> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Issues EUA for Janssen Covid Vaccine
- URL: https://www.fdaweb.com/fda-issues-eua-for-janssen-covid-vaccine/
- Published: 2021-03-01T12:00:00.000Z
- Updated: 2026-09-14T16:48:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148766

FDA 2/27 issued an emergency use authorization (EUA) to Janssen Biotech for its single intramuscular Covid-19 vaccine injection. The EUA follows an unanimous (22-0) advisory committee vote 2/26 ([see earlier story](https://www.fdaweb.com/fda-panel-backs-eua-for-janssen-covid-vaccine/)). The company’s data “show that the vaccine’s known and potential benefits outweigh its known and potential risks, supporting the company’s request for the vaccine’s use in people 18 years of age and older,” FDA said in a [release](https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines?ref=fdaweb.com).

The agency said that the Janssen vaccine is manufactured using a specific type of virus called adenovirus type 26 (Ad26). “The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive ‘spike’ protein of the SARS-CoV-2 virus,” it said. “While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.”

The authorization was based on data showing that the vaccine was 67% effective in preventing moderate to severe/critical Covid-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical Covid-19 occurring at least 28 days after vaccination, FDA said. Additionally, the vaccine was about 77% effective in preventing severe/critical Covid-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical Covid-19 occurring at least 28 days after vaccination.