Filenews 13 October 2021
The EMA ended the rolling review of CVnCoV, CureVac AG's COVID-19 vaccine, after the company informed the Agency of its withdrawal from the process.
As of February 2021, the EMA's Committee for Medicinal Products for Human Use (CHMP) is evaluating data on CVnCoV as part of a rolling review, according to which the company submits data as it becomes available in order to accelerate the evaluation of a potential marketing authorisation application.
At the time of the company's withdrawal, the EMA had received non-clinical (laboratory) data, data from current clinical studies, data on the quality and production process of the vaccine and the risk management plan (RMP).
Although the EMA accelerated the evaluation of the data, some questions about the quality of the vaccine, which affect the benefit-risk balance of the vaccine, and the fact that the results of the main study showed only a moderate efficacy of the vaccine in adults, had not yet been satisfactorily answered.
In its letter to the EMA, the company said it withdrew because it decided to focus its efforts on a different COVID-19 vaccine development program. The withdrawal means that the EMA is no longer looking at data on the vaccine and will not complete this review. The company reserves the right to apply for another rolling review or to apply for a marketing authorisation in the future.
Individuals who have taken part in clinical trials with CVnCoV and have questions about the status of their vaccination, the EU's covid digital certificate or the travel restrictions related to vaccination, should contact the competent authorities of their country of residence.
The EMA will continue by speeding up the review of data on vaccines and treatments for COVID-19 during the current pandemic. The EMA works closely with developers, advising early on the development process and evaluating data on the basis of a rolling review when appropriate.
More about the vaccine
Like other vaccines, CVnCoV was developed to prepare the body to defend itself against infection with 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 body's cells and cause COVID-19 disease. CVnCoV contains a molecule called messenger RNA (mRNA), which has instructions for the production of the spike protein. mRNA is contained in tiny particles of fat (lipids) that prevent its very rapid breakdown.
When a person is given the vaccine, some of his cells will read the mRNA instructions and temporarily produce the spike protein. The person's immune system will then recognize this protein as foreign, produce antibodies and activate the T cells (white blood cells) against it.
If later the person comes into contact with the SARS-CoV-2 virus, his immune system will recognize the protein and will be ready to defend the body against the virus.
The mRNA from the vaccine does not remain in the body but breaks down soon after vaccination.
More about rolling reviews
The rolling review is a regulatory tool used by the EMA to accelerate the evaluation of a highly promising drug or vaccine during a public health emergency, such as the COVID-19 pandemic. Usually, all data on the efficacy, safety and quality of a medicine or vaccine and all required documents must be ready at the start of the evaluation, in an official application for marketing authorisation. In the case of the rolling review, the CHMP evaluates the data as they are made available by current studies. The data is evaluated during the so-called "rolling evaluation cycles" - there is no predetermined number of cycles, as the process evolves according to the availability of the data. Once the CHMP has decided that sufficient data is available, the company can submit a formal application for marketing authorisation. By evaluating the data as they become available, the CHMP can give an opinion on the authorisation of the drug more quickly.
Throughout the pandemic, the EMA and its scientific committees are supported by the EMA's COVID-19 Pandemic Task Force (COVID-ETF). This group brings together experts from across the European Medicines Regulatory Network to advise on the development, authorisation and monitoring of the safety of medicines and vaccines for COVID-19 and to facilitate swift and coordinated regulatory action.
