Johnson & Johnson Reports EUA Submission to the US FDA for Supporting the Booster of its Single Shot COVID-19 Vaccine Candidate

October 6, 2021 Auto Bot EUA, FDA, Johnson & Johnson, regulatory 0

Shots:

  • The submission is based on the P-III ENSEMBLE 2 study that evaluates the booster dose COVID-19 vaccine in adults aged ≥18yrs with COVID-19
  • The results demonstrated a 94% protection against symptomatic COVID-19 in the US for booster dose @56 days after primary dose & 100% protection against severe/critical COVID-19 @14 days post-booster vaccination
  • The company also submits the data from the P-I/IIa study which showed a substantial increase in Ab levels 9-fold at 1wks. when a booster of COVID-19 vaccine was given 6mos. after the single shot & continues to increase to a 12-fold at 4wks. The single-shot vaccine showed durable immune responses & was well-tolerated

Click here to read full press release/ article | Ref: J&J | Image: Nguoi Lad Dong

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