독 CureVac Vaccine, Immune Efficacy 47%... WHO Emergency Approval Unlikely (Comprehensive)

Disappointment Spreads Over Interim Results of Phase 3 Clinical Trial
EU Preorders 450 Million Doses... Supply Issues Expected to Arise

[Image source=EPA Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] Disappointment is spreading as German pharmaceutical company CureVac announced that the immune efficacy of its self-developed COVID-19 vaccine was only 47%. Until now, CureVac's vaccine had attracted attention as the world's third messenger ribonucleic acid (mRNA) vaccine developed after Pfizer and Moderna, and it is known that the European Union (EU) had even placed a pre-order for 450 million doses. Concerns are rising that this may affect future vaccine procurement in countries, including South Korea, that were planning to undertake contract manufacturing of the CureVac vaccine.

According to foreign media such as The New York Times (NYT) on the 16th (local time), CureVac announced on that day that the interim results of the phase 3 clinical trial of its vaccine recorded an immune efficacy of 47%. CureVac had been conducting clinical trials with 40,000 volunteers worldwide, including Europe and Latin America, and announced the interim results after analyzing 134 cases.

Franz Werner Haas, CEO of CureVac, said at a press conference on the day, "We expected better interim data, but it was difficult to prove high efficacy due to unprecedentedly diverse variants," adding, "We are currently analyzing the final results, so the overall vaccine efficacy may change, and we still plan to apply for approval."

However, it is known that with an immune efficacy of 47%, the vaccine cannot receive emergency approval from the U.S. Food and Drug Administration (FDA) or the World Health Organization (WHO), leading to growing disappointment. Last year, both the FDA and WHO set the minimum immune efficacy for emergency use authorization of COVID-19 vaccines at 50%.

In the international medical community, the prevailing analysis is that the immune efficacy is unlikely to change significantly even in the final data. Dr. Natalie Dean, a biostatistician at the University of Florida, told the NYT in an interview, "Most of the data already seem to be included in the interim results, so it is unlikely that the figures will change dramatically."

If the immune efficacy of the CureVac vaccine does not reach 50% in the final results, concerns are emerging that it will negatively impact vaccine supply in the EU, which placed large pre-orders, as well as in countries considering contract manufacturing. According to CNBC, the EU decided to pre-order 405 million doses of the vaccine from CureVac, and Germany separately ordered an additional 20 million doses apart from the EU order. In South Korea, on the 15th, during a state visit to Austria, President Moon Jae-in requested contract manufacturing in a video meeting with CEO Haas, saying, "Please consider South Korea as a priority production base."