Phase 1 results for the first SARS-CoV-2 vaccine tested in humans, Moderna's mRNA-1273 developed with the U.S. National Institutes of Health (NIH), show all 45 participants generated a strong immune response. Larger trials are underway.
Teams worldwide are racing to develop a SARS-CoV-2 vaccine. In March 2020, Moderna's mRNA-1273 became the first tested in humans. This Phase 1 trial enrolled 45 healthy adults aged 18-55, divided into three groups of 15 receiving two doses of 25, 100, or 250 micrograms.
A preliminary report published in the New England Journal of Medicine on July 14, 2020, confirmed a "robust" immune response in all participants, with neutralizing antibodies providing potential protection against the coronavirus. However, about half experienced mild side effects like fatigue, chills, headaches, and muscle pain.
"These Phase 1 data demonstrate that mRNA-1273 induces a robust immune response at all dose levels and supports 100 µg as the optimal dose for Phase 3," stated the researchers.
Phase 2 recruitment is complete, including 300 young adults and 50 seniors. Phase 3 launches July 27, 2020, enrolling 30,000 participants—3000 receiving the vaccine and the rest a placebo—with results expected in October 2020.
In May 2020, Moderna partnered with Swiss firm Lonza to scale production to one billion doses per year (over 10 years) at 50 mcg per dose for global distribution.
