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CureVac said it will pursue European approval for its coronavirus vaccine candidate despite disappointing overall efficacy results, arguing that final analysis of its late-stage trial shows 77 per cent protection against severe disease and full protection against hospitalisation and death.
Earlier in June, shares in the German biopharmaceutical company fell by about 50 per cent after its interim data showed an overall efficacy of 47 per cent, far below that of rivals Moderna and BioNTech that also developed messenger ribonucleic acid (mRNA) jabs.
Final analysis by Nasdaq-listed CureVac showed overall efficacy of 48 per cent against Covid-19 of any severity, and 53 per cent against mild disease. In subjects between 18 and 60 years old, it said the higher efficacy against severe disease meant it still had a pathway for approval for its CVnCoV vaccine from the European Medicines Agency.
“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 per cent 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,” Franz-Werner Haas, chief executive, said.
CureVac has argued that performance of its mRNA vaccine, which it is producing with the help of pharmaceutical giant Bayer, was lower because it dealt with 15 different virus variants. About 86 per cent of coronavirus cases in its trial came from strains listed by the World Health Organization as “variants of concern” or “variants of interest”. But more recent studies have still shown higher efficacy among other vaccines.
Haas said the CureVac trial, which studied 40,000 subjects across Europe and Latin America, would also offer valuable data on coronavirus variants. Almost none of its subjects suffered from the original coronavirus strain, while some 11 per cent, the company said, were less-explored variants.
Earlier this month, CureVac told the Financial Times it could seek regulatory approval for certain age groups, certain severity levels, or potentially as a booster shot. It also has insisted that a second-generation vaccine to tackle virus variants, which it is developing with GlaxoSmithKline, should not be affected by its original vaccine’s disappointing results, because it is designed differently.