1180: Moderna Filing for FDA Emergency Vaccine Approval, Reports 94.1% Efficacy
The Moderna COVID-19 vaccine was found to be 94.1% effective in the final analysis of its 30,000-participant phase 3 study. The company has filed for an emergency use authorization (EUA) from the Food and Drug Administration (FDA).
Eleven individuals in the mRNA-1273 vaccinated group later tested positive for COVID-19, compared with 185 participants given two placebo injections, yielding a point estimate of 94.1% efficacy. This finding is in line with the 94.5% efficacy in interim trial results that were announced on November 16.
The vaccine prevented serious cases of infection. All 30 severe infections were noted among those randomly assigned to placebo. The FDA will review the vaccine safety and efficacy data at the next Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on December 17. If and when approved, healthcare providers will be able to use the new 91301 CPT code specific to mRNA-1273 vaccination.
Vaccine efficacy was consistent across different groups analyzed according to age, race/ethnicity, and gender. The 196 COVID-19 cases in the trial included 33 adults above 65 years of age and 42 individuals from diverse communities, including 29 Hispanic or Latinx, six Black or African Americans, four Asian Americans, and three multiracial participants.
The vaccine appeared to be generally well tolerated with no serious safety concerns identified thus far, the company reported.
The most common solicited adverse events in a previous analysis included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. These solicited adverse reactions appeared to increase in frequency and severity after the second dose. A continuous review of safety data is under process.
One COVID-19-related death in the study was reported in the placebo group.
Dr KK Aggarwal
President CMAAO, HCFI and Past National President IMA