This week’s Pandora Report provides updates on the BIOSECURE Act, FDA’s recent actions regarding COVID-19 vaccines, and more. The Pandora Report will be going on break and will return on January 9, 2026. Happy holidays!
Congress Passes BIOSECURE Act Embedded in FY 2026 NDAA
The BIOSECURE Act, first introduced during the 188th Congress, has now been passed by Congress after it was included in the FY 2026 National Defense Authorization Act, which was signed into law by President Trump on December 18. The act failed to pass during the last Congress, in part because of concerns about a lack of due process for companies targeted by its provisions. While some parts have changed, the core of the legislation remains the same: It prevents US executive agencies from contracting with or funding companies that are considered “biological companies of concern.”
Unlike its predecessor, this reconciled version does not rely on a blacklist of Chinese life sciences firms, but instead delegates this task to the Office of Management and Budget while also referencing the Section 1260H list from the Department of Defense. The ban on cooperation with certain Chinese entities also includes federal contracts with pharmaceutical companies that use services or products from these entities. This is concerning as many pharmaceutical companies conduct early clinical trials in China to save time and money on the clinical trial process. Between approximately 70 and 80% of US pharmaceutical companies directly collaborate with Chinese firms.
Further Reading:
- “BIOSECURE Act Update,” Morrison Foerster
- “BIOSECURE Act Could Affect Half of US Biopharmaceutical Development,” European Biotechnology
- “Cotton Introduces Bill to Protect American Biotech Innovation from Communist China,” Office of US Senator Tom Cotton
FDA Allegedly Moves to Add Black Box, Expands COVID-19 Vaccine Inquiry
According to CNN, discussions have taken place internally at the FDA about possibly adding a black box warning to COVID-19 vaccines. These warnings (officially called boxed warnings) are the strictest warning FDA can require from a drug manufacturer as they are designed to alert providers and patients to serious, life-threatening, or permanently disabling risks associated with a drug’s use in the case of an adverse reaction. The FDA previously announced in June of this year that it will require updated warnings about myocarditis and pericarditis in labeling of mRNA COVID-19 vaccines. FDA Commissioner Marty Makary denied his agency is considering requiring the boxed warning for COVID-19 vaccines.
This comes on the heels of reports FDA has expanded its investigation of deaths involving COVID-19 vaccines to include adults as well as children. The initial inquiry was announced in September and focused only on children, seemingly spurred by Secretary Kennedy’s claims that these vaccines are deadly and dangerous, contrary to scientific consensus. In November, Vinay Prasad, the agency’s top vaccine regulator, informed staff that the organization had linked 10 children’s deaths to the vaccines, despite offering no evidence in the memo to support his claims. Experts have, in response, highlighted that COVID-19 itself has killed at least 1.2 million people in the US, more than 2,000 of whom where children.
Further Reading:
- “Health Experts Slam Possible FDA ‘Black Box’ Warning for COVID Vaccines,” Lauren J. Young, Scientific American
- “The United States Isn’t Prepared for Another Pandemic. Here’s What Should Happen,” Matt Field, The Bulletin of the Atomic Scientists
US Global Aid Changes and Challenges Continue
It was recently announced that Uganda will receive up to $1.7 billion in US funding for its health sector over the next five years, making the country the latest in a group that reached similar deals under the Trump administration’s “America First Global Health Strategy.” The funds will primarily support health programs focused on HIV/AIDS, TB, malaria, maternal and child health, and polio. Uganda’s government will increase its own health expenditure by $500 million to “gradually assume greater financial responsibility over the course of the framework.”
Rwanda and Kenya recently announced similar deals. However, a Kenyan court has suspended implementation of the country’s $2.5 billion deal with the US over data privacy concerns. The interim ruling bars Kenyan authorities from taking steps to enact the deal “insofar as it provides for or facilitates the transfer, sharing or dissemination of medical, epidemiological or sensitive personal health data.” Kenyan Health Minister Aden Duale has said that the government will comply with the ruling, but that it will challenge it.
Further Reading:
- “What We Know-and Don’t Know-About the Trump Administration’s Global Health Agreements,” Jocilyn Estes and Janeen Madan Keller, Center for Global Development
- “Expanding Faith-based Healthcare in Nigeria through the America First Global Health Strategy,” US Department of State
- “Trump Officials Celebrated with Cake After Slashing Aid. Then People Died of Cholera.” Anna Maria Barry-Jester and Brett Murphy, ProPublica
“Protecting Children from Biological Weapons in Armed Conflict”
From UNICEF: “Biological threats are no longer theoretical. Accelerating advances in synthetic biology, genomics, automation, and artificial intelligence (AI) are reshaping the landscape of risk, creating new pathways for the development, modification, and use of biological agents in armed conflict. In this emerging security environment, children — already the most vulnerable in any crisis — would pay the highest price.”
