NEW YORK: Global healthcare company Johnson & Johnson plans to start a phase 3 clinical trial of its Covid-19 vaccine ahead of its original schedule, possibly in late September, a senior company executive said.
Johnson & Johnson is in talks with the US National Institute of Health to begin the vaccine trial in the final stage ahead of schedule, said Paul Stoffels, the company’s chief scientific officer, during a profit call with investors on Thursday.
J&J announced its top candidate for the Covid-19 vaccine on March 30. Preclinical data on the vaccine was published in the Journal of Science in May. The company went ahead with a study of a final Ad26.COV2-S recombinant vaccine candidate in a challenge model of non-human primates.
These results will be published in a major scientific journal in the coming weeks, Stoffels said.
The company now plans to begin Phase 1 / 2a studies of the vaccine later this month, representing an acceleration of its schedule from the original September date to the end of July.
Stoffels added that these studies will establish both the safety and immunogenicity of our vaccine candidate, as well as assess the single dose and the booster dose regimen.
The trials will be conducted on more than 1,000 healthy adults ages 18 to 55, as well as adults 65 and older.
Stoffels reported that the study sites are in the US and Belgium.
“We are also planning a Phase 2 study in the Netherlands, Spain and Germany and plan to conduct a Phase 1 study in Japan. We anticipate the start of the trial on July 22 in Belgium and the following week in the United States,” he said. Stoffels. said.
J & J’s Covid-19 vaccine program is leveraging Janssen Pharmaceutical Companies (Janssen) adenovector technology that provides the ability to rapidly develop new vaccine candidates.
The company previously announced its commitment to supply more than a billion doses worldwide throughout 2021, provided the vaccine is safe and effective.
Johnson & Johnson’s efforts to accelerate the development and production of a SARS-CoV-2 vaccine are reinforced by a collaboration between Janssen and the Advanced Biomedical Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR)) at the U.S. Department of Health and Human Services.
Through this partnership, J&J and BARDA committed more than $ 1 billion in investment to co-finance vaccine research, development and clinical trials.
Johnson & Johnson is in talks with the US National Institute of Health to begin the vaccine trial in the final stage ahead of schedule, said Paul Stoffels, the company’s chief scientific officer, during a profit call with investors on Thursday.
J&J announced its top candidate for the Covid-19 vaccine on March 30. Preclinical data on the vaccine was published in the Journal of Science in May. The company went ahead with a study of a final Ad26.COV2-S recombinant vaccine candidate in a challenge model of non-human primates.
These results will be published in a major scientific journal in the coming weeks, Stoffels said.
The company now plans to begin Phase 1 / 2a studies of the vaccine later this month, representing an acceleration of its schedule from the original September date to the end of July.
Stoffels added that these studies will establish both the safety and immunogenicity of our vaccine candidate, as well as assess the single dose and the booster dose regimen.
The trials will be conducted on more than 1,000 healthy adults ages 18 to 55, as well as adults 65 and older.
Stoffels reported that the study sites are in the US and Belgium.
“We are also planning a Phase 2 study in the Netherlands, Spain and Germany and plan to conduct a Phase 1 study in Japan. We anticipate the start of the trial on July 22 in Belgium and the following week in the United States,” he said. Stoffels. said.
J & J’s Covid-19 vaccine program is leveraging Janssen Pharmaceutical Companies (Janssen) adenovector technology that provides the ability to rapidly develop new vaccine candidates.
The company previously announced its commitment to supply more than a billion doses worldwide throughout 2021, provided the vaccine is safe and effective.
Johnson & Johnson’s efforts to accelerate the development and production of a SARS-CoV-2 vaccine are reinforced by a collaboration between Janssen and the Advanced Biomedical Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR)) at the U.S. Department of Health and Human Services.
Through this partnership, J&J and BARDA committed more than $ 1 billion in investment to co-finance vaccine research, development and clinical trials.
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