Coronavirus COVID-19 Update for April 30, 2022

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Clinical Reports

Children and COVID-19: State Date Report
A joint report from the American Academy of Pediatrics and the Children’s Hospital Association. Summary of publicly reported data from 49 states, NYC, DC, PR, and GU Version: 4/16/22. The numbers in this report represent cumulative counts since states began reporting. The data are based on how public agencies collect, categorize and post information. All data reported by state/local health departments are preliminary and subject to change and reporting may change over time. Notably, in the summer of 2021 and winter of 2022, some states have revised cases counts previously reported, begun reporting less frequently, or dropped metrics previously reported. For example, due to several changes on their dashboards and the data currently available, AL, TX, HI, DC and MS data in this report are not current (cumulative data through 7/29/21, 8/26/21, 1/13/22, 3/3/22, and 3/10/22 respectively). Readers should consider these factors. States may have additional information on their web sites.
Clinical characteristics with inflammation profiling of long COVID and association with 1-year recovery following hospitalization in the UK: a prospective observational study
These results are from a post-hospitalization COVID-19 study (PHOSP-COVID) which was a prospective, longitudinal cohort study recruiting adults (aged ≥18 years) discharged from hospital with COVID-19 across the UK. Recovery was assessed using patient-reported outcome measures, physical performance, and organ function at 5 months and 1 year after hospital discharge. Study authors start the study by saying there is no evidence based effective pharmacological or non-pharmacological interventions for patients with long COVID. In this group, 2320 participants were discharged from hospital between March 7, 2020, and April 18, 2021, were assessed at 5 months after discharge and 807 (32·7%) participants completed both the 5-month and 1-year visits. Mean age of 58·7 (SD 12·5) years, and 224 (27·8%) had received invasive mechanical ventilation (WHO class 7–9). The proportion of patients reporting full recovery was unchanged between 5 months (501 [25·5%] of 1965) and 1 year (232 [28·9%] of 804). Factors associated with being less likely to report full recovery at 1 year were female sex (odds ratio 0·68 [95% CI 0·46–0·99]), obesity (0·50 [0·34–0·74]) and invasive mechanical ventilation (0·42 [0·23–0·76]). They found that increased inflammatory mediators of tissue damage and repair, including IL-6 concentration and obesity were associated with lower likelihood of recovery.

Antiviral Therapeutics and Vaccines

Moderna files for authorization of Its COVID-19 Vaccine in young children six months to under six years of age
This submission was based on interim results from the Phase 2/3 KidCOVE study. The interim results showed a robust neutralizing antibody response in the 6 month to under 6 years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile. The antibody criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study. The previously announced results included a supportive preliminary efficacy analysis on cases mostly collected during the Omicron wave, including home testing for COVID-19. When the analysis is limited only to cases confirmed positive for SARS-CoV-2 by central lab RT-PCR vaccine efficacy remained significant at 51% (95% CI: 21-69) for 6 months to <2 years and 37% (95% CI: 13-54) for 2 years to <6 years. These efficacy estimates are similar to vaccine efficacy estimates in adults against Omicron after two doses of mRNA-1273.

Public health impact of covid-19 vaccines in the US: observational study
This was an observational study looking at the impact of vaccination on mortality. These investigators included and analyzed covid-19 cases, deaths, and vaccinations reported to the CDC. They tracked mortality as our primary outcome. The secondary outcome was incidence of COVID-19 mortality rates. Incidence rates ratios were used to compare rates across vaccination coverage levels. They found a 10% improvement in vaccination coverage was associated with an 8% (95% confidence interval 8% to 9%) reduction in mortality rates and a 7% (6% to 8%) reduction in incidence. Higher vaccination coverage levels were associated with reduced mortality and incidence rates.

FDA approves first COVID-19 Treatment for Young Children
On the April 25th, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 viral testing, who are hospitalized, or not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death. Before now, Veklury was only approved to treat certain adults and pediatric patients (12 years of age and older who weigh at least 40 kilograms, which is about 88 pounds) with COVID-19.

Veru Announces Presentation of Phase 2 Data of Sabizabulin for the Treatment of Hospitalized Severe COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome
These are the results of a double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating oral, once-a-day dosing of sabizabulin versus placebo in approximately 40 hospitalized COVID-19 patients who were at high risk for ARDS. The trial was conducted in five sites across the United States. Patients hospitalized with documented evidence of COVID-19 infection and at high risk for ARDS were enrolled. Subjects received daily oral dosing of sabizabulin or placebo, as well as standard of care for 21 days or until released from hospital. The primary efficacy endpoint was the proportion of patients alive without respiratory failure at Day 29. Respiratory failure was defined as endotracheal intubation and mechanical ventilation, extracorporeal membrane oxygenation, high-flow nasal cannula oxygen delivery, noninvasive positive pressure ventilation, and/or clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision making is driven solely by resource limitation. In this cohort of patients with severe COVID-19, sabizabulin treatment resulted in an 82% relative reduction in deaths (p=0.0442) in the ITT population. Further, sabizabulin treatment resulted in a reduction in mean days in the ICU from 9.6 days in the placebo group to 2.6 days (p=0.0261) in the sabizabulin treated group, a 73% relative reduction in the mean days in the ICU. Similarly, there was a reduction in mean days on mechanical ventilation from 5.1 days in the placebo group to 1.2 days, a 78% relative reduction in days on mechanical ventilation. Sabizabulin was safe and well tolerated with no treatment related adverse events observed on the study.

Epidemiology

Seroprevalence of Infection-Induced SARS-CoV-2 Antibodies — United States, September 2021–February 2022
These results are from the national commercial laboratory seroprevalence study which is a cross-sectional, national survey that estimates the proportion of the population in 50 U.S. states, the District of Columbia, and Puerto Rico that has infection-induced antibodies to SARS-CoV-2.† Sera are tested for anti-nucleocapsid (anti-N) antibodies, which are produced in response to infection but are not produced in response to COVID-19 vaccines currently authorized for emergency use or approved by the Food and Drug Administration in the United States. As of February 2022, approximately 75% of children and adolescents had serologic evidence of previous infection with SARS-CoV-2, with approximately one third becoming newly seropositive since December 2021. The greatest increases in seroprevalence during September 2021–February 2022, occurred in the age groups with the lowest vaccination coverage; the proportion of the U.S. population fully vaccinated by April 2022 increased with age (5–11, 28%; 12–17, 59%; 18–49, 69%; 50–64, 80%; and ≥65 years, 90%).*** Lower seroprevalence among adults aged ≥65 years, who are at greater risk for severe illness from COVID-19, might also be related to the increased use of additional precautions with increasing age. These findings illustrate a high infection rate for the Omicron variant, especially among children. Seropositivity for anti-N antibodies should not be interpreted as protection from future infection. Vaccination remains the safest strategy for preventing complications from SARS-CoV-2 infection, including hospitalization among children and adults.