On Jun. 10, 2020, Johnson & Johnson announced that through its Janssen Pharmaceutical subsidiary it has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Initially scheduled to begin in September, the trial was expected to commence in the second half of July.

The randomized, double-blind, placebo-controlled Phase 1/2a study will evaluate the safety, reactogenicity (response to vaccination), and immunogenicity (immune response) of the investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant in 1045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. The study took place in the U.S. and Belgium.

The Company is in discussions with the National Institutes of Allergy and Infectious Diseases with the objective to start the Phase 3 SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, clinical trial ahead of its original schedule, pending outcome of Phase 1 studies and approval of regulators.

As the Company progresses the clinical development of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, it continued to increase manufacturing capacity and is in active discussions with global partners to ensure worldwide access. The Company committed to the goal of supplying more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.

Johnson & Johnson’s efforts to expedite development and production of a SARS-CoV-2 vaccine were enhanced by a collaboration between Janssen and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services. COVID-19 is caused by SARS-CoV-2, which belongs to a group of viruses called coronaviruses that attack the respiratory system. To date, there is currently no approved vaccine for COVID-19.