Johnson & Johnson Seeks FDA Emergency Approval for Its Booster Shot
By Physician's Briefing Staff | October 05, 2021
Johnson & Johnson announced Tuesday that it has asked the U.S. Food and Drug Administration to approve emergency use of its COVID-19 booster shot.
The request to authorize an extra vaccine dose for people who have previously received the Johnson & Johnson single-shot vaccine was filed Tuesday, the company said in a statement. The company noted that it provided the FDA with data on booster intervals ranging from two to six months, but it did not formally recommend one to the agency.
"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 percent," Mathai Mammen, M.D., global head of Janssen Research & Development, a subsidiary of Johnson & Johnson, said in the company's statement. "We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters."
Last month, J&J released data suggesting its vaccine was 81 percent effective against hospitalizations at least five months after vaccination. An FDA advisory panel will review the J&J data next week and vote on whether to recommend boosters. The panel will do the same review for the Moderna booster shot during that meeting, the Associated Press reported. If both the FDA and the U.S. Centers for Disease Control and Prevention give their approval, booster shots of the two companies' COVID-19 vaccines could become available later this month.
