German CureVac Vaccine Shows Only 47% Immune Efficacy... "WHO Approval Also Difficult" (Update)

"Phase 3 Clinical Final Report Likely Shows Similar Efficacy"
Disappointment Expected in Europe with Over 400 Million Doses Pre-Ordered

[Image source=EPA Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] Global disappointment is growing after Germany's CureVac announced that its COVID-19 vaccine showed 47% immune efficacy in the interim results of its Phase 3 clinical trial. CureVac's vaccine had raised expectations as the world's third messenger RNA (mRNA) COVID-19 vaccine following Pfizer and Moderna, and it was reported that the European Union (EU) had pre-ordered more than 400 million doses. Concerns are emerging that this will affect vaccination and procurement issues in countries, including South Korea, that were planning contract manufacturing.

According to foreign media such as The New York Times (NYT) on the 16th (local time), CureVac announced that the immune efficacy of its COVID-19 vaccine was only 47% in the interim results of its Phase 3 clinical trial. Franz Werner Haas, CureVac's CEO, said at a press conference that day, "We are working hard to accurately interpret the final results of Phase 3," and "We still plan to apply for approval."

However, it is known that the international medical community believes it will be difficult for CureVac's immune efficacy to increase significantly even in the final Phase 3 results. Dr. Natalie Dean, a biostatistician at the University of Florida, told the NYT in an interview, "Vaccine efficacy usually improves when the final results come out compared to the interim results," but "most of the data is already included in the interim results, so it is unlikely to change dramatically."

If CureVac's vaccine does not exceed 50% immune efficacy in the final Phase 3 results, it will not be able to receive emergency approval from the U.S. Food and Drug Administration (FDA) or the World Health Organization (WHO). Both the FDA and WHO have set the minimum immune efficacy for emergency approval at 50%.

The news of CureVac vaccine's low immune efficacy led to investor disappointment, and CureVac's stock, listed on Nasdaq, was halved that day. CureVac's stock, which started at $98.76, plummeted 52.8% to $46.5 in the over-the-counter market after the immune efficacy announcement.