Cambridge's Moderna Gets FDA Fast Track Approval For Potential Coronavirus Vaccine
CAMBRIDGE (CBS) – Cambridge biotech company Moderna says it's received a big boost from the FDA to fast track its development of a potential coronavirus vaccine.
Moderna is now in the second phase of its study, which was approved last week by the Food and Drug Administration.
The federal agency has now given the drug "Fast Track designation" which means Moderna will get more frequent meetings with the FDA to discuss the vaccine development plan and the data that goes with it. It also allows the company to be eligible for "Accelerated Approval and Priority Review."
The purpose of Fast Track, according to the FDA, is "to get important new drugs to the patient earlier."
"The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients," the FDA website states.
Moderna's phase 2 is expected to begin soon. It will evaluate the safety of two vaccinations given 28 days apart.
The company plans to enroll 600 participants in the study. One group of 300 people will be adults between the ages of 18 and 55 years old. The other 300 will be above 55.
"Participants will be followed through 12 months after the second vaccination," Moderna said in a statement Tuesday.
Phase 3 of the research is scheduled to start in the early summer.
Moderna is teaming up with Swiss company Lonza to make one billion doses of the vaccine per year, if it is approved.
Public health officials have said it could take 18 months to fully validate a vaccine. Moderna began its work in January.
"If we are successful we hope to know that in the late fall and early winter." Dr. Anthony Fauci said of the Moderna trials while testifying Tuesday at a Senate hearing on coronavirus.
Moderna's vaccine is one of eight currently in clinical development.
