독일 CureVac efficacy low... EMA "50% threshold not applied"

"Premature... Special Caution Needed for Variant Viruses"

[Image source=EPA Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] The German pharmaceutical company CureVac's COVID-19 vaccine showed poor results in Phase 3 clinical trials, and the European Medicines Agency (EMA) has stated that it will not apply the '50% efficacy standard.'

Marco Cavaleri, EMA's head of vaccine strategy, told reporters on the 17th (local time), according to major foreign media, "We need to collect all the final data from this clinical trial and analyze the results according to various regions, age groups, and variants."

Following Pfizer and Moderna, CureVac's vaccine, which had attracted attention as the world's third mRNA (messenger RNA) COVID-19 vaccine, announced yesterday that its efficacy was 47%. The lower-than-expected efficacy of the CureVac vaccine is attributed to variant viruses.

EMA stated, "At this point, it is premature to determine what this (Phase 3) result means," adding, "We will pay special attention to variant viruses that have higher transmissibility than the original virus."

EMA requested pharmaceutical companies to design clinical trials to achieve at least 50% efficacy. Cavaleri explained, "However, this does not mean that we will not examine the entire body of evidence."

The World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA) require a minimum of 50% efficacy for COVID-19 vaccine candidates. Major foreign media reported, "Unlike the FDA, EMA announced last November, before the first vaccine data was released, that it would not set a minimum efficacy standard."

This content was produced with the assistance of AI translation services.