German biotech group CureVac has launched a final-stage, large-scale trial for its Covid-19 vaccine, which will eventually involve 35,000 participants across Europe and Latin America.
The company, which uses a similar mRNA platform to vaccines developed by BioNTech/Pfizer and US rival Moderna, said it would test its product on people aged 18 and over.
Unlike BioNTech’s vaccine, which needs to be kept at roughly minus 70C during transportation, CureVac’s jab remains stable for at least three months at standard fridge temperatures, the company said.
The group will join 13 other drugmakers in proceeding to phase 3 trials, according to the World Health Organization.
“The clinical safety and immunogenicity data achieved to date look promising and we are hopeful that this trial will continue to demonstrate the impact of mRNA technology and our vaccine,” said chief executive Franz-Werner Haas.
Founded in 2000, the Tübingen-based group is the oldest of the three leading companies developing vaccines and therapies based on messenger RNA technology, which sends instructions to the immune system through a genetic code. Until this month, it had never been used in a licensed drug.
The development of CureVac’s Covid-19 shot, however, has lagged behind German rival BioNTech, which received US authorisation last week, and Moderna, which applied for emergency approval last month.
The company is unlikely to apply for regulatory approval until the middle of next year, according to people familiar with the matter.
CureVac, which tested several dosages in early-stage trials, will proceed with a dose of 12 micrograms, less than half that of BioNTech’s vaccine, which requires 30 micrograms per dose. The smaller dose could make it easier to ship larger amounts of the shot.
The company, which has not partnered with a large pharmaceutical group to develop its Covid-19 vaccine, has said it will have the capacity to produce up to 300m doses in 2021, and a further 600m doses in 2022 — far fewer than BioNTech/Pfizer, which expects to produce 1.3bn doses next year.
This year, CureVac signed a deal with the EU to supply up to 405m doses of its two-course product.
However, the company, which was reportedly targeted for acquisition by the Trump administration in the spring — an advance that CureVac’s management claims never happened — has abandoned plans to supply its vaccine to the US, citing market saturation.