Pandora Report: 9.23.2022

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 FundThe 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.

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