Phase 3 trial begins for one-dose COVID-19 vaccine candidate
Johnson & Johnson announced the start of a phase 3 trial that will enroll up to 60,000 people to study the safety and efficacy of its single-dose COVID-19 vaccine candidate.
Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, developed the vaccine and is leading the trial.
“Four COVID-19 vaccine candidates are in phase 3 clinical testing in the United States just over 8 months after SARS-CoV-2 was identified. 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,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in an NIH press release.
“It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need,” Fauci said. “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.”
The study will include up to 60,000 volunteers at roughly 215 research sites in the U.S. and abroad. The recombinant vector vaccine candidate utilizes a human adenovirus that has been modified to no longer replicate in humans and cause disease.
CDC Director Robert R. Redfield, MD, said recently that a COVID-19 vaccine may not be available to the general public until sometime in 2021.
“Scientific partners from government, industry and academia are working hand-in-hand to develop safe, effective vaccines to put this pandemic in our rear-view mirror,” NIH Director Francis S. Collins, MD, PhD, said in the release. “While administrative steps are being streamlined to speed the process, safety and effectiveness measures are just as rigorous than ever.”