Diana Ernst, RPh

The EUA submission is based on data from the randomized, double-blind, placebo-controlled ENSEMBLE trial.

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.

Chemotherapy agents such as vincristine sulfate injection, vinblastine sulfate injection, and vinorelbine tartrate injection should only be prepared in IV infusion bags.

Additional research from the vaccine manufacturers would be needed to support any changes to the dosing schedule.

The EUA was based on data from the placebo-controlled COVE study that investigated the efficacy and safety of mRNA-1273 in more than 30,000 adults aged 18 years and older.

The EUA recommendation was based on data from the placebo-controlled COVE study that investigated the efficacy and safety of mRNA-1273 in more than 30,000 adults aged 18 years and older.

The allocation and distribution of vaccine is being managed by the Department of Defense, in partnership with agencies within the Department of Health and Human Services.

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 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.