FDA unveils standards for EUA of local vaccinesUNBLINDING: The efficacy of locally developed COVID-19 vaccines must at least be on par with the AstraZeneca vaccine to be granted emergency use authorizationBy Kayleigh Madjar / Staff writer, with CNAThe Food and Drug Administration (FDA) yesterday announced emergency use authorization (EUA) standards for locally developed COVID-19 vaccines, just hours before Medigen Vaccine Biologics Corp (高端) announced its phase 2 trial results. The standards include safety data from at least 3,000 subjects and efficacy test results at least on par with the AstraZeneca vaccine, the FDA said. To determine the appropriate level, the FDA is to commission Ministry of Health and Welfare hospitals to conduct studies comparing the effect of domestic vaccines with that of foreign vaccines, Wu said. The unblinding would only reveal if there were differences between the subjects who received a vaccine and those who received a placebo, Wu said. The results must still be sent to the FDA before it can begin EUA procedures, she added.

Source: Taipei Times June 10, 2021 15:56 UTC