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EMA ends Rolling Review Of CureVac's COVID-19 Vaccine

The European Medicines Agency has ended its rolling review of CureVac NV’s mRNA COVID-19 vaccine, CVnCoV, after the company told the agency it was withdrawing from the review. The company says it will now focus on developing second-generation mRNA vaccines in collaboration with GlaxoSmithKline plc.

The EMA’s human medicines committee, the CHMP, had been reviewing data on the vaccine since February 2021 as part of the rolling review. Under such reviews, companies submit data as it becomes available in order to speed up the evaluation process. Once enough evidence is in, a marketing authorization application can be filed.

The agency had received laboratory data, data from ongoing clinical studies, data on quality and manufacturing processes and the risk management plan at the time of the withdrawal.

The EMA said it had been speeding up the review of the data, but that some issues still needed to be addressed at the time of withdrawal. These included questions about the quality of the vaccine, which impacted the benefit-risk balance of CVnCoV, and the fact that the main study supporting the vaccine “showed only a modest vaccine efficacy in adults.”

The pivotal Phase IIb/III HERALD study showed that the vaccine demonstrated overall efficacy of 48% against COVID-19 disease of any severity.

Strategic

The company said in a statement that the decision was a strategic one that would allow it to focus its COVID-19 vaccine efforts on developing second-generation mRNA vaccines with GSK.

CureVac said it had estimated that CVnCoV would be approved by the second quarter of 2022 at the earliest, by which time the company expected second-generation vaccine candidates to be in late-stage clinical development.

It added that the decision also took into consideration the “evolving dynamics” of the pandemic response and the need for differentiated vaccines to address the developing endemic situation.

A direct result of the decision is that the existing Advance Purchase Agreement with the European Commission, based on using CVnCoV to respond to the pandemic, will cease, said CureVac. “CureVac is assessing the possibility of leveraging CVnCoV commitments for the second-generation vaccine candidates. CureVac remains in contact with the European Commission and is supportive of its public health efforts,” it added.

The collaboration between CureVac and GSK has been “tightened” with further resources and experts added “to accelerate development and manufacturing of the broad second-generation program,” said CureVac.

The companies expect a second-generation candidate to enter into clinical development in the coming months and they aim to secure regulatory approval in 2022.

CureVac said that published preclinical results show “the strong potential of the initial second-generation mRNA COVID-19 vaccine candidate, CV2CoV, compared to CureVac’s first generation mRNA, CVnCoV. The data demonstrates up to 10x higher immunogenicity in animal models.”

It added that the two companies would be accelerating efforts to take forward the development of modified mRNA vaccine constructs alongside work on the second-generation mRNA vaccine technology.

The COVID-19 collaboration between GSK and CureVac focuses on second generation mRNA vaccines that could potentially target different COVID-19 variants, address different diseases in a combination shot, and improve vaccine administration formats. The collaboration builds on an existing mRNA partnership that was begun in July 2020 for infectious disease targets. It was extended after both companies allocated additional resources.

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