A vaccine for the coronavirus would be a tipping point in the fight against the disease that has quickly spread across most of the world. Scientists have been working feverishly to test and create something strong enough to stop the spread and thankfully a huge break in the fight against COVID-19 has come this week.
Three pharmaceutical companies have this week launched the first human clinical trials of experimental COVID-19 treatments.
It usually takes at least 18 months for vaccines to go through proper process before they can be deployed. Getting a vaccine to market is usually a long, complicated and expensive process, but these are abnormal circumstances. So, the Food and Drug Administration is expediting any coronavirus vaccine approval using pathways such as Emergency Use Authorization.
The trial 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.
One vaccine is called mRNA-1273 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, M.D. “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. COVID-19 cases were first identified in December 2019 in Wuhan, Hubei Province, China. As of March 15, 2020, the World Health Organization (WHO) has reported 153,517 cases of COVID-19 and 5,735 deaths worldwide. More than 2,800 confirmed COVID-19 cases and 58 deaths have been reported in the United States as of March 15, according to the Centers for Disease Control and Prevention (CDC).”
The second trial is for a treatment for hospitalized COVID-19 patients developed by Sanofi and Regeneron that is evaluating rheumatoid arthritis treatment Kevzara in patients with COVID-19.
The drug may slow the overactive inflammatory response in the lungs caused by the virus, according to the companies. This double-blind trial of 400 participants will begin at 16 medical centers in New York.
“This work is critical to national efforts to respond to the threat of this emerging virus,” Dr. Lisa Jackson, senior investigator at Kaiser Permanente Washington Health Research Institute said. “We are prepared to conduct this important trial because of our experience as an NIH clinical trials center since 2007.”
Adults in the Seattle area who are interested in joining this study should visit https://corona.kpwashingtonresearch.org. For more information about the study, visit ClinicalTrials.gov and search identifier NCT04283461.