这些疫苗如果现在做临床试验,过不了50%有效性的关口。
很有可能,去年6月,德国的一个疫苗赶上Delta,在老龄组效果不佳,总体没有达到50%,放弃了。
ABANDONED
VACCINE NAME: CVnCoV
EFFICACY:
48%
DOSE: 2 doses, 4 weeks apart
TYPE: Muscle injection
STORAGE: Stable at least 3 months at 36–46°F (2–8°C)
The German company
CureVac generated a lot of hope for its mRNA vaccine for Covid-19 in 2020, only to see it deliver disappointing results in clinical trials the following year.
The company, founded in 2001, had years of experience developing experimental mRNA vaccines for a host of diseases. In early 2020, they began work on a Covid-19 vaccine, called CVnCoV. In March, the Trump administration unsuccessfully tried to entice
CureVac to
move its research on their mRNA vaccine from Germany to the United States.
The company
plowed ahead with its work in Germany, seeing responses to the vaccine
in mice and
monkeys before launching clinical trials in July. CVnCoV showed promise in several respects: it could remain stable in a refrigerator rather than a freezer, and preliminary studies suggested it would work well at a low dose, reducing its cost.
In December, CureVac launched
a Phase 3 trial, recruiting up to 36,500 volunteers in Germany. The European Union began a
rolling review in February, intended to speed up approval if the Phase 3 trial delivers positive results.
Meanwhile, CureVac prepared for mass production of the vaccine. The company negotiated a deal to provide the European Union with
up to 400 million doses of their vaccine. They projected manufacturing
up to 300 million doses in 2021 and up to
a billion doses the following year. Starting in January 2021, CureVac forged a series of partnerships with pharmaceutical giants
Bayer,
Celonic,
GSK, and
Novartis, to support the production of their vaccine and develop new ones against
coronavirus variants.
In June 2021, CureVac reported disappointing results from their Phase 3 trial. Overall, CVnCoV had an efficacy of just 48 percent against Covid-19. It proved somewhat better for younger volunteers: For those between the ages of 18 and 60, the efficacy rose to 53 percent. In that group, the researchers also found the vaccine provided 100 percent protection against hospitalization and death. Researchers later
pointed to the vaccine dosage along with the rise of new variants as potential reasons for the low efficacy. On Sept. 14, CureVac
announced that it had cancelled its manufacturing deals with Celonic and German company Wacker, citing a decline in demand for CVnCoV.
Despite the disappointing results, the company moved ahead with preparing an application to the European Union for emergency authorization for the use of the vaccine in people 60 and under. But European regulators gave no indication they would continue speeding along their review. As a result, on Oct. 12, CureVac
announced that it would withdraw CVnCoV from the regulatory approval process.
Instead, CureVac is focusing its efforts on a next-generation vaccine for Covid-19, called CV2CoV, that it is developing with GSK. This updated version produces more spike proteins, and thus a stronger immune response. In November, researchers at Harvard published a
study in the journal Nature showing that monkeys given CV2CoV produced antibodies to the coronavirus at a level comparable to the Comirnaty vaccine from Pfizer and BioNTech. Reuters
reported in November that CureVac was planning on starting a Phase 1 trial on CV2nCoV within the next few months.
Updated Nov. 26