J&J launches large-scale study of COVID-19 vaccine

Sep. 23, 2020 7:04 AM ETJohnson & Johnson (JNJ)JNJBy: Douglas W. House, SA News Editor15 Comments
  • Johnson & Johnson (NYSE:JNJ) initiates a 60K-subject Phase 3 clinical trial, ENSEMBLE, evaluating the safety and immunogenicity of its single-shot COVID-19 vaccine candidate Ad26.COV2.S (JNJ-78436735).
  • The study will enroll participants at least 18 years old, with a significant percentage of people over the age of 60, including people with and without comorbidities associated with increased risk for progression to severe COVID-19. Trial sites are located in the U.S., Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
  • The primary efficacy endpoint is the number of participants with first occurrence of confirmed moderate-to-severe/critical COVID-19 with seronegative status up to 2.1 years. Moderate disease is defined as one sign and one symptom (e.g., shortness of breath or cough) or two symptoms from the FDA's list in its guidance document.
  • The estimated completion date is March 2023.
  • According to CSO Paul Stoffels, the company might be able to determine safety and efficacy by year-end.
  • In parallel, JNJ has agreed in principle to collaborate with the UK government on a separate Phase 3 in multiple countries to investigate a two-dose vaccine candidate.
  • Shares up 2% premarket on light volume.
  • SA Authors are Bullish. 

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