaccines Research and Review on October 11. “Dr. Kaslow has more than 35 years of experience in vaccine research and development. He joined PATH in 2012 as Director of PATH’s Malaria Vaccine Initiative (MVI), leading the development of well-tolerated and effective vaccines against malaria. Prior to joining PATH, he was a Vice President of Vaccines and Infectious Disease at Merck Research Laboratories, while serving in key advisory positions with MVI and the Bill & Melinda Gates Foundation.” He was also the founder of the NIH’s Malaria Vaccine Development Unit.

His predecessor, Dr. Marion Gruber, retired last year and her deputy, Dr. Philip Krause, left the FDA a month later in November. According to the New York Times, “One reason is that Dr. Gruber and Dr. Krause were upset about the Biden administration’s recent announcement that adults should get a coronavirus booster vaccination eight months after they received their second shot, according to people familiar with their thinking.” Biopharma Dive explains further that “Shortly after the departures were announced, both were listed as co-authors of an article published in The Lancet that then argued against broad rollout of COVID-19 vaccine boosters, at a time when the Biden administration was preparing to begin a booster campaign.”

World Bank and WHO Launch Financial Intermediary Fund (FIF) for Pandemic Prevention, Preparedness, and Response

This week, World Bank and WHO announced the establishment of the FIF for pandemic prevention, preparedness, and response. “The fund will provide a dedicated stream of additional, long-term financing to strengthen PPR capabilities in low- and middle-income countries and address critical gaps through investments and technical support at the national, regional, and global levels. The fund will draw on the strengths and comparative advantages of key institutions engaged in PPR, provide complementary support, improve coordination among partners, incentivize increased country investments, serve as a platform for advocacy, and help focus and sustain much-needed, high-level attention on strengthening health systems.” The first round of calls for investments to be funded by the FIF will be available in November this year.

United Nations General Assembly Passes Resolution A/76/L.76%20

The UNGA earlier this month passed Resolution A/76/L.76%20 calling on the 78th UNGA to hold a high-level meeting on pandemic prevention, preparedness, and response. Among other things, the resolution states, “Recognizing that health is a precondition for and an outcome and indicator of all three dimensions – economic, social and environmental – of sustainable development and that, despite progress made, challenges in global health, including major inequities and vulnerabilities within and among countries, regions and populations, still remain and demand persistent and urgent attention,…

1. Decides to hold a one-day high-level meeting, to be convened by the President of the General Assembly in collaboration with the World Health Organization, and at the level of Heads of State and Government, by no later than the last day of the general debate of the Assembly at its seventy-eighth session, to adopt a succinct political declaration aimed at, inter alia, mobilizing political will at the national, regional and international levels for pandemic prevention, preparedness and response;
2. Recommends that the President of the General Assembly appoint two co-facilitators to present options and modalities for the high-level meeting, as well as the political declaration.”

The Lancet-“COVID-19 Response: A Massive Global Failure”

With COVID-19 deaths the lowest they have been since March 2020, the Lancet released its much anticipated commission report and accompanying infographic this week discussing global failures in responding to the COVID-19 pandemic and recommendations for improvement. The report explains “The Commission delivers a number of recommendations that are divided into three main areas. First, practical steps to finally control and understand the COVID-19 pandemic. Second, realistic, feasible, and necessary investments to strengthen the first line of defence against emerging infectious agents in countries by strengthening health systems and widening universal health coverage. Third, ambitious proposals to ignite a renaissance in multilateralism, integrating the global response to the risk of future pandemics with actions to address the climate crisis and reversals in sustainable development.”

“Global Guidance Framework for the Responsible Use of the Life Sciences: Mitigating Biorisks and Governing Dual-Use Research”

This week, the WHO released the Global guidance framework for the responsible use of the life sciences, which calls on leaders and other stakeholders to “mitigate biorisks and safely govern dual-use research, which has a clear benefit but can be misused to harm humans, other animals, agriculture and the environment.” According to the WHO’s press release, “This is the first global, technical and normative framework for informing the development of national frameworks and approaches for mitigating biorisks and governing dual-use research,” and “The Framework addresses the decades-long challenges of preventing the accidental and deliberate misuse of biology and other life sciences, as well as how to manage governance and oversight to both accelerate and spread innovation, while mitigating negative impacts. The life sciences are increasingly crossing over with other fields, such as chemistry, artificial intelligence and nanotechnology, which changes the landscape of risks, with those that span multiple sectors and disciplines more likely to be missed.” The Schar School’s Dr. Gregory Koblentz contributed to several of the working groups formed in the creation of this framework.

