London - CureVac said its COVID-19vaccine was 48% effective in the final analysis of its pivotalmass trial, only marginally better than the 47% reported afteran initial read-out two weeks ago. The German biotech firm said that efficacy, measured by preventing symptomatic disease, was slightly better at 53% when excluding trial participants older than 60 years, an age groupthat is by far the most severely affected. CureVac said on June 16 its COVID-19 vaccine, known asCVnCoV, proved only 47% effective in an initial trial read-outand that new variants had proved a headwind, denting investor confidence in its ability to take on rival shots.
That wiped billions of euros from its market value. Wednesday's news sent U.S.-listed shares of the company10.2% lower to $66 after the bell. Late-stage trials of BioNTech/Pfizer and Moderna vaccines, which like CureVac's are based on mRNA technology, had efficacy rates of well above 90% across allage groups but took place when the original version of the coronavirus was dominant. Data on their products have, however, so far suggested only some what weaker protection against new variants. The CureVac study, which involved about 40,000 adult volunteers in Europe and Latin America, showed that efficacy was77% in the age group below 60 years of age when considering only moderate to severe symptoms and excluding mild cases. CureVac said it had sent the data to the European MedicinesAgency (EMA) as part of an ongoing dialogue with the EU drugsregulator. CureVac previously said that the regulatory hurdle was 50%efficacy in principle but that various other considerationswould come into play.
"In this final analysis, CVnCoV demonstrates a strong public health value in fully protecting study participants in the agegroup of 18 to 60 against hospitalization and death and 77% against moderate and severe disease – an efficacy profile, whichwe believe will be an important contribution to help manage theCOVID-19 pandemic and the dynamic variant spread," said Chief Executive Officer Franz-Werner Haas. CureVac had registered 228 infections overall for the finalanalysis, after 134 cases for the interim analysis. Public health representatives across the globe are pushingfor a fast deployment of available vaccines to counter highly contagious mutations of COVID-19 such as the Delta variant thatfirst emerged in India. The EMA has said it would not impose a 50% efficacy threshold for vaccines and that full trial data was necessaryfor it to make a sound assessment on the benefits and risks of ashot. Under CureVac's only major supply deal for the producttested in the trial, the European Union secured up to 405million doses of the vaccine in November, of which 180 millionare optional. In a bet on CureVac's technology, Britain placed aconditional 50 million dose order in February onyet-to-be-developed vaccines that build on the product tested inthe trial. CureVac had lined up a network of manufacturing partnersincluding Celonic Group of Switzerland, Novartis, Bayer, Fareva, Wacker and Rentschler BiopharmaSE.