J&J Initiates Global P-III Clinical Study of its COVID-19 Vaccine

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J&J Initiates Global P-III Clinical Study of its COVID-19 Vaccine


  • The initiation of the ENSEMBLE trial follows positive interim results of P-I/IIa study demonstrating the safety and immunogenicity of JNJ-78436735 following a single vaccination. The results have been submitted to medRxiv and expected to be published imminently
  • The P-III ENSEMBLE study is designed to assess the safety & efficacy of a single vaccine dose vs PBO in up to 60-000 adults aged ≥18yrs.- including those that are over age 60. The trial will include both with/ out comorbidities associated with an increased risk for progression to severe COVID-19
  • The company will continue to ramp up its manufacturing capacity to meet its goal of providing 1B doses/year. J&J anticipates the first batches of a COVID-19 vaccine to be available for EUS in early 2021- if proven to be safe and effective

Click here ­to­ read full press release/ article | Ref: J&J | Image: StraitTimes

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