CAMBRIDGE, MA — Moderna Therapeutics a clinical stage biotechnology company, pioneering an experimental vaccine for the coronavirus, announced on Thursday that the Food and Drug Administration had cleared its application to proceed to a clinical trial involving about 600 people.
“The imminent Phase 2 study start is a crucial step forward,” Stéphane Bancel, Moderna’s chief executive, said in a statement.
The main goal of this set of tests is to find out if the vaccine is safe and if positive results from the first few dozen volunteers in the first phase can be replicated in a much larger group. If it is successful, later studies, known as Phase 3 trials, will determine exactly how well the vaccine works.
Moderna has manufactured and released more than 100 batches of vaccines and therapeutics from its Norwood site for human clinical trials and in late February shipped vials of its vaccine candidate to the National Institute of Allergy and Infectious Disease for further research.
Philanthropist Noubar Afeyan is the co-founder and chairman of Moderna Therapeutics. He is also co-founder of Aurora Prize for Awakening Humanity.