J&J Accelerates COVID-19 Vaccine Candidate
Janssen Pharmaceutical announced 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.
This new recombinant vaccine candidate is now expected to commence human studies in the second half of July 2020, said Johnson & Johnson, in a June 10, 2020 press statement.
J&J has committed to the goal of supplying more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.
This randomized, double-blind, placebo-controlled Phase 1/2a study will evaluate the safety, reactogenicity, and immunogenicity of the investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant in 1,045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older.
The study will take place in both Belgium and the USA.
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, “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.”
“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.”
Additionally, J&J is in discussions with the National Institutes of Allergy and Infectious Diseases with the objective to start the Phase 3 SARS-CoV-2 vaccine clinical trial ahead of its original schedule, pending the outcome of Phase 1 studies and approval of regulators.
As the Company progresses the clinical development of its investigational SARS-CoV-2 vaccine, it continues to increase manufacturing capacity and is in active discussions with global partners to ensure worldwide access.
The COVID-19 disease is caused by SARS-CoV-2 infection, which belongs to a group of viruses called coronaviruses that attack the respiratory system.
The US Centers for Disease Control and Prevention (CDC) announced on March 3, 2020, that a significant portion of individuals infected with SARS-CoV-2 lack symptoms (“asymptomatic”) and that even those who eventually develop symptoms (“pre-symptomatic”) can transmit the coronavirus to others for several days before showing symptoms.
This means that this coronavirus can spread between people interacting in close proximity—for example, speaking, coughing, or sneezing—even if those people are not exhibiting symptoms, says the CDC.
There is currently no US Food and Drug Administration approved vaccine to prevent COVID-19.
Johnson & Johnson’s efforts to expedite the development and production of a SARS-CoV-2 vaccine are enhanced by a collaboration between Janssen and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response, at the U.S. Department of Health & Human Services.
Precision Vaccinations publishes coronavirus vaccine development news.