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 Thursday that the vaccine maker was close to finalizing the recruitment for the vaccine’s Phase 3 clinical trial. Approval could come not long after, he said, given the urgent need for additional effective coronavirus vaccines and the expedited regulatory approval process.
“We are expecting, according to our calculations, that towards the end of April or beginning of May that we will have the data,” Haas told CNBC’s Squawk Box Europe.
“So we expect to be given approval, depending on the data certainly, in the beginning of June.”
Once the trial is underway, the German biotech CureVac will wait for safety data and then conduct an interim analysis of results from the late-stage study. Crucially, it will also have to wait until a certain number of trial participants 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’s called a “rolling review;” this is where the data is analyzed by regulators as it emerges, speeding up the assessment of new, potentially life-saving vaccines or medicines during public health emergencies.
The U.K. 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, despite the fact it has not yet been authorized, in anticipation of the shot’s approval.
CureVac CEO Haas said the company was trying to avoid manufacturing pitfalls hit by other vaccine makers. This issue has perhaps been most notable at AstraZeneca and has put the vulnerability of global supply chains into sharp relief.
“Manufacturing is certainly a struggle at the moment,” he said.
“It’s not only that we are producing by ourselves, but we have an entire network in Europe, with other companies supporting us with manufacturing there as well, but it’s very hard sometimes to get the equipment, to get the facilities built-up but also the material to produce the mRNA.”
“But we’re doing everything to get as many doses produced as we can,” Haas added.