Johnson & Johnson's COVID-19 Booster Dose Wins FDA Adcomm Backing

Loading...
Loading...
  • The FDA's Vaccines and Related Biological Products Advisory Committee voted 19-0 to authorize a second shot of Johnson & Johnson's JNJ COVID-19 vaccine to follow at least two months after the initial dose.
  • Related Link: Johnson & Johnson COVID-19 Booster Shot Generates 9X Spike-Binding Antibodies, Early Data Shows.
  • The vote came after Janssen presented data from multiple studies suggesting a second shot provides a significant boost in efficacy compared to the single-dose regimen, including one trial that demonstrated a roughly 94% efficacy rate against moderate and severe infection in the U.S. 
  • The submission also included data from a real-world study that demonstrated the effectiveness of 76% for COVID-19-related infections and 81% for COVID-19-related hospitalizations, with no evidence of reduced effectiveness over six months – including when the Delta variant.
  • J&J had administered more than 15.2 million doses of its vaccine. Because data wasn't readily available, it is uncertain how many of these recipients will be immediately eligible to receive a second dose of the vaccine.
  • Price Action: JNJ shares are down 0.01% at $161.28 during the premarket session on Monday's last check.
  • Photo by Johaehn from Pixabay
Market News and Data brought to you by Benzinga APIs
Posted In: BiotechNewsHealth CareFDAGeneralBriefsCOVID-19 CoronavirusCOVID-19 Vaccine
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...