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Oct. 5, 2021, 6:42 a.m. EDT

J&J amends FDA EUA submission for COVID-19 booster with data showing 94% protection against moderate to severe illness

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By Ciara Linnane

Johnson & Johnson /zigman2/quotes/201724570/composite JNJ +1.38% said Tuesday it has submitted an amendment to the emergency use authorization it's seeking from the U.S. Food and Drug Administration for a booster shot of its COVID-19 vaccine with additional data showing it increased protection to 94% against moderate to severe or critical COVID-19 in the U.S. The submission includes recent data from a Phase 3 trial that found the booster given 56 days after primary dose provided 94% protection against symptomatic illness in moderate to severe/critical COVID-19 and 100% protection against severe/critical COVID-19, at least 14 days post-booster vaccination. The submission further includes Phase 1/2 data that shows a booster given six months after the single shot vaccine increases antibody levels nine-fold a week after the booster that climbs to 12-fold higher four weeks after the booster. J&J is planning to submit the data to other regulators, to the World Health Organization and National Immunization Technical Advisory Groups. Shares were up 0.5% premarket and have gained 1.2% in the year through Monday, while the Dow Jones Industrial Average /zigman2/quotes/210598065/realtime DJIA -1.34% has gained 11%.

/zigman2/quotes/201724570/composite
US : U.S.: NYSE
$ 158.08
+2.15 +1.38%
Volume: 9.84M
Dec. 1, 2021 4:00p
P/E Ratio
23.63
Dividend Yield
2.68%
Market Cap
$410.50 billion
Rev. per Employee
$613,918
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/zigman2/quotes/210598065/realtime
US : Dow Jones Global
34,022.04
-461.68 -1.34%
Volume: 498.38M
Dec. 1, 2021 5:04p
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