J&J Submits Data to the FDA to Support a Booster of its COVID-19 Vaccine

Data show that the vaccine was 94% effective against moderate infection and 100% effective against severe disease.

Johnson & Johnson has submitted data to the FDA to support use its COVID-19 vaccine as a booster shot in people 18 years of age and older.

The submission includes recent results from the phase 3 ENSEMBLE 2 study that found a booster of J&J’s COVID-19 vaccine given 56 days after the primary dose provided 94% protection against symptomatic, moderate-to-severe COVID-19 in the United States and 100% protection against severe/critical COVID-19.

Also part of the submission is phase 1/2a data showing that when a booster of the vaccine was given six months after the 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.

In a study published in the New England Journal of Medicine, investigators found the J&J vaccine provided antibody and T-cell immune responses eight months after the single dose, including against the Delta and other variants.

Additionally, last month, J&J released data reinforcing the strong and long-lasting protection of its COVID-19 vaccine. The largest real-world evidence study for a COVID-19 vaccine reported to date in the United States demonstrated stable vaccine effectiveness of 79% for COVID-19-related infections and 81% for COVID-19-related hospitalizations.

“Our single-shot vaccine generates strong immune responses and long-lasting immune memory. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 further increases,” Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson, said in a statement.