Johnson & Johnson said Wednesday that a Phase I/IIa trial of its COVID-19 vaccine candidate, originally scheduled to begin in September, is now expected to start in the second half of July. Chief scientific officer Paul Stoffels explained that “based on the strength of the preclinical data we have seen so far, and interactions with regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine, Ad26.COV2-S, recombinant.”
The Phase I/IIa trial will assess safety, response to vaccination and immune response of Ad26.COV2-S, recombinant, in 1045 healthy adults from 18 to 55 years of age, as well as those aged 65 and older. Participants in the study, which will be conducted in the US and Belgium, will be randomised to receive the experimental vaccine or placebo.
The company said it is in active discussions with global partners, and says it is committed to supplying more than 1 billion doses of the vaccine worldwide in 2021, should it be found safe and effective. Partners include the US Biomedical Advanced Research and Development Authority (BARDA), with whom Johnson & Johnson has pledged to contribute more than $1 billion to co-fund vaccine R&D and clinical testing.
Johnson & Johnson is also in talks with the US National Institutes of Allergy and Infectious Diseases to start a late-stage trial of Ad26.COV2-S, recombinant, ahead of its original schedule, pending the outcome of Phase I testing and approval from regulators.
Meanwhile, Moderna has started testing its coronavirus vaccine candidate mRNA-1273 in a mid-stage trial that will enroll 600 participants, while it expects to initiate late-stage studies in July. Meanwhile, AstraZeneca, Sanofi, Pfizer and GlaxoSmithKline are all at various stages of development of their COVID-19 vaccine candidates.