The company will become the first to test the simpler regimen of its candidate which is being developed by Janssen Pharmaceutical Companies, Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, told FOX Business.
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While this will be the fourth phase three study of a coronavirus candidate in the United States after Moderna, Pfizer and AstraZeneca, J&J is leading with the innovative dosing.
The Phase 3 Ensemble study follows "positive interim results" from the company’s Phase 1/2a clinical study, "which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development," Johnson & Johnson said.
Barouch, who is leading the coronavirus vaccine effort in partnership with the pharmaceutical giant, notes the results were "necessary" before moving onto the next trial phase.
The pre-clinical data has already indicated that the company's "SARS-CoV-2 vaccine candidate generated a strong antibody response and provided protection with a single dose," Dr. Paul Stoffels, Johnson & Johnson's chief scientific officer, said in an earlier statement.
The pharmaceutical giant will now involve up to 60,000 adults from diverse backgrounds, including significant representation from those that are over 60 years old, to test the efficacy of the single vaccine dose.
The trial will start in the United States and then "rapidly incorporate" other countries, Barouch said. Johnson & Johnson aims to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
"In order to evaluate the effectiveness of Janssen’s COVID-19 vaccine, countries and clinical trial sites which have a high incidence of COVID-19 and the ability to achieve a rapid initiation will be activated," the company disclosed Wednesday.
While the first Phase 3 clinical trial will focus on a one-shot regimen, a later trial will test a two-shot regimen.
Thus far, the candidate has also proven that it does not require a frozen cold chain which means it's proven to be stable for several months at refrigerator temperature, Barouch said.
"That'll be an advantage for distribution of the vaccine," he said. "If the vaccine ends up being safe and effective."
Barouch cautioned, however, that there is no clear timeline for when the candidate will be ready for distribution.
"What's important is that the trials are endpoint driven, which means that there's not a calendar date when the study stops," he said.
Earlier this month, Johnson & Johnson, along with Pfizer, AstraZeneca, BioNTech, GlaxoSmithKline, Merck, Moderna, Novavax and Sanofi, released the joint statement regarding their "on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles."
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The CEOs of each company promised not to apply for FDA approval, even for emergency use, until certain standards are met.
If and when deemed safe and effective, Johnson & Johnson said it aims to supply more than one billion doses globally through the course of 2021.
The vaccine will also be provided at a "global not-for-profit basis for emergency pandemic use," the pharmaceutical giant previously said.
A manuscript with full data regarding the results of the Phase 1/2a first-in-human clinical trial has been submitted to medRxiv and should be posted online "imminently" Barouch said.