• A Citywide Approach to SARS-CoV2 Testing

      Broach, John P.; Lowell, Monica; Brown, Olga; Martin, Clayton; Muller, Michelle; Shirshac, Jeanne; Perrone, Domenica; Smith, Will; Castiel, Matilde; Kobayashi, Kimiyoshi J.; et al. (2021-06-30)
      The COVID-19 pandemic caused more than 30 million infections in the United States between March 2020 and April 2021. In response to systemic disparities in SARS-CoV2 testing and COVID-19 infections, health systems, city leaders and community stakeholders in Worcester, Massachusetts created a citywide Equity Task Force with a specific goal of making low-barrier testing available to individuals throughout our community. Within months, the state of Massachusetts announced the Stop the Spread campaign, a state-funded testing venture. With this funding, and through our community-based approach, our team tested more than 48,363 individuals between August 3, 2020 and February 28, 2021. Through multiple PDSA (Plan-Do-Study-Act) cycles, we optimized our process to test close to 300 individuals per hour. Our positivity rate ranged from 1.5% with our initial testing events to a high of 13.4% on January 6, 2021. During the challenges of providing traditional inpatient and ambulatory care during the pandemic, our health system, city leadership, and community advocacy groups united to broaden the scope of care to include widespread, population-based SARS-CoV2 testing. We anticipate that the lessons learned in conducting this testing campaign can be applied to further surges of SARS-CoV2, international environments, and future respiratory disease pandemics.
    • A COVID clash: How to proceed when IACUCs and IBCs disagree

      Silverman, Jerald (2021-01-01)
      Mayfield proposed to perform his mouse experiments at the ABSL-3 level and keep the SARS-CoV-2 coronavirus under BSL-3 conditions. But although Mayfield had proper past experience working under BSL-3 and ABSL-3 conditions, Great Eastern did not have BSL-3 or ABSL-3 facilities. Mayfield was well aware of this problem and with the knowledge of the school’s IACUC and Institutional Biosafety Committee (IBC) chairpersons, he had submitted IACUC and IBC applications to a nearby contract research organization (CRO) that had the needed biocontainment facilities and would allow Mayfield to use those facilities. Both of those applications had been approved by the CRO and now, following Great Eastern policy, the same approved applications were submitted for concurrence by the IBC and IACUC of Great Eastern University. The IACUC voted to agree with the CRO’s approval, but the IBC did not, citing inadequate containment if a mouse were to escape from its cage while at the CRO. The result was a de facto halt to the planned experiments.
    • A cross-reactive human IgA monoclonal antibody blocks SARS-CoV-2 spike-ACE2 interaction

      Monir, Ejemel; Li, Qi; Hou, Shurong; Schiller, Zachary; Wallace, Aaron; Amcheslavsky, Alla; Yilmaz, Nese Kurt; Toomey, Jacqueline R.; Schneider, Ryan; Ramchetty, Anudeep S.; et al. (2020-08-21)
      COVID-19 caused by SARS-CoV-2 has become a global pandemic requiring the development of interventions for the prevention or treatment to curtail mortality and morbidity. No vaccine to boost mucosal immunity, or as a therapeutic, has yet been developed to SARS-CoV-2. In this study, we discover and characterize a cross-reactive human IgA monoclonal antibody, MAb362. MAb362 binds to both SARS-CoV and SARS-CoV-2 spike proteins and competitively blocks ACE2 receptor binding, by overlapping the ACE2 structural binding epitope. Furthermore, MAb362 IgA neutralizes both pseudotyped SARS-CoV and SARS-CoV-2 in 293 cells expressing ACE2. When converted to secretory IgA, MAb326 also neutralizes authentic SARS-CoV-2 virus while the IgG isotype shows no neutralization. Our results suggest that SARS-CoV-2 specific IgA antibodies, such as MAb362, may provide effective immunity against SARS-CoV-2 by inducing mucosal immunity within the respiratory system, a potentially critical feature of an effective vaccine.
    • A diamidobenzimidazole STING agonist protects against SARS-CoV-2 infection

