Johnson & Johnson announced new data for its COVID-19 vaccine showing that protection against COVID-19 increases when a booster shot is administered. The safety profile of the vaccine remained consistent and was generally well-tolerated when administered as a booster.
 
J&J provided available data to the U.S. FDA and plans to submit the data to other regulators, and to inform decision-making on local vaccine administration strategies, as needed.
 
The largest real-world evidence study for a COVID-19 vaccine reported to date in the U.S. demonstrated stable vaccine effectiveness of 79 percent for COVID-19-related infections and 81 percent for COVID-19-related hospitalizations. There was no evidence of reduced effectiveness over the study duration, including when the Delta variant became dominant in the U.S. The study included 390,000 people who received the J&J COVID-19 vaccine versus approximately 1.52 million unvaccinated people matched on age, sex, time, three-digit zip code, and comorbidities and predictors for COVID-19 infection severity conducted from March to late July 2021.
 
The Phase 3 ENSEMBLE trial also showed strong protection against severe/critical disease and death was observed at least 28 days post-final vaccination: 75 percent overall efficacy against severe/critical COVID-19; 89 percent against hospitalization; 83 percent against COVID-19-related death.
 
The Phase 3 ENSEMBLE 2 study showed that another shot of the Johnson & Johnson COVID-19 vaccine given 56 days after the first provided: 100 percent protection against severe/critical COVID-19 – at least 14 days post-final vaccination; 75 percent protection against symptomatic COVID-19 globally and 94 percent protection against symptomatic COVID-19 in the U.S. When a booster of the Johnson & Johnson COVID-19 vaccine was given two months after the first shot, antibody levels rose to four to six times higher than observed after the single shot.
 
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.