J&J asks for emergency use authorization of COVID-19 vaccine booster

J&J asks for emergency use authorization of COVID-19 vaccine booster
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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 New York Times first reported Monday that Johnson & Johnson was planning to request emergency use authorization this week, citing officials familiar with the company’s plan.

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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 (CDC).

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.

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.

The CDC released a study last week finding that the side effects of a booster shot are similar to those of a second dose and were mostly mild or moderate and short lived.

Updated at 7:32 a.m.