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The Cambridge-based company that has been developing a coronavirus vaccine announced Thursday that federal regulators have cleared it to advance the potential vaccine to the next phase of development.
Moderna Therapeutics' vaccine candidate, mRNA-1273, will soon begin Phase 2 of development, which the U.S. Centers for Disease Control said is when "the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended."
The potential vaccine is now on track to begin Phase 3 — which involves giving the drug to thousands of people to test for efficacy — early this summer, the company said.
"The imminent Phase 2 study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2. With the goal of starting the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first [biologic license application] approved as soon as 2021," Moderna CEO Stéphane Bancel said. "We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective."
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.
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