The German pharmaceutical company CureVac has announced that it is abandoning the development of its vaccine against Covid CVnCoV. This candidate based on mRNA technology had been under the scrutiny of the European Medicines Agency (EMA) for eight months and finally she will not get punctured.
CVnCoV was one of the first projects to advance and the company had had the support of Bill Gates since 2015 (for the development of mRNA-based therapies) and also from the German government. However, in June the effectiveness data gave the drug a blow: 47% in the interim analyzes, insufficient according to the estimated criteria for success. At the time, CureVac CEO Franz-Werner Haas said the company was expecting stronger results in the interim analysis and that the trial, which was still ongoing, would continue. “The final effectiveness could still change,” he encouraged as collected Europa Press.
Three Spanish hospitals participated in these trials, the Clínico San Carlos in Madrid and the Basque centers of Biocruces and Biodonostia. This newspaper has contacted Biocruces, where they have not wanted to make assessments about it, although they have recalled that the decision to suspend the trials was made by the pharmaceutical company.
The immunologist and researcher at the CSIC Matilde Cañelles emphasizes that this vaccine “has remained within the limit required by the EMA but it is not that it does not work. Now we will probably have to decide what to do with the volunteers, perhaps they will be given a third dose, but they are vaccinated.
Cañelles values what happened with this vaccine as “a consequence of the evolution of the pandemic, the fact that it is withdrawn does not mean that more vaccines will not be developed, but it does mean that the objective is to have improved versions such as second generation”. The new vaccines, explains the immunologist, will be asked for results in “prevention of transmission or greater effectiveness against variants, for example.”
Thus, in the statement on Tuesday in which the European Medicines Agency reported the withdrawal of the vaccine, it explained that the German company is going to focus on a second-generation vaccine that has been in development for months with the GSK laboratory. This vaccine, called CV2CoV, offered positive results in animals in the month of May, as published in a preprint, against the Alpha and Beta variants. In its statement, the company claimed that, based on what was discussed with the EMA, the potential approval of the vaccine would occur in the second quarter of 2022 and by then its second-generation candidate would already be in advanced clinical trial phases and that the need now is “for differentiated vaccines.”
The company acknowledged that after this withdrawal, the advance purchase agreement with the EU (since the end of 2020) ceases and that it is looking at the possibility, in contact with the European Commission, of “taking advantage of CVnCoV commitments for candidates for vaccines from second generation”.
Although the start date for clinical trials of this second-generation vaccine was set as the third quarter of 2021 in May, CureVac and GSK spoke yesterday of “entering into clinical development in the coming months, with the aim of achieving regulatory approval for the commercial preparation of an improved COVID-19 vaccine in 2022, “according to the statement.
Both companies claim that the immunogenicity of CV2CoV in animals is “up to 10 times higher” than the previous CureVac. In the alliance of both companies they have highlighted that their second-generation vaccine focuses on the potential to “target different variants of COVID-19, the ability to address different diseases in a combined injection and improved vaccine delivery formats.”