The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has started the third rolling review process, the evaluation of successive data submissions to speed up the marketing authorisation procedure, for a vaccine against COVID-19 for the EU. The vaccine is Ad26.COV2.S, a COVID-19 vaccine candidate from Janssen-Cilag International N.V..
The entire evaluation process of the CHMP at the European Medicines Agency (EMA) until a medicinal product is authorised for the European market usually takes much longer than one year. During this process, quality, safety, and efficacy data of a vaccine product are checked and assessed. Now, a third COVID-19 vaccine candidate is undergoing the rolling review process: the process is designed to speed up the evaluation of a COVID-19 vaccine candidate on its way to a potential authorisation. For example, the evaluation of pharmaceutical and non-clinical development data packages can be started before the full clinical data for the formal marketing authorisation application are available.
The decision of the CHMP to start the ongoing review of Ad26.COV2.S is based on preliminary results of laboratory studies and early clinical trials in adults. These studies suggest that the vaccine triggers a specific immune response directed against the SARS CoV2 coronavirus.
The company is currently conducting further clinical trials to assess safety and efficacy of the vaccine candidate. As soon as the data from these and other clinical trials become available, the CHMP will evaluate them with regard to the risk/benefit profile. The continuous review of further data packages will continue until all required data are available to formally apply for marketing authorisation.
Ad26.COV2.S is a preventive COVID-19 vector vaccine candidate: The genome of an adenovirus that is incapable of replication has been modified to contain the genetic blueprint for the protein known as spike protein (S), which is present on the surface of the SARS-CoV-2 coronavirus. After vaccination, a few body cells take up the adenovirus vector, form messenger RNA (mRNA) with the genetic blueprint of the spike protein and produce it based on the blueprint. The immune system recognises this protein as foreign and forms natural defenses - antibodies and T-cells. When the vaccinated person later comes into contact with SARS-CoV-2, the antibodies recognise the virus and the T-cells recognises virus-infected cells. This way a COVID-19 disease or a severe course of this infectious disease can be prevented.
Updated: 03.12.2020
