Johnson & Johnson Submits Emergency Use Authorization Amendment to FDA Supporting COVID-19 Booster Vaccine

The phase 3 ENSEMBLE 2 study found that a booster of Johnson & Johnson’s single-shot vaccine administered 56 days after the primary dose provided 94% protection against symptomatic COVID-19.

Johnson & Johnson has submitted data to the FDA supporting emergency use authorization for a booster to its COVID-19 vaccine, with research suggesting significant increased protection against severe or critical disease, the company stated in a press release.

The submission includes results from the phase 3 ENSEMBLE 2 study, which found that a booster of the vaccine administered 56 days after the primary dose provided 94% protection against symptomatic COVID-19 and 100% protection against severe or critical disease, at least 14 days after administration, according to the release.

The submitted data also included findings from the phase 1/2a study, which found that when a booster of the vaccine was given 6 months after the primary dose, antibody levels increased 9-fold 1 week after administration and continued to increase to a 12-fold increase 4 weeks after receiving the booster. When given either as a booster or a primary dose, the vaccine was generally well-tolerated.

“Our clinical program has found that a booster of our COVID-19 vaccine increases levels of protection for those who have received our single-shot vaccine to 94%,” said Mathai Mammen, MD, PhD, global head of Janssen research and development at Johnson & Johnson, in the press release. “We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters.”

These new findings are in addition to data released in September, which reinforced the protection of Johnson & Johnson’s COVID-19 vaccine. The largest real-world evidence study for a COVID-19 vaccine reported in the United States found stable vaccine efficacy of 79% for COVID-19-related infections and 81% for COVID-19-related hospitalizations.

There was no evidence of reduced efficacy over the study duration conducted from March to July 31, 2021, according to the press release. Comparable vaccine efficacy was demonstrated when the study was extended to August 31, 2021, including when the Delta variant spread across the United States. These findings are consistent with the phase 3 ENSEMBLE trial, in which strong protection against severe or critical disease and death was observed at least 28 days after final vaccination.

REFERENCE

Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the US FDA to Support Booster of its Single-Shot COVID-19 Vaccine. Johnson & Johnson; October 5, 2021. Accessed October 5, 2021. https://www.jnj.com/johnson-johnson-announces-submission-of-emergency-use-authorization-amendment-to-the-u-s-fda-to-support-booster-of-its-single-shot-covid-19-vaccine