Johnson & Johnson Asks FDA To Authorize Booster Shot For Its COVID Vaccine
By Bill Galluccio
October 5, 2021
Johnson & Johnson has asked the Food and Drug Administration to authorize a booster shot for its COVID vaccine. The company submitted late-stage clinical trial data that shows the effectiveness of the booster shot.
The drugmaker said that a booster shoot administered 56 days after the first dose increased the protection against symptomatic COVID-19 infections to 94% and provided100% protection against severe disease.
Dr. Mathai Mammen, head of global research and development for J&J's vaccine arm, Janssen, told CNN that the company is working with the FDA to go over the data.
"We're describing the data to them," he said. "The process is not that we asked for a very specific interval -- we're providing them data, and we're going to be presenting to the committee. They'll take all that into consideration when they ultimately decide on an appropriate interval."
The FDA's Vaccines and Related Biological Products Advisory Committee will discuss the request during a meeting on October 15.
Last month, the FDA authorized a booster shot for Pfizer's vaccine for adults over the age of 65, people over the age of 18 who have a high risk of being exposed to the coronavirus, and those who are at risk of severe illness.
The FDA is also considering authorizing a booster shot for Moderana's vaccine.