Paul-Ehrlich-Institut

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Eu­ro­pean Medicines Agen­cy (EMA) has start­ed Sec­ond Rolling Re­view Pro­ce­dure of a COVID-19 Vac­cine Can­di­date for Eu­rope

The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency EMA has started the second rolling review process for a COVID-19 vaccine for Europe. The procedure aims to accelerate the evaluation process towards COVID-19 vaccine authorisation by starting the assessment of data packages from the non-clinical and clinical development of a vaccine candidate before all necessary data for a marketing authorisation application have been collected and submitted. The rolling review process will continue until the data provides sufficient evidence to allow for a formal regulatory submission and benefit-risk assessment. Despite the acceleration, the requirements for quality, safety and efficacy of the medicines concerned remain high. The vaccine is a COVID-19 vaccine candidate from BioNTech.

Persons check documents (Source: Aymanejed/Pixabay.com)

In Europe, the evaluation of a whole range of medicines is coordinated in a centralised procedure by the European Medicines Agency (EMA), while the authorisation for all EU member states is handled by the European Commission. The evaluation of an application for marketing authorisation after submission by the experts of the national competent authorities takes up to 210 working days. Additional time is required for the applicant to answer questions and, if necessary, to compile further data. The entire evaluation process normally takes considerably longer than one year. The regular accelerated assessment procedure allows 170 days for the regulatory assessment. Further reductions are possible in case of an emergency such as a public health threat. A second COVID-19 vaccine candidate is now undergoing rolling review - the ongoing review of successive data packages - to further reduce the evaluation time where possible.

Normally, a complete marketing authorisation application with all the necessary data must be submitted before the evaluation process can begin. In the rolling review procedure, on the other hand, the lead reviewers (rapporteur and co-rapporteur, experts from two EU Member States) of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) already evaluate individual successively submitted data packages as soon as they are available and have been submitted. At the end of this rolling review, the CHMP also checks at what point in time sufficient data are available to allow a final benefit-risk assessment. A CHMP decision on the recommendation for authorisation of a vaccine candidate to the European Commission is then made comparatively quickly.

The CHMP's decision to start the ongoing review of BioNTech's COVID-19 vaccine is based on preliminary results from non-clinical studies and early clinical trials in adults, which indicate that the vaccine product is immunogenic in humans, i.e. that it can induce specific immune responses against SARS coronavirus-2. A rolling review and an accelerated assessment procedure does not mean that there will be any reduction in the care required for the trial.

The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, supports the COVID-19 vaccine development with highest priority. Experts from the Paul-Ehrlich-Institut are actively involved and often in a leading role in European centralised authorisation procedures and medicines evaluations.

Background: mRNA COVID-19 Vaccine from BioNTech

The COVID-19 vaccine product BNT162b2 developed by BioNTech is a so-called mRNA vaccine. The messenger RNA (mRNA) of the BNT162b2 vaccine contains genetic information for the blueprint of the spike protein of the SARS coronavirus-2 and is mixed with small fat molecules (lipid particles) that mediate the uptake of the mRNA into a few human body cells. After vaccination, the genetic information is read from the receiving cells of the body and the spike protein is produced and presented to the immune system. The immune system recognises the spike protein as foreign and produces, among other things, antibodies and T-cells that are supposed to protect against a symptomatic infection or a severe COVID-19 course.

Updated: 06.10.2020