COVID-19 Mitigation in a K-12 School Setting: A Case Study of Avenues: The World School in New York City.

In this case study, we describe a well-resourced private school in New York City that implemented COVID-19 mitigation measures based on public health expert guidance and the lessons learned from this process. Avenues opened in New York City in 2012 and has since expanded, becoming Avenues: The World School, with campuses in São Paulo, Brazil; Shenzhen, China; the Silicon Valley, California; and online. It offers education at 16 grade levels: 2 early learning years, followed by a prekindergarten through grade 12. We describe the mitigation measures that Avenues implemented on its New York campus. We compare COVID-19 case prevalence at the school with COVID-19 case positivity in New York City, as reported by the New York State Department of Health. We also compare the school's indoor air quality to ambient indoor air quality measures reported in the literature. The school's mitigation measures successfully reduced the prevalence of COVID-19 among its students, staff, and faculty. The school also established a consistently high level of indoor air quality safety through various ventilation mechanisms, designed to reduce common indoor air pollutants. The school received positive parent and community feedback on the policies and procedures it established, with many parents commenting on the high level of trust and quality of communication established by the school. The successful reopening provides useful data for school closure and reopening standards to prepare for future pandemic and epidemic events.

Integrating safety, security, sustainability, and social responsibility principles into the U.S. bioeconomy.

Bioindustrial manufacturing is undergoing rapid expansion and investment and is seen as integral to nations' economic progress. Ensuring that bioindustrial manufacturing benefits society as the field expands is of critical, urgent importance. To better understand the industry's ethical trajectory and to shape policy, we explored the views of biotechnology leaders on four aspects of ethical and social responsibility-safety, security, social responsibility, and sustainability-what we have termed "4S principles." We identified policy actions governments and other stakeholders may take to maximize societal benefits in industrial biotechnology. IMPORTANCE: We analyzed biotech leaders' views on safety, security, social responsibility, and sustainability to recommend policies to maximize benefits and economic growth.

Virology-the path forward.

In the United States (US), biosafety and biosecurity oversight of research on viruses is being reappraised. Safety in virology research is paramount and oversight frameworks should be reviewed periodically. Changes should be made with care, however, to avoid impeding science that is essential for rapidly reducing and responding to pandemic threats as well as addressing more common challenges caused by infectious diseases. Decades of research uniquely positioned the US to be able to respond to the COVID-19 crisis with astounding speed, delivering life-saving vaccines within a year of identifying the virus. We should embolden and empower this strength, which is a vital part of protecting the health, economy, and security of US citizens. Herein, we offer our perspectives on priorities for revised rules governing virology research in the US.

Shaping the future US bioeconomy through safety, security, sustainability, and social responsibility.

Biomanufacturing practitioners and researchers describe the norms that should govern the growing, global field, to include safety, security, sustainability, and social responsibility. These '4S Principles' should be broadly adopted so that the future of the field may provide the greatest benefits to society.

The Model State Indoor Air Quality Act.

This Viewpoint discusses how poor indoor air quality can affect health and examines the Model State Indoor Air Quality Act, which provides science-based regulatory standards aimed at ensuring public indoor environments provide healthy air.

Proposal for a national diagnostics action plan for the United States.

Providing a definitive diagnostic test in a disease emergency is critical to limit pathogen spread, develop and deploy medical countermeasures, and mitigate the social and economic harms of a serious epidemic. While major accomplishments have accelerated test development, expanded laboratory testing capacity, and established widespread point-of-care testing, the United States does not have a plan to rapidly respond, to develop, manufacture, deploy, and sustain diagnostic testing at a national scale. To address this gap, we are proposing a National Diagnostics Action Plan that describes the steps that are urgently needed to prepare for future infectious disease emergencies, as well as the actions we must take at the first signs of such' events. These recommendations require substantial collaboration between the US government (USG) and the private sector to solve a series of challenges now, as well as to prepare for the massive and rapid scale-up of laboratory and point-of-care test development and testing capacity in future emergencies. The recommendations include establishing pre-event contracts; ensuring rapid access to clinical samples; creating a permanent public-private testing coordinating body to allow for rapid information sharing and improved cooperation among the USG, test developers, and clinical laboratories; and accelerating testing rollout at the beginning of an event-and thus, the effective public health management of a disease crisis.

