Exploratory stage 2. Scientists will examine blood samples in the laboratory to detect and quantify immune responses to SARS-CoV-2.Investigators will closely monitor participant safety. How crucial is phase 3 in vaccine clinical trials? The Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response and NIAID are providing funding support for the trial. We know we can meaningfully contribute to helping determine whether this vaccine is effective in preventing COVID-19 disease. “Operation Warp Speed is supporting a portfolio of vaccines like the NIH/Moderna candidate so that, if the results of clinical trials meet FDA’s gold standard, these products can reach Americans without a day’s delay.”NIAID scientists developed the stabilized SARS-CoV-2 spike immunogen (S-2P). This scientifically rigorous, randomized, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last.”Moderna is leading the trial as the regulatory sponsor and is providing the investigational vaccine for the trial.
The trial also seeks to answer if the vaccine can prevent death caused by COVID-19 and whether just one dose can prevent symptomatic COVID-19, among other objectives.Trial volunteers will receive two intramuscular injections approximately 28 days apart. Vaccine watch: 2 companies enter phase 3 trials ABC News’ Bob Woodruff reports on two companies now starting testing of a COVID-19 vaccine on tens of thousands of volunteers. https://www.sfgate.com/news/article/Kaiser-Phase-3-testing-coronavirus-Pfizer-BioNTech-15478815.php Photo: Eva Hambach, AFP Via Getty Images The investigational vaccine directs the body’s cells to express the spike protein to elicit a broad immune response. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20892 Photo: Eva Hambach, AFP Via Getty Images Participants will be asked to provide a daily assessment of symptoms through resolution and have saliva sampled periodically, so investigators can test for SARS-CoV-2 infection.Study investigators will regularly review trial safety data.

The vaccine, known as mRNA-1273, was co-developed by the Cambridge, Massachusetts-based biotechnology company Moderna, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID), … The trial, which will be conducted at U.S. clinical research sites, is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19.“Although face coverings, physical distancing and proper isolation and quarantine of infected individuals and contacts can help us mitigate SARS-CoV-2 spread, we urgently need a safe and effective preventive vaccine to ultimately control this pandemic,” said NIAID Director Anthony S. Fauci, M.D. Participants will be randomly assigned 1:1 to receive either two 100 microgram (mcg) injections of mRNA-1273 or two shots of a saline placebo. FILE - A man gets a flu shot at a health facility in Washington, DC January 31, 2020.FILE - A man gets a flu shot at a health facility in Washington, DC January 31, 2020.FILE - A man gets a flu shot at a health facility in Washington, DC January 31, 2020.FILE - A man gets a flu shot at a health facility in Washington, DC January 31, 2020.Kaiser Permanente has joined a Phase 3 clinical trial to test a coronavirus vaccine candidate currently in production by Pfizer and BioNTech, and will seek to enroll 1,400 adults aged 18-85 in California and Oregon to join in the study, a press release from the medical organization states.