Intranasal Vaccines, Vax Data for RWD Exploration, Down Syndrome Impacts: COVID-19 Updates

February 26, 2021 | A survey of how rehabilitation is helping patients with severe COVID-19, what COVID-19 means for Down Syndrome patients, and the timing of vaccines. Plus: real world data for COVID-19 vaccination, intranasal COVID-19 vaccine, more.

Research Updates

Researchers at NCI collaborated with two healthcare data analytics companies (HealthVerity and Aetion) and five commercial laboratories to look at how protected individuals are by a prior SARS-CoV-2 infection. In cohort study of more than 3.2 million US patients with a SARS-CoV-2 antibody test, 0.3% of those indexed with positive test results had evidence of a positive nucleic acid amplification test beyond 90 days after index, compared with 3.0% indexed with negative antibody test results. They published their findings in JAMA Internal Medicine. DOI: 10.1001/jamainternmed.2021.0366

Researchers conducted a rapid systematic review of the published literature to establish the evidence for rehabilitation interventions tested in populations of patients admitted to ICU and critical care with severe respiratory illness and consider whether the evidence is generalizable to patients with COVID-19. They concluded that exercise, early mobilization and multicomponent programs may improve recovery following ICU admission for severe respiratory illness that could be generalizable to those with COVID-19. Rehabilitation interventions can bring hope and confidence to individuals but there is a need for an individualized approach and the use of behavior change strategies, the authors write. They published their work in Physiotherapy. DOI: 10.1016/

A researcher team including researchers from the University of Louisville, Johns Hopkins, and the U.S. Department of Defense Joint Artificial Intelligence Center, theorized that SARS-CoV-2 would be impacted by temperature and humidity like other coronaviruses. They tracked infections from January to April 2020. The data analysis showed that between 30 and 100 degrees Fahrenheit, a 1-degree Fahrenheit increase in daily low temperature was associated with a 1% decrease in the rate of increase in COVID-19 cases, and a 1-degree decrease in temperature was associated with an increase in that rate by 3.7%. By analyzing data from early in the pandemic, the results were obtained without significant influence by lockdowns, masking or other social efforts to contain the virus. They published their findings in PLOS One. DOI: 10.1371/journal.pone.0246167

According to an international survey for clinicians or caregivers on patients with COVID-19 and Down Syndrome (DS) conducted by the T21RS COVID-19 Initiative, leading signs/symptoms of COVID-19 and risk factors for severe disease course are similar to the general population. However, individuals with DS present significantly higher rates of medical complications and mortality, especially from age 40. The survey ran from April to October 2020 and included data on more than 1,000 individuals. The results are published in eClinicalMedicine. DOI: 10.1016/j.eclinm.2021.100769

In a pooled analysis of four randomized trials, a team of researchers from the University of Oxford and other institutions argued that if given at 3-month intervals, the ChAdOx1 nCoV-19 (AZD1222) vaccine results in higher vaccine efficacy than a 6-week interval, with the first dose offering 76% protection in the 3 months between doses. The regimen may also be beneficial while vaccine supplies are initially limited. The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4–12 weeks. The planned roll-out in the UK will involve vaccinating people in high-risk categories with their first dose immediately and delivering the second dose 12 weeks later. The analysis was published in The Lancet. DOI: 10.1016/S0140-6736(21)00432-3

Rash is a common feature of the multisystem inflammatory syndrome in children (MIS-C), a post-infectious hyperinflammatory disease associated with prior SARS-CoV- 2 infection. Because the differential diagnosis of fever and rash in children is broad, understanding clinical characteristics of MIS-C may assist with diagnosis. A team from the Children’s Hospital of Philadelphia describe the cutaneous findings observed in a series of children with MIS-C-associated rash in a recent publication in Open Forum Infectious Diseases. DOI: 10.1093/ofid/ofab074


Industry Updates

TriNetX has announced that COVID-19 vaccination data is now available within the TriNetX platform and real-world data (RWD) set for clinical and observational research. Researchers across industry and academia are now equipped to initiate their own studies with de-identified patient populations that have been immunized against COVID-19 with either Pfizer-BioNTech or Moderna COVID-19 vaccines. Press release.

Maryland-based biopharmaceutical company Altimmune announced that the United States Food and Drug Administration has cleared the company's Investigational New Drug application for its Phase 1 clinical trial of AdCOVID, a novel, single-dose, intranasal COVID-19 vaccine candidate. Altimmune's Phase 1 clinical trial will evaluate safety and immunogenicity of AdCOVID in up to 180 healthy volunteers between the ages of 18 and 55. AdCOVID will be administered as a nasal spray at one of three dose levels. Altimmune will look primarily for safety and tolerability, but it will also measure immunogenicity of AdCOVID by serum IgG binding and neutralizing antibody titers, mucosal IgA antibody from nasal samples and T cell responses.