Johnson & Johnson today announced that through its Janssen Pharmaceutical Companies (Janssen) 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 is now expected to commence in the second half of July. <\/p>\n\n\n\n
Paul Stoffels, M.D.,\nVice Chairman of the Executive Committee and Chief Scientific Officer, Johnson\n& Johnson, said, \u201cBased on the strength of the preclinical data we have\nseen so far and interactions with the regulatory authorities, we have been able\nto further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Simultaneously, we\nare continuing our efforts to build important global partnerships and invest in\nour vaccine production technology and manufacturing capabilities. Our goal is\nto ensure we can deliver a vaccine to the world and protect people everywhere\nfrom this pandemic.\u201d<\/p>\n\n\n\n
The randomized,\ndouble-blind, placebo-controlled Phase 1\/2a study will evaluate the safety,\nreactogenicity (response to vaccination), and immunogenicity (immune response)\nof the investigational SARS-CoV-2 vaccine, Ad26.COV2-S,\nrecombinant\nin 1045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and\nolder. The study will take place in the U.S. and Belgium. <\/p>\n\n\n\n
The Company is in discussions with\nthe National Institutes of Allergy and Infectious Diseases with the objective\nto start the Phase 3 SARS-CoV-2\nvaccine, Ad26.COV2-S, recombinant,\nclinical trial ahead of its original schedule, pending outcome of Phase 1\nstudies and approval of regulators.<\/p>\n\n\n\n
As\nthe Company progresses the clinical development of its investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant, it\ncontinues to increase manufacturing capacity and is in active discussions with\nglobal partners to ensure worldwide access. The Company committed to the goal of supplying\nmore than one billion doses globally through the course of 2021, provided the\nvaccine is safe and effective. <\/p>\n\n\n\n
Johnson &\nJohnson\u2019s efforts to expedite development and production of a SARS-CoV-2 vaccine are enhanced by a collaboration between Janssen and\nthe Biomedical Advanced Research and Development Authority (BARDA), part of the\nOffice of the Assistant Secretary for Preparedness and Response (ASPR) at the\nU.S. Department of Health & Human Services.<\/p>\n\n\n\n
COVID-19 is caused by\nSARS-CoV-2, which belongs to a group of viruses called coronaviruses that\nattack the respiratory system. There is currently no approved vaccine for\nCOVID-19.<\/p>\n\n\n\n