Sunday, September 24, 2023

CureVac Launches Large-Scale Covid Vaccine Trial

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German biotechnology group CureVac has launched a large-scale final trial for its Covid-19 vaccine, which will eventually involve 35,000 participants across Europe and Latin America.

The company, which uses an mRNA platform similar to vaccines developed by BioNTech / Pfizer and its US rival Moderna, said it will test its product on people aged 18 and older.

Shares of the company, which went public on the Nasdaq in New York in August, weeks after the German government paid 300 million euros to take a 23% stake, rose 7% to 126 dollars in pre-negotiation.

Unlike BioNTech’s vaccine, which must be stored at around minus 70 ° C during transport, CureVac’s jab remains stable for at least three months at standard refrigerator temperatures, the company said.

The group will join 13 other drugmakers to conduct phase 3 trials, according to the World Health Organization.

“The clinical safety and immunogenicity data obtained to date appear promising and we hope this trial will continue to demonstrate the impact of mRNA technology and our vaccine,” said Managing Director 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 via a genetic code. Until this month, it had never been used in a licensed drug.

However, the development of CureVac’s Covid-19 coup has lagged behind its German rival BioNTech, which received US clearance last week, and Moderna, which requested emergency approval last month.

The company is unlikely to seek regulatory approval until the middle of next year, according to people familiar with the matter.

CureVac, which has tested several assays in preliminary trials, will proceed at a dose of 12 micrograms, less than half that of the BioNTech vaccine, which requires 30 micrograms per dose. The smaller dose might make it easier to send larger amounts of shot.

The company, which has not partnered with a large pharmaceutical group to develop its Covid-19 vaccine, said it would have the capacity to produce up to 300 million doses in 2021, and an additional 600 million doses in 2022 – far less than BioNTech / Pfizer, which plans to produce 1.3 billion doses next year.

This year, CureVac signed an agreement with the EU to deliver up to 405 million doses of its two-course product.

However, the company, which was reportedly targeted for an acquisition by the Trump administration in the spring – a move CureVac management says never happened – has scrapped plans to deliver its vaccine to the United States, citing saturation. of the market.


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