Moderna on Tuesday said that its experimental Covid-19 vaccine has gained 'Fast Track' designation from the Food and Drug Administration (FDA). Moderna, which is working on a coronavirus vaccine candidate codenamed mRNA-1273, has completed the Phase 1 clinical study for the vaccine and has said it is preparing for the mid-stage trial.
The mid stage trial is expected to begin shortly and is expected to enroll up to 600 participants. The news saw Moderna's shares rallying on Tuesday. Moderna has been racing to develop a vaccine to treat the novel coronavirus that has killed more than 285,000 people globally. Moderna is one of the few companies that have made quite a lot of progress in developing a vaccine for Covid-19 and plans to start is late stage study in early summer.
New status to help speed up treatment
Moderna's is the first company to have gained a 'Fast Track' status from the Food and Drug Administration, which is likely to help in taking forward the treatment of coronavirus. Fast Track is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need.
"Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus," said Tal Zaks, Chief Medical Officer at Moderna. A vaccine that earns the Fast Track status becomes eligible for more frequent meetings with the Food and Drug Administration in addition to a rolling submission of the marketing application.
A big leap for Moderna
Moderna had earlier received a Fast Track designation for its investigational Zika vaccine (mRNA-1893) and its methylmalonic acidemia (mRNA-3704) and propionic acidemia (mRNA-3927) programs. The biotech giant has been making fast progress in developing a potential Covid-19 vaccine. The company was given an emergency approval last week by the Food and Drug Administration to proceed to a Phase 2 clinical trial of its experimental coronavirus vaccine, which is expected to begin shortly.
The company is also gearing up for its Phase 3 study which it plans to begin in early summer. There are currently no drugs or therapies to treat Covid-19 and drugmakers across the world are speeding up development to come up with a vaccine, which most say will take at least 12 to 18 months. More than a 100 Covid-19 vaccine candidates are in development stage, with only 10 managing to reach the clinical trial stage so far, according to the World Health Organization.