Pandora Report: 1.22.2021

Felicitations to President Joe Biden and Vice President Kamala Harris! This week marked the inauguration of our 46th president, but also the one-year anniversary of the first SARS-CoV-2 diagnosis in the US. Biden has grand plans to kick off his tenure, not the least of which is an ambitious plan to vaccinate 100 million Americans in 100 days.

Procuring PPE through Innovation, Evaluation, and Coordination: A Strategy for True Cooperative Procurement

Dr. Nathan Myers, an associate professor of political science and public administration at Indiana State University and an advisor to Continuity of Supply Initiative (CoSI), discusses the need for a more efficient, effective, and resilient system for the continued procurement of personal protective equipment (PPE) during a major emergency. Myers proposes the creation of a framework for a master agreement between suppliers and healthcare providers in which PPE would remain available at reasonable prices during normal circumstances and across a range of emergency situations. Read Myers’ article here.

COVID-19 Update

As of 22 January 2021, one year after the first case of SARS-CoV-2 infection was detected in the US, our country has had 24.7 million total cases and 410,000 deaths. Globally, there have been 96.2 million total cases and 2.06 million deaths. The Food and Drug Administration (FDA) has granted emergency use authorization to two mRNA vaccines, and 17,546,374 doses have been administered as of 21 January.

The B1117 variant of SARS-CoV-2, shown to be highly transmissible, has now been detected in 12 states. This variant is believed to have emerged in September in the UK and is now the dominant strain circulating there. Several lines of evidence indicate that B117 transmits more efficiently than other variants of the novel coronavirus. New variants identified in the United Kingdom, South Africa and Brazil that appear to be more transmissible than previous strains are not proving to be more lethal. The modeled trajectory of B1117 in the US finds rapid growth in the early months of 2021, with the strain becoming the predominant variant in March. According to Dr. Anthony Fauci, though the COVID-19 vaccines may not be as effective against new, more contagious strains of the coronavirus, getting vaccinated remains critically important.   

That said, a coronavirus virus variant found in South Africa in late 2020, called 501Y.V2, has sparked some concern regarding immunity and vaccine efficacy. The 501Y.V2 lineage carries many mutations in the SARS-CoV-2 spike protein, which is the immune system’s prime target, including some changes linked to weakened antibody activity against the virus. According to Tulio de Oliveira, a bioinformatician at the University of KwaZulu-Natal in South Africa, there is now proof of several reinfections with 501Y.V2 in the country. Two South African teams will soon test the 501Y.V2 variant with serum from people who participated in COVID-19 vaccine trials, but similar studies are ongoing at laboratories worldwide.

The Independent Panel’s Second Report on Progress

The Independent Panel for Pandemic Preparedness and Response released its second report on progress, which was informed by the review of hundreds of documents, expert consultations across many sectors, case studies, submissions received by the Panel from Member States, academia, civil society, and citizens, and nearly 100 interviews with those at the frontlines of pandemic preparedness and response. The Independent Panel was established by the World Health Organization and is tasked with “charting what went wrong, what lessons can be learnt from that, and what could be done better in future.” Ultimately, the report emphasizes an unequivocal message: course correction in pandemic response is needed immediately. The Independent Panel strongly recommends that all countries immediately and consistently adopt the public health measures which will reduce the spread and the impact of COVID-19: mask-wearing, social distancing, and contact tracing and isolation. There were critical early failures in the global and national responses to the pandemic, and there were pre-existing failures to prepare adequately for a pandemic threat, despite years of warnings and red flags. Further, the pandemic has revealed the inequalities both within and between nations, and the response has deepened these inequalities. Despite these many issues, this crisis has created a unique opportunity to “reset the system” to correct structural inequalities in health.

The Biden-Harris Administration Pandemic Response & Vaccinations Plans

Newly inaugurated President Joe Biden and Vice President Kamala Harris released a National Strategy for COVID-19 Response and Pandemic Preparedness, which outlines seven goals: (1) restore trust with the American people; (2) mount a safe, effective, and comprehensive vaccination campaign; (3) mitigate spread through expanding masking, testing, treatment, data, workforce, and clear public health standards; (4) immediately expand emergency relief and exercise the Defense Production Act; (5) safely reopen schools, businesses, and travel, while protecting workers; (6) protect those most at risk and advance equity, including across racial, ethnic and rural/urban lines; and (7) restore US leadership globally and build better preparedness for future threats.

Biden’s COVID-19 response team consists of several notable experts. Dr. Beth Cameron, NTI’s vice president for global biological policy and programs, is leading the White House biodefense council. Dr. Rochelle Walensky is the director of the Centers for Disease Control and Prevention (CDC); she will “have her hands full rehabilitating morale and the CDC’s public image.” Economist Jeffrey Zients is the COVID-19 response coordinator. Xavier Becerra is nominated as the Secretary of Health and Human Services. David Kessler, former Commissioner of the Food and Drug Administration (FDA), will lead the new iteration of Operation Warp Speed (OWS). Dr. Anthony Fauci, a familiar and trusted public health figure, will be Biden’s chief medical adviser.

