U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine. Health officials said the decision was based on scientific evidence, including data 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. The terms of the EUA allow use of the vaccine while more data are gathered.
“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. “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world.”
The Company has begun shipping its COVID-19 vaccines to the U.S. govern-ment and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20
million people in the U.S.