On 22 December 2020, the European Commission issued a conditional marketing authorisation for the Covid-19 vaccine developed by BioNTech and Pfizer. All Member States have approved this authorisation following a scientific recommendation based on in-depth evaluations and accurate studies on the vaccine's quality/efficacy, carried out by the European Medicines Agency (EMA). This organisation's role is to ensure the supervision and control of medicines' safety in the European Union.
"Today, we are adding an important piece to the success of the European strategy for facing the pandemic. We have approved the first safe and effective vaccine against COVID-19, and soon there will be others. The doses of the vaccine approved today will be available in all EU countries simultaneously and under the same conditions. The forthcoming European vaccination days will also be a moment of great unity: we are all in the same boat. There could not be a better way to end this difficult year and leave the pandemic behind" says European Commission President Ursula Von Der Leyen.
Covid-19: EU strategy on vaccines
The European Medicines Agency and the European Commission use European legislation provisions to address emergencies and shorten the approval time, without sacrificing a full and accurate evaluation of all scientific aspects and the requirements for a proper risk-benefit analysis. The EMA has created accelerated examination procedures to quickly evaluate questions, thanks to the support of the so-called "clinical reviews". The latter allows data on medicinal products under consideration to be analysed as soon as they are made available (rather than waiting for all stages of testing to be completed). The standard authorisation procedure for a medicinal product usually lasts 67 days, 22 of which are for consultation with the Member States. The particular "conditioned" process we are dealing with dramatically reduces the timing, obtaining the authorisation to market the medicine in just three days.
The authorisation process
Any company wishing to market a vaccine in the European Union must submit a marketing authorisation to the EMA. Should a company receive a positive response, the Agency makes a recommendation, with which the European Commission subsequently authorises and markets the vaccine in the European market. To remedy need and urgency, the European Union has developed a specific regulatory instrument to allow rapid and flexible marketing of medicines: this is the conditional marketing authorisation procedure (CMA). This procedure provides a solid framework for quick approval without compromising the guarantees necessary to protect European citizens' health.
BioNTech and Pfizer have submitted a formal application for marketing authorisation, which in case of an emergency, allows providing rapid assessments, ensuring accurate examinations carried out in compliance with all the requirements of safety, efficacy and quality of the vaccine.
The CMA is based on less complete processes and data collection than those required for ordinary authorisation. Therefore, in a pandemic environment generated by Covid-19, conditional approval is an excellent means of benefiting from a particular medicinal product's immediate availability. Once authorisation is granted, companies are required to provide additional data within a specified time limit, confirming that the benefits of the medicinal product outweigh the risks. In this case, the two pharmaceutical companies applied on 1 December 2020, based on a data study dating from 6 October. This analysis made it possible to reinforce the demand by demonstrating how the data met the requirements of efficacy, safety and quality of the vaccine.
The process involves two balancing steps and the support of different experts: two rapporteurs, an evaluator (peer reviewer), specialised committees and working groups, and the EMA's Committee for Medicinal Products for Human Use (composed of members from all EU countries) which only makes the recommendation if the evidence shows that the benefits of vaccination outweigh the risks.
The European Commission is legally responsible for the marketing authorisation. Following the recommendation drawn up by the EMA and the verification of the solidity of the elements/data, the European Commission consults the Member States responsible for marketing. If the Member States' qualified majority is in favour, the Commission may adopt the authorisation decision, resulting in the vaccine's marketing throughout the EU without requesting further authorisation from the Member States.
Translated by Vittoria Visconti