Major companies like Moderna and AstraZeneca have launched clinical trials for potential COVID-19 vaccines. Which ones should be on the PCP’s radar? We’ve got answers.
Vaccines typically require years of research and testing, but with >8 million confirmed cases globally of novel coronavirus disease 2019 (COVID-19), researchers are racing to develop safe and effective vaccines and treatments. With >135 vaccines currently in development worldwide, however, it can be difficult for physicians to keep track of key developments. Scroll through the slides below to find out the latest information on 5 COVID-19 vaccines and treatments in the pipeline.
On June 10, 2020, Johnson & Johnson announced the accelerated initiation of Phase 1/2a of the first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S. The randomized, double-blind, placebo-controlled trial will evaluate Ad26.COV2-S recombinant in 1045 healthy adults aged 18-55 years and aged ≥65 years. The trial is slated to start in July in the US and Belgium.
On May 29, 2020, Moderna announced the first participants were dose in the Phase 2 study of mRNA-1273, a vaccine against SARS-CoV-2 encoding for a prefusion stabalized form of the Spike protein. The study will examine the safety, reactogenicity, and immunogenicity of 2 vaccinations of mRNA-1273 given 28 days apart in 600 healthy patients across 2 cohorts of adults aged 18-55 years and older adults aged ≥55 years. Each participant will be assigned to receive placebo, a 50 μg or 100 μg dose at both vaccinations.
On May 5, 2020, Pfizer announced that, in partnership with German-based company BioNTech, the first patients were dosed in the US in a Phase 1/2 trial for the BNT162 vaccine program to prevent COVID-19. The trial is part of a global development program, and the dosing of the first cohort in Germany was completed 1 week prior. The study will determine the safety, immunogenicity, and optimal dose level of 4 mRNA vaccine candidates that each represent a different combination of mRNA format and target antigen. Stage 1 of the study will enroll up to 360 healthy adults aged 18-55 years and 65-85 years.
On June 5, 2020, AstraZeneca announced that results from a peer-reviewed case series of 19 hospitalized patients with COVID-19 and severe hypoxia and/or inflammation showed Calquence (acalabrutinib) reduced inflammation and improved clinical outcomes in those patients with severe COVID-19. The results were published in the journal Science Immunology.
In a June 10, 2020 University of Birmingham press release, it was announced that 2 UK drug companies, Izana Bioscience and Celltrion Healthcare, were teaming up with the Universities of Birmingham and Oxford as part of the major CATALYST trial. The trial will test a series of new COVID-19 treatments and Izana Bioscience will provide the first of 4 potential treatments. Namilumab (IZN-101) is a fully human antibody that targets the cytokine GM-CSF, a key driver of lung inflammation in COVID-19 patients. The second drug, Infliximab (CT-P13), is from Celltrion Healthcare and is a TNF therapy that attaches to a protein involved in inflammation.