New York: Global healthcare company Johnson & Johnson is planning to start a Phase-3 clinical trial of its Covid-19 vaccine ahead of its original schedule, potentially in late September, said a top executive of the company.
Johnson & Johnson is in talks with the US National Institute of Health to start the late-stage trial of the vaccine ahead of schedule, Paul Stoffels, the Chief Scientific Officer of the company said during an earnings call with investors on Thursday.
J&J announced its lead Covid-19 vaccine candidate on March 30.
Preclinical data on the vaccine were published in the Journal of Science in May. The company moved ahead with a study of a final Ad26.COV2-S, recombinant, vaccine candidate in a nonhuman primate challenge model.
These results will be published in a major scientific journal in the coming weeks, Stoffels said.
The company is now planning to start with Phase 1/2a studies of the vaccine later this month, representing an acceleration of its time line from the original date of September to the end of July.
Stoffels added that these studies will establish both the safety and immunogenicity of our vaccine candidate as well as evaluate the single-dose and the booster dose regimen.
The trials will be conducted in more than 1,000 healthy adults aged 18 to 55 years as well as adults aged 65 years and older.
Stoffels informed that the study sites are located in the US and Belgium.
“We are also planning for a Phase 2 study in the Netherlands, Spain, and Germany and plan to conduct a Phase 1 study in Japan. We anticipate the initiation of the trial on July 22 in Belgium and the following week in the US,” Stoffels said.
J&J’s Covid-19 vaccine programme is leveraging Janssen Pharmaceutical Companies’ (Janssen) adenovector technology that provides the ability to rapidly develop new vaccine candidates.
The company earlier announced its commitment to supply more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.
Johnson & Johnson’s efforts to expedite development and production of a SARS-CoV-2 vaccine are enhanced by a collaboration between Janssen and the 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.
Through this partnership, J&J and BARDA committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing.