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EMA ends Rolling Re­view of CVn­CoV COVID-19 Vac­cine fol­low­ing With­draw­al by Cure­Vac AG

On 12 October 2021, the European Medicines Agency (EMA) ended the rolling review of CureVac's COVID-19 vaccine candidate CVnCoV after CureVac had withdrawn its application.

COVID-19 Vaccine Ampoules CureVac (Source: Giovanni Cancemi/Shutterstock.com)

Since February 2021, the Committee for Medicinal Products for Human Use (CHMP) had been assessing data on the vaccine candidate CVnCoV in a rolling review. The company CureVac had been submitting data on this on an ongoing basis as it became available, in order to expedite the evaluation of the COVID-19 vaccine candidate.

At the time of the withdrawal of the company's application, the EMA had received non-clinical (laboratory) data, data from ongoing clinical trials, data on the quality and manufacturing process of the vaccine, and the risk management plan (RMP).
Questions regarding the quality of the vaccine and implications for the benefit-risk balance of the vaccine remained unanswered.

In its letter to the EMA, the company explained that it withdrew because it wanted to focus its efforts on another COVID-19 vaccine development programme. The withdrawal means that the review of data on the vaccine at the European level will be stopped and not completed. The company retains the right to request another rolling review or submit a marketing authorisation application in the future.

The CHMP will continue to review data on COVID-19 vaccines and treatments under accelerated conditions during the ongoing pandemic.

Background: CureVac's COVID-19 vaccine CVnCoV

The vaccine candidate CVnCoV from the Tübingen-based biotechnology company CureVac was an mRNA vaccine, similar to the COVID-19 vaccines Comirnaty from the BioNTech/Pfizer company and the Spikevax Moderna vaccine already authorised in Europe, but based on unmodified mRNA.

Updated: 14.10.2021