The Biden administration was also left with quite a mess created by the Trump administration’s false claim that a stockpile of millions of COVID-19 vaccine doses would be made available for immediate distribution. Unfortunately, no such stockpile exists. Biden’s $1.9 trillion stimulus plan includes an emergency vaccination and relief package that aims to administer 100 million shots during his first 100 days in office. The plan identifies priority groups, starting with adults ages 65 and older and essential frontline workers, including teachers and grocery store clerks. The Federal Emergency Management Agency (FEMA) will establish 100 federally-supported vaccination centers across the country. Of these funds, $400 billion are earmarked for combating the pandemic, including $50 billion to escalate COVID-19 testing, $20 billion to boost vaccination efforts, and funds to hire 100,000 public health workers.

Retraction of US Withdrawal from WHO

Biden, on his first day as president, wrote a letter to António Guterres, secretary-general of the United Nations, that retracts the US intention to withdraw from the World Health Organization. The US withdrawal was initiated on 6 July 2020 and would have been effective on 6 July 2021. Biden acknowledged that the “plays a crucial role in the world’s fight against the deadly COVID-19 pandemic as well as countless other threats to global health and health security.” The letter makes clear that the US will “continue to be a full participant and a global leader in confronting such threats and advancing global health and health security.”

A Threat to Confront: Far-Right Extremists and Nuclear Terrorism

A new article, co-written by Biodefense MS alumnus Rebecca Earnhardt, highlights the threats from far-right extremists and nuclear terrorism. Acts of violence by far-right extremists are on the rise in the United States, and national security experts are considering whether US far-right extremist groups that espouse violence can carry out something catastrophic. Adding fuel to this fire, recent events raise questions regarding if greater focus should be given in the United States on far-right, domestic extremist threats. These extremists create a unique danger as a result of their prevalence in federal institutions – the military – and the possibility that they might infiltrate nuclear facilities to access sensitive information and nuclear materials. The nexus of violent far-right extremist ideology and terrorism is not new; however, the adoption of accelerationism to this dangerous ideology is spurring the desire to destabilize society. The authors encourage a “robust response to violent far-right extremist threats vis-a-vis nuclear security is necessary to minimize risk.” Read the full article here.

Cyberattack on European Medicines Agency

The European Medicines Agency (EMA), an agency of the European Union that evaluates and supervises medicinal products, experienced a cyberattack targeting documents related to COVID-19 medicines and vaccines. EMA revealed that some of these unlawfully acquired documents have been leaked on the internet. The leaked materials include internal/confidential email correspondence dating from November, which relate to evaluation processes for COVID-19 vaccines. EMA also announced that some of the correspondence were “manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.” Near the turn of the year, two EU marketing authorizations for COVID-19 vaccines were granted, pending an independent scientific assessment. Given the high SARS-CoV-2 infection rate in the EU, vaccines are urgently needed to protect citizens from the virus. Criminal efforts to undermine trust in vaccines could leave much of the country susceptible.

Laboratory Safety Manual, 4th Edition: Risk Assessment

The World Health Organization (WHO) Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors globally, serving as a de facto global standard that presents best practices and sets trends in biosafety. The LBM4 suite consists of one core document and seven subject-specific monographs which were developed in order to accommodate diverse interests and requests for learning more specific details, supplementing the core document. Readers are encouraged to start with the core document and learn the subject explained in each monograph accordingly. Download the LBM4 here.

Event – The Chemical and Biological Non-Proliferation Regime after COVID-19

The COVID-19 global pandemic and recent cases of chemical weapon use – in Syria and against the Skripals and Alexey Navalny – have demonstrated the multifaceted nature of biological and chemical threats that States face in the twenty-first century. These threats have also underscored the importance of strengthening the international norms against the hostile misuse of chemical and biological sciences enshrined in the 1975 Biological and Toxin Weapons Convention (BTWC) and the 1997 Chemical Weapons Convention (CWC). But the centerpiece of international efforts to prevent the misuse of modern chemistry and biology – The Chemical Weapons Convention and the Biological and Toxin Weapons Convention – rarely come to the attention of Parliament and public. A recent report from the Parliament Joint Committee on National Security Strategy stated that “future biological risks to the UK will evolve rapidly, originating within or beyond its borders.” These risks include serious disease outbreaks but also the “slow burn” threat of antimicrobial resistance as well as misuse of harmful biological substances.

This webinar will discuss the difficulties of integrating the various means of governance related to biosecurity and national security. The event will also review the state of the BTWC and CWC and identify practical opportunities to strengthen these critical Conventions and guarantee their relevance against the backdrop of rapid scientific and technological advancement and growing international instability. Register here.

Event – Emerging SARS-CoV-2 Variants: What You Need to Know

B.1.351 in South Africa. B.1.1.7 in the United Kingdom. These emerging coronavirus variants, some billed as more contagious forms of SARS-CoV-2, have dominated reports as they popped up across the globe within the last couple months. Genetic mutation is anticipated, especially for RNA viruses as they multiply, but at what point should clinicians and the scientific community become concerned? With a novel pathogen like SARS-CoV-2, there are still many unknowns. How did these variants emerge? Are they indeed more transmissible? Do they cause more serious disease? What does the scientific evidence support? What should the public response be? Will the developed vaccines provide coverage against these variants? Join MJH Life Sciences for a COVID-19 Coalition webinar event, “Emerging SARS-CoV-2 Variants: What You Need to Know,” for an enlightened conversation with a panel of frontline experts, including a virologist, an epidemiologist, and an immunologist, hosted by Dr. Carlos del Rio. Register here.

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