CureVac mRNA Covid Vaccine Looks Just in Time After J&J Snag
(Bloomberg) -- CureVac NV is some five months behind the front-runner messenger RNA vaccines against Covid-19. But after the industry’s recent setbacks, that’s starting to look like good timing.
The German company will unveil clinical trial results within weeks and has said it should be able to secure approval in the European Union by the end of the second quarter -- and possibly as early as next month.
CureVac, which has been working with mRNA technology for two decades, stands to benefit from the doubts cast in recent weeks on the vaccine approach used by AstraZeneca Plc and Johnson & Johnson as well as the positive safety record of the two mRNA shots that preceded it.
“Messenger RNA has emerged as a key technology that leads the charge against the Covid-19 pandemic,” Chief Executive Officer Franz-Werner Haas said in a statement.
The company on Thursday reported an operating loss of 109.8 million euros ($131 million) for last year as it spent more on research and development. Thanks to government funding as well as its initial public offering in August, it had 1.3 billion euros in cash on hand at the end of the year.
CureVac has promised as many as 300 million doses this year and 1 billion doses in 2022, and in contrast to the other mRNA makers, it’s focusing on Europe -- a potential boon for governments that had been relying on the J&J and Astra shots to revive their vaccination campaigns. The company is also testing widely in South America, where nations are using Chinese vaccines that are facing scrutiny over potentially lower efficacy.
CureVac’s two-dose vaccine relies on a technology similar to that used by the Pfizer Inc.-BioNTech SE alliance and Moderna Inc.
Though unproven before last year, the fast, adaptable mRNA approach -- which essentially transforms the body’s own cells into vaccine factories -- has proven highly effective against Covid and so far avoided the potential safety concerns that have emerged around another type of vaccines.
Johnson & Johnson’s shot was put on hold in the U.S. earlier this week and delayed in the European Union as regulators assess a potential link with a rare type of blood clot; a connection with the same type of clot has already led much of Europe to restrict use of Astra’s vaccine to older people.
The issues surrounding the Astra and J&J shots potentially expand the market for mRNA vaccines, including CureVac’s, said Zhiqiang Shu, an analyst with Berenberg Capital Markets. Shu projects 1.5 billion euros in Covid revenue for CureVac this year, with “potentially massive upside to this if production can be expanded.”
CureVac’s stock has gained 22% this week in U.S. trading.
The company said Thursday it plans to pursue vaccines against emerging variants and push forward more mRNA vaccines for other infectious diseases, as well as for cancer and other treatments. It will also test its lead vaccine with a flu shot to see if the two are compatible. The impact of new Covid variants will probably be visible in late-stage trial data, Ulrike Gnad-Vogt, interim chief development officer, said in a briefing.
Unlike its local rival BioNTech, CureVac didn’t rush to seal an early partnership deal with a global pharma player. Instead, the Tuebingen, Germany-based company took more time in early stages of testing, running animal trials and working to ensure its shot would be stable at higher temperatures.
This paid off in a vaccine that can be stored at refrigerator temperatures for three months -- versus freezer requirements for the other two mRNA shots -- but CureVac also found itself falling behind its rivals’ rapid-pace clinical trial schedule. While both Pfizer-BioNTech and Moderna delivered late-stage trial results in November, CureVac didn’t vaccinate its first volunteer in late-stage trials until December.
Since then, CureVac has assembled a web of production partners for its shot, including German pharma and chemicals giant Bayer AG, which will also help with regulatory clearances and global distribution. Novartis AG is also on board.
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