感染防御効果５０％以下のトランプ汁は集団接種しちゃダメ・・・米国FDA

Pfizer Covid vaccine 39% effective in Israel, prevents severe ...

https://www.cnbc.com › 2021/07/23

Jul 23, 2021 — The two-dose vaccine still works very well in preventing people from getting seriously sick, demonstrating 88% effectiveness against ...

Pfizer Shot Just 39% Effective Against Delta Infection - Forbes

https://www.forbes.com › sites › roberthart › 2021/07/23

Jul 23, 2021 — In a statement, Pfizer and BioNTech noted that while real-world data from Israel show vaccine efficacy in preventing infection and ...

israeli data suggests possible waning in effectiveness of pfizer ...

https://www.nytimes.com › covid-vaccine-israel-pfizer

Jul 23, 2021 — Analyzing the government's national health statistics, researchers estimated that the Pfizer shot was just 39 percent effective against ...

  

 

Contains Nonbinding Recommendations

Emergency Use Authorization for Vaccines to Prevent COVID-19 Guidance for Industry Document issued on May 25, 2021. This document supersedes the guidance of the same title issued on

February 22, 2021 and October 2020.

略

3. Clinical

a. FDA acknowledges the potential to request an EUA for a COVID-19 vaccine based on an interim analysis of a clinical endpoint from a Phase 3 efficacy study.
Issuance of an EUA requires a determination that the known and potential benefits of the vaccine outweigh the known and potential risks. For a preventive COVID-19 vaccine to be potentially administered to millions of individuals, including healthy individuals, data adequate to inform an assessment of the vaccine’s benefits and risks and support issuance of an EUA would include not only meeting the prespecified success criteria for the study’s primary efficacy endpoint as described in the guidance for industry entitled “Development and Licensure of
Vaccines to Prevent COVID-19” (Ref. 1) (i.e. a point estimate for a placebo-controlled efficacy trial of at least 50%, with a lower bound of the appropriately alpha-adjusted confidence interval around the primary efficacy endpoint point estimate of >30%) but also additional safety and effectiveness data as described below. The timing of interim analyses planned for a Phase 3 study would thus
ideally be aligned with the ability of the analyses to meet these criteria. 

https://www.fda.gov/media/142749/download

少なくともファイザーはホントはもう集団接種させちゃダメなトランプ汁なんですよ。モデルナがそうなるのも時間の問題。（爆ｗｗｗｗｗｗｗｗｗｗｗ 

本来FDAはもうEmergency Use Authorizationを撤回してなきゃダメな数字なんですよ。（爆ｗｗｗｗｗｗｗ

2021年8月11日水曜日

ファイザーがダメならモデルナ！・・・とワクチンカルトがわるあがき

https://tokumei10.blogspot.com/2021/08/blog-post_88.html