EU regulator will weigh COVID-19 vaccine candidates with below 50% efficacy

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A top official with Europe’s regulatory agency on Thursday said it would weigh COVID-19 vaccines for approval despite the efficacy potentially falling below a 50% threshold.

The comments from Marco Cavaleri, head of Biological Health Threats and Vaccines Strategy at the European Medicines Agency follow news that German biotech CureVac’s  COVID-19 mRNA vaccine candidate revealed a disappointing 47% efficacy against COVID-19 disease of any severity, and failed to meet statistical success criteria in a late-stage trial. However, Dr. Franz-Werner Haas, CEO of CureVac, said "the overall vaccine efficacy may change" as the company proceeds toward a final analysis.

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"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," Cavaleri said during a press briefing Thursday. "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."

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The U.S. FDA had also established a 50% efficacy threshold for authorization of COVID-19 vaccines.

During a conference call Thursday, the CureVac CEO attributed the low efficacy to a "dramatically transformed variant environment, suggesting that we are virtually fighting a different virus and a different pandemic over the last six months."

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.