“This UNICEF working paper examines how emerging biotechnologies may be weaponized in future conflicts, how these threats intersect with cyber and information operations, and why children may be deliberately targeted for strategic or psychological effect. Drawing on foresight scenarios and legal-policy analysis, it identifies critical gaps in global biosecurity, including attribution challenges, weak verification mechanisms, and insufficient child-centered preparedness frameworks.”
“Children’s physiology, dependency, and limited access to life-saving services place them at disproportionate risk in any biological incident. In conflict-affected settings, where health systems are degraded and humanitarian access is constrained, these dangers are multiplied. A deliberate biological attack would not only devastate young lives — it would undermine community stability, disrupt recovery for generations, and violate the most fundamental principles of international humanitarian and human rights law.”
“This working paper delivers a clear message to the international community: existing biosecurity and disarmament architectures — national, regional, and multilateral — are not yet configured to protect children from the evolving risks of biological weapons. It calls for immediate action across the multilateral system:
- Integrate child-specific risks into biosecurity assessments, early-warning systems, and preparedness frameworks.
- Strengthen global governance under the Biological Weapons Convention and related UN mandates.
- Build rapid-response capacities that prioritize children’s health, protection, and continuity of care.”
Protecting children from biological weapons is not a technical aspiration: it is a moral and legal imperative. The international community must act now to ensure that no child becomes a casualty of tomorrow’s biological conflicts.”
Read here.
“Monitoring Approaches to Support BWC Compliance”
This report from VERTIC and KCL discusses three possible approaches to monitoring compliance with the BWC (the BWC Confidence-Building Measures, the Verification Experts Group, and emerging technologies), and “…identifies a number of recommendations for BWC States Parties: supporting the CBM process; practicing and normalizing consultation and clarification; seeking greater understanding of confidence and uncertainties in verification; and discussing practical aspects of different verification measures; practicing verification in the field via exercises.”
“AIxBio = Big Promise + New Risks”
Kaitlyn Gibbons for NTI: “Artificial intelligence (AI) is transforming the life sciences and public health: accelerating drug discovery, vaccine development, and outbreak detection. But with rapidly advancing capabilities comes unprecedented risks — these same tools could be misused to design dangerous pathogens.”
“NTI’s tabletop exercise at the Munich Security Conference this past February explored risks and opportunities at the convergence of AI and the life sciences. The scenario: a fictional extremist group uses AI-enabled tools to engineer a novel virus that triggers a global pandemic, resulting in more than 850 million cases and 60 million deaths.”
“The takeaway: the scenario represents a plausible near-term risk that technical experts and counterterrorism professionals find deeply concerning. It’s a risk that the world isn’t ready for.”
Read more here.
“Where Lab-Made DNA is Created — and Barely Policed”
Shayna Korol recaps the launch of the Global DNA Synthesis Map by the International Biosecurity and Biosafety Initiative for Science in this article for Vox: “The map reveals that only 10 percent of synthetic DNA providers currently screen for DNA sequences of concern, meaning that companies could be sending out the makings of a dangerous pathogen. That’s a tremendous biosecurity gap. More than 700 companies provide synthetic nucleic acids, the building blocks of genetic material, and benchtop DNA synthesis devices, which allow scientists to synthesize custom DNA sequences in their own labs rather than ordering it from a commercial provider. More than 500 of those companies need to screen orders to guarantee compliance with local regulations.”
Nexus Series: AIxBio: Workshop 2 – Strategies for Responding to Exponential AI and Biotechnology Growth
From AI for SynBio: “Background: The ever-increasing acceleration of agentic artificial intelligence (AI) and biological design tools has transformed the technological landscape, enabling tremendous benefits and potential misuse that could massively impact national security and public health. Mitigating this risk will require collaboration across Government, Industry, and Academia with both technical and policy focus. Significant effort has already been made to raise awareness of this challenge, but additional discussion is necessary to maintain pace with the speed of evolving technology. The second workshop in this series will build upon insights from our first workshop and take place over two days.”
This event will take place in Washington DC on March 10-11, 2026. Learn more and RSVP here.
International Conference CBRNe Research & Innovation
From CBRNE: “The last 40 years have demonstrated that both military and civilian populations could be exposed to highly hazardous CBRNE agents following conflicts, natural outbreaks and disasters, industrial incidents or terrorist attacks. Worldwide, researchers, responders and industrial capacities have been commited to provide adapted response to these challenges. The CBRNE Research & Innovation Conference includes workshops and demonstrations of innovative materials, technologies and procedures, according to the following themes: Detection (identification), Protection (decontamination, medical countermeasures), and risk & crisis management.
