The National Institutes of Health announced today that J&J’s Janssen Pharmaceuticals COVID-19 vaccine candidate (JNJ-78436725) has begun the Phase 3 trial to evaluate if it can prevent symptomatic COVID-19 after a single dose regimen.
Up to 60,000 volunteers are slated to be enrolled in the trial, which will take place across up to nearly 215 clinical research sites in the U.S. and across the globe, according to an NIH news release. Janssen is leading the trial as a regulatory sponsor with funding from National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, and the Biomedical Advanced Research and Development Authority (BARDA).
Last month, the U.S. Dept. of Health and Human Services and Defense Dept. agreed to a $1 billion deal for the Janssen candidate, as the J&J subsidiary is set to offer large-scale manufacturing and the delivery of the vaccine, with the federal government owning 100 million doses.
“Four COVID-19 vaccine candidates are in Phase 3 clinical testing in the United States just over eight months after SARS-CoV-2 was identified,” NIAID Director Dr. Anthony Fauci said in the release. “This is an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia. It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need.
“The Janssen candidate has showed promise in early-stage testing and may be especially useful in controlling the pandemic if shown to be protective after a single dose.”
Janssen’s candidate is a recombinant vector vaccine using a human adenovirus to express the SARS-CoV-2 spike protein in cells. It uses the same vector in the first dose of its prime-boost vaccine regimen against Ebola, which recently received European commercial approval.
Preclinical findings for the vaccine candidate demonstrated that it induced neutralizing antibody responses in rhesus macaques and offered complete or near-complete protection against the virus infection in the lungs nad nose. The candidate’s safety, reactogenicity and immunogenicity are being evaluated in a Phase 1/2a trial in the U.S. and Belgium, with interim results supporting further development.
The Phase 3 trial is operating in collaboration with the U.S. government’s “Operation Warp Speed” initiative that seeks to provide a safe vaccine by the end of 2020, with Janssen joining vaccine candidate developers Moderna (NSDQ:MRNA) and AstraZeneca (NYSE:AZN) under the operation’s umbrella. Pfizer (NYSE:PFE) and BioNTech’s (NSDQ:BNTX) vaccine candidate is the fourth one to reach Phase 3 clinical trials.
“To have just one candidate vaccine in Phase 3 trials less than a year after a virus was first reported would be a remarkable accomplishment; to have four candidates at that stage is extraordinary,” HHS Secretary Alex Azar said. “By building a portfolio of candidate vaccines, Operation Warp Speed is maximizing the chances that we will have substantial supplies of a safe and effective vaccine—and maybe multiple vaccine options—by January 2021.”