就說那個pfizer疫苗在美國的臨試吧
https://clinicaltrials.gov/ct2/show/study/NCT04368728
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 43998 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS |
Actual Study Start Date : | April 29, 2020 |
Estimated Primary Completion Date : | August 3, 2021 |
Estimated Study Completion Date : | January 31, 2023 |
注意那個時間線,預計要到今年八月才能完成初步目標;在2023年一月才能完成整個臨床,然後,才能有正式的結論性報告。之後,才能向FDA正式申請批準使用。
去年十月份發布的,隻是階段性成果,滿足了FDA緊急授權的基本要求。
關於疫苗有效性、持續性和安全性數據收集整理仍在進行中,臨試主辦方沒有義務公布。除非FDA或IRB要求公布。
CDC應該有疫苗實施和效果的數據,但CDC隻是聯邦政府的執行機構,沒有自主權,得聽吆喝。