“100 Days of Monkeypox: Evaluating the U.S. Response to the Emerging Global Outbreak”

Dr. Daniel P. Regan, a biomedical engineer and a Fellow at the Janne E. Nolan Center on Strategic Weapons, recently authored this Council on Strategic Risks briefer on the United States’ first 100 days dealing with monkeypox. The brifer “…details the early dynamics of the outbreak, evaluates the testing, vaccination, and therapeutic rollout, and provides an outlook and analysis meant to help the United States prevent and address similar biological threats.”

“Differential Technology Development: A Responsible Innovation Principle for Navigating Technology Risks”

This article, available as a pre-print on SSRN, discusses differential technology development  and its potential benefits for private and government research funding and technology regulations. The abstract reads “Responsible innovation efforts to date have largely focused on shaping individual technologies. However, as demonstrated by the preferential advancement of low-emission technologies, certain technologies reduce risks from other technologies or constitute low-risk substitutes. Governments and other relevant actors may leverage risk-reducing interactions across technology portfolios to mitigate risks beyond climate change. We propose a responsible innovation principle of “differential technology development”, which calls for leveraging risk-reducing interactions between technologies by affecting their relative timing. Thus, it may be beneficial to delay risk-increasing technologies and preferentially advance risk-reducing defensive, safety, or substitute technologies. Implementing differential technology development requires the ability to anticipate or identify impacts and intervene in the relative timing of technologies. We find that both are sometimes viable and that differential technology development may still be usefully applied even late in the diffusion of a harmful technology. A principle of differential technology development may inform government research funding priorities and technology regulation, as well as philanthropic research and development funders and corporate social responsibility measures. Differential technology development may be particularly promising to mitigate potential catastrophic risks from emerging technologies like synthetic biology and artificial intelligence.”

“Over Half of Known Human Pathogenic Diseases Can be Aggravated by Climate Change”

While Mora et al.’s August article re-confirms what we intuitively know, it offers a sobering reminder and quantification of the immense risks unchecked climate change brings. Their abstract explains “It is relatively well accepted that climate change can affect human pathogenic diseases; however, the full extent of this risk remains poorly quantified. Here we carried out a systematic search for empirical examples about the impacts of ten climatic hazards sensitive to greenhouse gas (GHG) emissions on each known human pathogenic disease. We found that 58% (that is, 218 out of 375) of infectious diseases confronted by humanity worldwide have been at some point aggravated by climatic hazards; 16% were at times diminished. Empirical cases revealed 1,006 unique pathways in which climatic hazards, via different transmission types, led to pathogenic diseases. The human pathogenic diseases and transmission pathways aggravated by climatic hazards are too numerous for comprehensive societal adaptations, highlighting the urgent need to work at the source of the problem: reducing GHG emissions.”

Dr. Jennifer Doudna Authors Piece on the Benefits of Gene Editing

Dr. Jennifer Doudna, a pioneering American biochemist who received the 2020 Nobel Prize in Chemistry alongside Emmanuelle Charpentier for their work on CRISPR gene editing, recently authored a piece in the Atlantic, “Starting a CRISPR Revolution Isn’t Enough,” discussing the great strides and improvements that the technology has experienced in recent years. She covers the origins of modern biotechnology from the 1970s onwards before moving on to the growing CRISPR economy, which was valued at $5.2 billion in 2020, and what investments she thinks governments and research organizations need to make today to ensure the benefits of the technology are broad in application. She also cautions that “Powerful technology, of course, comes with the potential for misuse, and CRISPR’s powers raise important questions…These strategies could help fight the spread of invasive species and devastating diseases such as malaria, but without careful assessment and governance, they could also pose a risk to whole ecosystems.”

She further elaborates on this in her discussion of the “CRISPR babies” scandal that resulted from He Jiankui’s work editing the genomes of viable human embryos that later became twin children. She explains the need for regulations to prevent such use of the technology, writing “Without these guardrails, we may not only harm humans and our environment, but also risk societal backlash against the very technologies that could preserve and improve our health and make our planet more livable.”

