The company made the decision after the FDA requested more vaccine data for the mRNA-1083 vaccine. Moderna plans to resubmit their Biologics License Application (BLA) for the vaccine later this year.
FDA leadership says they expect more testing for COVID-19 vaccines and that they generate antibody titers in people in order for vaccines to be considered for approval.
Regulatory action follows reports of serious adverse events during use in elderly individuals; vaccine remains authorized for younger age groups in the US and Europe with over 40,000 doses administered globally.