CureVac withdraws vaccine from Ema approval process and focuses on second generation mRna

CureVac announces the decision to withdraw its first generation Covid vaccine candidate (CVnCoV) from the current approval process underway at the European Drug Agency Ema. Reason for the decision: the German company will focus on the development of the second generation mRNA vaccine candidates it is working on in collaboration with the British Gsk.

The decision – explains CureVac – is also aligned with the evolving dynamics of the response to the pandemic: in fact, there is a greater need for differentiated vaccines to address a situation in which the Sars-CoV-2 virus will be endemic.

As a direct consequence of this choice announced today, CureVac also informs that “the current advance purchase agreement with the European Commission, which was based on the use of the candidate CVnCoV vaccine” to address the needs of the acute phase of the pandemic, will cease. However, the company is evaluating the possibility of leveraging CVnCoV commitments for second-generation vaccine candidates.

In light of a recent EMA communication, CureVac estimates that the first potential approval of CVnCoV would come in the second quarter of 2022. The same period in which CureVac and GSK expect second-generation candidates to have already progressed to the advanced clinical stage. In fact, the companies plan to enter the clinical development phase in the coming months, with the aim of obtaining regulatory approval for the market debut of an improved anti-Covid vaccine compared to the ‘first version’ in 2022.

While CureVac therefore continues to stay in touch with the European Commission, his and GSK’s commitment is all focused on the second generation of Covid-19 vaccines. So much so that the companies explain that they have strengthened their collaboration, adding additional resources and experts to accelerate the development and production of the broad second generation program. On this front – reads a note – published preclinical results have shown “the strong potential” of a candidate, CV2CoV, compared to the first generation of CureVac. The data show “up to 10 times higher immunogenicity” in animal models. In parallel with work on second-generation mRna vaccine technology, Gsk and CureVac will accelerate efforts to advance the development of modified mRna vaccine constructs.

“The global fight against Covid continues and we remain committed to making a difference with a safe and effective vaccine – says Franz-Werner Haas, CEO of CureVac – This goal has not changed, but the requirements to effectively address the virus and the emerging variants. In the ongoing transition from acute to endemic pandemic, our decision to withdraw CVnCoV from the regulatory approval process and focus our efforts on second generation mRna vaccine candidates reflects the expected changes in public health needs, which our second generation can potentially address. We will now take advantage of CVnCoV’s knowledge and infrastructure to focus our resources on advanced second generation vaccines in close collaboration with GSK. “


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