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Archive - Mar 16, 2020

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NIH Clinical Trial of Investigational Vaccine for COVID-19 Begins; Vaccine Is mRNA Coding for Viral Spike Protein; Vaccine Developed by Collaborating Scientists at Moderna and NIAID

A Phase 1 clinical trial evaluating an investigational vaccine designed to protect against coronavirus disease 2019 (COVID-19) has begun at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is funding the trial. KPWHRI is part of NIAID’s Infectious Diseases Clinical Research Consortium. The open-label trial will enroll 45 Seattle-based healthy adult volunteers ages 18 to 55 years over approximately 6 weeks. The first participant received the investigational vaccine today (March 16, 2020). The study is evaluating different doses of the experimental vaccine for safety and its ability to induce an immune response in participants. This is the first of multiple steps in the clinical trial process for evaluating the potential benefit of the vaccine. The vaccine is called mRNA-1273 (a messenger RNA molecule that codes for a COVID-19 spike protein) and was developed by NIAID scientists and their collaborators at the biotechnology company Moderna, Inc., based in Cambridge, Massachusetts. The Coalition for Epidemic Preparedness Innovations (CEPI) supported the manufacturing of the vaccine candidate for the Phase 1 clinical trial. “Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” said NIAID Director Anthony S. Fauci, MD. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.” Infection with SARS-CoV-2, the virus that causes COVID-19, can cause a mild to severe respiratory illness and include symptoms of fever, cough, and shortness of breath.

Hopkins/Einstein Experts Recommend Using Antibodies from COVID-19 Survivors As Stopgap Measure to Treat Patients and Protect Healthcare Workers; Approach Has Seen Success in Deadly Pathogen Outbreaks for 100 Years

Countries fighting outbreaks of the novel coronavirus disease COVID-19 should consider using the antibodies of people who have recovered from infection to treat cases and provide short-term immunity—lasting weeks to months—to critical health care workers, argue two infectious disease experts--Arturo Casadevall, MD, PhD, Professor and Chair of the Department of the Molecular Microbiology and Immunology at The Johns Hopkins Bloomberg School of Public Health in Baltimore. and Liise-anne Pirofski, MD, Chief of the Division of Infectious Diseases at the Albert Einstein College of Medicine in New York City. In an open-access essay published online on March 13, 2020 in The Journal of Clinical Investigation (https://www.jci.org/articles/view/138003). Dr. Casadevall and Dr. Pirofski, wrote that the infusion of antibody-containing serum from convalescing patients has a long history of effective use as a stopgap measure against infectious diseases, and can be implemented relatively quickly—long before other antiviral treatments, monoclonal antibodies, and vaccines are developed, approved, and available. The JCI essay is titled “The Convalescent Sera Option for Containing COVID-19.” “In addition to public health containment and mitigation protocols, this may be our only near-term option for treating and preventing COVID-19, and it is something we can start putting into place in the next few weeks and months,” Dr. Casadevall says. To date, the novel coronavirus SARS-CoV-2 that appears to have originated in Wuhan, China, in late 2019 has caused outbreaks of COVID-19 across the world.