The changing nature of the virus also makes it difficult to conduct human clinical trials and get a new antibody to patients in time for it to work against the current variants. At a meeting in December, drugmakers asked US and European regulators to consider adopting new standards for approving new antibody drugs, especially those meant for immunocompromised people. They suggested that new antibody drugs that are similar to previously authorized ones shouldn’t have to go through large clinical trials to test their effectiveness. Instead, extensive lab tests and small safety trials, like what’s done for the annual flu vaccine, may be sufficient.
Researchers are now looking for the holy grail
→ Continue reading at Wired - Science