A Research and Development (R&D) Roadmap for Broadly Protective Coronavirus Vaccines: A Pandemic Preparedness Strategy

Broadly protective coronavirus vaccines are an important tool for protecting against future SARS-CoV-2 variants and could play a critical role in mitigating the impact of future outbreaks or pandemics caused by novel coronaviruses. The Coronavirus Vaccines Research and Development (R&D) Roadmap (CVR) is aimed at promoting the development of such vaccines. The CVR, funded by the Bill & Melinda Gates Foundation and The Rockefeller Foundation, was generated through a collaborative and iterative process, which was led by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and involved 50 international subject matter experts and recognized leaders in the field. This report summarizes the major issues and areas of research outlined in the CVR and identifies high-priority milestones. The CVR covers a 6-year timeframe and is organized into five topic areas: virology, immunology, vaccinology, animal and human infection models, and policy and finance. Included in each topic area are key barriers, gaps, strategic goals, milestones, and additional R&D priorities. The roadmap includes 20 goals and 86 R&D milestones, 22 of which are ranked as high priority. By identifying key issues, and milestones for addressing them, the CVR provides a framework to guide funding and research campaigns that promote the development of broadly protective coronavirus vaccines.

A research and development (R&D) roadmap for broadly protective coronavirus vaccines: A pandemic preparedness strategy.

Broadly protective coronavirus vaccines are an important tool for protecting against future SARS-CoV-2 variants and could play a critical role in mitigating the impact of future outbreaks or pandemics caused by novel coronaviruses. The Coronavirus Vaccines Research and Development (R&D) Roadmap (CVR) is aimed at promoting the development of such vaccines. The CVR, funded by the Bill & Melinda Gates Foundation and The Rockefeller Foundation, was generated through a collaborative and iterative process, which was led by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and involved 50 international subject matter experts and recognized leaders in the field. This report summarizes the major issues and areas of research outlined in the CVR and identifies high-priority milestones. The CVR covers a 6-year timeframe and is organized into five topic areas: virology, immunology, vaccinology, animal and human infection models, and policy and finance. Included in each topic area are key barriers, gaps, strategic goals, milestones, and additional R&D priorities. The roadmap includes 20 goals and 86 R&D milestones, 26 of which are ranked as high priority. By identifying key issues, and milestones for addressing them, the CVR provides a framework to guide funding and research campaigns that promote the development of broadly protective coronavirus vaccines.

Rapid onset of functional tic-like behaviors among adolescent girls-Minnesota, September-November 2021.

Background: On October 15, 2021, the Minnesota Department of Health began investigating a school cluster of students experiencing tic-like behaviors thought to be related to recent COVID-19. The objective of this report is to describe the investigation, key findings, and public health recommendations. Methods: Affected students and proxies were interviewed with a standardized questionnaire including validated depression and anxiety screens. Results: Eight students had tic-like behaviors lasting >24 h after initial report with onset during September 26-October 30, 2021. All eight students were females aged 15-17 years. All students either had a history of depression or anxiety or scored as having more than minimal anxiety or depression on validated screens. Four students previously had confirmed COVID-19: the interval between prior COVID-19 and tic symptom onset varied from more than a year prior to tic symptom onset to at the time of tic symptom onset. Conclusion: The onset of tic-like behaviors at one school in Minnesota appeared to be related more to underlying mental health conditions than recent COVID-19. These findings highlight the need to better understand functional tic-like behaviors and adolescent mental health.

Rapid onset of functional tic-like behaviors among adolescent girls—Minnesota, September–November 2021

Background On October 15, 2021, the Minnesota Department of Health began investigating a school cluster of students experiencing tic-like behaviors thought to be related to recent COVID-19. The objective of this report is to describe the investigation, key findings, and public health recommendations. Methods Affected students and proxies were interviewed with a standardized questionnaire including validated depression and anxiety screens. Results Eight students had tic-like behaviors lasting >24 h after initial report with onset during September 26–October 30, 2021. All eight students were females aged 15–17 years. All students either had a history of depression or anxiety or scored as having more than minimal anxiety or depression on validated screens. Four students previously had confirmed COVID-19: the interval between prior COVID-19 and tic symptom onset varied from more than a year prior to tic symptom onset to at the time of tic symptom onset. Conclusion The onset of tic-like behaviors at one school in Minnesota appeared to be related more to underlying mental health conditions than recent COVID-19. These findings highlight the need to better understand functional tic-like behaviors and adolescent mental health.

