US FDA Approves Phase 2 Trial for Coronavirus Vaccine
The U.S. Food and Drug Administration has given Moderna approval to start phase 2 trials for its experimental coronavirus vaccine.
The company announced that it’s planning to have 600 participants in the phase 2 study, which it expects to begin “shortly.” It’s also finalizing the protocol for phase 3, “which is expected to begin in the early summer of 2020.”
The Moderna vaccine is one of many under development but was the first to begin phase one testing back in March. The first phase included 45 young, healthy volunteers. The goal was to learn about the vaccine’s safety and see how the immune system responds to it.
Dr Anthony Fauci, the U.S. government’s top expert, has cautioned that even if everything goes perfectly, 12 to 18 months to develop a vaccine would set a speed record.
If early evidence was strong enough and the virus is still widespread, the Food and Drug Administration might even consider emergency use of a vaccine before final test results were in, Dr Peter Marks, who directs the FDA office that oversees vaccines, recently told reporters.
