The European Medicines Agency (EMA) has reported that ongoing vaccine review has been completed
CVnCoV against Covid-19 after the decision of the German company CureVac from withdraw from the process because it has decided to focus its efforts on a different Covid-19 vaccine development program.
Since February 2021, the EMA’s Committee for Human Medicines (CHMP) has been reviewing the CVnCoV data as part of an ongoing review, whereby the company submits the data as it becomes available to speed up the evaluation of a possible application for marketing authorization, reports EP.
At the time of the company’s withdrawal, EMA had received non-clinical (laboratory) data, data from ongoing clinical studies, data on the quality and manufacturing process of the vaccine, and the risk management plan (RMP). . Although the EMA was speeding up the review of the data, some questions about the quality of the vaccine, the impact on the benefit-risk balance of the vaccine, and the fact that the results of the main study showed only a modest efficacy of the vaccine in adults they still kept the review.
This withdrawal means that the EMA is no longer reviewing the vaccine data and will not complete this review. While the company reserves the right to request another continuous review or submit a marketing authorization request in the future.
The EMA asks people who have participated in clinical trials with CVnCoV and have questions about their vaccination status, Covid certificate EU digital data or travel restrictions associated with vaccination, contact the relevant authorities in your country of residence.
Like other vaccines, CVnCoV was developed to prepare the body to defend itself against infection by SARS-CoV-2, the virus that causes Covid-19. The SARS-CoV-2 virus uses proteins on its outer surface, called spike proteins, to enter the cells of the body and cause Covid-19. CVnCoV contains a molecule called messenger RNA (MRNA) that has instructions for producing the spike protein. The mRNA is contained in small fat (lipid) particles that prevent it from breaking down too quickly.