A man pipets a blue liquid in a laboratory of the biopharmaceutical company Curevac.
Sebastian Gollnow | photo alliance | Getty Images
Coronavirus vaccine maker CureVac has said it hopes its Covid shot will receive European approval in the second quarter.
CureVac’s CEO Franz-Werner Haas told CNBC on Thursday that the vaccine manufacturer was nearing completion of recruitment for the vaccine’s Phase 3 clinical trial. Approval could not come long after, he said, given the urgent need for additional effective coronavirus vaccines and accelerated regulatory approval process.
“We expect, according to our calculations, to have the data available in late April or early May,” Haas told CNBC’s Squawk Box Europe.
“So, depending on the data, we expect to receive approval in early June.”
Once the trial is underway, German biotech CureVac awaits safety data and then conducts an interim analysis of the results from the late phase of the study. Crucially, it will also have to wait for a certain number of trial participants to develop Covid-19 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 an “ongoing review”; this is where the data is analyzed by regulatory agencies as it appears, accelerating the assessment of new, potentially life-saving vaccines or 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. Pending approval of the shot, the company is already producing its vaccine, despite it not being approved yet.
CureVac CEO Haas said the company was trying to avoid manufacturing pitfalls hit by other vaccine makers. Perhaps most notable at AstraZeneca, this issue has highlighted the vulnerability of global supply chains.
“Production 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 with the production there, but sometimes it’s very difficult to get the equipment, to get the facilities built, but also the material to produce the mRNA. “
“But we do everything we can to get as many doses as possible produced,” added Haas.