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Curevac: 100 study participants infected with corona are missing

2021-06-09T18:09:40.292Z


The vaccine developer Curevac has to put its plan to apply for approval for its corona vaccine by the end of June to act. There are no data for the crucial study because there are too few infected test subjects.


Enlarge image

Vaccination with the Curevac vaccine:

For the third decisive effectiveness study, there is not a lack of participants, but of subjects infected with the coronavirus

Photo: YVES HERMAN / REUTERS

The stock exchange promptly punished the silence on the news: Curevac shares closed around 13 percent lower after it became known on Tuesday from circles of the Federal Ministry of Health that the approval of the corona vaccine would be delayed at least until August. What a spokeswoman for the Tübingen-based company then said on Wednesday did not really convince investors; after the price plunge, the share only made marginal ground up until the afternoon.

"The reason we weren't able to deliver the clinical data from the phase 3 study to the European Medicines Agency as quickly as planned is that not enough infections have occurred among the participants," said company spokeswoman Sarah Fakih.

So far, 59 corona cases have occurred in the study.

160 are required according to Fakih.

In other words: The decline in the number of corona infections is putting the latecomer Curevac, next to Biontech the second great vaccine hope, in distress.

However, Curevac is "confident that we will achieve the required 160 infections among the almost 40,000 test subjects in the foreseeable future," the spokeswoman said.

There is no shortage of study participants.

There would be no need to look for new participants for the study.

"We hope that we can present the last data of our clinical study to the Ema by the end of June"

Curevac spokeswoman

Sarah Fakih

"We hope to have the final data from our clinical study at Ema by the end of June," said Fakih.

When the European Medicines Agency will evaluate the data and approve it is difficult to predict.

For other corona vaccine candidates, the approval process itself took between four and six weeks in the past.

State Health Minister Manne Lucha (Greens) said on Tuesday, citing Federal Health Minister Jens Spahn (CDU), that, given the current situation, approval may not be expected until August.

"We can't comment on that," said Fakih.

So far, Curevac had given the end of June as the date.

Vaccination quota in Germany is increasing - Curevac is running out of time

Because the approval date cannot be estimated, the Federal Ministry of Health has not included any delivery of Curevac in its current plans for the current year.

At the end of May, the federal government's internal delivery forecasts said that 1.4 million cans of Curevac would come by the end of June, 9.4 million by the end of September and then 28.9 million in the last quarter.

According to an overview by the RKI, 46.5 percent of people in Germany (as of Wednesday) have been vaccinated against the corona virus at least once, 22.8 percent are fully vaccinated.

The vaccination rate should continue to rise rapidly.

The further the vaccination campaign advances in this country, the more Curevac falls behind, at least in Germany, and has to rely on being able to get any booster vaccinations.

rei / DPA

Source: spiegel

All news articles on 2021-06-09

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