- The FDA has released the briefing document for the COVID-19 vaccine candidate from Johnson & Johnson (NYSE:JNJ) ahead of its review scheduled for later this week.
- The company shares are trading ~1.5% higher in the pre-market.
- Based on preliminary late-stage trial data, the single-dose shot after 14 days of the vaccination has demonstrated 66.9% of vaccine efficacy against moderate to severe/critical COVID19 across all geographic areas, according to the document.
- The vaccine efficacy has stood at 66.1% (55.0, 74.8) after at least 28 days of the vaccination.
- For the secondary endpoints, the efficacy against severe/critical COVID-19 at least 14 days and at least 28 days post-vaccination has reached 76.7% (54.6, 89.1) and 85.4% (54.2, 96.9), respectively.
- Subject to regulatory approval, JNJ expects to deliver 20M doses of its vaccine to the U.S. by March.