Policy & Regulation
Johnson & Johnson begins global Phase 3 registration trial for COVID-19 vaccine candidate
25 September 2020 -

Johnson & Johnson (NYSE:JNJ) said on Thursday that its Janssen Pharmaceutical Companies pharmaceuticals division has launched a large-scale, international phase 3 registration trial (ENSEMBLE) for its COVID-19 vaccine candidate JNJ-78436735 (Ad26.COV2.S.)

The Phase 3 ENSEMBLE study is a randomized, placebo-controlled, double-blind study designed to evaluate the safety and effectiveness of a single dose of vaccine versus placebo. Up to 60,000 adults aged 18, including a significant number of those over 60, will be recruited in Argentina, Brazil, Chile , Colombia, Mexico, Peru , South Africa and the US. The first participant has been dosed in this study.

In addition, the company continues to expand manufacturing capacity and remains on track to meet its goal of delivering 1bn vaccine doses a year. It expects the first batches of COVID-19 vaccine for emergency use to be available in early 2021 if safety and efficacy are met.

Janssen's COVID-19 vaccine candidate uses the company's AdVac technology platform and if successful, the vaccine is estimated to be stable for two years at -20 ° C and at least three months at 2-8 ° C when it is launched.



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