Paul-Ehrlich-Institut

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Start of the Rolling Re­view Pro­ce­dure for Sino­vac’s Whole Virus Vac­cine Called "COVID-19 (Vero Cell) in­ac­ti­vat­ed" at the Eu­ro­pean Medicines Agen­cy

On 4 May 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 candidate called "COVID-19 Vaccine (Vero Cell) Inactivated". The term rolling review procedure refers to the evaluation of successively submitted data to accelerate the marketing authorisation procedure. The Chinese company, Sinovac Life Sciences Co., developed the vaccine. It is intended that this vaccine shall be marketed in Europe by the Italian Life´n S.r.I. company.

Vial with Vaccine (Source: Shutterstock.com)

The decision by the CHMP to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) as well as early clinical trials in adults. These studies indicate that the vaccine will induce the formation of specific antibodies against SARS-CoV-1 and will confer protection against COVID-19.

Background – COVID-19-vaccine "COVID-19 Vaccine (Vero Cell) Inactivated"

Other than with the previously authorised COVID-19 vaccines, or those currently undergoing a rolling review in the EU, "COVID-19 Vaccine (Vero Cell) Inactivated" is an inactivated whole virus and is administered as inactivated non-infectious SARS-CoV-2 virus particles. Thus, the whole virus – in inactivated form – is used as antigen, which serve to confer immune protection. The vaccine contains a substance that enhances the effectiveness (adjuvant).

Rolling Review

In the case of a rolling review procedures, the CHMP at the EMA evaluates individual submitted data packets as soon as they become available. This enables the CHMP to evaluate partial data packets successively without requiring the full marketing authorisation application to be submitted as a single full data packet, as is the normal practice.

The procedure serves to accelerate the evaluation of a COVID-19 vaccine candidate for the marketing authorisation.

In the rolling review procedure, processes such as the collection of clinical study data and the evaluation of non-clinical data and data for the manufacture and quality take place in parallel. His permits shorter processing times required for a potential marketing authorisation without sacrificing the quality of the evaluation.

A vaccine can only be granted a marketing authorisation from the European Commission if proof has been provided of its quality, safety, and efficacy, and the experts of the medicines authorities of the EU member state in the CHMP at the EMA have rated the risk/benefit ratio as favourable.

Updated: 06.05.2021