Johnson & Johnson COVID-19 Vaccine Authorized by U.S. FDA For Emergency Use - the First Single-Shot Vaccine in Fight Against Global Pandemic.
Data demonstrated protection against COVID-19 related hospitalization and death, across countries with different variants. Shipping vaccine immediately, delivering more than 20 million doses to U.S. in March, 100 million doses in first half of 2021.
The company announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.
This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.
This article was originally published by Johnson & Johnson press release on February 27, 2021.
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