Johnson & Johnson
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said Thursday that its lead vaccine candidate protected against infection with SARS-CoV-2, the virus that causes COVID-19, in pre-clinical studies. The vaccine provided 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, the company said. Based on the strength of the data, a Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, in healthy volunteers, has now commenced in the United States and Belgium, the company said. Discussions are underway with partners with the objective 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 approval of regulators, Johnson & Johnson said.