Amerikan Gıda ve İlaç Dairesi (FDA), Covid-19’a karşı üretilecek aşılar için kabul edilme şartlarını açıkladı. FDA’in onay vereceği aşılarda, klinik deneylerde hastalığın şiddetini plasebo ilaçlara göre en az yüzde 50 oranda azaltması koşulu aranacak.
FDA ise çalışmalara yardımcı olacak bir onay rehberi açıkladı.
Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines
Today, the U.S. Food and Drug Administration took important action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 by providing guidance with recommendations for those developing COVID-19 vaccines for the ultimate purpose of licensure. The guidance, which reflects advice the FDA has been providing over the past several months to companies, researchers, and others, describes the agency’s current recommendations regarding the data needed to facilitate the manufacturing, clinical development, and approval of a COVID-19 vaccine.