This event will take place in Arcachon, France from May 19 – 21, 2026. Learn more and RSVP here.
GHS 2026
From GHS: “We’re excited to officially announce that the 4th Global Health Security Conference (GHS2026) will be held in Kuala Lumpur on the 9 – 12 June, 2026!”
“Building on the incredible momentum of GHS2024 in Sydney, we look forward to bringing together the global health security community once again – this time in one of Southeast Asia’s most vibrant and dynamic cities.”
“Registration and Call for Abstracts are now live!”
Learn more, submit abstracts, and register here.
African Atomic Voices Network (AAVN)
From AAVN: “The African Atomic Voices Network (AAVN) is a collaborative, career-development community for young professionals, students, and researchers from Africa (aged 18–35) who are working in, or passionate about, nuclear issues and related global security challenges such as artificial intelligence, emerging technologies, and chemical & biological security. The Network empowers African young professionals to shape global conversations and ensures that Africa’s voice is amplified in nuclear and broader global security discourse.”
Learn more and join the network here.
CNS Young Women in Nonproliferation Initiative
From the initiative: “Established in 2018, the CNS Young Women in Nonproliferation Initiative aims to encourage undergraduate women to consider careers in WMD nonproliferation, arms control, and disarmament. As part of this initiative, we offer a mentorship program that enables undergraduate women to work directly with leading experts in their areas of professional interest.”
Learn more and join the network here.
Cyberbiosecurity Quarterly Call for Papers
“We are pleased to announce the launch of Cyberbiosecurity Quarterly, a new academic and trade journal dedicated to the intersection of cybersecurity and the bioeconomy. Published by Kansas State University’s New Prairie Press and sponsored by the Bioeconomy Information Sharing and Analysis Center (BIO-ISAC), this quarterly journal will serve as an important resource for professionals, researchers, and policymakers working to safeguard digital and physical biological infrastructures. Cyberbiosecurity is an emerging discipline that addresses the protection of biomanufacturing, biomedical research, synthetic biology, digital agriculture, and other life sciences sectors from digital threats. This journal will explore topics at the nexus of cybersecurity, digital biosecurity, and the bioeconomy, including but not limited to:
- Best practices for network configuration and management in biomedical environments (ingress/egress protection, segmentation, isolation, access control, traffic protection, etc.)
- Cybersecurity Vendor Management and Assessment
- Cyber and Digital Biosecurity Education for the Bioeconomy’s Workforce
- The Quality-Cybersecurity Tension in Practice and Techniques for Mitigation
- Threat Intelligence for Cyber-Physical Biological Systems
- Regulatory and Policy Perspectives on Cyberbiosecurity
- Incident Response and Risk Mitigation in Biomanufacturing
- AI and Machine Learning in Digital and Cyber Biosecurity”
Learn more and submit your papers here.
Call for Presenters: International Bio Recovery Summit
The American Bio Recovery Association (ABRA) has opened its Call for Presenters for the 2026 International Bio Recovery Summit, taking place March 16-18 in Aberdeen, Maryland. As the industry’s leading event, the summit brings together bio-recovery professionals to address emerging challenges, regulatory updates, new technologies, and evolving safety standards in the field. ABRA invites experts to submit proposals aligned with conference objectives – including discussions on industry guidelines, insurance claims, hazardous substances, and business practices.
Learn more and submit your presentation by December 31 here.
64th ISODARCO Course
From ISODARCO: “In recent years, the global security landscape has become increasingly volatile, shaped by a convergence of geopolitical tensions, technological advancements, and evolving nuclear doctrines. The post-Cold War order that once provided a measure of predictability in global security has eroded. Conflicts such as the wars in Ukraine and Gaza, rising tensions in the Indo-Pacific, and strategic competition between major powers have reshaped alliances and strategic postures.”
“At the same time, disruptive technologies including artificial intelligence, quantum computing, hypersonic missiles, and cyber threats – are adding new layers of complexity to both nuclear and conventional deterrence dynamics. These technologies are not only distorting the information landscape but also compressing decision-making timelines and complicating signaling mechanisms, increasing the risk of miscalculation.”
“Effectively managing nuclear escalation risks in this environment will require a combination of innovative diplomacy, technological safeguards, and renewed dialogue mechanisms to rebuild trust, reduce misperceptions, and stabilize strategic relations.”
“The ISODARCO 2026 Winter Course presents an invaluable opportunity for students and experts to discuss and examine these dynamics in depth and explore approaches to re-establishing strategic stability and reducing nuclear dangers in a volatile world.”
This course will take place January 11-18, 2026, in Andalo. Learn more and apply here.
The Pandora Report 