Strong evidence from a large, real-world evidence study, and preliminary data from a phase 3 booster-dose trial may support J&J's next steps toward FDA authorization of a COVID-19 booster.
Johnson & Johnson (J&J) released preprint data today from a large real-world evidence trial that showed the company's single-dose adenovirus-based COVID-19 vaccine was associated with 79% overall efficacy for the prevention of COVID-19 and 81% efficacy for prevention of hospitalizations associated with the virus.
No evidence of reduced effectiveness was observed during the study period, including as the COVID-19 Delta variant became the dominant strain in the US, according to a company statement.
The data is from the company's pivotal ENSEMBLE program and also included preliminary data from the phase 3 ENSEMBLE 2 trial which is evaluating a 2-dose regimen of the vaccine. The company reports that a booster dose, given 56 days after the initial shot, was associated with 94% efficacy at preventing symptomatic SARS-CoV-2 infection in the US, and 75% efficacy worldwide.
The study included 390 000 people who received the J&J COVID-19 vaccine vs 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.
These data were consistent with the Phase 3 ENSEMBLE trial, where strong protection against severe/critical disease and death was observed at least 28 days post-final vaccination:
Booster shot at 2 months provided 94% protection against COVID-19 in the US
The phase 3 ENSEMBLE 2 study showed that another shot of the Johnson & Johnson COVID-19 vaccine given 56 days after the first provided:
The J&J booster, when given 2 months after the first shot, produced antibody levels 4- to 6-times higher than observed after the single shot.
Booster at 6 months provided 12-fold increase in antibodies
When a booster dose of the J&J COVID-19 vaccine was given 6 months after the single shot, antibody levels increased 9-fold one week after the booster and continued to climb to 12-fold higher 4 weeks after the booster. Rises in antibody levels were irrespective of age.
“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,” said Mathai Mammen, MD, PhD, global head, Janssen Research & Development, Johnson & Johnson.
Given the ongoing spread of the SARS-CoV-2 infection, including from variants both known and unknown, prioritizing protection for as many individuals as possible, against hospitalization and death, is "critical," said Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, in the press statement.
"A single-shot COVID-19 vaccine that is easy to use, distribute and administer, and that provides strong and long-lasting protection is crucial to vaccinating the global population.”
The Company has provided available data to the US Food and Drug Administration and plans to submit the data to other regulators.