The European Medicines Agency (EMA) announced today that it is launching a rolling evaluation of the Valneva vaccine against COVID-19 (VLA2001).
The decision of the EMA Committee for Drugs for Human Use (CHMP) to initiate the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical trials in adults. These studies suggest that the vaccine activates the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease.
The EMA will evaluate the data as soon as it becomes available to decide whether the benefits outweigh the risks. The rolling review will continue until sufficient information is available for a formal marketing authorization application.
The EMA will assess VLA2001 compliance with standard EU standards for efficiency, safety and quality. Although the EMA cannot predict overall timetables, it will take less time than normal to evaluate a possible implementation due to the work done during the rolling review.
The EMA will provide further information when the marketing authorization for the vaccine is submitted.
According to Coreper, the vaccine works as follows:
VLA2001 is expected to prepare the body to defend itself against infection with SARS-CoV-2, the virus that causes COVID-19. The vaccine contains inactivated SARS-CoV-2 which can not cause the disease. VLA2001 also contains two “adjuvants”, substances that help boost the immune response to the vaccine.
When a person receives the vaccine, their immune system recognizes the inactivated virus as foreign and produces antibodies against it. If later, the vaccinated person comes in contact with SARS-CoV-2, the immune system will recognize the virus and be ready to defend itself against it.
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