On Friday, Moderna announced that its mRNA vaccine targeting the novel coronavirus behind COVID-19 has been given to the initial round of humans participating in its Phase 2 trial. The announcement comes only two weeks after Moderna detailed the results from its Phase 1 testing, which involved dosing people ages 18 to 55. If all goes as planned, the Phase 3 trial will start in July.
Moderna is conducting the Phase 2 trial as part of its Investigational New Drug (IND) application; it is one of the multiple companies attempting to develop a vaccine for the novel coronavirus. At this point in time, Moderna says that the initial Phase 2 participants in each age cohort have been dosed with the experimental vaccine.
The vaccine is called mRNA-1273 and it will be given to the participants — of which 600 are planned — 28 days apart. The participants are split into two age groups, one ages 18 to 55, the other 55 and older. The Phase 2 test involves dosing some participants with a placebo and the rest with either 50μg or 100μg doses.
Moderna expects the Phase 3 study will start in July and involve vaccine doses from 25µg to 100µg. The participants in Phase 2 will be tracked for 12 months after receiving the second vaccine dose. Results from the Phase 1 testing found that in the eight participants, all three doses — 25µg to 100µg — increased immunogenicity with only redness at the injection site as a side effect in a single patient.
Companies are scrambling to develop a vaccine that will protect against the novel coronavirus, but it’s still unclear whether one can be successfully made. It typically takes several years to develop a new vaccine; major companies are attempting to cut that time frame down to, optimistically speaking, a single year, though it’s more likely that any vaccine that hits the market won’t arrive until at least next summer at best.