FDA to hold emergency meeting on COVID vaccine side effects in adolescents
New York Medical College professor Dr. Bob Lahita discusses new concerns about COVID vaccine side effects in children and adolescents
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."
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.