FDA: Johnson & Johnson COVID vaccine is safe and effective

來源: 2021-02-24 15:31:09 [博客] [舊帖] [給我悄悄話] 本文已被閱讀:

https://www.axios.com/johnson-fda-analysis-33162951-9b5d-41e5-8d74-3c9bfdebd87f.html

Details: The shot was found to be 66.9% effective against moderate to severe/critical COVID-19 cases 14 days after vaccination, and 66.1% effective after 28 days. Against severe/critical cases, the vaccine was 76.6% effective after 14 days and 85.4% effective after 28 days.

A large clinical trial showed no COVID-19 hospitalizations or deaths 28 days after patients received the vaccine.
"The analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA," FDA staff wrote.

The FDA analysis also offered a breakdown of the efficacy of the vaccine in Brazil and South Africa, where more contagious variants of the coronavirus have been dominant.

United States:

Moderate to severe/critical: 72%
Severe/critical: 85.9%

South Africa:

Moderate to severe/critical: 64%
Severe/critical: 81.7%

Brazil:

Moderate to severe/critical: 68.1%
Severe/critical: 87.6%

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the J&J vaccine is administered as a single dose and does not need to be stored at ultra-low temperatures — meaning the logistics for mass distributions would be far simpler.

The big picture: The U.S. government has struck an agreement with J&J to provide 100 million doses by the end of June.

More than half of the J&J doses sold thus far are destined for the developing world, with 500 million doses purchased by the global COVAX initiative and 120 million by the African Union.