Coronavirus vaccine maker CureVac said it hopes its Covid injection will receive European approval in the second quarter.
CureVac CEO Franz-Werner Haas told CNBC on Thursday that the vaccine manufacturer is close to completing recruitment for a phase 3 clinical trial of the vaccine. Approval could come shortly thereafter, he said, given the urgent need for additional effective coronavirus vaccines and the accelerated regulatory approval process.
“We expect, according to our estimates, that we will have data in late April or early May,” Haas told CNBC’s Squawk Box Europe.
“So we expect to get approval, depending on the data for sure, in early June.”
Once the trial is underway, the German biotechnology CureVac will wait for safety data and then conduct an interim analysis of the results of the study at a late stage. Crucially, they will have to wait until a number of participants develop Covid-19 to see how effective the vaccine is in preventing the virus.
The data is then provided to regulatory bodies, such as the European Medicines Agency, for a so-called “ongoing review”. this is where data is analyzed by regulators as soon as it emerges, accelerating the assessment of new, potentially life-saving vaccines or drugs during public health emergencies.
The UK and the EU have pre-ordered up to 455 million doses of Mure DNA vaccine CureVac, subject to regulatory approval. The company is already producing its vaccine, despite the fact that it has not been approved yet, awaiting the approval of the firearm.
CureVac CEO Haas said the company is trying to avoid production pitfalls hit by other vaccine manufacturers. This issue was perhaps most noticeable in AstraZeneca and abruptly alleviated the vulnerability of global supply chains.
“Production 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 supporting us in production, but sometimes it is very difficult to procure equipment, build facilities, but also material for mRNA production.”
“But we do our best to produce as many doses as possible,” Haas added.