Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-shot COVID vaccine, to prevent COVID-19 in individuals 18 years of age and older.
This decision was based on the totality of scientific evidence, 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.
Alex Gorsky, Chairman and Chief Executive Officer at Johnson & Johnson said, “We will do everything we can to help bring this pandemic to an end, in the United States and throughout the world”.
Johnson & Johnson is making its COVID-19 vaccine available on a not-for-profit basis for emergency pandemic use. The Company has begun shipping this vaccine 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.
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson said, “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. A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide”.
The Janssen COVID-19 Vaccine will be given as an injection into the muscle. The Janssen COVID-19 Vaccine vaccination schedule is a single dose.
The Janssen Single-Shot COVID vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 in individuals 18 years of age and older. There is no FDA-approved vaccine to prevent COVID-19.
You can read more details here.