Paul-Ehrlich-Institut

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Rolling Re­view be­gins for Pro­tein Sub­unit Vac­cine against COVID-19

On 20 July 2021, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) began the rolling review process for the COVID-19 vaccine Vidprevtyn developed by French manufacturer Sanofi Pasteur. In a rolling review process, the data required for a full marketing authorisation application can be submitted sequentially for evaluation while some of the studies and assessments are still ongoing. Vidprevtyn is a protein-based subunit vaccine consisting of a cell-culture-produced version of the spike protein of SARS-CoV-2 with the addition of an adjuvant.

Person in front of a  laptop with documents (Source: ElleAon/Shutterstock.com)

The decision by the CHMP is based on preliminary results from laboratory studies (non-clinical trials) and early clinical trials in adults. These studies show that the vaccine is immunogenic, and production of antibodies and immune cells against SARS-CoV-2 was demonstrated. Like other vaccines, Vidprevtyn is expected to provide protection from COVID-19 and to prevent severe or even fatal disease progression in particular. Unlike the vaccines authorized to date, Vidprevtyn does not contain the genetic information on the spike protein of SARS-CoV-2, but rather the spike protein itself, which is produced in insect cells. Vidprevtyn contains an adjuvant, a substance that boosts the immune response to the vaccine. After vaccination, the immune system recognizes the protein particles as foreign and forms natural defences, antibodies and T-cells. If the vaccinated person then subsequently comes into contact with SARS-CoV-2, the immune system recognizes the spike protein and fights the viral infection.

The CHMP will evaluate the data gradually after submission, and the rolling review process will continue until sufficient data has been presented for a complete marketing authorisation application. The decision by the CHMP on recommending authorisation of a vaccine candidate to the European Commission can be made quickly based on the advance rolling review once the complete marketing authorisation application is available. Following evaluation of all the data presented as a whole, the CHMP assesses whether the vaccine meets the required standards for quality, safety and efficacy and whether the risk-benefit ratio is favourable.

Rolling review

In a rolling review process, the lead reviewers of two EU member states’ medicines authorities (the rapporteur and the co-rapporteur) from the Committee for Medical Products for Human Use (CHMP) at the European Medicines Agency (EMA) work with their relevant teams of experts to evaluate individual packages of submitted data as soon as they are available. They ask follow-up questions and evaluate the applicant’s responses. The data required for a complete marketing authorisation application can thus be submitted in appropriate partial data packages one after the other, rather than as a single, complete data package, as it is usually the case.

The process serves to speed up the evaluation of a COVID-19 vaccine candidate with a view to regulatory approval. The evaluation of data packages on pharmaceutical and non-clinical developments, for example, can be started even before clinical data are available for the formal marketing authorisation application. With rolling reviews, processes can also take place in parallel – for example the collection of clinical study data and the evaluation of non-clinical data as well as data on production and quality – so that the time taken for a potential approval can be reduced, while at the same time there are no shortcuts in the thoroughness of the evaluation. A vaccine can then only gain approval through the European Commission if there is sufficient demonstration of quality, safety and efficacy and if the risk-benefit ratio is rated favourable by the experts from the medicines authorities of the EU member states in the CHMP at the EMA.

Updated: 21.07.2021