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Johnson & Johnson begins "large scale" Phase 3 trial of coronavirus vaccine

WASHINGTON, Sept 23 (KUNA) -- Johnson & Johnson announced Wednesday the launch of its "large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE)" for its coronavirus vaccine candidate.
"The initiation of the ENSEMBLE trial 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," the company said in a statement.
It added that "based on these results and following discussions with the US Food and Drug Administration (FDA), ENSEMBLE will enroll up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19." "Johnson & Johnson has continued the scaling up of its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year," it affirmed.
The Company stressed that it is "committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use and anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective." (end) si.rk