Johnson & Johnson (NYSE:JNJ) announced today that its Janssen Pharmaceutical subsidiary has moved up first-in-human clinical trials of its COVID-19 vaccine candidate to late July, versus the previously planned start in September.
“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,” said Dr. Paul Stoffels, J&J’s chief scientific officer.
“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,” Stoffels said.
The randomized, double-blind, placebo-controlled Phase 1/2a study will take place in the U.S. and Belgium and will involve 1,045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. The study will evaluate the safety, reactogenicity (response to vaccination), and immunogenicity (immune response) of the investigational vaccine.
J&J also said it is in discussions with the National Institutes of Allergy and Infectious Diseases over starting the Phase 3 clinical trial ahead of its original schedule, pending the outcome of Phase 1 studies and regulatory approval. The overall goal is to provide more than 1 billion doses worldwide in 2021, provided the vaccine is safe and effective.
Filed Under: clinical trials, Drug Discovery, Infectious Disease