      Humphries, Fiachra; Shmuel-Galia, Liraz; Jiang, Zhaozhao; Wilson, Ruth; Landis, Philip; Ng, Sze-Ling; Parsi, Krishna M.; Maehr, Rene; Cruz, John; Morales-Ramos, Angel; et al. (2021-05-18)
      Coronaviruses are a family of RNA viruses that cause acute and chronic diseases of the upper and lower respiratory tract in humans and other animals. SARS-CoV-2 is a recently emerged coronavirus that has led to a global pandemic causing a severe respiratory disease known as COVID-19 with significant morbidity and mortality worldwide. The development of antiviral therapeutics are urgently needed while vaccine programs roll out worldwide. Here we describe a diamidobenzimidazole compound, diABZI-4, that activates STING and is highly effective in limiting SARS-CoV-2 replication in cells and animals. diABZI-4 inhibited SARS-CoV-2 replication in lung epithelial cells. Administration of diABZI-4 intranasally before or even after virus infection conferred complete protection from severe respiratory disease in K18-ACE2-transgenic mice infected with SARS-CoV-2. Intranasal delivery of diABZI-4 induced a rapid short-lived activation of STING, leading to transient proinflammatory cytokine production and lymphocyte activation in the lung associated with inhibition of viral replication. Our study supports the use of diABZI-4 as a host-directed therapy which mobilizes antiviral defenses for the treatment and prevention of COVID-19.
    • A Dispatch Screening Tool to Identify Patients at High Risk for COVID-19 in the Prehospital Setting

      Albright, Amy; Gross, Karen; Hunter, Michael; O'Connor, Laurel (2021-10-27)
      INTRODUCTION: Emergency medical services (EMS) dispatchers have made efforts to determine whether patients are high risk for coronavirus disease 2019 (COVID-19) so that appropriate personal protective equipment (PPE) can be donned. A screening tool is valuable as the healthcare community balances protection of medical personnel and conservation of PPE. There is little existing literature on the efficacy of prehospital COVID-19 screening tools. The objective of this study was to determine the positive and negative predictive value of an emergency infectious disease surveillance tool for detecting COVID-19 patients and the impact of positive screening on PPE usage. METHODS: This study was a retrospective chart review of prehospital care reports and hospital electronic health records. We abstracted records for all 911 calls to an urban EMS from March 1-July 31, 2020 that had a documented positive screen for COVID-19 and/or had a positive COVID-19 test. The dispatch screen solicited information regarding travel, sick contacts, and high-risk symptoms. We reviewed charts to determine dispatch-screening results, the outcome of patients' COVID-19 testing, and documentation of crew fidelity to PPE guidelines. RESULTS: The sample size was 263. The rate of positive COVID-19 tests for all-comers in the state of Massachusetts was 2.0%. The dispatch screen had a sensitivity of 74.9% (confidence interval [CI], 69.21-80.03) and a specificity of 67.7% (CI, 66.91-68.50). The positive predictive value was 4.5% (CI, 4.17-4.80), and the negative predictive value was 99.3% (CI, 99.09-99.40). The most common symptom that triggered a positive screen was shortness of breath (51.5% of calls). The most common high-risk population identified was skilled nursing facility patients (19.5%), but most positive tests did not belong to a high-risk population (58.1%). The EMS personnel were documented as wearing full PPE for the patient in 55.7% of encounters, not wearing PPE in 8.0% of encounters, and not documented in 27.9% of encounters. CONCLUSION: This dispatch-screening questionnaire has a high negative predictive value but moderate sensitivity and therefore should be used with some caution to guide EMS crews in their PPE usage. Clinical judgment is still essential and may supersede screening status.
    • A hybrid Shewhart chart for visualizing and learning from epidemic data