While Dr. Doudna focuses primarily on the benefits of this technology, it does bring significant security concerns as discussed by the Schar School’s Dr. Sonia Ben Ouagrham-Gormley in her award-winning paper, “From CRISPR babies to super soldiers: challenges and security threats posed by CRISPR,“ and by Dr. Gregory Koblentz and his co-authors in their report, “Editing Biosecurity: Needs and Strategies for Governing Genome Editing“.

“Conspiracy Theories About COVID-19 Help Nobody”

Dr. Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Organization (VIDO) at the University of Saskatchewan, and Dr. Michael Worobey, department head of Ecology and Evolutionary Biology at the University of Arizona, recently published an argument piece in Foreign Policy discussing how COVID-19 conspiracy theories harm us all. They focus on ” the idea that SARS-CoV-2, the virus that causes COVID-19, was engineered in a laboratory” and the appointment of Dr. Jeffrey Sachs, who they describe as “a Columbia University economist with no expertise in virology, evolution, epidemiology, or public health,” as the chair of the Lancet‘s COVID-19 commission.

They write, “Although biosafety and biosecurity are of paramount importance, especially to virologists who actually handle these dangerous pathogens, they are irrelevant to the zoonotic origin of SARS-CoV-2 and polarize an ongoing discussion that must occur in a multidisciplinary, bipartisan way. Fictional origin stories that politicize regulating essential research only serve to remove the science from a necessarily scientific discourse…The suspicion cast on virologists and epidemiologists is profoundly harmful.”

Rasmussen and Worobey were co-authors of the two Science papers released this summer that strongly supported the idea that SARS-CoV-2 is zoonotic in origin and initially infected people naturally at the Huanan Seafood Wholesale Market in Wuhan-“The molecular epidemiology of multiple zoonotic origins of SARS-CoV-2” and “The Huanan Seafood Wholesale Market in Wuhan was the early epicenter of the COVID-19 pandemic.” They also authored an opinion piece discussing this work in plain language for the Globe and Mail in July that is available here.

What We’re Listening To 🎧

Radiolab: 40,000 Recipes for Murder

The Schar School’s Dr. Sonia Ben Ouagrham-Gormley was interviewed on NPR’s Radiolab. The episode, 40,000 Recipes for Murder, asks the question, “Two scientists realize that the very same AI technology they have developed to discover medicines for rare diseases can also discover the most potent chemical weapons known to humankind. Inadvertently opening the Pandora’s Box of WMDs. What should they do now?” Listen here.

The Retort Episode 3: The Evolving Chemical and Biological Weapon Challenge

In this episode, Dr. Edwards talks with Dr. Jean Pascal Zanders, founder of The Trench, about developments leading to modern CBW, the development of modern international law, and current and emerging challenges in this area. Read Dr. Zanders blog about it here and watch/listen to the episode here.

Interested in Studying Biodefense? Come to Our Information Session!

Are you a Pandora Report reader who just can’t get enough? Consider applying to the Schar School’s Biodefense Program, which offers several graduate certificates, an MS in Biodefense (both in-person and online), and a PhD in Biodefense if you’re really into this. On October 11 at 12 pm ET you can join us virtually to learn more about admissions for the MS and graduate certificates, including info on the application process, student experiences, and graduate outcomes. Register here.

Monkeypox: Have We Learned Anything from COVID-19?

“The Scowcroft Institute of International Affairs at the Bush School of Government & Public Service at Texas A&M University will host a panel discussion entitled Monkeypox: Have we learned anything from COVID-19?, featuring moderator Dr. Gerald Parker and panelists Drs. Robert Carpenter, Syra Madad, Jennifer A. Shuford, and Bob Kadlec. Dr. Gerald Parker will moderate a panel of experts, including Drs. Robert Carpenter, Syra Madad, Jennifer A. Shuford, and Bob Kadlec, as they explore the Monkeypox outbreak. Recently declared a public health crisis by the federal government, Monkeypox is the thing on everyone’s mind. The panel will answer questions such as: Are we making the same mistakes with Monkeypox as we did with COVID-19? How can we do better with this and future pandemic threats? Is this something we need to be concerned about? And more. This will be a hybrid event. It will take place in person in Hagler Auditorium in the Annenberg Presidential Conference Center and virtually via zoom, (link available upon registration) and will start promptly at 5:30 PM CT.” Register online to attend.

