Johnson & Johnson (NYSE: JNJ) announced on Tuesday that it has submitted data to the U.S. Food and Drug Administration for an emergency use authorization of a booster shot of its COVID-19 vaccine in Americans aged 18 years and above.
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 (NYSE: PFE)-BioNTech (NASDAQ: BNTX) vaccine for Americans aged 65 years and older, people at high risk of severe disease and frontline workers. Pfizer-BioNTech also sought to authorized booster doses for all Americans aged 16 years and older, but health regulators decided to limit booster shots to just population groups that are at more risk. That means that the Johnson & Johnson shot will most likely only been authorized for the more vulnerable, not the broader American adult population.
Moderna (NASDAQ: MRNA) has also submitted an emergency use authorization application for a booster shot of its two-dose vaccine to the FDA last month, and the health regulator's advisory panel will hold a meeting on Oct. 14 to rule on the extra dose.
Johnson & Johnson added that it plans to submit the data to other global health regulators, including the World Health Organization.