UPDATE (September 23, 2020): At the end of March, as the severity of the coronavirus pandemic and COVID-19 were becoming increasingly apparent, Johnson & Johnson announced that it expected to be able to test its candidate vaccine on people by September 2020. The pharmaceutical company met that goal with July's Phase 1/2a first-in-human clinical study, and it has now announced that its Phase 3 clinical trial has launched.
The Phase 3 trial, called ENSEMBLE, is beginning after Phase 1/2a's interim results showed that its "safety profile and immunogenicity after a single vaccination were supportive of further development," according to a September 23 press release from Johnson & Johnson. "[ENSEMBLE] is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single vaccine dose versus placebo in up to 60,000 adults 18 years old and older, including significant representation from those that are over age 60. The trial will include those both with and without comorbidities associated with an increased risk for progression to severe COVID-19, and will aim to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States."
Pending the outcome of ENSEMBLE, and in line with the company's initial expectations of the vaccine timeline, Johnson & Johnson says it still anticipates the first batches of its COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective.
"With our vaccine candidate now in our global Phase 3 trial, we are one step closer to finding a solution for COVID-19," Mathai Mammen, Johnson & Johnson's global head of Janssen Research & Development, LLC, said in the new statement, "We used a highly scientific and evidence-based approach to select this vaccine candidate. We are extremely grateful for the tireless efforts of our researchers and for the vital contributions of those participants who have volunteered to take part in our studies. Together, we are working to help combat this pandemic."
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