June 30 (Reuters) - CureVac said its COVID-19
vaccine was 48% effective in the final analysis of its pivotal
mass trial, only marginally better than the 47% reported after
an 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 group
that is by far the most severely affected.
CureVac said on June 16 its COVID-19 vaccine, known as
CVnCoV, proved only 47% effective in an initial trial read-out
and 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.
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 all
age groups but took place when the original version of the
coronavirus was dominant.
Data on their products have, however, so far suggested only
somewhat weaker protection against new variants.
The CureVac study, which involved about 40,000 adult
volunteers in Europe and Latin America, showed that efficacy was
77% 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 Medicines
Agency (EMA) as part of an ongoing dialogue with the EU drugs
CureVac previously said that the regulatory hurdle was 50%
efficacy in principle but that various other considerations
would come into play.
"In this final analysis, CVnCoV demonstrates a strong public
health value in fully protecting study participants in the age
group of 18 to 60 against hospitalization and death and 77%
against moderate and severe disease an efficacy profile, which
we believe will be an important contribution to help manage the
COVID-19 pandemic and the dynamic variant spread," said Chief
Executive Officer Franz-Werner Haas.
CureVac had registered 228 infections overall for the final
analysis, after 134 cases for the interim analysis.
Public health representatives across the globe are pushing
for a fast deployment of available vaccines to counter highly
contagious mutations of COVID-19 such as the Delta variant that
first emerged in India.
The EMA has said it would not impose a 50% efficacy
threshold for vaccines and that full trial data was necessary
for it to make a sound assessment on the benefits and risks of a
Under CureVac's only major supply deal for the product
tested in the trial, the European Union secured up to 405
million doses of the vaccine in November, of which 180 million
In a bet on CureVac's technology, Britain placed a
conditional 50 million dose order in February on
yet-to-be-developed vaccines that build on the product tested in
CureVac had lined up a network of manufacturing partners
including Celonic Group of Switzerland, Novartis, Bayer
, Fareva, Wacker and Rentschler Biopharma
($1 = 0.8377 euros)
(Reporting by Ludwig Burger, Editing by Rosalba O'Brien)