Janssen Single-Shot COVID-19 Vaccine Gets Emergency Use Authorization
The EUA was based on data from the randomized, double-blind, placebo-controlled ENSEMBLE trial.
The EUA was based on data from the randomized, double-blind, placebo-controlled ENSEMBLE trial.
The combination therapy reduced the risk of hospitalization or death by 70%.
If keeping to the authorized schedule is not feasible, the second dose may be scheduled for administration up to 42 days (6 weeks) after the first dose, according to ACIP.
Additional research from the vaccine manufacturers would be needed to support any changes to the dosing schedule.
The study was conducted by Pfizer and the University of Texas Medical Branch.
The recommendation was made based on the number of confirmed COVID-19 cases among these 2 groups, as well as ethical and scientific considerations.
The investigational treatment from Regeneron consists of 2 potent, virus-neutralizing antibodies.
The analysis of the primary outcomes was based on 170 confirmed cases of COVID-19.
The placebo-controlled COVE study is investigating the efficacy and safety of mRNA-1273 at the 100mcg dose (given intramuscularly in a 2-dose series, approximately 28 days apart) in more than 30,000 adults aged 18 years and older.
An interim analysis of the phase 2 study evaluated the combination therapy in recently diagnosed patients with mild to moderate COVID-19.