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CureVac outlines COVID-19 vaccine production plans ahead of regulatory approval

Company is aiming to receive European approval in June

German biopharma company CureVac is readying for the rollout of its mRNA-based COVID-19 vaccine CVnCoV, which may receive approval in June, according to the company’s chief executive officer (CEO).

CureVac CEO Franz-Werner Haas told CNBC last week that the company is planning for approval in the EU in the second quarter, depending on the results from late-stage trials evaluating the vaccine.

Those results are expected in the next few weeks, with the phase 2/3 vaccine trials now fully enrolled, according to Haas.

That includes a pivotal phase 2b/3 study in Europe and Latin America – HERALD – which has currently enrolled over 40,000 participants. Another phase 2a in Peru and Panama has also completed recruitment with 674 participants.

CureVac is also working towards addressing variants of concerns, namely the B.1.351 variant first identified in South Africa.

In March, data from the first challenge infection study of CureVac’s vaccine in a preclinical mouse model demonstrated that CVnCoV fully protected mice from lethal infection cause by the B.1.351 variant.

Ahead of the potential regulatory approval in the EU, CureVac said that it expects to expand its production network throughout 2021 with the aim of manufacturing up to 300 million doses this year.

The company also increased its capacity guidance for 2022 from up to 600 million to up to one billion doses.

The potential approval of CVnCoV comes months after the emergency authorisations of other mRNA-based vaccines, namely Moderna and Pfizer/BioNTech’s respective jabs.

However, CureVac’s vaccine has been attracting more attention recently, as restrictions on jabs from Johnson & Johnson and AstraZeneca/Oxford University highlight the need for additional candidates to bolster mass vaccination plans.

"mRNA has emerged as a key technology that leads the charge against the COVID-19 pandemic, but it is only starting to realize its full potential in the development of new prophylactic vaccines and therapeutics in other areas such as oncology,” commented Haas.

The European Commission has already secured an initial 225 million doses of CureVac’s vaccine candidate, with a further option to purchase another 180 million doses.

To support the planned rollout of its COVID-19 jab, CureVac has signed a number of strategic agreements, including with Novartis and Bayer.

Novartis plans to manufacture the mRNA and bulk drug product of CureVac's CVnCoV for up to 50 million doses by the end of 2021, with further scale-up to 200 million doses in 2022.

Meanwhile, Bayer is contributing its expertise and established infrastructure in clinical operations, regulatory affairs, pharmacovigilance, medical information and supply chain performance to support the development, supply and key territory operations of CVnCoV.

Article by
Lucy Parsons

16th April 2021

From: Regulatory



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