A man pipettes a blue liquid in a laboratory of the biopharmaceutical company Curevac.
Sebastian Gollnow | image alliance | Getty Images
The manufacturer of coronavirus vaccines, CureVac, has said it hopes its Covid shot will receive European approval in the second quarter.
CureVac CEO Franz-Werner Haas told CNBC on Thursday that the vaccine manufacturer is nearing completion of recruitment for the phase 3 clinical trial of the vaccine. Approval could come soon, he said, given the urgent need for additional effective coronavirus vaccines and the accelerated regulatory approval process.
“According to our calculations, we expect to have the data by the end of April or the beginning of May,” Haas told CNBC’s Squawk Box Europe.
“So we expect to receive approval, according to the data for sure, in early June.”
Once the process is ongoing, German biotechnology CureVac will wait for safety data and then perform an intermediate analysis of the results of the late study. Crucially, you will have to wait until a certain number of participants in the process develop Covid-19 to see how effective the vaccine is in preventing the virus.
The data is then forwarded to regulators, such as the European Medicines Agency, for what is called “continuous review”; Here the data are analyzed by regulators as they appear, accelerating the evaluation of new vaccines or medicines that can save lives in the event of a public health emergency.
The UK and the EU have pre-ordered up to 455 million doses of CureVac mRNA vaccine, subject to regulatory approval. The company is already producing its vaccine, despite the fact that it has not yet been authorized, pending approval of the shooting.
CureVac CEO Haas said the company is trying to avoid the pitfalls of other vaccine manufacturers. This problem was probably the most notable in AstraZeneca and put the vulnerability of global supply chains in a strong relief.
“Manufacturing is definitely a struggle right now,” he said.
“Not only do we produce ourselves, but we have a whole network in Europe, with other companies that support us and production there, but it is very difficult sometimes to get the equipment, to build the facilities, but also the material that produces mRNA. “
But we do everything to get as many doses as possible, we can add Haas.