J&J accelerates clinical trial of investigational COVID-19 vaccine

Johnson & Johnson (J&J) has announced that through its Janssen Pharmaceutical Companies (Janssen) it has accelerated the initiation of the Phase I/IIa first-in-human clinical trial of its investigational vaccine for SARS-CoV-2, the virus causing the COVID-19 pandemic. Initially scheduled to begin in September, the trial is now expected to commence in the second half of July.

Dr Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer of J&J, said: “Based on the strength of the pre-clinical 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 randomised, double-blind, placebo-controlled Phase I/IIa study will evaluate the safety, reactogenicity (response to vaccination) and immunogenicity (immune response) of 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 the US and Belgium.

J&J is in discussions with the US National Institutes of Allergy and Infectious Diseases (NIAID) with the objective to start the Phase III Ad26.COV2-S, recombinant, clinical trial ahead of its original schedule, pending the outcome of Phase I studies and approval of regulators.

The company says it is committed to the goal of supplying more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.

J&J’s efforts to expedite the development and production of a SARS-CoV-2 vaccine are supported by a collaboration between Janssen and the US Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health & Human Services (HHS).