CureVac COVID-19 vaccine hits just 48% efficacy in final analysis

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German biotech company CureVac announced its COVID-19 vaccine demonstrated 48% efficacy against COVID-19 of any severity in a final readout of late-stage trial data. The results reflect a slight increase over preliminary data suggesting 47% efficacy during the company’s readout earlier this month.

A final analysis of the international Phase 2b/3 study of the vaccine candidate, CVnCoV, indicated 83 infections occurred in the vaccine group, and 145 cases in the placebo group, translating to the 48% efficacy. Trial participants aged 18 to 60 saw an increase in efficacy at 53% against any severity of disease across 15 identified strains, 77% protection against moderate-to-severe disease and 100% protection against hospitalization and death, the company said in a release posted Wednesday.

Results in older age groups were inconclusive. Further findings suggested variants of concern (VOC) were behind the majority of COVID-19 cases in the late-stage trial, with just 3% of cases tied to the original strain.

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The low efficacy comes in contrast to Pfizer and Moderna's mRNA COVID-19 vaccines with over 90% efficacy and only somewhat diminished protection in the face of viral variants.

Nevertheless, CureVac's CEO said he believes the candidate will help mitigate the pandemic.

"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 or 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 Dr. Franz-Werner Haas, CEO of CureVac, in a statement. "In the current context of an increasingly diverse environment of COVID-19 variants, and with very little residual prevalence of the original strain, we are confident that the HERALD study offers clinically relevant data regarding the effect of emerging variants on vaccine efficacy."

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CureVac submitted findings to Europe's regulator, which earlier this month, said it would weigh COVID-19 vaccines for approval despite the efficacy potentially falling below a 50% threshold.

"With respect to the 50% threshold, we were asking in agreement with the other regulators that the studies are designed in a way that they could prove that the efficacy is at least 50% but we made clear right from the start this does not mean that we will not look into the entirety of the evidence," Marco Cavaleri, head of Biological Health Threats and Vaccines Strategy at the European Medicines Agency previously said during a press briefing. "We will consider the benefits and the risks demonstrated by the vaccine and come out with a decision on whether such a vaccine could be approved or not."