2 ms·
Does this mean we can finally have the already-approved, over-17-year-old, and not-produced Lyme disease vaccine?
by hedora 3y ago
Does this mean we can finally have the already-approved, over-17-year-old, and not-produced Lyme disease vaccine?
- Vecr 3y agoTo do that for any drug, the FDA needs to approve the new factory setup at a minimum, and that would probably take at least 3 years in practice. Problem is, vaccines are biologicals and you don't get generics for biologicals so that's out from the start. You'd have to re-do at least part of the trials to get a biosimilar licensed.