First Covid-19 vaccine for EU authorised by EMA

21 Dec 2020

Image: © syhin_stas/

Following the EMA’s recommendation, the European Commission must also give the vaccine the green light to begin the roll-out to member states.

The European Medicines Agency (EMA) has today (21 December) recommended a conditional marketing authorisation for the Covid-19 vaccine developed by Pfizer-BioNTech.

Following a rigorous evaluation of the vaccine, named Comirnaty, the EMA’s human medicines committee has concluded that there is sufficiently robust data on the quality, safety and efficacy of the vaccine to recommend it for use.

Emer Cooke, executive director of the EMA, said today’s news is an important step forward in the fight against the pandemic. “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,” she said.

“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.”

Development of Pfizer-BioNTech vaccine candidate was announced in March of this year and set out to use RNA to accelerate the production of proteins similar in composition to SARS-CoV-2, which could be used to trigger the body’s immune system to fight the actual virus.

In November, initial results from a phase-three trial involving more than 43,000 found the vaccine to be 90pc effective in preventing the disease among a small sample of study participants. In early December, final efficacy results for the vaccine were published in the peer-reviewed New England Journal of Medicine, demonstrating a vaccine efficacy of 95pc.

The vaccine is given as two injections into the arm, at least 21 days apart. The trials found that the most common side effects 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.

As the vaccine is recommended for a conditional marketing authorisation, results from the ongoing main trial will continue to be published and reviewed. This trial and additional studies will provide information on how long protection lasts, how well the vaccine prevents severe Covid-19, how well it protects immuno-compromised people, children and pregnant women, and whether it prevents asymptomatic cases.

While the European Commission has yet to approve the use of the vaccine, it is likely to fast-track the decision-making process in order to begin the roll-out to member states.

Last week, European Commission president Ursula von der Leyen announced that Covid-19 vaccinations will begin in EU countries from 27 December.

Jenny Darmody is the editor of Silicon Republic