J&J asks for emergency use authorization of coronavirus vaccine booster
Johnson & Johnson announced Tuesday that it has asked the Food and Drug Administration (FDA) to grant emergency authorization for a booster shot of its COVID-19 vaccine for individuals aged 18 years and older.
In a statement, the company said it based its filing on the results of a late-stage clinical trial that found a booster dose of its single-shot vaccine given 56 days after the first dose provided 94 percent protection against symptomatic COVID-19, and 100 percent protection against severe and critical disease at least 14 days after the second dose.
The move comes as the Biden administration ramps up its campaign to administer booster doses.
The U.S. began rolling out booster doses late last month. More than 5.7 million people have received a booster dose, according to data from the Centers for Disease Control and Prevention.
The FDA has already authorized booster shots for Pfizer’s vaccine for individuals aged 65 and older and those at high risk of severe disease.
Moderna has also begun submitting data to the agency about a booster dose of its vaccine.
Coming up, FDA meeting: The FDA’s vaccine advisory panel will meet later this month to discuss booster doses of Moderna and J&J’s vaccine. Both vaccines are currently authorized for adults aged 18 and older.