German clinical trial for COVID-19 vaccine approved

BERLIN

German biotech firm CureVac received regulatory approval on Wednesday for human trials of a potential COVID-19 vaccine.

“The authorisation is the result of a careful assessment of the risk/benefit profile of the vaccine candidate,” the Paul-Ehrlich-Institut, German regulatory authority, said in a press release.

CureVac will start testing its experimental vaccine in the coming days, at several hospitals in Germany and neighbouring Belgium, the company said.

It will be the 11th authorized clinical trial worldwide for a COVID-19 vaccine candidate.

“CureVac’s mRNA vaccine candidate utilizes nucleotides without chemical modifications in the mRNA and is designed to provide a strong and balanced activation of the immune system. The mRNA encodes the full-length spike protein of SARS-CoV-2 and is formulated with lipid nanoparticles (LNP),” the company said.

In the authorized first part of the clinical trial, 144 healthy volunteers aged between 18 and 60 will be vaccinated, to determine the optimal dose and to evaluate the safety of the vaccine in humans.

The German regulatory authority said it expected further progress in COVID-19 vaccine research in the coming months.

“The Paul-Ehrlich-Institut is certain that additional clinical trials for COVID-19 vaccine candidates will start in Germany in the next few months. Combating the pandemic will require more than one vaccine product in order to ascertain sufficient supplies,” it said.