      Parry, Gareth; Provost, Lloyd P.; Provost, Shannon M.; Little, Kevin; Perla, Rocco J. (2021-12-04)
      OBJECTIVE: As the globe endures the coronavirus disease 2019 (COVID-19) pandemic, we developed a hybrid Shewhart chart to visualize and learn from day-to-day variation in a variety of epidemic measures over time. CONTEXT: Countries and localities have reported daily data representing the progression of COVID-19 conditions and measures, with trajectories mapping along the classic epidemiological curve. Settings have experienced different patterns over time within the epidemic: pre-exponential growth, exponential growth, plateau or descent and/ or low counts after descent. Decision-makers need a reliable method for rapidly detecting transitions in epidemic measures, informing curtailment strategies and learning from actions taken. METHODS: We designed a hybrid Shewhart chart describing four 'epochs' ((i) pre-exponential growth, (ii) exponential growth, (iii) plateau or descent and (iv) stability after descent) of the COVID-19 epidemic that emerged by incorporating a C-chart and I-chart with a log-regression slope. We developed and tested the hybrid chart using international data at the country, regional and local levels with measures including cases, hospitalizations and deaths with guidance from local subject-matter experts. RESULTS: The hybrid chart effectively and rapidly signaled the occurrence of each of the four epochs. In the UK, a signal that COVID-19 deaths moved into exponential growth occurred on 17 September, 44 days prior to the announcement of a large-scale lockdown. In California, USA, signals detecting increases in COVID-19 cases at the county level were detected in December 2020 prior to statewide stay-at-home orders, with declines detected in the weeks following. In Ireland, in December 2020, the hybrid chart detected increases in COVID-19 cases, followed by hospitalizations, intensive care unit admissions and deaths. Following national restrictions in late December, a similar sequence of reductions in the measures was detected in January and February 2021. CONCLUSIONS: The Shewhart hybrid chart is a valuable tool for rapidly generating learning from data in close to real time. When used by subject-matter experts, the chart can guide actionable policy and local decision-making earlier than when action is likely to be taken without it.
    • A layperson encounter, on the "modified" RNA world

      Pederson, Thoru (2021-11-16)
      A chance conversation with a nonscientist about the mRNA-COVID vaccines, conveyed here, reminded the author of our enduring responsibility to accurately portray science to the public.
    • A Mobile Health Tool for Peer Support of Individuals Reentering Communities After Incarceration

      Fuller, Julia M.; Ho, Y. Xian; Morse, Robert; Fix, Gemmae; Cutrona, Sarah L.; Gaziano, Thomas; Connolly, Samantha L.; Hass, Robert; Jackson, Jonathan; McInnes, D. Keith (2021-05-01)
      Individuals just released from prison, or returning citizens (RCs), face high mortality rates during the reentry period, with cardiovascular disease (CVD) being a leading cause. Peer mentors can support RCs' health, but they traditionally work in person, which may not always be feasible, particularly during pandemic outbreaks such as COVID-19. We used human-centered design to build a prototype of RCPeer, a web/mobile application (app) to support peer-led reentry efforts through CVD risk screening, action planning, linkage to resources addressing reintegration needs (e.g., housing, transportation), and goal-setting. We assessed feasibility, acceptability, and usability of RCPeer using mixed-methods. System Usability Scale (SUS) scores were 68 for peers and 66 for RCs, indicating good usability. Qualitative data suggests that RCPeer can support reentry tasks through RCs and peers sharing data, strengthen RC-peer relationships, and facilitate RCs meeting their goals. Future work is needed to enhance usability for RCs with limited technology experience.
    • A Multi-Institutional Partnership Catalyzing the Commercialization of Medical Devices and Biotechnology Products.

      Hafer, Nathaniel; Buchholz, Bryan; Dunlap, Denise; Fournier, Brennan; Latham, Scott; Picard, Mary Ann; Tello, Steven; Gibson, Laura L.; Lilly, Craig M.; McManus, David D. (2021-04-08)
      The commercialization of medical devices and biotechnology products is characterized by high failure rates and long development lead times particularly among start-up enterprises. To increase the success rate of these high-risk ventures, the University of Massachusetts Lowell (UML) and University of Massachusetts Medical School (UMMS) partnered to create key academic support centers with programs to accelerate entrepreneurship and innovation in this industry. In 2008, UML and UMMS founded the Massachusetts Medical Device Development Center (M2D2), which is a business and technology incubator that provides business planning, product prototyping, laboratory services, access to clinical testing, and ecosystem networking to medical device and biotech startup firms. M2D2 has three physical locations that encompass approximately 40,000 square feet. Recently, M2D2 leveraged these resources to expand into new areas such as health security, point of care technologies for heart, lung, blood, and sleep disorders, and rapid diagnostics to detect SARS-CoV-2. Since its inception, M2D2 has vetted approximately 260 medical device and biotech start-up companies for inclusion in its programs and provided active support to more than 80 firms. This manuscript describes how two UMass campuses leveraged institutional, state, and Federal resources to create a thriving entrepreneurial environment for medical device and biotech companies.
    • A Multi-level Biosensor-based Epidemic Simulation Model for COVID-19

