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J&J Submits Data to FDA to Support COVID-19 Vaccine Booster
A Phase 3 study found that Johnson & Johnson’s COVID-19 vaccine booster elicited 94% protection against the coronavirus.
Johnson & Johnson recently submitted data to the FDA to support its COVID-19 vaccine booster shot in adults 18 and older.
The submission includes results from the Phase 3 ENSEMBLE study, which found that a booster shot of the vaccine elicited 94 percent protection against the coronavirus.
The most extensive real-world evidence study for a COVID-19 vaccine reported to date in the US enrolled 390,000 individuals who received the Johnson & Johnson COVID-19 vaccine versus nearly 1.52 million unvaccinated individuals.
In the trial, a booster shot of Johnson & Johnson’s COVID-19 vaccine at two months provided 100 percent protection at least 14 days post-final vaccination and 75 percent protection against symptomatic COVID-19 globally.
Also part of the submission is Phase 1/2a data showing that when researchers administered a booster of the vaccine six months after the single shot, antibody levels increased nine-fold one week after the booster and continued to increase to 12-fold higher four weeks after.
“We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” Mathai Mammen, MD, PhD, global head, Janssen research & development at Johnson & Johnson, said in the announcement.
“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,” Mammen continued.
Previously, a single shot of Johnson & Johnson’s COVID-19 vaccine elicited 79 percent protection against COVID-19-related infections, 89 percent protection against hospitalization, 83 percent protection against COVID-19-related death, and 81 percent protection over the total study duration.
The data in the trial included the period when the Delta variant became prominent in the US and was consistent with the ENSEMBLE trial.
Johnson & Johnson will submit the most recent data to other regulators, the World Health Organization (WHO), and National Immunization Technical Advisory Groups (NITAGs) globally to inform decision-making on local vaccine administration strategies.
