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The European Medicines Agency while under completion in 2019, Amsterdam. Inset: vaccine clinical trial.



EMA recommends first COVID-19 vaccine for authorisation in the EU

© 1995-2020 European Medicines Agency*

Update: Comirnaty is now authorised across the EU. This follows the granting of a conditional marketing authorisation by the European Commission on 21 December 2020.

The European Medicines Agency (EMA)  has recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent COVID-19 in people from 16 years of age. EMA’s scientific opinion paves the way for the first marketing authorisation of a COVID-19 vaccine in the EU by the European Commission, with all the safeguards, controls and obligations this entails.

EUROPEAN COMMISSION PRESIDENT URSULA VON DER LEYEN: The European Commission authorised the first marketing of the Pfizer-BioNTech Cominarty on 21 December 2020.

Conditional marketing authorisation

conditional marketing authorisation is one of EU’s regulatory mechanisms for facilitating early access to medicines that fulfill an unmet medical need, including in emergency situations such as the current pandemic.

conditional marketing authorisation is a formal authorisation of the vaccine, covering all batches produced for the EU and providing a robust assessment to underpin vaccination campaigns.

Evaluating Comirnaty

EMA’s human medicines committee (CHMP) has completed its rigorous evaluation of Comirnaty, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation. This will provide a controlled and robust framework to underpin EU-wide vaccination campaigns and protect EU citizens.

PFIZER-BIONTECH COVID-19 VACCINE. Photo taken 14 December 2020

“Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many,” said Emer Cooke, Executive Director of EMA. “We have achieved this milestone thanks to the dedication of scientists, doctors, developers and trial volunteers as well as many experts from all EU Member States.

“Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards. However, our work does not stop here. We will continue to collect and analyse data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the EU.”

A very large clinical trial showed that Comirnaty was effective at preventing COVID‑19 in people from 16 years of age.

The trial involved around 44,000 people in total. Half received the vaccine and half were given a dummy injection. People did not know whether they received the vaccine or the dummy injection.

Efficacy was calculated in over 36,000 people from 16 years of age (including people over 75 years of age) who had no sign of previous infection. The study showed a 95% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (8 cases out of 18,198 got COVID-19 symptoms) compared with people who received a dummy injection (162 cases out of 18,325 got COVID-19 symptoms). This means that the vaccine demonstrated a 95% efficacy in the clinical trial.

During the clinical trial, Comirnaty showed 95% efficacy in the participants at risk of severe COVID-19. The high efficacy was maintained across genders, racial and ethnic groups.

The trial also showed around 95% efficacy in the participants at risk of severe COVID-19, including those with asthma, chronic lung disease, diabetes, high blood pressure or a body mass index ≥ 30 kg/m2. The high efficacy was maintained across genders, racial and ethnic groups.

Comirnaty is given as two injections into the arm, at least 21 days apart. The most common side effects with Comirnaty were usually mild or moderate and got better within a few days after vaccination. They included pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever. The safety and effectiveness of the vaccine will continue to be monitored as it is used across the Member States, through the EU pharmacovigilance system and additional studies by the company and by European authorities.

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*The European Medicines Agency is an agency of the European Union in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency.

Featured image: European Medicines Agency HQ/Ceescamel via Wikipedia, CC BY-SA4.0. Vaccine clinical vaccine, cropped/NIAID, CC BY2.0
Ursula von der Leyen/©Renew Europe, CC BY-ND2.0 via Flickr
Covid-19 vaccine/Marco Verch Professional Photographer’s Photostream, CC BY2.0