Johnson and Johnson has announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its COVID-19 vaccine. The vaccine prevents COVID-19 in individuals 18 years of age and older, requires only one dose, and does not need to be stored ultracold. The vaccine was 85 % effective in preventing severe disease across all regions studied and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.
The terms of the EUA allow the use of the vaccine while more data are gathered. Johnson and Johnson has begun shipping its COVID-19 vaccine and expects to deliver 100 million single-shot vaccines to the U.S. during the first half of 2021. The U.S. government will manage the allocation and distribution of the vaccine in the country.
The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older. A total of 43,783 participants were enrolled in the study. The vaccine was tested in South Africa against the South African variant and in Brazil against the Brazilian variant.
The vaccine is estimated to remain stable for two years at –20 °C, and a maximum of three months at routine refrigeration at temperatures of 2 to 8 °C. The COVID-19 vaccine is based on the AdVac® vaccine platform, a proprietary technology based on adenovirus vectors that was also used to develop and manufacture Janssen’s European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines.
- Johnson & Johnson, New Brunswick, NJ, USA
- FDA EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and full EUA Prescribing Information
Also of Interest
- Collection: SARS-CoV-2 Virus
What we know about the new coronavirus and COVID-19