The Japanese agency that examines new medicines says domestic testing will not be necessary in cases when clinical trial data is available from overseas on existing coronavirus vaccines that have been tailored to new variants.
This is the new policy announced by the Pharmaceuticals and Medical Devices Agency, or PMDA, for screening COVID-19 vaccines going forward.
The agency says that when drug makers seek approval for vaccines that have been modified from authorized ones in response to variants, data from overseas clinical trials can be used to confirm their safety and efficacy.
Experts have pointed out that some coronavirus variants may reduce the effectiveness of existing vaccines. That has prompted drug makers to develop new ones for the variants.
In principle, Japan requires domestic clinical trials for approval of vaccines. Officials say the agency's new policy may shorten the time needed to approve vaccines for variants.