Paul-Ehrlich-Institut

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Rolling Re­view Pro­ce­dure start­ed for the COVID-19 Vac­cine Can­di­date Sput­nik V from Rus­sia at the Eu­ro­pean Medicines Agen­cy

On 4 March 2021, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) started the fifth rolling review procedure – the evaluation of successively submitted data to accelerate the marketing authorisation procedure – for a COVID-19 vaccine candidate. This vaccine candidate is Sputnik V (Gam-COVID-Vac) from the Russian Gamaleya National Centre of Epidemiology and Microbiology at Moscow, for which the aim is to obtain an EU marketing authorisation.

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

In the evaluation process for a vaccine for the European market by the CHMP, experts of the medicines authorities of the EU member states assess data on the quality, safety, and efficacy of a vaccine candidate. For this vaccine candidate, the rolling review procedure is used in the same way as for the previous four vaccines. This procedure is designed to accelerate the assessment of a COVID-19 vaccine candidate. In this procedure, the experts start on evaluating the data packets on the quality, manufacture, non-clinical, and clinical development before all data are available for the formal application for a marketing authorisation.

The decision by the CHMP to start the continued assessment of the data is based on preliminary results of laboratory studies and clinical trials on adults. These studies show that the vaccine is immunogenic, i. e. it triggers the formation of antibodies and immune cells targeted against SARS Coronavirus (Cov)-2. The on-going assessment of additional data packets to be submitted later shall be continued until all data required for a formal application for a marketing authorisation are available.

Background: COVID-19 vaccine candidate Sputnik V (Gam-COVID-Vac)

Like the COVID-19 vaccine by AstraZeneca, which is already authorised in Europe, the vaccine candidate Sputnik V by the Russian Gamaleya National Centre of Epidemiology and Microbiology is a vector vaccine based on an adenoviral vector. Sputnik V consists of two different replicable vectors (Ad26 and Ad5), which, based on Adenovirus 26 or Adenovirus 5, respectively, have been developed from the family of cold viruses. The viruses have been modified in such a way that they can transmit each gene with the blueprint for the formation of the surface spike protein of SARS-CoV-2. The two vectors are administered separately from each other: During the first vaccination, Ad26-S is administered, and the second vaccination is performed with Ad5-S. These adenoviruses cannot replicate and will not cause a disease. After the vaccination, the vaccine viruses with the spike protein gene are inserted in few human body cells. The cells use the gene to generate the spike protein. The immune system recognises the spike protein as foreign and forms antibodies and immune cells, which are intended to confer protection against a COVID-19 infection and a serious course of COVID-19.

Updated: 04.03.2021