The first dose of a potential coronavirus vaccine has been administered to a clinical trial participant in the US.
The vaccine is called mRNA-1273. It uses messenger RNA (mRNA) to direct the body’s immune cells to express a virus protein that the developers hope will induce a robust immune response. Different doses will be analysed for their safety and efficacy. Scientists have been able to rapidly develop this vaccine due to earlier studies of related coronaviruses which caused severe acute respiratory symptoms, such as Middle East respiratory syndrome (MERS).
This is the first trial to examine mRNA-1273 in humans, as it has only been previously tested in animal models. There are currently no approved vaccines that exist to prevent infection with SARS-CoV-2.
In the trial, sponsored by the National Institutes of Health (NIH), 45 healthy adults between 18 and 55 years old will be evaluated after receiving the first dose of the investigational vaccine this week. The participant will receive two doses via intramuscular injection into the upper arm, approximately 4 weeks apart. They will receive either 25 microgram, 100 microgram or 250 microgram doses. Safety data will be reviewed before initiating the second round of dosing. After the second round of dosing, the volunteers will require clinical follow-up visits to monitor any long term adverse effects, as well any other medical issues. They will also be asked to provide regular blood samples so laboratories can detect and measure the immune response to the vaccine. A trial protocol team will periodically review safety data to advise the developers on the next steps.
“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” said National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony S. Fauci, M.D. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”
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