- CureVac, the German biotech once seen as a leading mRNA vaccine developer alongside Moderna and Pfizer, on Tuesday said it will scale back manufacturing plans for its coronavirus shot in Europe.
- The company attributed the downsizing to "reduced short-term peak demand for vaccines following the first wave of the pandemic vaccination efforts" as well as "corresponding changes in the demand of its first-generation COVID-19 vaccine candidate." As a result, manufacturing contracts with Wacker and Celonic will be terminated. Other manufacturing agreements with Rentschler Biopharma and Novartis are not affected.
- CureVac is still awaiting a decision from the European Medicines Agency on approval of its first-generation vaccine. Last month, the company reportedly decided against seeking authorization in the U.S. from the Food and Drug Administration. In an email, a CureVac spokesperson clarified that "at no point" did the company intend to ask for FDA clearance.
While not acknowledged directly, the "corresponding changes in demand" could also stem from disappointing clinical trial results CureVac released for its vaccine in mid-June, which showed an efficacy lower than what the FDA and other regulators said they hoped to see for a prospective shot.
In the company's initial analysis, the vaccine was only 47% effective at preventing COVID-19. At that time, CureVac defended its results by saying the study was run in the "unprecedented context of at least 13 variants." But this explanation did not stop investors from selling off its shares, which dropped 50% in value within a day of the June announcement.
CureVac later posted final results showing a marginally higher efficacy rate of 48% against COVID-19 of any severity.
At the onset of the pandemic, the prospects for CureVac to develop a leading vaccine candidate appeared higher. The company’s former American CEO joined executives of other developers at a March 2020 meeting with former President Donald Trump. Shortly thereafter, however, CureVac found itself at the center of a controversy as rumors spread that the U.S. had sought to buy or gain control of the company. CureVac denied any offer was ever extended, but the ensuing turmoil distracted from its development efforts.
The company fell behind the development pace set by Moderna and Pfizer soon after, despite using similar mRNA technology.
It's still not entirely clear why the efficacy of CureVac's vaccine was so far below that of Moderna's and Pfizer's. The company chose a significantly lower dose than either of its competitors and, also unlike the other two companies, did not chemically modify the genetic sequence used in its vaccine.
Although CureVac is scaling back its first-generation vaccine production efforts, it’s still working with GlaxoSmithKline to develop a second-generation candidate, which could be particularly useful as variants fuel new surges in the pandemic. The company said the candidate from this partnership is expected to enter clinical testing in the fourth quarter of 2021.
CureVac is not the only vaccine maker recently forced to scale back. On Monday, the U.K. government canceled its order of 100 million doses of the French biotech Valneva’s coronavirus vaccine candidate, saying the company breached the obligations of its deal.
Note: This story has been updated to clarify the 47% efficacy CureVac first reported was from the company's initial analysis of its clinical trial results, and to include comment from a company spokesperson.