Modified vaccines targeting new variants of the coronavirus won't require domestic clinical trials if the production process and handling of the shots are similar to those of the original authorized vaccine, the nation’s medicine regulator has said.
Drugmakers would still need to submit data from clinical trials overseas that shows immune response to the variants when they apply for Japanese approval, the Pharmaceuticals and Medical Devices Agency (PMDA) said in a statement this week.
That could significantly speed up the nation's lengthy approval process and allow for the smooth rollout of vaccines targeting more contagious and deadly variants.