Johnson & Johnson submit request for approval on booster to FDA

Johnson & Johnson said Tuesday that the company had submitted data to the Food and Drug Administration to support the use of a booster dose of its Covid-19 vaccine.

The announcement comes two weeks after the company presented the results of a randomized, controlled Phase 3 study showing that a booster dose given two months after the initial dose of its one-and-done vaccine offered 75% protection against moderate to severe Covid-19 globally, and 94% in the U.S.

Johnson & Johnson Sends Booster Vaccine Data to FDA. What Comes Next. | Barron’s (