J&J seeks FDA backing for booster of single-shot COVID-19 jab

Healthcare giant Johnson & Johnson (NYSE: JNJ) has submitted data to the US Food and Drug Administration (FDA) to support use of a booster shot of its COVID-19 vaccine in adults.

The submission includes recent results from the Phase III ENSEMBLE 2 study that found a booster of the vaccine given 56 days after the primary dose provided 94% protection against moderate to severe/critical COVID-19 and 100% protection against severe/critical COVID-19, at least 14 days post-booster vaccination.

"We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters"Also part of the submission is Phase I/IIa data showing that 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. The jab, when given as a booster or primary dose, was generally well-tolerated.