CureVac’s COVID-19 Vaccine Falters in Late-Stage Trial

CureVac’s messenger-RNA (mRNA)-based COVID-19 vaccine, CVnCoV, was just 48 percent effective in a final analysis from a late-stage trial ― one percentage point higher than reported in an earlier phase 3 analysis and still below the FDA’s 50 percent efficacy threshold required for Emergency Use Authorization.

The vaccine may have a better chance of authorization in the EU, where the European Medicines Agency has said it will not require 50 percent efficacy for COVID-19 vaccines but will look at full trial data to assess a shot’s benefits and risks.

The EU has an advance purchase agreement with CureVac for 225 million CVnCoV doses with an option for an additional 180 million doses, contingent upon the shot securing regulatory clearance.

The German drugmaker cited SARS-CoV-2 variants ― specifically 15 strains found in the 40,000-person trial conducted in Latin America and Europe ― as the chief reason for CVnCoV’s limited efficacy in preventing symptomatic infections.