Johnson & Johnson [NYSE: JNJ] disclosed that it has decided to seek the authorization of the FDA for its COVID-19 booster shot in individuals 18 years of age and older. The submission depends on the results of the Phase 3 ENSEMBLE 2 study in which booster shots demonstrate 94% of protection against COVID-19.
JNJ disclosed that its clinical program has discovered that a booster of the JNJ COVID-19 vaccine increases levels of protection for those who have got a single-shot vaccine to 94 percent. The firm is looking forward to talking with the FDA and other health authorities to back their decisions regarding boosters.
The submission to FDA also includes that Phase 1/2a data disclosed 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 surge to 12-fold higher four weeks after the booster. The vaccine, when given as a booster or primary dose, was usually well-tolerated.
Furthermore, the Phase 3 ENSEMBLE 2 study that found a booster of the JNJ COVID-19 vaccine given 56 days after the primary dose showed 94% protection against symptomatic moderate to severe/critical COVID-19 and 100 percent protection against severe/critical COVID-19, at least 14 days post-booster vaccination.
In addition, the firm is intending to submit the data to other regulators, the World Health Organization (WHO), and National Immunization Technical Advisory Groups (NITAGs) worldwide to provide information to decision-making on local vaccine administration strategies, as required.