FDA Urges HCPs to Follow Authorized Dosing Schedules for COVID-19 Vaccines
Additional research from the vaccine manufacturers would be needed to support any changes to the dosing schedule.
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.
The trial will continue as planned and final analysis is expected when the number of confirmed COVID-19 cases reaches 164.
In a statement, the Company noted that the actions being taken are considered “routine” when an unexplained illness is reported in a clinical trial.
Using a blood sample, the test is able to analyze more than 300 cancer-associated genes for alterations.