Johnson & Johnson (NYSE: JNJ) officially enters the fight against COVID-19 as its single-shot vaccine was approved over the weekend. The U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the novel coronavirus vaccine in individuals 18 years of age and older.
Note that the terms of the EUA allow use of the vaccine while more data is gathered. The company plans to file for a Biologics License Application with the FDA later in 2021.
This decision was based on the totality of scientific evidence, including data from the Phase 3 Ensemble study that demonstrated the vaccine was 85% effective in preventing severe disease across all regions studied, and it showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.
Separately, the company announced that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices has recommended Johnson & Johnson’s vaccine.
Management noted that this recommendation follows the FDA’s decision to grant an EUA for its single-shot vaccine, which has the potential to play a pivotal role in helping to end the COVID-19 pandemic.
Accordingly, Johnson & Johnson has begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the United States. The company plans to deliver 100 million single-shot vaccines to the country during the first half of 2021.
Johnson & Johnson stock traded up over 1% to $160.98 Monday morning, in a 52-week range of $109.16 to $173.65. The consensus price target is $185.44.