Coronavirus vaccine maker CureVac is hoping its Covid shot will get European approval in the second quarter.
Franz-Werner Haas, CEO of CureVac, told CNBC on Thursday that the vaccine maker was close to finalizing recruitment for the vaccine’s Phase 3 clinical trial. In view of the urgent need for additional effective coronavirus vaccines and the accelerated regulatory approval process, approval cannot take place long afterwards.
“According to our calculations, we expect to have the data by late April or early May,” Haas told CNBC’s Squawk Box Europe.
“We therefore assume that, depending on the dates, we will receive the approval in early June.”
As soon as the study is running, the German biotechnology company CureVac will wait for safety data and then carry out an interim analysis of the results of the late study. It is also crucial that a certain number of study participants have to wait for Covid-19 to develop to determine how effective the vaccine is in preventing the virus.
The data is then sent to regulatory authorities such as the European Medicines Agency for so-called “ongoing review”. This is where the data is analyzed by regulators to expedite the evaluation of new, potentially life-saving vaccines or drugs in public health emergencies.
The UK and EU have pre-ordered up to 455 million doses of CureVac’s mRNA vaccine, pending regulatory approval. The company is already making its vaccine, even though it hasn’t been approved, pending approval of the shot.
Haas, CEO of CureVac, said the company is trying to avoid manufacturing pitfalls that have been hit by other vaccine manufacturers. This issue was perhaps most noticeable at AstraZeneca, and has significantly relieved the vulnerability of global supply chains.
“Manufacturing is certainly a struggle right now,” he said.
“It’s not just that we manufacture ourselves, we have a whole network in Europe, with other companies that also support us in manufacturing, but it is sometimes very difficult to get the equipment to set up the plants, however also the material for the production of the mRNA. “
“But we are doing everything we can to produce as many cans as possible,” added Haas.