Johnson & Johnson
The pharmaceutical giant said its submission includes data from a late-stage clinical trial that found that a booster dose given 56 days after the initial dose provided 94% protection against symptomatic COVID-19 infection in the United States and 100% protection against severe disease, at least 14 days after the booster shot was administered.
"Our clinical program has found that a booster of our COVID-19 vaccine increases levels of protection for those who have received our single-shot vaccine to 94%. We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters," said Dr. Mathai Mammen, global head at Janssen Research & Development, in a press statement. "At the same time, we continue to recognize that a single-shot COVID-19 vaccine that provides strong and long-lasting protection remains a crucial component to vaccinating the global population."
Johnson & Johnson's filing comes as the FDA's vaccine advisory committee is scheduled to meet on Oct. 15 to discuss whether or not to authorize a second dose of the company's vaccine.
About 15.1 million Americans have received Johnson & Johnson's single-dose COVID vaccine, according to latest data from the U.S. Centers for Disease Control and Prevention. That total compares to Pfizer-BioNTech's nearly 231 million and Moderna's 152 million doses administered, meaning roughly 116 million and 76 million Americans, respectively, getting inoculated with the two-dose regimens.
The FDA has only authorized a booster dose of the Pfizer
Moderna
Johnson & Johnson added that it plans to submit the data to other global health regulators, including the World Health Organization.