![]() “We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.” ![]() “This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world – all of whom shared a goal of bringing a single-shot vaccine to the public,” said Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson. The Company plans to file for a Biologics License Application (BLA) with the FDA later in 2021. The terms of the EUA allow use of the vaccine while more data are gathered. 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. 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. NEW BRUNSWICK, N.J., Febru– Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. ![]()
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