Coronavirus COVID-19 Update for April 2, 2021

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Clinical Reports

Provisional Death Counts for Coronavirus Disease 2019 (COVID-19)
This page reports counts of deaths involving COVID-19 and other select causes of death by time-period in which the death occurred, sex, and age group. While deaths increase with age, we are now seeing increased deaths in the 0-17 year (246) and 18-29 year (1,957) groups.

Antiviral Therapeutics and Vaccines

Pfizer-BioNtech announce positive topline results of pivotal COVID-19 vaccine study in adolescents
Pfizer today announced that, in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated. These are topline results from a pivotal Phase 3 trial in 2,260 adolescents.

- In participants aged 12-15 years old, BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in trial of vaccinated 16-25 year old participants in an earlier analysis, and was well tolerated
- The companies plan to submit these data to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as soon as possible to request expansion of the Emergency Use Authorization (EUA) and EU Conditional Marketing Authorization for BNT162b2
- The companies also provided an update on the Phase 1/2/3 study of BNT162b2 in children aged 6 months to 11 years

GSK and Vir Biotechnology announce submission of Emergency Use Authorization request to FDA for VIR-7831 for the early treatment of COVID-19
GlaxoSmithKline plc and Vir Biotechnology, Inc. today announced the submission of an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for VIR-7831 (GSK4182136) an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalisation or death. The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation. Results of the interim analysis, based on data from 583 patients enrolled in the trial, demonstrated an 85% (p=0.002) reduction in hospitalisation or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial. As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrolment due to evidence of profound efficacy. Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA.

Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. New in vitro data from pseudotyped virus assays published online in bioRxiv in March 2021 support this hypothesis as they demonstrate that VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants. Based on additional soon to be published preclinical data, VIR-7831 also appears to maintain activity against the California variant.

Diagnostics

FDA Authorizes Cue Health’s COVID-19 Test for At-Home and Over The Counter Use
Cue Health Inc. (Cue) announced the healthcare technology company has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for over the counter sale of its fast, accurate, COVID-19 test, making it the nation’s first molecular diagnostic test available to consumers without a prescription. The Cue COVID-19 Test for Home and Over The Counter (OTC) Use (Cue OTC Test) uses a lower nasal swab and delivers results in about 20 minutes to the user’s mobile smart device. The Cue OTC Test is authorized for use by symptomatic and asymptomatic individuals, adults and children ages 2 and older with adult assistance. With an easy-to-use, fully guided experience, the Cue OTC Test offers convenience, privacy, safety, and the ability to test frequently, with the accuracy of a centralized lab test. The Cue Home and OTC Test detects the RNA of SARS-CoV-2, the virus that causes COVID-19, with the accuracy of a central lab test. It is a highly sensitive and specific nucleic acid amplification test (NAAT) that runs on the rechargeable Cue Cartridge Reader, a reusable device which fits in the palm of your hand. Results are displayed directly onto the user’s mobile smart device via the Cue Health App. Each Cue OTC Test Cartridge Pack includes the single-use, self-contained Cue Test Cartridge and the Cue Sample Wand, which is the swab for minimally invasive sample collection. Together, these components make up the Cue Health Monitoring System to offer clinical-grade performance at home or in a non-clinical setting. In prospective studies to evaluate the use of the Cue OTC Test, the results were 97.4% agreement for positive cases and 99.1% agreement for negative cases compared to the results from a highly sensitive EUA PCR laboratory-based test.
DxTerity COVID-19 Saliva at-Home Collection Kit with Prepaid Express Return Shipping and Laboratory PCR Testing
The FDA has authorized this home test for SARS-CoV-2 home detection in symptomatic and asymptomatic individuals. This non-invasive easy to use at-home saliva test detects the presence of viral genetic material but will not confirm immunity or detect antibodies. This test is authorized by FDA for emergency use during the COVID emergency. Kit includes everything needed for sample collection. Only a small amount of saliva sample is needed. Registration and sample collection can be done at home or office. Sample collection is unsupervised, so the report may not be valid for all travel purposes.
T-Detect test authorized by FDA for emergency use
The T-Detect COVID test is the first clinical test that detects T cells to confirm recent or past SARS-CoV-2 infections. T-Detect COVID test results are a binary positive/negative result. A positive result means there was a recent or past exposure to SARS-CoV-2, the virus that causes COVID-19. A negative result indicates that past exposure to SARS-CoV-2 probably did not occur. The T-Detect COVID test measures a T cell response against SARS-CoV-2, the virus that causes COVID-19, present in a subject’s blood. The test utilizes Adaptive’s immunoSEQ Technology to sequence T-cell receptors (TCRs) from a blood sample and identifies TCRs that Adaptive has mapped for recognition of SARS-CoV-2 antigens. The test identifies subjects who have evidence of a cellular immune response against SARS-CoV-2.