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Johnson & Johnson begins final trial phase for COVID-19 vaccine

By
Don Jacobson
Dr. Anthony Fauci said Wednesday the Johnson & Johnson vaccine may ultimately be especially useful in controlling the pandemic. File Photo by Justin Lane/EPA-EFE
Dr. Anthony Fauci said Wednesday the Johnson & Johnson vaccine may ultimately be "especially useful in controlling the pandemic." File Photo by Justin Lane/EPA-EFE

Sept. 23 (UPI) -- Johnson & Johnson announced Wednesday that it has begun the third and final phase of clinical trials for its COVID-19 vaccine.

The pharma company said the late-stage trial for its JNJ-78436735 candidate will include 60,000 adult volunteers in 215 locations worldwide.

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Code-named "Ensemble," the third-phase trial follows positive results in an earlier study in which the vaccine -- which is being developed by Johnson & Johnson's Janssen Pharmaceutic Companies subsidiary -- was shown to be safe, company officials said.

The results of that trial will be published for peer review "imminently," said Johnson & Johnson Chairman and CEO Alex Gorsky.

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"This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process," Gorsky said in a statement.

"We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol."

The vaccine is among four that have been supported by the Trump administration's Operation Warp Speed program to reach Phase 3 trials, along with candidates in development at Moderna, Pfizer and AstraZeneca.

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The Ensemble trial is partly funded by the National Institute of Allergy and Infectious Diseases and will seek to enroll participants in the United States, Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.

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"Four COVID-19 vaccine candidates are in Phase 3 clinical testing in the United States just over eight months after [the novel coronavirus] was identified," NIAID Director Dr. Anthony Fauci said in a statement Wednesday.

"This is an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia."

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Multiple COVID-19 vaccines will likely be needed to meet global demand, Fauci said, adding that the Johnson & Johnson vaccine "may be especially useful in controlling the pandemic if shown to be protective after a single dose."

A number of potential coronavirus vaccines are now in various stages of development. Click here for our COVID-19 vaccine tracker.

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