Improving U.S. Biosafety and Biosecurity: Revisiting Recommendations from the Federal Experts Security Advisory Panel and the Fast Track Action Committee on Select Agent Regulations.

Introduction: In response to a series of biosafety incidents in 2014, the White House directed two high-level expert committees to analyze biosafety and biosecurity in U.S. laboratories and make recommendations for work with select agents and toxins. Overall, they recommended 33 actions to address areas related to national biosafety, including promoting a culture of responsibility, oversight, outreach and education, applied biosafety research, incident reporting, material accountability, inspection processes, regulations and guidelines, and determining the necessary number of high-containment laboratories in the United States. Methods: The recommendations were collected and grouped into categories previously defined by the Federal Experts Security Advisory Panel and the Fast Track Action Committee. Open-source materials were examined to determine what actions had been taken to address the recommendations. The actions taken were compared against the reasoning provided in the committee reports to determine if the concerns were sufficiently addressed. Results: In this study, we found that 6 recommendations were not addressed and 11 were insufficiently addressed out of 33 total recommended actions. Discussion and Conclusion: Further work is needed to strengthen biosafety and biosecurity in U.S. laboratories handling regulated pathogens (biological select agents and toxins [BSAT]). These carefully considered recommendations should now be enacted, including determining if there is sufficient high-containment laboratory space for response to a future pandemic, developing a sustained applied biosafety research program to improve our understanding of how high-containment research should be performed, bioethics training to educate the regulated community on the consequences of unsafe practices in BSAT research, and the creation of a no-fault incident reporting system for biological incidents, which may inform and improve biosafety training. Significance: The work presented in this study is significant because previous incidents that occurred in Federal laboratories highlighted shortcomings in the Federal Select Agent Program and the Select Agent Regulations. Progress was made on implementing recommendations to address the shortcomings, but efforts were lost or forgotten over time. The COVID-19 pandemic has provided a brief window of interest in biosafety and biosecurity, and an opportunity to address these shortcomings to increase readiness for future disease emergencies.

The Biological Weapons Convention should endorse the Tianjin Biosecurity Guidelines for Codes of Conduct.

The Tianjin Biosecurity Guidelines for Codes of Conduct for Scientists are a set of ten principles designed to promote responsible science and strengthen biosecurity governance. They should be broadly adopted, including being endorsed by the Biological Weapons Convention at its 9th Review Conference in November 2022.

COVID-19 and the gain of function debates: Improving biosafety measures requires a more precise definition of which experiments would raise safety concerns.

The COVID-19 pandemic has rekindled debates about gain-of-function experiments. This is an opportunity to clearly define safety risks and appropriate countermeasures.

Antibody (Serology) Tests for COVID-19: a Case Study.

Serology (antibody) tests to detect previous SARS-CoV-2 infection have been in high demand from the beginning of the COVID-19 pandemic. The initial shortage of diagnostic tests coupled with asymptomatic infections led to a significant demand for serology tests to identify past infections. Despite serious limitations on the interpretation of a positive antibody test in terms of immunity to SARS-CoV-2, antibody testing was initially considered for release from social distancing, return to employment, and "immunity passports." The regulatory approach to antibody tests was limited; manufacturers were encouraged to develop and market antibody tests without submitting validation data to the FDA. FDA guidance grew more stringent, but many poor-quality tests were already on the market-potentially inappropriately used for individual decision-making. This is a case study describing COVID-19 serology tests and the U.S. market and describes lessons learned for a future health security crisis.