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European Commission approves first COVID-19 vaccine

Overview

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.

Sources: europa.eu

Translated by Vittoria Visconti


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  • L'Autore

    Elena Pavan

    Elena Pavan è una studentessa italo-francese di giurisprudenza presso l’Università Cattolica del Sacro Cuore di Milano. I suoi interessi vertono soprattutto intorno alla Proprietà Intellettuale, il Diritto d’Autore nel campo della moda e dell’arte, e il diritto Commerciale e Societario. Ha completato il suo percorso educativo con un Corso di Alta Formazione in Fashion Law presso l’Alta Scuola Federico Stella. Ha lavorato a Bordeaux per una società immobiliare, percorso lavorativo che l’ha portata ad integrare la CCI France-Italie a Milano. È membro di Elsa Italy, un’associazione di studenti di giurisprudenza, e membro dell’Istituto Francese a Milano. Ha svolto attività di volontariato presso l’Humanitas Hospital di Milano, l’ONU online e il Fondo Ambiente Italiano. Attualmente è consulente legale di Mondo Internazionale (Responsabile Regolamentazione Interna ed Internazionale), un’associazione senza scopo di lucro con il focus di valorizzare il capitale umano dei giovani, e consulente per Taras Consulting, società che si occupa di internazionalizzazione d’impresa.Collabora conIus in Itinere per le aree “Fashion Law” ed “IP & IT”.

    Elena Pavan is an Italian-French law student currently enrolled at the Università Cattolica del Sacro Cuore at Milan (the Sacred Heart Catholic University at Milan). She has a particular interest in private property rights pertaining to copyright, intellectual property, Art/Fashion objects, and International Corporate & Commercial Law.Her work experience includes a legal consulting collaboration with a real estatedeveloping company located in France. She is an activist for CCI France-Italie, as well as a member of the Elsa Italy which is a European Association founded by law students. She is also a currently involved with the French Institute of Milan.Actually, she is a Consultant (legal) for Taras Consulting, Milan, and Legal Consultant for Mondo Internazionale (Internal and International Regulations Advisor).She is a part of the “Diritto e Società” team in Mondo Internazionale.Her philanthropic interests have encouraged her to volunteer at the Humanitas Hospital of Milan as well as becoming an active member of the FAI institute (a non-profit organization funded to protect and preserve cultural sites located on the Italian territory), and as an online volunteer for the UN.She is a collaborator for Ius in Itinere - IP & IT and Fashion Law area.Her future goals include becoming a business lawyer, with a specialization in the legal rights involving the art/fashion and corporate world as her interests revolve around art, fashion and commercial law.

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