J&J submits data to FDA for emergency use green light of COVID-19 booster shot
Johnson & Johnson has submitted data to the Food and Drug Administration to support use of a booster shot of the Johnson & Johnson COVID-19 vaccine in individuals 18 years of age and older.
The submission includes recent results from the Phase 3 ENSEMBLE 2 study that found a booster of the Johnson & Johnson COVID-19 vaccine given 56 days after the primary dose provided 94% protection against symptomatic (moderate to severe/critical) COVID-19 in the U.S. (CI, 58%-100%) and 100% protection (CI, 33%-100%) against severe/critical COVID-19, at least 14 days post-booster vaccination.
Also part of the submission is Phase 1/2a data showing that when a booster of the Johnson & Johnson COVID-19 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.
“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%. We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” said Mathai Mammen, global head, Janssen Research & Development, Johnson & Johnson. “At the same time, we continue to recognize that a single-shot COVID-19 vaccine that provides strong and long-lasting protection remains a crucial component to vaccinating the global population.”
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Last month, the company 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 U.S. demonstrated stable vaccine effectiveness of 79% (CI, 77%-80%) for COVID-19-related infections and 81% (CI, 79%-84%) for COVID-19-related hospitalizations. There was no evidence of reduced effectiveness over the study duration conducted from March to July 31, 2021. Comparable vaccine effectiveness was demonstrated when the study was extended to Aug. 31, 2021, including when the Delta variant became dominant in the United States. Sequencing data were not available for analysis.
The company noted that 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.
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The company said it plans to submit the data to other regulators, the World Health Organization and National Immunization Technical Advisory Groups worldwide to inform decision-making on local vaccine administration strategies, as needed.