      Balkus, Salvador V.; Fang, Hua (Julia); Rumbut, Joshua; Moormann, Ann M.; Boyer, Edward (2021-11-15)
      In order to design effective public health policies to combat the COVID-19 pandemic, local governments and organizations must be able to forecast the expected number of cases in their area. Although researchers have developed individual models for predicting COVID-19 based on sensor data without requiring a test, less research has been conducted on how to leverage those individual predictions in forecasting virus spread for determining hierarchical predictions from the community level to the state level. The Multi-Level Adaptive and Dynamic Biosensor Epidemic Model, or m-ADBio, is designed to improve on the traditional SEIR model used to forecast the spread of COVID-19. In this study, the predictive performance of m-ADBio is examined at the state, county, and community levels through numerical experimentation. We find that the model improves over SEIR at all levels, but especially at the community level, where the m-ADBio model with sensor-based initial values yielded no statistically significant difference between the forecasted cases and the true observed data -meaning that the model was highly accurate. Therefore, the m-ADBio model is expected to provide a more timely and accurate forecast to help policymakers optimize pandemic management strategy.
    • A Novel DNA and Protein Combination COVID-19 Vaccine Formulation Provides Full Protection against SARS-CoV-2 in Rhesus Macaques

      Li, Yuzhong; Hu, Guangnan; Wang, Shixia; Li, Qihan; Lu, Shan; Cun, Wei (2021-02-08)
      The current study aims to develop a safe and highly immunogenic COVID-19 vaccine. The novel combination of a DNA vaccine encoding the full-length Spike (S) protein of SARS-CoV-2 and a recombinant S1 protein vaccine induced high level neutralizing antibody and T cell immune responses in both small and large animal models. More significantly, the co-delivery of DNA and protein components at the same time elicited full protection against intratracheal challenge of SARS-CoV-2 viruses in immunized rhesus macaques. As both DNA and protein vaccines have been proven safe in previous human studies, and DNA vaccines are capable of eliciting germinal center B cell development, which is critical for high -affinity memory B cell responses, the DNA and protein co-delivery vaccine approach has great potential to serve as a safe and effective approach to develop COVID-19 vaccines that provide long-term protection.
    • A paradox of social distancing for SARS-CoV-2: loneliness and heightened immunological risk

      Rozenkrantz, Liron; Bernstein, Michael H.; Hemond, Christopher C. (2020-08-10)
      The World Health Organization declared the SARS-CoV-2 virus a global pandemic in March of 2020. In an effort to reduce the harms and rate of exponential spread, regional and national governments across the world instituted a variety of measures. These have included orders for citizens to practice social distancing, which in the US has affected over 300 million people. In their most extreme, these social distancing measures are isolation orders to “shelter in place”, at one point affecting ~17 million Americans. Data regarding the effects of these policies are emerging, but two outcomes include greater social isolation and likely increased loneliness. An important distinction arises between these two concepts. Social isolation is the objective lack of, or reduction in, social contact. Loneliness is the subjective discrepancy between the desired and actual levels of social connection. Objective social isolation and subjective loneliness are only weakly correlated (r ~ 0.2), but both have independent real-world health consequences and are associated with long-term increases in mortality (29% and 26%, respectively). The magnitude of these effects rival that of smoking and obesity on long-term health risks. Emerging evidence for the social repercussions of the pandemic is worrisome; a recent longitudinal study following more than 35,000 people reported that while overall loneliness has not changed during the COVID pandemic, individuals who described high levels of baseline social isolation are now experiencing significantly worse pandemic-related loneliness. Now more than ever the most socially vulnerable would likely benefit from clinical assessment and support. Our own unpublished survey data (N = 155) indicate that 60% of respondents from an online campaign in the USA, Israel, and UK report a greater sense of loneliness since the pandemic began.
    • A Physician's Guide for Workers' Return to Work during COVID-19 Pandemic

      Baptista, Marcos C.; Burton, Wayne N.; Pawlecki, Brent; Pransky, Glenn (2020-12-21)
      OBJECTIVE: Higher risk for developing severe forms of COVID-19 has been associated with health risk factors and medical conditions which are common among workers globally. For at risk workers, return to work may pose unique risks which require protective policies and procedures. METHODS: A review of the medical literature was conducted on health risk factors and medical conditions associated with increased COVID-19 morbidity and mortality. RESULTS: The relative risk of acquiring and the severity of COVID-19 for workers is associated with three pillars: individual risk, workplace risk, and community risk. Matrices were developed to determine a worker's individual risk. CONCLUSIONS: A practical tool was developed for physicians managing COVID-19 relative risk in workers.
    • A rapid, sensitive, and reproducible in vivo PBMC humanized murine model for determining therapeutic-related cytokine release syndrome

