The Fda’s Vaccines and Associated Biological Products Advisory Committee (VRBPAC) examined Moderna’s COVID-19 vaccine as extremely reliable with a beneficial safety profile, based upon interim information from a continuous stage 3 trial
The panel acknowledged that further research studies will be required post issuance of an Emergency Usage Authorization (EUA) to collect extra information on the safety and efficiency of the vaccine. A rundown document launched by the FDA on Dec. 17, 2020, summed up interim results and included suggestions from VRBPAC on usage of Moderna’s mRNA-1273 COVID-19 vaccine.
” On November 30, 2020, ModernaTX (the Sponsor) submitted an EUA demand to FDA for an investigational COVID-19 vaccine (mRNA-1273) meant to prevent COVID-19,” the committee wrote.
The mRNA-1273 Vaccine Trial
Among 30,351 individuals aged 18 years and older, the efficacy, security, and immunogenicity of the mRNA-1273 vaccine candidate was evaluated in a randomized, stratified, observer-blind, placebo-controlled stage 3 research study. Individuals were arbitrarily assigned (1:1) to receive two injections of either 100 mcg of mRNA-1273(n=15,181) or saline placebo (n=15,170) administered intramuscularly on day 1 and day 29.
The primary efficacy endpoint was efficacy of mRNA-1273 versus PCR-confirmed COVID-1