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原文標題：

CureVac’s Covid-19 Vaccine Disappoints in Clinical Trial
CureVac 的 Covid-19 疫苗在臨床試驗中令人失望

原文連結：

https://www.nytimes.com/2021/06/16/health/covid-vaccine-curevac.html

發布時間：

June 16, 2021, 5:25 p.m. ET

原文內容：

The German company CureVac delivered disappointing preliminary results on
Wednesday from a clinical trial of its Covid-19 vaccine, dimming hopes that
it could help fill the world’s great need.

The trial, which included 40,000 volunteers in Latin America and Europe,
estimated that CureVac’s mRNA vaccine had an efficacy of just 47 percent,
among the lowest reported so far from any Covid-19 vaccine maker. The trial
will continue as researchers monitor volunteers for new cases of Covid-19,
with a final analysis expected in two to three weeks.

“We’re going to full speed for the final readout,” Franz-Werner Haas,
CureVac’s chief executive, said in an interview. “We are still planning for
filing for approval.”

The company plans to apply for authorization initially to the European
Medicines Agency. The European Union reached an agreement last year to
purchase 405 million doses of the vaccine if the agency authorizes it.
Independent experts, however, said it would be difficult for CureVac to
recover. Natalie Dean, a biostatistician at the University of Florida, said
that the vaccine’s efficacy rate might improve somewhat by the end of the
trial. But because most of the data is already in, it’s unlikely the vaccine
will turn out to be highly protective. “It’s not going to change
dramatically,” she said.

And with an efficacy rate that low — far lower than the roughly 95 percent
of competing mRNA vaccines made by Pfizer-BioNTech and Moderna — the results
do not bode well for CureVac’s shots getting adopted.
“This is pretty devastating for them,” said Jacob Kirkegaard, a vaccine
supply expert at the Peterson Institute for International Economics, a think
tank in Washington.

The news was disappointing to experts who had hoped the company could provide
vaccines for low- and middle-income countries that don’t have nearly enough.
CureVac had some advantages over the other mRNA vaccines, such as keeping
stable for months in a refrigerator. What’s more, compared with its
competitors, CureVac’s vaccine used fewer mRNA molecules per jab, lowering
its cost.

The trial results released on Wednesday were based on data from 135
volunteers who got sick with Covid-19. An independent panel compared the
number of sick people who had received a placebo with those who had received
the vaccine. Although the vaccine did seem to offer some protection, the
statistical difference between the two groups was not stark, working out to
an efficacy rate of 47 percent.

Annual flu shots, by comparison, can reach 40 to 60 percent effectiveness.
Both the World Health Organization and the Food and Drug Administration set a
threshold of 50 percent efficacy to consider Covid-19 vaccines for emergency
authorization. If CureVac were to stay at 47 percent in the final analysis,
it would fail to meet that standard.

The results caught scientists by surprise. The vaccine is made from
engineered mRNA, the same technology used by the Pfizer-BioNTech and Moderna
vaccines. And CureVac’s shots yielded promising results in animal
experiments and early clinical trials.

“This one’s a bit of a head-scratcher,” Dr. Dean said.
Dr. Haas blamed the disappointing results on the high number of virus
variants in the countries where the vaccine was tested. Out of 124 of the
Covid-19 cases that the company’s scientists genetically sequenced, only one
was caused by the original version of the coronavirus.


機翻如下：

德國公司CureVac週三公佈了其Covid-19疫苗的一項臨床試驗的初步結果，令人失望，使
其能夠幫助填補世界上的巨大需求的希望破滅。



"CureVac公司首席執行官Franz-Werner Haas在接受採訪時說："我們正在全速進行最後的
解讀。"我們仍在計畫申請批准"。

該公司計畫首先向歐洲藥品管理局申請授權。歐盟去年達成協議，如果該機構授權，將購
買4.05億劑量的疫苗。

然而，獨立專家表示，CureVac公司將很難恢復。佛羅里達大學的生物統計學家Natalie
Dean說，在試驗結束時，該疫苗的有效率可能會有一些提高。但由於大部分數據已經出來
了，疫苗不太可能變成高度保護性的。"她說："它不會有很大的變化。

而且療效如此之低--遠遠低於輝瑞生物技術公司和Moderna公司生產的競爭性mRNA疫苗的
大約95%--這些結果對於CureVac公司的疫苗被採用不是一個好兆頭。

"華盛頓智庫彼得森國際經濟研究所的疫苗供應專家Jacob Kirkegaard說："這對他們來說
是相當大的打擊。





相比之下，每年的流感疫苗可以達到40%到60%的效果。世界衛生組織和美國食品和藥物管
理局都設定了一個閾值，即50%的療效，以考慮對Covid-19疫苗進行緊急授權。如果
CureVac在最終分析中保持在47%的水準，它將無法達到這一標準。



迪恩博士說："這個問題有點讓人頭疼"。



心得/評論：


針對delta變種的新希望curevac初步報告大爆死.........

連50%都沒到

這是mRNA技術近期最不利的消息了

雖然我還是對mRNA的前景充滿信心

但是不能不承認這是一大衝擊

讓我們繼續看下去




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