      Ye, Chunting; Yang, Hongyuan; Cheng, Mingshan; Shultz, Leonard D.; Greiner, Dale L.; Brehm, Michael A.; Keck, James G. (2020-08-09)
      Immunotherapy is a powerful treatment strategy being applied to cancer, autoimmune diseases, allergies, and transplantation. Although therapeutic monoclonal antibodies (mAbs) have demonstrated significant clinical efficacy, there is also the potential for severe adverse events, including cytokine release syndrome (CRS). CRS is characterized by the rapid production of inflammatory cytokines following delivery of therapy, with symptoms ranging from mild fever to life-threating pathology and multi-organ failure. Overall there is a paucity of models to reliably and accurately predict the induction of CRS by immune therapeutics. Here, we describe the development of a humanized mouse model based on the NOD-scid IL2rg(null) (NSG) mouse to study CRS in vivo. PBMC-engrafted NSG, NSG-MHC-DKO, and NSG-SGM3 mice were used to study cytokine release in response to treatment with mAb immunotherapies. Our data show that therapeutic-stimulated cytokine release in these PBMC-based NSG models captures the variation in cytokine release between individual donors, is drug dependent, occurs in the absence of acute xeno-GVHD, highlighting the specificity of the assay, and shows a robust response following treatment with a TGN1412 analog, a CD28 superagonist. Overall our results demonstrate that PBMC-engrafted NSG models are rapid, sensitive, and reproducible platforms to screen novel therapeutics for CRS.
    • A response to COVID-19 school closures: The feasibility of a school-linked text message intervention as an adaptation to school-supervised asthma therapy

      Arenas, Juliana; Becker, Sarah; Seay, Hannah; Frisard, Christine F.; Hoque, Shushmita; Spano, Michelle; Lindenauer, Peter K.; Sadasivam, Rajani S.; Pbert, Lori; Trivedi, Michelle (2022-02-01)
      BACKGROUND: School-supervised asthma therapy improves asthma medication adherence and morbidity, particularly among low-income and underrepresented minority (URM) children. However, COVID-19-related school closures abruptly suspended this therapy. In response, we developed a school-linked text message intervention. OBJECTIVE: The purpose of the study is to investigate the feasibility and acceptability of a school-linked text message intervention. METHODS: In December 2020, children previously enrolled in school-supervised asthma therapy in Central Massachusetts were recruited into this school-linked text message intervention. We sent two-way, automated, daily text reminders in English or Spanish to caregivers of these children, asking if they had given their child their daily preventive asthma medicine. Our study team notified the school nurse if the caregiver did not consistently respond to text messages. School nurses performed weekly remote check-ins with all families. The primary outcome of the study was feasibility: recruitment, retention, and intervention fidelity. Secondarily we examined intervention acceptability and asthma health outcomes. RESULTS: Twenty-six children (54% male, 69% Hispanic, 8% Black, 23% White, 93% Medicaid insured) and their caregivers were enrolled in the intervention with 96% participant retention at 6 months. Caregiver response rate to daily text messages was 81% over the study period. Children experienced significant improvements in asthma health outcomes. The intervention was well accepted by nurses and caregivers. CONCLUSION: A school-linked text messaging intervention for pediatric asthma is feasible and acceptable. This simple, accessible intervention may improve health outcomes for low-income and URM children with asthma. It merits further study as a potential strategy to advance health equity.
    • A review of acute limb ischemia in COVID-positive patients

