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# J&J Seeks EUA for Booster Jab
- URL: https://www.fdaweb.com/j-j-seeks-eua-for-booster-jab/
- Published: 2021-10-05T12:00:00.000Z
- Updated: 2026-09-14T17:17:51.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150297

Johnson & Johnson has submitted data to support an emergency use authorization for its Covid-19 booster shot in those 18 years of age and older. The filing, according to the company, includes data from the [Phase 3 ENSEMBLE 2 study](https://www.jnj.com/johnson-johnson-announces-real-world-evidence-and-phase-3-data-confirming-strong-and-long-lasting-protection-of-single-shot-covid-19-vaccine-in-the-u-s?ref=fdaweb.com) that found a booster given 56 days after the primary dose provides 94% protection against symptomatic (moderate to severe/critical) Covid-19 and 100% protection against severe/critical Covid.

Additionally, Johnson & Johnson says its submission includes [data](https://www.jnj.com/johnson-johnson-announces-data-to-support-boosting-its-single-shot-covid-19-vaccine?ref=fdaweb.com) showing that when a booster vaccine was administered six months after the initial single shot, “antibody levels increased nine-fold one week after the booster and continued to climb to 12-fold higher four weeks after the booster. The vaccine, when given as a booster or primary dose, was generally well-tolerated.”