COVID-19: Janssen' single-dose vaccine to prevent COVID-19 in individuals 18 years of age and older, authorized by U.S. FDA for emergency use
The U.S. Food and Drug Administration ( FDA ) has issued Emergency Use Authorization ( EUA ) for single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical, to prevent COVID-19 in individuals 18 years of age and older.
This decision was based on the totality of scientific evidence, including data from the phase 3 ENSEMBLE study that has demonstrated 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 Janssen COVID-19 single-dose vaccine is compatible with standard vaccine storage and distribution channels with ease of delivery to remote areas.
The vaccine is estimated to remain stable for two years at -4°F ( -20°C ), and a maximum of three months at routine refrigeration at temperatures of 36-46°F ( 2 to 8°C ).
The COVID-19 vaccine should not be re-frozen if distributed at temperatures of 36°–46°F ( 2°-8°C ).
ENSEMBLE is a randomized, double-blind, placebo-controlled clinical trial in individuals 18 years of age and older.
The study was designed to evaluate the safety and efficacy of the vaccine candidate in protecting against both moderate and severe COVID-19 disease, with assessment of efficacy as of day 14 and as of day 28 as co-primary endpoints. The study enrolled a total of 43,783 participants.
The trial, conducted in eight countries across three continents, has included a diverse and broad population including 34% of participants over age 60.
The study enrolled 44% of participants in the United States. 74% of participants in the U.S. were white / caucasian; 15% hispanic and/or latinx; 13% black / african american; 6% asian and 1% were native american.
41% of participants in the study had comorbidities associated with an increased risk for progression to severe COVID-19. ( Xagena )
Source: Janssen, 2021