Johnson & Johnson (NYSE: JNJ) made some progress in the fight against COVID-19 on Wednesday. The company announced that it would launch its human study for its lead vaccine candidate in the United States and Belgium.
Overall, the pharma giant’s early single-does trials demonstrated solid results. Specifically, the vaccine elicited a robust immune response as demonstrated by “neutralizing antibodies,” successfully preventing subsequent infection and providing complete or near-complete protection in the lungs from the virus in non-human primates.
Currently, planning also is underway for a Phase 2a study in the Netherlands, Spain and Germany and a Phase 1 study in Japan.
As it stands, the Phase 1/2a trial will evaluate the safety, reactogenicity (expected reactions to vaccination, such as swelling or soreness) and immunogenicity of Ad26.COV2.S in over 1,000 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older.
Looking ahead, Johnson & Johnson’s COVID-19 Phase 3 clinical development program is currently being discussed with partners. The objective is to start a pivotal Phase 3 clinical trial of the single vaccine dose versus placebo in September, pending the interim data of the Phase 1 and 2 trials and regulatory approval. At the same time, the company is planning to start a parallel Phase 3 clinical trial of a two-dose regimen versus placebo.
As these clinical trials are ongoing, the company continues to increase manufacturing capacity and is in active discussions with global strategic partners to support worldwide access. Johnson & Johnson plans to meet its goal to supply more than a billion doses globally through the course of 2021, provided the vaccine is safe and effective.
Johnson & Johnson stock was relatively flat at $146.64 on Thursday, in a 52-week range of $109.16 to $157.00. The consensus price target is $166.06.