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Tuesday, April 20, 2021

J&J files for U.S. COVID-19 vaccine authorization

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J&J files for U.S. COVID-19 vaccine authorization
J&J files for U.S. COVID-19 vaccine authorization

Johnson & Johnson said on Thursday it has asked U.S. health regulators to authorize its single-dose COVID-19 vaccine for emergency use, and it will apply to European authorities in coming weeks.

Gloria Tso reports.

Johnson & Johnson asked U.S. regulators to greenlight its COVID-19 vaccine for emergency use on Thursday, and says it will apply to European authorities in the coming weeks.

The company's application to the U.S. Food and Drug Administration follows its report last week which said its vaccine had a 66% success rate of preventing moderate and severe disease in its global trial.

That's less than the currently authorized Pfizer-BioNTech and Moderna shots, which were 95% effective in global trials.

But studies on those shots were carried out before the highly contagious new variants of the virus appeared to have emerged.

J&J's vaccine is single-dose and could help boost supplies and simplify the U.S. vaccination campaign, as concerns emerge over the potential of lower vaccine efficacy against those variants.

Unlike the two other vaccines, J&J's also doesn't need to be shipped frozen.

The U.S. has agreed to pay $1 billion for 100 million doses, which J&J said it expected to supply in the first half of the year.

The company aims to deliver 1 billion doses this year with production in the United States, Europe, South Africa and India.

The FDA said Thursday evening it's scheduled a meeting on Feb.

26 to discuss the company's request for emergency use authorization.

Both Pfizer and Moderna's vaccines were authorized just a day after those meetings.


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