Coronavirus COVID-19 Update for May 28, 2021

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Clinical Reports

Illness duration and symptom profile in a large cohort of symptomatic UK school-aged children tested for SARS-CoV-2
In children, SARS-CoV-2 is usually asymptomatic or causes a mild illness of short duration. Persistent illness has been reported; however, its prevalence and characteristics are unclear. We aimed to determine illness duration and characteristics in symptomatic UK school-aged children tested for SARS-CoV-2 using data from the COVID Symptom Study, the largest citizen participatory epidemiological study to date. Data from 258,790 children aged 5-17 years were reported by an adult proxy between 24 March 2020 and 22 February 2021. Illness duration and symptom profiles were analysed for all children testing positive for SARS-CoV-2 for whom illness duration could be determined, considered overall and within younger (5-11 years) and older (12-17 years) age groups. Data from symptomatic children testing negative for SARS-CoV-2, matched 1:1 for age, gender, and week of testing, were also assessed. 1,734 children (588 younger children, 1,146 older children) had a positive SARS-CoV-2 test result and calculable duration of illness within the study time frame. The commonest symptoms were headache (62.2%) and fatigue (55.0%). Median illness duration was six days (vs. three days in children testing negative), and was positively associated with age (rs 0.19, p<1.e-4) with median duration of seven days in older vs. five days in younger children. Seventy-seven (4.4%) children had illness duration ≥28 days (LC28), more commonly experienced by older vs. younger children (59 (5.1%) vs. 18 (3.1%), p=0.046). The commonest symptoms experienced by these children were fatigue (84%), headache (80%) and anosmia (80%); however, by day 28 the median symptom burden was two. Only 25 (1.8%) of 1,379 children experienced symptoms for ≥56 days. Few children (15 children, 0.9%) in the negatively-tested cohort experienced prolonged symptom duration; however, these children experienced greater symptom burden (both throughout their illness and at day 28) than children positive for SARS-CoV-2. Some children with COVID-19 experience prolonged illness duration. Reassuringly, symptom burden in these children did not increase with time, and most recovered by day 56. Some children who tested negative for SARS-CoV-2 also had persistent and burdensome illness. A holistic approach for all children with persistent illness during the pandemic is required.

Antiviral Therapeutics and Vaccines

Moderna Announces TeenCOVE Study of its COVID-19 Vaccine in Adolescents Meets Primary Endpoint and Plans to Submit Data to Regulators in Early June
Moderna, Inc today announced that the Phase 2/3 study of its COVID-19 vaccine (mRNA-1273) in adolescents has met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine using the primary definition. In addition, a vaccine efficacy of 93% in seronegative participants was observed starting 14 days after the first dose using the secondary CDC case definition of COVID-19, which tested for milder disease. This study, known as the TeenCOVE study, enrolled more than 3,700 participants ages 12 to less than 18 years in the U.S. The Company plans to submit these data to regulators globally in early June.

Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summary
This document outlines the storage and handling conditions for Pfizer-BioNTech COVID-19 vaccine

Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death. This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions. The safety and effectiveness of this investigational therapy continues to be evaluated for treatment of COVID-19. Sotrovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. This treatment has not shown benefit in patients hospitalized due to COVID-19 and monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation.

Diagnostics

COVID-19 Testing to Sustain In-Person Instruction and Extracurricular Activities in High Schools — Utah, November 2020–March 2021
COVID-19–associated cessation of kindergarten through grade 12 in-person instruction and extracurricular activities can have negative social, emotional, and educational consequences for children. Utah implemented two high school COVID-19 testing programs to sustain in-person instruction and extracurricular activities. During November 30, 2020–March 20, 2021, among 59,552 students who received testing, 1,886 (3.2%) had a positive result. These programs facilitated the completion of approximately 95% of high school extracurricular competition events and saved an estimated 109,752 in-person instruction student-days. School-based COVID-19 testing should be considered part of a comprehensive prevention strategy to identify SARS-CoV-2 infections in schools and sustain in-person instruction and extracurricular activities.

Epidemiology

Interim guidance for child care, day camp, and overnight camp programs during the COVID-19 public health emergency
This Interim Guidance for Child Care, Day Camp, and Overnight Camp Programs during the COVID-19 Public Health Emergency (“Interim COVID-19 Guidance for Child Care, Day Camp, and Overnight Camp Programs”) was created to provide owners/operators of child care, day camp, and overnight camp programs with precautions to help protect against the spread of COVID-19. The following guidance is organized around three distinct categories: people, places, and processes.

COVID-19 Mitigation Practices and COVID-19 Rates in Schools: Report on Data from Florida, New York and Massachusetts
This paper reports on the correlation of mitigation practices with staff and student COVID-19 case rates in Florida, New York, and Massachusetts during the 2020-2021 school year. We analyze data collected by the COVID-19 School Response Dashboard and focus on student density, ventilation upgrades, and masking. We find higher student COVID-19 rates in schools and districts with lower in-person density but no correlations in staff rates. Ventilation upgrades are correlated with lower rates in Florida but not in New York. We do not find any correlations with mask mandates. All rates are lower in the spring, after teacher vaccination is underway.

Mask Use and Ventilation Improvements to Reduce COVID-19 Incidence in Elementary Schools — Georgia, November 16–December 11, 2020
Kindergarten through grade 5 schools educate and address the students’ physical, social, and emotional needs. Preventing SARS-CoV-2 transmission in schools is imperative for safe in-person learning. COVID-19 incidence was 37% lower in schools that required teachers and staff members to use masks and 39% lower in schools that improved ventilation. Ventilation strategies associated with lower school incidence included dilution methods alone (35% lower incidence) or in combination with filtration methods (48% lower incidence). Mask requirements for teachers and staff members and improved ventilation are important strategies in addition to vaccination of teachers and staff members that elementary schools could implement as part of a multicomponent approach to provide safer, in-person learning environments.