A man pipettes a blue liquid in a laboratory of the biopharmaceutical company Curevac.
Sebastian Gollnow | alliance image | Getty Images
Coronavirus vaccine maker CureVac has said it expects its Covid shot to receive European approval in the second quarter.
CureVac CEO Franz-Werner Haas told CNBC on Thursday that the vaccine maker was about to end recruitment for the phase 3 clinical trial of the vaccine. Approval could come soon after, he said, given the urgent need for effective coronavirus vaccines and the accelerated regulatory approval process.
“We expect, according to our calculations, that by the end of April or early May we will have the data,” Haas told CNBC’s Squawk Box Europe.
“So we expect them to be approved, according to the data, no doubt in early June.”
Once the trial is underway, German biotechnology CureVac will wait for the safety data and perform a tentative analysis of the results of the final phase study. Crucially, you will also have to wait until a number of trial participants develop Covid-19 to see the effectiveness of the vaccine in preventing the virus.
The data is sent to regulatory authorities, such as the European Medicines Agency, for what is called a “continuous review”; this is where regulators analyze data as it appears, accelerating the evaluation of new vaccines or potentially life-saving drugs during public health emergencies.
The UK and EU have pre-ordered up to 455 million doses of the CureVac mRNA vaccine, subject to regulatory approval. The company is already producing its vaccine, although it has not yet been authorized, in anticipation of the approval of the shot.
CureVac CEO Haas said the company was trying to prevent the manufacture of traps affected by other vaccine manufacturers. This problem has perhaps been most notable at AstraZeneca and has jeopardized the vulnerability of global supply chains.
“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 also support us with manufacturing there, but sometimes it is very difficult to get the equipment, build the facilities, but also the material. to produce mRNA “.
“But we are doing everything to produce as many doses as we can,” Haas added.