Moderna has moved incredibly quickly to begin testing a potential vaccine for the new coronavirus in U.S. patients. The biotech company went from taking the genetic sequence of the new coronavirus to manufacturing its first batch of vials in less than a month.
Reality check: Best-case scenario, a vaccine could be ready for production by next year — but that's assuming the drug proves to be both safe and effective, which is completely unknown right now.
What they're saying: My colleague Dan Primack and I spoke with Moderna CEO Stéphane Bancel to understand the timing of this very fluid situation.
- After this phase 1 trial and a potential phase 2 trial over the summer, Bancel believes the vaccine can begin a phase 3 trial by this fall.
- A phase 3 trial would enroll at least 3,000 people, and if data shows the vaccine is safe and effective for that sample, the FDA could approve it.
- Anthony Fauci of the NIH has said it's a possibility there could be a novel coronavirus vaccine in 2021, "and I would agree with that," Bancel said.
Yes, but: There's no data yet. It's a scientific feat to get to this stage so quickly, but that will matter a lot less if the vaccine doesn't work well or if people suffer serious side effects.
- "We cannot make any mistakes on safety," Bancel said.
The intrigue: Moderna, which uses a complex gene-based technology that changes how cells function, has a lot of experience researching vaccines — it has done some animal testing on a vaccine for a related coronavirus, MERS.
- But none of Moderna's vaccines have led to federal approvals yet.
The bottom line: The global desire to find something to prevent another COVID-19 pandemic should not kick aside the need for scientific evidence.
