Johnson & Johnson (NYSE: JNJ) (the Company) 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.
A Seasoned Vet
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, is a seasoned veteran in the high pressure world of “Big Pharma” and is actively engaged in managing the effort for the public. Upon the announcement of entry into this race, he was already thrust into walking an incredibly thin line when asked difficult questions about unbelievably difficult timelines. But this executive is a master at such high-pressure moments and continues to do so sharing the momentum. He noted recently, “Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant. Simultaneously, we are continuing our efforts to build important global partnerships and invest in our vaccine production technology and manufacturing capabilities. Our goal is to ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic.”
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 will take 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 continues 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.
Part of Operation Warp Speed: The Pressure on for a Safe & Effective Vaccine
Johnson & Johnson’s efforts to expedite development and production of a SARS-CoV-2 vaccine are 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. There is currently no approved vaccine for COVID-19. Note that President Trump’s “Operation Warp Speed” involves BARDA and all agencies and assets of the federal government. The declaration was made that a safe and effective vaccine would be ready by January 2021—an extremely challenging timeline but drug developers are stepping up to move toward unprecedented goals. Upon J&J’s entry into this intense race, TrialSite News suggested the company was “walking on a thin line” but if any executive can manage, maneuver and navigate these pressures, its Mr. Stoffels. Can it all come together so that Janssen pulls ahead of the current pack as of now? They certainly may.