The 45 participants, aged 18 to 55 years, were enrolled at either the Kaiser Permanente Washington Health Research Institute in Seattle or at Emory University in Atlanta; the first volunteer was vaccinated on March 16,after the genetic sequence of the SARS-CoV-2 virus was published. All of the volunteers received one of three levels of doses of the vaccine, which were given in two injections about a month apart.
There were no serious side effects associated with the vaccine at any of the dosing levels, though more than half of the study participants who received the vaccine experienced minor events including fatigue, headache, chills, and pain at the injection site. All of the participants produced antibodies to SARS-CoV-2, the virus that causes COVID-19.
The preventative treatment relies on a new technology that hasn’t yet yielded an approved vaccine for an infectious disease. Using mRNA from the SARS-CoV-2 virus, the shot uses the body’s own cells to mimic the process of a natural infection, by producing viral proteins that are recognized by the immune system.
How long the vaccine-induced immune response lasts to protect against COVID-19 isn’t clear yet; the 45 participants in this study will be monitored for a year to find out. In the meanwhile, Moderna is already planning for its phase 2 study of the vaccine, which will include 300 people—half placed in a placebo group. The study will continue to evaluate safety and efficacy of the vaccine, as well as narrow down the right dose for the final phase of testing.
involving 30,000 people, which will also compare the efficacy of the actual vaccine against a placebo.
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