Transmission of and Infection With COVID-19 Among Vaccinated and Unvaccinated Attendees of an Indoor Wedding Reception in Minnesota.

Importance: Characterizing rates of SARS-CoV-2 infection among vaccinated and unvaccinated persons with the same exposure is critical to understanding the association of vaccination with the risk of infection with the Delta variant. Additionally, evidence of Delta variant transmission by children to vaccinated adults has important public health implications. Objective: To characterize transmission and infection of SARS-CoV-2 among vaccinated and unvaccinated attendees of an indoor wedding reception. Design, Setting, and Participants: This cohort study included attendees at an indoor wedding reception in Minnesota in July 2021. Data were collected from REDCap surveys and routine surveillance interviews. The full list of attendees and a partial list of emails were obtained. Fifty-seven attendees completed the emailed survey. Eighteen additional attendees were identified from the state health department COVID-19 surveillance database. Exposures: Attendance at an indoor event. Main Outcomes and Measures: Risk of SARS-CoV-2 infection among vaccinated and unvaccinated attendees, identification of an index case, whole genome sequencing (WGS) to identify the COVID-19 variant, understanding of transmission patterns, and assessment of secondary transmission. The primary case definition was an individual with a positive SARS-CoV-2 test who attended the wedding in the 14 days prior to their illness. Results: Data were gathered for 75 attendees (mean [SE] age, 37.5 [13.7] years; 57 [76%] female individuals), of whom 56 (75%) were fully vaccinated, 4 (5%) were partially vaccinated, and 15 (20%) were unvaccinated. Of 62 attendees who were tested, 29 (47%) tested positive, including 16 of 46 fully vaccinated attendees (35%), 2 of 4 partially vaccinated attendees (50%), and 11 of 12 unvaccinated attendees (92%). Being unvaccinated was associated with a higher risk of infection compared with being vaccinated (risk ratio, 2.64; 95% CI, 1.71-4.06; P = .001). One unvaccinated adult required hospitalization. An unvaccinated child who was symptomatic on the event date was identified as the index case. Eleven specimens were available for WGS. All sequenced specimens were closely related and were identified as the Delta variant. WGS supported secondary transmission from a vaccinated individual with SARS-CoV-2. Conclusions and Relevance: This cohort study identified a COVID-19 Delta variant outbreak at an indoor event despite a high proportion of vaccinated attendees. It found that vaccination was associated with a reduced risk of infection.

First Identified Cases of SARS-CoV-2 Variant P.1 in the United States - Minnesota, January 2021.

Since December 2020, the Minnesota Department of Health (MDH) Public Health Laboratory has been receiving 100 specimens per week (50 from each of two clinical partners) with low cycle threshold (Ct) values for routine surveillance for SARS-CoV-2, the virus that causes COVID-19. On January 25, 2021, MDH identified the SARS-CoV-2 variant P.1 in one specimen through this surveillance system using whole genome sequencing, representing the first identified case of this variant in the United States. The P.1 variant was first identified in travelers from Brazil during routine airport screening in Tokyo, Japan, in early January 2021 (1). This variant has been associated with increased transmissibility (2), and there are concerns that mutations in the spike protein receptor-binding domain might disrupt both vaccine-induced and natural immunity (3,4). As of February 28, 2021, a total of 10 P.1 cases had been identified in the United States, including the two cases described in this report, followed by one case each in Alaska, Florida, Maryland, and Oklahoma (5).

COVID-19 Outbreak Associated With a Fitness Center-Minnesota, September-November 2020.

The Minnesota Department of Health investigated a coronavirus disease 2019 (COVID-19) outbreak at a fitness center in Olmsted County, Minnesota. Twenty-three severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections (5 employees and 18 members) were identified. An epidemiological investigation supported by whole genome sequencing demonstrated that transmission of SARS-CoV-2 occurred at the fitness center despite following recommended prevention strategies.

