What is the problem with the Tübingen vaccine developer Curevac? The plan to apply for approval by the end of June has now been shelved. The reason is surprising.
Tübingen – The number of people willing to be vaccinated in Germany continues to rise, and 46.5 percent of people in Germany have already been vaccinated against the coronavirus at least once. But the coveted vaccine is still in short supply, and hopes that the vaccine from Curevac will be approved soon have been dashed.
Corona vaccine from Curevac: approval delayed – containment of the pandemic responsible
The reason for the delay is the current decline in the number of corona infections. This was announced by Sarah Fakih, company spokeswoman for the biotechnology company Curevac on Wednesday in Tübingen. “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 there haven’t been enough infections among the participants,” said Fakih. So far, 59 corona cases have occurred in the study. 160 are required.
The approval process is linked to the fact that too few test subjects in the control groups of the clinical study were currently infected with the coronavirus. “We are confident that we will achieve the required 160 infections among the almost 40,000 test subjects in the foreseeable future,” explained Fakih. However, this has nothing to do with the fact that Curevac did not have enough participants in the studies, but that too few people were infected because of the declining infection rates. There would be no need to look for new participants for the study.
“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.
Corona vaccine from Curevac: When can the vaccine be used nationwide?
Baden-Württemberg’s state health minister Manne Lucha said on Tuesday, citing Federal Health Minister Jens Spahn, that according to the current situation, approval may not be expected until August. Fakih: “We can’t comment on that.” So far, Curevac had named the end of June as the date. In the current plans to supply doctors and vaccination centers in June, no vaccine from Curevac has been factored in. At the end of May, the federal government’s internal delivery forecasts said that 1.4 million doses of Curevac would come by the end of June, 9.4 million by the end of September and 28.9 million in the last quarter.