OR WAIT null SECS
EMA has halted the rolling review of CureVac's COVID-19 candidate, CVnCoV, due to the company withdrawing from the process.
The European Medicines Agency (EMA) has announced, in an Oct. 12, 2021 press release, that the rolling review of CVnCoV—CureVac’s COVID-19 vaccine candidate—has been brought to an end as a result of the company withdrawing from the process.
EMA’s review of CVnCoV had started in February 2021, which involved the agency’s Committee for Medicinal Products for Human Use reviewing submitted data on a rolling basis in an accelerated review pathway. Data from non-clinical and ongoing clinical studies had been received and were under review, in addition to data on the quality and manufacturing process of the vaccine. Furthermore, a risk management plan had been submitted to the agency by the company.
However, questions around the quality of the vaccine were being raised that could impact the benefit-risk balance of the vaccine, and results from the main studies under consideration only provided modest vaccine efficacy in adults. Therefore, CureVac withdrew from the process and stated, in a letter to EMA, that it has taken the decision to focus on another COVID-19 vaccine development program.
As a result of the withdrawal, EMA will no longer continue reviewing data on CVnCoV and will not provide conclusions on the review. The company does still have the option of requesting another rolling review or can submit a marketing authorization application in the future.
EMA specified in its press release that any participants of the clinical trials for CVnCoV who have questions about their vaccination status should contact the relevant authority in their country of residence.