Transmission Dynamics of Severe Acute Respiratory Syndrome Coronavirus 2 in High-Density Settings, Minnesota, USA, March-June 2020.

Coronavirus disease has disproportionately affected persons in congregate settings and high-density workplaces. To determine more about the transmission patterns of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in these settings, we performed whole-genome sequencing and phylogenetic analysis on 319 (14.4%) samples from 2,222 SARS-CoV-2-positive persons associated with 8 outbreaks in Minnesota, USA, during March-June 2020. Sequencing indicated that virus spread in 3 long-term care facilities and 2 correctional facilities was associated with a single genetic sequence and that in a fourth long-term care facility, outbreak cases were associated with 2 distinct sequences. In contrast, cases associated with outbreaks in 2 meat-processing plants were associated with multiple SARS-CoV-2 sequences. These results suggest that a single introduction of SARS-CoV-2 into a facility can result in a widespread outbreak. Early identification and cohorting (segregating) of virus-positive persons in these settings, along with continued vigilance with infection prevention and control measures, is imperative.

First Identified Cases of SARS-CoV-2 Variant B.1.1.7 in Minnesota - December 2020-January 2021.

On January 9, 2021, the Minnesota Department of Health (MDH) announced the identification of the SARS-CoV-2 variant of concern (VOC) B.1.1.7, also referred to as 20I/501Y.V1 and VOC 202012/01, in specimens from five persons; on January 25, MDH announced the identification of this variant in specimens from three additional persons. The B.1.1.7 variant, which is reported to be more transmissible than certain other SARS-CoV-2 lineages*,† (1), was first reported in the United Kingdom in December 2020 (1). As of February 14, 2021, a total of 1,173 COVID-19 cases of the B.1.1.7 variant had been identified in 39 U.S. states and the District of Columbia (2). Modeling data suggest that B.1.1.7 could become the predominant variant in the United States in March 2021 (3).

COVID-19 Outbreak Associated with a 10-Day Motorcycle Rally in a Neighboring State - Minnesota, August-September 2020.

During August 7-16, 2020, a motorcycle rally was held in western South Dakota that attracted approximately 460,000 persons from across the United States to numerous indoor and outdoor events over a 10-day period. During August-September 2020, the Minnesota Department of Health (MDH) investigated a coronavirus disease 2019 (COVID-19) outbreak associated with the rally in Minnesota residents. Fifty-one primary event-associated cases were identified, and 35 secondary or tertiary cases occurred among household, social, and workplace contacts, for a total of 86 cases; four patients were hospitalized, and one died. Approximately one third (34%) of 87 counties in Minnesota had at least one primary, secondary, or tertiary case associated with this rally. Genomic sequencing supported the associations with the motorcycle rally. These findings support current recommendations for mask use, physical distancing, reducing the number of attendees at gatherings, isolation for patients with COVID-19, and quarantine for close contacts to slow the spread of SARS-CoV-2 (1). Furthermore, although these findings did not capture the impact of the motorcycle rally on residents of other states, they demonstrate the rationale for consistent mitigation measures across states.

COVID-19-Associated Hospitalizations Among Health Care Personnel - COVID-NET, 13 States, March 1-May 31, 2020.

Health care personnel (HCP) can be exposed to SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), both within and outside the workplace, increasing their risk for infection. Among 6,760 adults hospitalized during March 1-May 31, 2020, for whom HCP status was determined by the COVID-19-Associated Hospitalization Surveillance Network (COVID-NET), 5.9% were HCP. Nursing-related occupations (36.3%) represented the largest proportion of HCP hospitalized with COVID-19. Median age of hospitalized HCP was 49 years, and 89.8% had at least one underlying medical condition, of which obesity was most commonly reported (72.5%). A substantial proportion of HCP with COVID-19 had indicators of severe disease: 27.5% were admitted to an intensive care unit (ICU), 15.8% required invasive mechanical ventilation, and 4.2% died during hospitalization. HCP can have severe COVID-19-associated illness, highlighting the need for continued infection prevention and control in health care settings as well as community mitigation efforts to reduce transmission.