Johnson & Johnson submits application for COVID-19 vaccine to FDA
Pharmaceutical giant Johnson & Johnson has submitted its application for emergency use authorization of its COVID-19 vaccine to the U.S. Food and Drug Administration, the company announced Thursday evening.
The single-shot vaccine is 66% effective at preventing symptomatic COVID-19, 85% effective at preventing severe illness and 100% protective from hospitalization and deaths, according to Johnson & Johnson.
Johnson & Johnson said it expects to have product available to ship immediately following authorization and to supply 100 million doses to the United States in the first half of 2021.
"Today’s submission for emergency use authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic," Dr. Paul Stoffels, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, said in a statement Thursday, adding that the company is "working with great urgency to make our investigational vaccine available to the public as quickly as possible."
The FDA said it will meet on Feb. 26 to review Johnson & Johnson's COVID-19 vaccine. An emergency-use authorization could be issued any time after the meeting concludes.
In addition to potentially offering a convenient, single-dose vaccine against the novel coronavirus, the Johnson & Johnson shot doesn't need to be frozen for shipping and long-term storage, like the COVID-19 vaccines developed by Pfizer and Moderna.
ABC News' Sony Salzman contributed to this report.