Johnson & Johnson is seeking an emergency use authorization (EUA) for a booster shot of its single-dose Covid-19 vaccine, according to a statement from the company.
The company cites data from a phase I/IIa trial that shows “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,” the drugmaker noted.
BreakingMED recently reported the results of the Phase III Ensemble trial, which is also included in the current submission.
“In the phase III ENSEMBLE 2 study, a second shot of the Johnson & Johnson vaccine given 56 days after the initial dose provided 100% protection against severe Covid-19 infection; 75% protection against symptomatic disease globally; and 94% protection against symptomatic disease in the U.S. This last finding, if accurate, would put a two-dose Johnson & Johnson vaccine regimen in like with the two mRNA-based Covid-19 vaccines currently authorized in the U.S., BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna),” BreakingMED reported.
Johnson & Johnson plans to submit its latest data to the World Health Organization and other regulators.
The single-dose vaccine currently has an FDA EUA for use in individuals age 18 and older.
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 125
Topic ID: 79,125,933,125,926,927,725,928,934