Johnson & Johnson requests emergency authorization from FDA
Johnson and Johnson submitted an application to the U.S. Food and Drug Administration (FDA) on Thursday, requesting emergency use authorization for its single-dose novel coronavirus (COVID-19) vaccine candidate.
The company announced late last month preliminary results from its international study, which found the vaccine was safe and 66 percent effective overall at preventing moderate to severe COVID-19 28 days after vaccination.
The FDA and a team of independent advisers will carefully and critically review Johnson & Johnson’s data, before deciding whether to grant emergency use authorization to what would be a third vaccine option in the United States. The panel will meet on February 26, 2021.
While the vaccine does not seem as strong as its two-dose competitors made by Pfizer and BioNTech and Moderna, experts say the single-dose option could be easier and help boost scare vaccination supplies.