Phase 1 results of the very first SARS-CoV-2 vaccine tested in humans have just been released. It turns out that the injection in 45 subjects participating in the study generated an immune response in each of them. The next phases of the trial will start soon and will involve a much larger number of volunteers.
Across the globe, dozens of teams are working to develop a vaccine against SARS-CoV-2 . In mid-March 2020, we were talking about the first vaccine tested on humans, namely mRNA-1273. This is the result of the work of the company Moderna and the National Institutes of Health (NIH) in the United States. The phase 1 trial had just started and involved 45 healthy adults aged 18 to 55. The volunteers were separated into three groups of 15, receiving twice a dose of 25, 100 or 250 micrograms.
A preliminary report published in the New England Journal of Medicine This July 14, 2020, revealed the results of phase 1. According to officials, a "robust" immune response was observed in the 45 patients concerned. Each of the volunteers produced neutralizing antibodies, enough to offer protection against the coronavirus. On the other hand, half of the volunteers suffered adverse effects . The latter had fatigue, chills, migraines, or even muscle pain.
“These phase 1 data demonstrate that vaccination with mRNA-1273 induces a robust immune response at all dose levels and clearly supports the choice of 100 µg in a prime and booster regimen as the optimal dose for the phase 3 study say the scientists.
Officials also said they have completed recruitment of 300 young adults for the phase 2 trial. Enrollment for the elderly sentinel group (50 volunteers) is also complete. . However, all eyes are on the next trial (phase 3) which will start on July 27, 2020 and will involve 30,000 people . Half of the volunteers will receive a dose of mRNA-1273 vaccine and the other half a simple placebo. The researchers hope that this last phase of confirmation will be completed in October 2020.
In May 2020, the company Moderna announced a collaboration with the Swiss Lonza for a larger scale manufacture of the mRNA-1273 vaccine. We are talking about one billion doses per year (over ten years) for worldwide use, based on doses of 50 mcg.
