Covid vaccine maker CureVac hopes to get EU approval in June

A man pipettes a blue liquid in a laboratory of the bio-pharmaceutical company Curevac.

Sebastian Gollnow | picture alliance | Getty Images

Coronavirus vaccine maker CureVac said it hopes the Covid shot will get European approval in the second quarter.

CureVac CEO Franz-Werner Haas told CNBC on Thursday that the vaccine manufacturer was close to finalizing the recruitment for the Phase 3 clinical trial of the vaccine. Approval may not come long after that, he said, given the urgent need for additional effective coronavirus vaccines and the rapid approval process.

“According to our calculations, we expect to have the data by the end of April or beginning of May,” Haas told CNBC’s Squawk Box Europe.

“We therefore expect to receive approval at the beginning of June, depending on the data.”

Once the trial is underway, German biotechnology CureVac will wait for safety data and then conduct an interim analysis of the results from the late-stage study. It is important that it also wait until a certain number of participants in the trial develop Covid-19 to see how effective the vaccine is in preventing the virus.

The data is then submitted to regulatory authorities, such as the European Medicines Agency, for what is being called an ‘ongoing 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 UK and EU have pre-ordered up to 455 million doses of CureVac’s mRNA vaccine, subject to regulatory approval. The company is already manufacturing its vaccine, despite the fact that it has not yet been approved, pending approval of the shot.

Haas, CEO of CureVac, said the company was trying to avoid potholes hit by other vaccine manufacturers. This issue was perhaps the most important at AstraZeneca and sharply alleviated the vulnerability of global supply chains.

“Manufacturing is definitely a struggle right now,” he said.

“We not only produce ourselves, but we have a whole network in Europe, with other companies supporting us there as well, but it is sometimes very difficult to get the equipment, to get the facilities built up, but also the materials to produce the mRNA. “

“But we do everything we can to produce as many doses as possible,” Haas added.

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