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 Agency announced that additional clarification of clinical data was needed prior to completing the review.
The recommendation was made based on the number of confirmed COVID-19 cases among these 2 groups, as well as ethical and scientific considerations.
This is the first time the Agency has authorized a COVID-19 diagnostic test that provides rapid results at home.
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.
The EUA was based on historical evidence indicating some effectiveness with convalescent plasma use in previous outbreaks of respiratory viruses, preclinical data, results from small clinical trials, and data from the National Expanded Access Treatment Protocol sponsored by the Mayo Clinic.