      Ilonzo, Nicole; Judelson, Dejah R.; Al-Jundi, Wissam; Etkin, Yana; O'Banion, Leigh Anne; Rivera, Aksim; Tinelli, Giovanni; Bellosta, Rafaello; Vouyouka, Ageliki (2021-06-01)
      This literature review discusses the current evidence on acute limb ischemia (ALI) in patients with COVID-19. Throughout the pandemic, these patients have been at increased risk of arterial thrombotic events and subsequent mortality as a result of a hypercoagulable state. The exact mechanism of thrombosis is unknown; however arterial thrombosis may be due to invasion of endothelial cells via angiotensin-converting enzyme 2 (ACE2) receptors, endothelial injury from inflammation, or even free-floating aortic thrombus. Multiple studies have been performed evaluating the medical and surgical management of these patients; the decision to proceed with operative intervention is dependent on the patient's clinical status as it relates to COVID-19 and morbidity of that disease. The interventions afforded typically include anticoagulation in patients undergoing palliation; alternatively, thrombectomy (endovascular and open) is utilized in other patients. There is a high risk of rethrombosis, despite anticoagulation, given persistent endothelial injury from the virus. Postoperative mortality can be high in these patients.
    • A review on how to do hematology consults during COVID-19 pandemic

      Sahu, Kamal Kant; Cerny, Jan (2020-11-08)
      The ongoing COVID-19 pandemic is the most trending and talked topic across the World. From its point of origin in Wuhan, China to clinical laboratory at NIH, a mere six-month-old SARS-CoV-2 virus is keeping the clinicians, and scientists busy at various fronts. However, COVID-19 is an emerging and evolving disease and each day brings in more data, new figures, and findings from the field of clinical practice. The role of hematologists has been increasingly recognized during the current pandemic because of several reasons. Most important of them are the characteristic hematological findings of COVID-19 patients that also have prognostic implications and that were not seen in other viral infections. The treatment of hematological complications in COVID-19 patients is very challenging given the critical care setting. There are interim and limited guidelines thus far due to the novelty of the disease. As this remains to be a quite fluid situation, all the appropriate medical societies including the major hematology bodies are proposing initial and interim guidelines (e.g. ASH guideline). This puts a hematologist on consult service in a dubious position where, he/she must tailor the recommendations on case to case basis. The purpose of this review is to provide the background context about the impact of COVID-19 on the blood system and to summarize the current interim guidelines to manage the associated hematological issues in COVID-19 infection.
    • A Series of Patients With Myocarditis Following SARS-CoV-2 Vaccination With mRNA-1279 and BNT162b2

      Dickey, John B.; Albert, Elisabeth; Badr, Mai; Laraja, Kristin M.; Sena, Laureen M.; Gerson, David S.; Saucedo, Jason E.; Qureshi, Waqas; Aurigemma, Gerard P. (2021-09-01)
      Wide availability of the 3 vaccines approved by the U.S. Food and Drug Administration for emergency use against SARS-CoV-2 has led to reports of adverse reactions not seen during clinical trials: We now report a series of patients who developed CMR-proven myocarditis shortly after vaccination.
    • A Splenic Infarction Related to Parainfluenza Infection in a Patient with AML: Lessons for COVID-19

      Sahu, Kamal Kant; Vogt, Bennett E.; Shanahan, Lindsey; Cerny, Jan (2021-09-02)
      Infection related thrombosis is a well-known entity. Antigen burden, immune response, complement activation, pro-coagulant condition, and smoking are only a few amongst the multiple risk factors which interplay in the development of thrombosis in any given case. Viral infections are amongst the many inciting factors known to predispose a prothrombotic state. We hereby report a known case of acute myelogenous leukemia, status post allogeneic stem cell trans-plantation who presented with two discrete episodes of sore throat and left upper quadrant pain. Infectious workup confirmed parainfluenza virus 3 on the first occasion, and rhinovirus infection on the second occasion. Computed tomography of the abdomen during both times suggested a splenic infarction. A comprehensive thrombotic workup was negative which suggested the diagnosis of viral infection-related splenic infarction. This case highlights the importance of caring for the potential eventualities of coagulopathy in cancer and other immunocompromised patients infected during the COVID-19 pandemic.
    • A Timely Update of Global COVID-19 Vaccine Development

      Klavinskis, Linda; Liu, Margaret; Lu, Shan (2020-10-15)
      The International Society for Vaccines (ISV) launched a virtual congress series www.ISVCongress.org as the leading platform for key COVID‐19 vaccine developersto share their progress and for the global vaccine community to contribute their collective expertise and wisdom about broader aspects of the global pandemic vaccine response. The aims were threefold: 1) to provide timely information about the processes put in place by regulatory agencies and NGOs for COVID-19 vaccine development, 2) to present primary data from groups developing vaccines, and 3) to provide a forum for discussion by experts about key challenges that confront the COVID-19 vaccine development process.