Sunday, 11 May 2025
No Result
View All Result
eudebates.tv
  • EU Policies
  • World
  • Special Debates
  • Events
  • Vote & Polls
eudebates.tv
No Result
View All Result

COVID-19 vaccine authorisation for Europeans from 16 years of age

EUdebates Team by EUdebates Team
21/12/2020
in Health
Reading Time: 6 mins read
0
Exterior of European Medicines Agency in Amsterdam - EMA
137
SHARES
1.4k
VIEWS
Share on FacebookShare on Twitter
ADVERTISEMENT

Join EU debates

EU should debate mandatory vaccination, says Von der Leyen.

WHO: 115k health and care professionals died from pandemic

Vaccinated Europeans now outnumber those infected by COVID

Made in China vaccine gets WHO global approval for emergency use

EU Medicines Agency (EMA) has recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent coronavirus disease 2019 (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.

Vaccine approval for Europeans from 16 years of age

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.

EU countries are now working to start vaccinations as soon as possible.

Exterior of European Medicines Agency in Amsterdam
European Medicines Agency

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

This is 🇪🇺 moment: we are one step closer to a safe & effective #COVID19 vaccine.
@EMA_News has recommended a conditional marketing authorisation for #BioNTech @pfizer vaccine.@EU_Commission & Member States will now proceed with urgency.#SafeVaccines #StrongerTogether pic.twitter.com/FVl4E4Z2fg

— Stella Kyriakides (@SKyriakidesEU) December 21, 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 European Medicines Agency 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.

COVID-19 vaccines: Development, evaluation and EU approval

“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.

It’s a decisive moment in our efforts to deliver safe & effective vaccines to Europeans!

The @EMA_News just issued a positive scientific opinion on the #BioNTech / @pfizer vaccine.

Now we will act fast. I expect a @EU_Commission decision by this evening.

— Ursula von der Leyen (@vonderleyen) December 21, 2020

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.

Where to find more information

The product information approved by the CHMP for Comirnaty contains prescribing information for healthcare professionals, a package leaflet for members of the public and details of conditions of the vaccine’s authorisation.

An assessment report, with details of EMA’s evaluation of Comirnaty, and the full risk management plan will be published within days. Clinical trial data submitted by the company in the application for marketing authorisation will be published on the Agency’s Clinical data website in due course.

More information is available in an overview of the vaccine in lay language, including a description of the vaccine’s benefits and risks and why European Medicines Agency EMA recommended its authorisation in the EU.

📣BREAKING NEWS: @EMA_News has recommended the BioNTech/Pfizer #COVID19 vaccine for authorisation in the EU.

EU countries are now working to start vaccinations as soon as possible.

More on how the EU is securing a safe & effective vaccine 👉 https://t.co/bZwtNzFuip pic.twitter.com/tyqGJ7UWNF

— EU Council (@EUCouncil) December 21, 2020

How Comirnaty works

Comirnaty works by preparing the body to defend itself against COVID-19. It contains a molecule called messenger RNA (mRNA) which has instructions for making the spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells.

When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.

If, later on, the person comes into contact with SARS-CoV-2 virus, their immune system will recognise it and be ready to defend the body against it.

The mRNA from the vaccine does not stay in the body but is broken down shortly after vaccination.

Exterior of European Medicines Agency in Amsterdam

Conditional marketing vaccine authorisation

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

A 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.

As Comirnaty is recommended for a conditional marketing authorisation, the company that markets Comirnaty will continue to provide results from the main trial, which is ongoing for 2 years. 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 immunocompromised people, children and pregnant women, and whether it prevents asymptomatic cases.

The company will also carry out studies to provide additional assurance on the pharmaceutical quality of the vaccine as the manufacturing continues to be scaled up.

Monitoring the safety of Comirnaty

In line with the EU’s safety monitoring plan for COVID-19 vaccines, Comirnaty will be closely monitored and subject to several activities that apply specifically to COVID-19 vaccines. Although large numbers of people have received COVID-19 vaccines in clinical trials, certain side effects may only emerge when millions of people are vaccinated.

Companies are required to provide monthly safety reports in addition to the regular updates required by the legislation and conduct studies to monitor the safety and effectiveness of the vaccines as they are used by the public. Authorities will also conduct additional studies to monitor the vaccines.

These measures will allow regulators to swiftly assess data emerging from a range of different sources and take appropriate regulatory action to protect public health if needed.

