MIAMI (CBSMiami) – Moderna’s Phase 3 study to find a COVID-19 vaccine is set to include volunteers from South Florida.
On Tuesday, the biotech company announced that the mRNA-1273 vaccine has induced immune responses in all volunteers in this Phase 1 study.
The vaccine was given 28 days apart in three dose levels to 45 healthy participants between the ages of 18 and 55.
The vaccine induced binding antibodies to the coronavirus spike protein after the first vaccination, the release said.
After two vaccinations, at day 57 of the study, antibody titers exceeded those in convalescent sera taken from 38 people who had COVID-19, a Moderna news release said.
Moderna said the vaccine was “generally safe and well-tolerated.”
“The most commonly reported systemic adverse events following second vaccination at the 100 µg (microgram) dose were fatigue (80%), chills (80%), headache (60%) and myalgia (53%), all of which were transient and mild or moderate in severity,” Moderna said in the news release. “The most common solicited local adverse event at the 100 µg dose was pain at the injection site (100%), which was also transient and mild or moderate in severity. Evaluation of clinical safety laboratory values grade 2 or higher and unsolicited adverse events revealed no patterns of concern.”
Moderna’s next step will be a 30,000-participant Phase 3 study set to start July 27.
According to ClinicalTrials.gov, the following South Florida facilities will be participating:
- Research Centers of America
- Hollywood, Florida, United States, 33024
- Suncoast Research Group
- Miami, Florida, United States, 33135
- University of Miami
- Miami, Florida, United States, 33136
- Palm Beach Research Center
- West Palm Beach, Florida, United States, 33409
If the Phase 3 trial goes well, regulators would have to give final approval. Moderna said it will have as many as a billion doses beginning next year.