The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) started the rolling review process - the evaluation of successively submitted data packages to accelerate the approval process - for another COVID-19 vaccine candidate for the EU on 2 December 2021. This is VLA2001, a COVID-19 vaccine candidate from the company Valneva.
In the evaluation process of a vaccine for the European market by the CHMP at the EMA, data on the quality, safety and efficacy of a vaccine product are reviewed by the experts of the medicines authorities of the EU Member States. The rolling review process is now being used again for a COVID-19 vaccine candidate: this accelerates the evaluation of a COVID-19 vaccine candidate with regard to a possible marketing authorisation. This is achieved by starting the evaluation of pharmaceutical and non-clinical development data packages before the full clinical data for the formal marketing authorisation application are available.
The CHMP's decision at the EMA to start the ongoing data review of VLA2001 is based on preliminary results from laboratory studies and initial results from clinical trials in adults. These studies indicate that the vaccine elicits an immune response specifically directed against the SARS-CoV-2 coronavirus.
The company is currently conducting additional clinical trials to determine the safety and efficacy of the vaccine candidate. As data from these and other clinical trials become available, the CHMP will review and evaluate them in terms of the benefit-risk profile. Ongoing review of further data packages will continue until all data required for a formal marketing authorisation application are available.
The vaccine candidate of the French-Austrian company Valneva is the first whole virus vaccine against COVID-19 developed in the EU and the second that is seeking approval in Europe.
The virus is propagated in so-called Vero cells. This is a cell line derived from kidney cells of the African vervet monkey. After the viruses have been grown, they are inactivated. The vaccine contains two boosters: aluminium hydroxide, which is known to be a component of some vaccines, and CpG 1018. CpG 1018 is also already contained as a booster in a hepatitis B vaccine approved in Europe.
Updated: 02.12.2021