Assessment of Comirnaty

During the assessment of Comirnaty, the CHMP had the support of EMA’s safety committee, PRAC, who assessed the risk management plan of Comirnaty, and the COVID-19 European Medicines Agency EMA pandemic task force (COVID-ETF), a group that brings together experts from across the European medicines regulatory network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.

The European Commission will now fast-track the decision-making process to grant a decision on the conditional marketing authorisation for Comirnaty, allowing vaccination programmes to be rolled out across the EU.

eudebates scientific evaluation and COVID-19 vaccines approval processes

Share this debate with your friends!
Follow #eudebates on Google News and on Facebook
Tags: CoronavirusCOVIDCOVID19EU Health Security CommitteeEuropean Medicines Agency (EMA)HealthcareHuman HealthPublic HealthStella Kyriakidesthe Future of MedicineUrsula von der LeyenVaccinationVaccinationsVaccinesWHOWorld Health Organisation
Share55Tweet34

Related EU debates

Ursula von der Leyen, President of the European Commission on the mandatory vaccination
Health

EU should debate mandatory vaccination, says Von der Leyen.

01/12/2021
Doctors mask virus health
Health

WHO: 115k health and care professionals died from pandemic

25/05/2021
A medical worker getting vaccinated against COVID-19 in Bulgaria
Health

Vaccinated Europeans now outnumber those infected by COVID

14/05/2021
Illustration picture of a vaccines - vaccine
Health

Made in China vaccine gets WHO global approval for emergency use

13/05/2021
small-baby mother newborn
Health

Health: Keep mothers and newborns together

16/04/2021
Stella Kyriakides, European Commissioner for Health and Food Safety
Health

World Health Day: Stella Kyriakides EU debates Health Union

06/04/2021

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

SOTEU 2022 - State of the Union speech

Watch State of the Union live: Ursula von der Leyen gives 2022 address #SOTEU

14/09/2022
Volunteers preparing food for Ukrainian refugees arriving at Berlin Central Station

EU steps up solidarity with refugees fleeing Ukraine

08/03/2022
pump jack oil diesel

REPowerEU to get rid of the dependencies of Russian fossil fuel

08/03/2022
Ursula von der Leyen President of the European Commission

EU sanctions against Russia following the invasion of Ukraine

26/02/2022
Finnish PM Sanna Marin

Finland: NATO membership ‘will change’ after Russian invasion

24/02/2022
NATO - EU joint Press Conference

EU responds to Russia’s invasion of Ukraine with massive sanctions

24/02/2022
  • Social Media Facebook twitter

    DeleteFacebook? What is the best Facebook european alternative?

    268 shares
    Share 107 Tweet 67
  • Travelling in Europe with COVID19 country colour travel code zones

    238 shares
    Share 95 Tweet 60
  • Why don’t Mediterranean boat migrants take the plane? Why don’t refugees fly?

    222 shares
    Share 89 Tweet 56
  • EU nasty and vindictive? Nigel Farage criticizes EU vaccines strategy

    202 shares
    Share 81 Tweet 51
  • Burkini Debate: To Ban or Not to Ban the Burkini, Burka and Niqab in EUROPE?

    193 shares
    Share 77 Tweet 48

Join eudebates newsletter!

Enter your email to receive our newsletter.

Don't worry, we don't spam
eudebates_logo

Follow us on social media:

Recent News

  • Watch State of the Union live: Ursula von der Leyen gives 2022 address #SOTEU
  • EU steps up solidarity with refugees fleeing Ukraine
  • REPowerEU to get rid of the dependencies of Russian fossil fuel
  • EU sanctions against Russia following the invasion of Ukraine
  • Finland: NATO membership ‘will change’ after Russian invasion

Newsletter

Join eudebates newsletter!

Enter your email to receive our newsletter.

Don't worry, we don't spam
SOTEU 2022 - State of the Union speech

Watch State of the Union live: Ursula von der Leyen gives 2022 address #SOTEU

14/09/2022
Volunteers preparing food for Ukrainian refugees arriving at Berlin Central Station

EU steps up solidarity with refugees fleeing Ukraine

08/03/2022
pump jack oil diesel

REPowerEU to get rid of the dependencies of Russian fossil fuel

08/03/2022
  • Home
  • EU Policies
  • Special Debates
  • Events
  • Vote & Polls
  • Video

© 2022 eudebates - EU debates, dialogue, communication for a better Europe - Privacy Policy.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In

Add New Playlist

No Result
View All Result
  • EU Policies
  • World
  • Special Debates
  • Events
  • Vote & Polls

© 2022 eudebates - EU debates, dialogue, communication for a better Europe - Privacy Policy.

We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it. Visit our Privacy and Cookie Policy.