- German biotech CureVac has withdrawn an approval application for its experimental coronavirus vaccine in Europe, choosing instead to focus resources on a new shot it's been developing with partner GlaxoSmithKline.
- In an announcement Tuesday, CureVac said the decision was due to a potential "overlap" in approval timelines for both shots as well as the changing dynamics of the pandemic, as multiple effective shots are already available. CureVac's shot likely wouldn't be approved until the middle of 2022, by which time the company expects to have a better vaccine in late-stage testing.
- The decision nonetheless marks an end for a project developed with the same messenger RNA technology underlying the widely used COVID-19 vaccines from Pfizer and Moderna. CureVac's shot was far less effective than the others in clinical testing, a result the company pinned on the circulation of variants during its trial.
After months sticking with its coronavirus vaccine, CureVac has finally given up.
CureVac executives had long argued the shot could still play a role in fighting COVID-19. Despite falling short of the 50% target for vaccine effectiveness established by regulators in the U.S. and Europe, the German biotech pointed to better results in certain subgroups, like adults between 18 and 60.
In July, the company vowed to file for approval in Europe, with CEO Franz-Werner Haas noting that the shot had shown strength against "the continuous variant dynamics" amid the ongoing spread of the coronavirus.
But the situation has since changed. Last month, the company scaled back manufacturing of its shot, citing waning demand after the initial wave of COVID-19 vaccinations in Europe. The regulatory review of CureVac's vaccine, meanwhile, is taking longer than expected, with a decision due in "later 2022" because of the "complexity of the data," Werner-Haas said on a conference call Tuesday.
In the meantime, boosters and vaccines tailored to specific variants are becoming more of a priority as the virus evolves and more of the global population is immunized. The international vaccine alliance COVAX, for instance, told CureVac that it expects to reach its distribution objectives by the middle of 2022 and will likely have "limited interest" in distributing the company's shot by then, Werner-Haas said.
Against this backdrop, CureVac has pulled its approval application and decided to focus its resources into a follow-up shot it's developing with GSK. The two began working with one another in 2020 to produce a range of mRNA vaccines for infectious diseases, as well as combination shots for multiple diseases. But a next-generation COVID-19 shot has moved to the forefront of the partnership.
CureVac said a newer vaccine candidate spurred a faster and stronger immune response than its first shot in animal testing, and performed better against several virus variants, including delta. The company expects to start human testing later this year, and to have a candidate in late-stage trials in 2022.
The coronavirus "has surprised us more than one time, and will probably continue to surprise us in the future," said Rina Rappuoli, head of vaccines R&D at GSK, on the call. "We need to be there with new vaccines, and with this technology I think we can do it."
CureVac blamed its disappointing clinical results in June on the spread of more challenging variants during human testing. However, key differences between its shot and others — most notably a chemical modification the company chose not to make — may have played a role. CureVac chief development officer Klaus Edvardsen said the partners are evaluating both "modified and unmodified" vaccine candidates and will choose the best one to move forward.
CureVac shares fell roughly 7% Tuesday, to $40 apiece. Shares have lost more than two thirds of their value since last year.