The drugmaker Moderna says early trial results from a possible vaccine for the novel coronavirus, which is the underlying cause of COVID-19, are positive.
The phase 1 trial involved 45 healthy people, in different age groups from 18 to 55, and was conducted in connection with the National Institutes of Allergies and Infectious Diseases (NIAID). Different doses of the vaccine were given to different groups of people, in a two-shot dose, and results on 8 of the participants showed that they had no side effects plus they developed antibodies to COVID-19. Moderna says the antibodies were at a level seen in blood samples taken from people who had recovered from COVID-19. The purpose of the Phase 1 trial was primarily to prove safety.
Previous studies in mice showed that the vaccine prevented the virus from replicating in the lungs of the mice.
In Phase 1, three people who received the highest dose had what Moderna calls “Grade 3 systemic effects” — fever, muscle aches, and headache, and one person had redness at the injection site.
Based on the interim Phase 1 data, Moderna says in Phase 2, they will look at different doses to find the optimal dose for ongoing studies. Moderna has received approval from the FDA to fast-track the studies, and the company plans to begin Phase 3 trials in July. If all goes well, and the vaccine proves to be safe and effective, they could begin manufacturing a vaccine by the end of the year.
https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-interim-phase-1-data-its-mrna-vaccine