A man pipettes a blue liquid in a laboratory of the biopharmaceutical company Curevac.
Sebastian Gollnow | image alliance | Getty Images
Coronavirus vaccine maker CureVac has said it hopes its Covid injection will receive European approval in the second quarter.
CureVac CEO Franz-Werner Haas told TBEN on Thursday that the vaccine maker was close to finalizing recruitment for the Phase 3 clinical trial of the vaccine. Approval could come soon after, he said, given the urgent need for additional effective coronavirus vaccines and the expedited regulatory approval process.
“We expect, by our calculations, that by the end of April or early May, we will have the data,” Haas told TBEN’s Squawk Box Europe.
“So we expect to receive approval, certainly based on the data, at the beginning of June.”
Once the trial is underway, German biotech CureVac will wait for safety data and then perform an interim analysis of the late stage study results. Basically, he will also have to wait for a number of trial participants to develop Covid-19 in order to see how effective the vaccine is at preventing the virus.
The data is then submitted to regulatory authorities, such as the European Medicines Agency, for what is called a “continuous review”; This is where data is analyzed by regulators as they emerge, speeding up the assessment 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 CureVac’s mRNA vaccine, subject to regulatory approval. The company is already producing its vaccine, although it has not yet been licensed, in anticipation of vaccine approval.
CureVac CEO Haas said the company is trying to avoid manufacturing pitfalls faced by other vaccine makers. This problem was perhaps most noticeable at AstraZeneca and highlighted the vulnerability of global supply chains.
“Manufacturing is definitely a struggle right now,” he said.
“It’s not only that we produce ourselves, but we have a whole network in Europe, with other companies that also support us in manufacturing, but sometimes it is very difficult to get the equipment, to build the facilities, but also the equipment to produce the mRNA. “
“But we’re doing everything to produce as many doses as possible,” added Haas.