European Medicines Agency (EMA) has started First Rolling Review Procedure of a COVID-19 Vaccine for Europe
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency EMA has started the first assessment procedure for a vaccine against COVID-19 for Europe. The assessment is performed as a "rolling review". The procedure serves to expedite the COVID-19 vaccine authorisation by starting the evaluation of the data packages of non-clinical and clinical development of a vaccine candidate before all the data required for a marketing authorisation procedure have been assessed. The formal marketing authorisation application can be submitted as soon as all data required are available. Such a procedure, for example, is possible for medicinal products which are urgently needed to combat a threat to public health. Despite the acceleration of the procedure, requirements for quality, safety, and efficacy remain high for the medicinal product concerned. The vaccine referenced here is the COVID-19 viral vector vaccine candidate from Oxford University and AstraZeneca company.
Many medicines are granted a marketing authorisation in Europe within a centralised marketing authorisation procedure – coordinated by the European Medicines Agency). The assessment of a marketing authorisation application takes up to 210 working days from the submission of a complete marketing authorisation dossier. In the event of an emergency such as a threat to the population’s health, there are options of expedited marketing authorisation procedures. The first marketing authorisation procedure submitted in Europe for a COVID-19 vaccine candidate, which is now evaluated, is performed using the “rolling review” – an on-going assessment of successively submitted data packages.
Under normal circumstance, a complete marketing authorisation application must be submitted before the evaluation procedure can be started, containing all the data required. In the case of a rolling review procedure, however, the responsible experts from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) (the rapporteur and the co-rapporteur, nominated from two different EU member countries) assess individual successively submitted data packages as soon as they become available. As part as this rolling review, the CHMP validates at which point in time sufficient data are available to permit a risk/benefit assessment, and, on the basis of these data, recommends whether an application can be made. A decision on the recommendation for a marketing authorisation will then be communicated to the European Commission within a relatively short period of time.
The CHMP decision to start the rolling review of the COVID-19 vaccine from AstraZeneca is based on preliminary results from non-clinical and early clinical studies which point to the ability of the vaccine to create specific immune reaction targeted against SARS coronavirus-2. Even if the procedure referenced here is an expedited marketing authorisation procedure, no sacrifices are made with regard to the care required for the review.
The Paul-Ehrlich-Institut supports the COVID-19 vaccine development with the highest priority. Experts from the Paul-Ehrlich-Institut contribute to European centralised marketing authorisation procedures.
Background: The COVID-19 Vaccine from AstraZeneca – a Vector Vaccine
The COVID-19 vaccine ChAdOx-S developed by Oxford University in the United Kingdom and the pharmaceutical company AstraZeneca is a so-called vector vaccine. It consists of an innocuous virus from the adenovirus family (common cold viruses) from chimpanzees, which is non-replication competent in humans and has been modified in such a way that it contains the gene with the blueprint for creating an optimised surface protein of the coronavirus (SARS-CoV-2-spike proteins). The adenovirus itself cannot replicate and does therefore not cause any diseases. After the vaccination, the vaccine virus containing the SARS-CoV-2 gene is inserted in only few human body cells. The cells use the gene for producing the spike protein. The immune system will recognise the spike protein as foreign and the immune system will react by forming antibodies and T-cells, which ideally protect humans from an infection with the SARS-CoV-2 coronavirus.