Curevac is late in the race to develop a corona vaccine.
Now the Tübingen-based biotech company threatens to fall even further behind.
Tübingen - The Tübingen biotech company Curevac has dampened hopes for approval of its corona vaccine in June. A Curevac spokesman told
Merkur.de *
on Wednesday that one had to wait until the missing data from the ongoing field study was available
. The data would then be checked internally and then promptly forwarded to the European Medicines Agency (EMA) for further examination. One does not want to anticipate the decision of the EMA.
In order to accelerate approval, Curevac opted for a rolling process for the planned approval of its vaccine candidate for CVnCoV.
The company delivers data to the EMA during the trials on study participants.
The final examination by the Amsterdam authorities usually takes three to four weeks.
According to earlier information, CVnCoV is now being tested on around 40,000 subjects.
Curevac: Company moves away from previous statements
With his statements, Curevac moves away from earlier statements about the schedule.
It was only in mid-April that Curevac boss Franz Werner Haas confirmed in an interview that it is expected that “the approval from the EMA will come in June, earlier than the end of June”.
Now the company has refused to make a clear statement about the appointment.
The discussion about possible delays in the approval of the Curevac vaccine had resumed on Monday. The trigger was corresponding statements by Health Minister Jens Spahn (CDU). According to participants, during a meeting of the health ministers, Spahn said that the EMA would “not expect the Curevac vaccine to be released before August”. Spahn relied on the assessment of the EMA.
Industry experts had already expressed doubts about the schedule at the end of May.
The trigger was a complicated press release from the company.
Among other things, it said that the study would be continued “in order to collect enough data to carry out a statistically significant effectiveness analysis”.
At the time, Curevac had 59 people on its panel who were infected with Covid-19.
Obviously, a lot more sick people are needed in order to be able to make a valid comparison of how often the disease occurs in vaccinated people compared to study participants who were injected with an ineffective agent.
Curevac: Mutants make approval more difficult
The starting position is also made more difficult for Curevac by the fact that the number of incidences is falling in many countries. This reduces the willingness of many people to even take part in the testing of a new active ingredient. In addition, the effectiveness of the active ingredient could also decrease during testing because CVnCoV is tailored to the original variant of the virus, but numerous mutants have now formed.