Building Capacities for Addressing Future Biological Threats

On Tuesday, September 20 from 9:00am–10:30am ET, the Council on Strategic Risks (CSR) will host a webinar entitled “Building Capacities for Addressing Future Biological Threats.” n this webinar, experts will discuss the changing biological threat landscape and some key avenues to improve preparedness and response capabilities for addressing future biological threats. The webinar will begin with a keynote address from Dr. David Christian Hassell. As Deputy Assistant Secretary in the Administration for Strategic Preparedness and Response in the U.S. Department of Health and Human Services, Dr. Hassell will share his expertise and vision on how the United States may continue to build on successes and opportunities to address future biological threats. A panel discussion will follow Dr. Hassell’s address featuring Dr. Pardis Sabeti, Professor at the Center for Systems Biology at Harvard University, who will share her ongoing work in biosurveillance and pathogen early warning and Dr. Akhila Kosaraju, CEO and President of Phare Bio, who will discuss the role of the private-sector in developing medical countermeasures and other technologies for reducing biological threats. You can register to attend here.

iGEM Responsibility Conference: Navigating the Future of Synthetic Biology

“For the first time ever, iGEM’s Responsibility Program is running a dedicated Responsibility Conference on the margins of this year’ s Grand Jamboree. The theme is ‘Navigating the future of synthetic biology’. The event is taking place from 26-27 October 2022 at the Paris Expo, Porte de Versailles, Paris, France. Join policy makers, technical experts, and other experts from around the world in exploring: Safe, secure, & responsible synbio beyond containment; Negotiating competing ideas of doing good; Applied biosafety & biosecurity; Lessons for governance of emerging technologies. If you are interested in taking part in this exciting new event, please register your interest online here, or contact us directly at responsibility@igem.org.”

Post-Pandemic Recovery: From What, For Whom, and How?

“The Johns Hopkins Center for Health Security invites you to a webinar on “Post-Pandemic Recovery: From What, For Whom, and How?” to be held on October 4 and October 6, 2022, 12:00-2:30pm ET. During this online symposium, we will engage a broad community of practitioners in discussions about operationalizing a holistic process of post-pandemic recovery: What systems can local jurisdictions set up and strengthen that sustain the long view on getting through and past the pandemic, reverse the social determinants of uneven impacts, and develop resilience to future public health emergencies?

On Day 1, representatives from diverse sectors will diagnose tangible harms from COVID-19 (urgent and enduring), prescribing remedies that can facilitate a comprehensive post-pandemic recovery. On Day 2, community advocates and practitioners will describe their experiences in planning for post-pandemic recovery in their jurisdictions, sharing lessons learned for peers elsewhere. A full list of speakers can be found in the agenda. The symposium kicks off a larger project, sponsored by the Open Philanthropy Project, that supports local decision makers in assessing COVID-19 recovery efforts.” Please register here.

National Science Advisory Board for Biosecurity Virtual Meeting

The National Science Advisory Board for Biosecurity (NSABB), chaired by Dr. Gerald Parker, Associate Dean for Global One Health at Texas A&M University, will host a virtual meeting on September 21 at 1 pm ET. The meeting will include a working group update on Potential Pandemic Pathogen Care and Oversight (P3CO) policy review and more with an opportunity for public comments. Read the preliminary draft findings and recommendations here and access the webcast here.

ICYMI: September 1 White House Webinar on the Annual Report of the American Pandemic Preparedness Plan

Earlier this month, the Biden administration hosted a webinar to discuss the first Annual Report of the American Pandemic Pandemic Preparedness Plan. Check it out on the White House YouTube channel.

Smithsonian’s Outbreak: Epidemics in a Connected World Exhibit to Close October 3

The Smithsonian Museum of Natural History’s temporary exhibit, Outbreak, is scheduled to close permanently next month following its four-year run. The exhibit helps guests “Learn how to think like an epidemiologist—find the connections between human, animal, and environmental health in an interactive simulation; Reflect on personal memories and photos from disease survivors and frontline healthcare workers; and Work cooperatively with other visitors to contain an outbreak before it spreads further in a multi-player game.” While this exhibit is closing, the Smithsonian plans to offer a new One Health webinar series this fall and you can still apply to be granted access to the DIY version of the exhibit for show anywhere in the world! Also, if you can’t make it to DC in time for the closure, check out the virtual tour available here.