Paul-Ehrlich-Institut

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CHMP starts Rolling Re­view for the first Virus-like Par­ti­cle Vac­cine against COVID-19

On 3 February 2021, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) started the rolling review procedure for the COVID-19 vaccine NVX-CoV2373 from the US manufacturer Novavax CZ AS. In a rolling review, the marketing authorisation data required for a complete marketing authorisation application can be submitted and evaluated successively. Unlike the previously authorised vaccines, NVX-CoV2373 is neither an mRNA nor a vector vaccine: It consists of virus-like particles containing the spike protein of SARS-CoV-2.

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 data) and early clinical studies in adults. These studies indicate that the vaccine triggers the production of antibodies and immune cells against SARS-CoV-2. Like other vaccines, NVX-CoV2373 is designed to prepare the human body to defend itself against an infection. However, unlike previously authorised vaccines, NVX-CoV2373 is a protein-based vaccine containing minute particles, which consist of a version of the spike protein of Coronavirus SARS-CoV-2 produced in the laboratory. NVX-CoV2373 also contains an adjuvant (matrix M1 adjuvant), a substance which enhances the immune response to the vaccines. After the vaccination, the immune system recognised the protein particles as foreign and forms natural defences – antibodies and T-cells. If the vaccinated person later comes into contact with SARS-CoV-2, the immune system recognises the spike protein and combats the virus. The Novavax CZ AS Company is currently conducting clinical trials in humans to determine safety, immunogenicity (how well the vaccine induces an immune reaction against the virus), and efficacy against COVID-19. The CHMP will successively evaluate the data from these clinical trials and others after they have been submitted. The rolling review procedure will be continued until sufficient data for a formal marketing authorisation application has been provided. The decision by the CHMP on the recommendation for a marketing authorisation of a vaccine candidate to the European Commission can be made promptly after the complete marketing authorisation application has been handed in. After the evaluation of the entirety of the data submitted, the CHMP assesses whether the vaccine meets the standards required for efficacy, safety, and pharmaceutical quality and has a favourable risk/benefit ratio.

Rolling Review

In the rolling review procedure, the experts responsible from two EU member states (called rapporteur and co-rapporteur) of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) and their respective expert teams evaluate individually submitted data packets as soon as these become available. They ask questions and assess the answers from the applicant. The data required for a complete marketing authorisation application can thus be handed in successively in meaningful partial data packets, not – as is done in the usual practice – in a single complete data packet.

The procedure serves to accelerate the evaluation of a single COVID-19 vaccine candidate for the marketing authorisation. The evaluation of data packets for pharmaceutical and non-clinical development, for example, will already be started before clinical data are available for the formal marketing authorisation application. It is important to note that in the rolling review procedure, processes take place in parallel – the assessment of clinical study data and the evaluation of non-clinical data as well as data on the manufacture and quality – so that although the period required for a potential marketing authorisation can be shortened, no sacrifices are made with regard to the thoroughness of the evaluation. The level of safety will thus be equally high as in the usual centralised marketing authorisation procedures. A vaccine can only obtain a marketing authorisation by the European Commission if proof has been given for the quality, efficacy, and safety and the risk/benefit ratio has been rated as favourable by the experts of the medicines authorities of the EU member states in the CHMP at the EMA.

Updated: 29.03.2021