Johnson & Johnson Seeks FDA Emergency Use Nod For COVID-19 Booster Dose

  • Johnson & Johnson JNJ has submitted data to the FDA seeking emergency use approval of its single-dose COVID-19 vaccine in individuals 18 years of age and older.
  • The submission includes results from the Phase 3 ENSEMBLE 2 study that booster shot at two months provided 94% protection against symptomatic COVID-19 in the U.S.
  • 100% protection was observed against severe/critical COVID-19, at least 14 days post-booster vaccination.
  • Also, part of the submission is Phase 1/2a data showing when a booster is given six months after the single shot, the antibody levels increased nine-fold one week after and continued to climb to 12-fold higher four weeks.
  • Related Link: Johnson & Johnson COVID-19 Booster Shot Generates 9X Spike-Binding Antibodies, Early Data Shows.
  • The vaccine, when given as a booster or primary dose, was generally well-tolerated.
  • Price Action: JNJ stock is up 0.48% at $159.98 during the premarket session on the last check Tuesday.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
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!