J&J seeks authorization for COVID-19 vaccine booster
Johnson & Johnson today announced its request that the Food and Drug Administration amend the current emergency use authorization for the J&J COVID-19 vaccine to include a booster dose. J&J’s submission includes phase 3 U.S. clinical trial data that affirms the booster’s effectiveness; when administered 56 days following a primary dose, J&J said, a booster provided 94% protection against symptomatic (moderate to severe/critical) COVID-19 and 100% protection against severe/critical COVID-19, at least 14 days after booster administration. The submission also includes phase 1/2a data on boosters’ effectiveness at the six-month juncture. The FDA later this month will meet to consider booster for J&J and Moderna.
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