Friday, 9 May 2025
No Result
View All Result
eudebates.tv
  • EU Policies
  • World
  • Special Debates
  • Events
  • Vote & Polls
eudebates.tv
No Result
View All Result

Johnson & Johnson COVID-19 Vaccine Authorized in Europe

EUdebates Team by EUdebates Team
15/03/2021
in Health
Reading Time: 6 mins read
0
A researcher holding a glass vaccine vial
130
SHARES
1.3k
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

European Commission granted a conditional marketing authorisation (CMA) for the Johnson & Johnson COVID‑19 vaccine by Janssen Pharmaceutica NV. This is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and the fourth COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA) and is endorsed by the Member States.

The President of the European Commission, Ursula von der Leyen, said: “The Janssen vaccine is the fourth authorised vaccine of the EU’s portfolio and will help us enhance the vaccination campaign in the second quarter of 2021. It only requires a single dose, which takes us another step closer to achieving our collective goal of vaccinating 70% of the adult population by the end of summer.”

EU debates with Johnson & Johnson, Pfizer and Sanofi to increase COVID-19 vaccine production

Stella Kyriakides, Commissioner for Health and Food Safety, said: “Our portfolio now contains four safe and effective COVID-19 vaccines that we are working tirelessly to deliver to citizens in Europe and beyond as soon as possible. A single dose vaccine can make a difference in the speed of rollout. The entry on the market of the Janssen vaccine ensures that we have access to a total of up to 1.8 billion doses of approved vaccines from different technology platforms – this is key to ensuring access to vaccinations for Europe and our international partners. We will continue to work tirelessly to support vaccine producers and ensure they deliver doses, as agreed in our contracts.”

One dose to adults aged 18 years and older

The Janssen vaccine will be in one dose to adults aged 18 years and older for preventing COVID-19. The vaccine is based on an adenovirus, a harmless virus which delivers the ‘instructions’ from the virus that causes COVID-19. This allows the body’s own cells to make the protein unique to the COVID-19 virus. The person’s immune system recognises that this unique protein should not be in the body and responds by producing natural defences against infection by COVID-19. The adenovirus in the vaccine cannot reproduce and does not cause disease.

On the basis of EMA’s positive opinion, the Commission has verified all the elements supporting the marketing authorisation and consulted Member States before granting the conditional marketing authorisation. The Commission approved the contract with Janssen on 8 October 2020. With the conditional market authorisation, Janssen will be able to deliver 200 million of their single dose COVID-19 vaccine to the EU starting in the second quarter of 2021. The contract allows Member States to purchase an additional 200 million doses. This will add to the total amount of 600 of the vaccine by BioNTech/Pfizer and the 460 million doses of the vaccine by Moderna, as well as the 400 million by AstraZeneca.

A medical worker getting vaccinated against COVID-19 in Bulgaria

What Is the Johnson & Johnson Vaccine?

The COVID-19 vaccine from Johnson & Johnson uses existing technology that involves a virus called adenovirus, a common cause of respiratory infections. The DNA in the adenovirus is modified so that it produces a key part of the SARS-CoV-2 virus particle to which the body then develops an immune response. The adenovirus that delivers the SARS-CoV-2 DNA particle cannot multiply, so it does not cause infection. Because this system is based on stable DNA molecules, it does not require ultracold storage, making it easier to distribute.

What is Conditional Marketing Authorisation (CMA) in European Union?

A conditional marketing authorisation (CMA) is an authorisation of medicines on the basis of less complete data required for a normal marketing authorisation. Such a CMA may be considered if the benefit of a medicine’s immediate availability to patients clearly outweighs the risk linked to the fact that not all the data are yet available. However, it also ensures that this COVID-19 vaccine meets the EU standards, as for all other vaccines and medicines.

Once a CMA has been granted, companies must provide within certain deadlines further data including from ongoing or new studies to confirm that the benefits continue to outweigh the risks. CMAs are foreseen in the EU legislation specifically for public health emergencies and is considered the most appropriate regulatory mechanism in this pandemic for granting access to all EU citizens and for underpinning mass vaccination campaigns.

The rest room of the COVID-19 vaccination centre

Janssen application for Johnson & Johnson Vaccine CMA

Janssen submitted an application for a CMA for their vaccine to EMA on 16 February 2021. Such a short time for evaluation is only possible because EMA has already reviewed some data during a rolling review. During this phase, EMA assessed quality data and data from laboratory studies which looked at how well the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2 (the virus that causes COVID-19). The Agency also looked at clinical safety data on the viral vector used in the vaccine. This rolling review and the assessment of the CMA application allowed EMA to quickly conclude on the safety, effectiveness and quality of the vaccine. EMA recommended granting the conditional marketing authorisation as the benefits of the vaccine outweigh its risks.

The European Commission has verified whether all necessary elements – scientific justifications, product information, educational material to healthcare professionals, labelling, obligations to marketing authorisation holders, conditions for use, etc. – were clear and sound. The Commission also consulted the Member States, as they are responsible for the vaccines marketing and the use of the product in their countries. Following the Member States’ endorsement and on the basis of its own analysis, the Commission decided to grant the conditional marketing authorisation.

How Does the Johnson & Johnson Vaccine Differ From Other Available COVID-19 Vaccines?

The Pfizer and Moderna COVID-19 vaccine technology uses genetic material (mRNA) that code for parts of the SARS-CoV-2 virus protein. This mRNA is protected by lipid nanoparticles (fat bubbles) that, when injected, cause a person’s own cells to make pieces of viral particles to which the body develops immunity. Because the genetic material is broken down quickly, it stays in a person’s cells for only a short period of time. For this reason, these vaccines must be kept in very cold environments until they are ready to be given.

Initially, the Johnson & Johnson vaccine was shown to produce antibodies against SARS-CoV-2 in 90% of people who received it after the first dose. The amount of antibodies was greater for those who received 2 doses of the vaccine. Data released by Johnson & Johnson suggest that 1 dose of vaccine was 66% effective in preventing moderate to severe COVID-19 and 100% effective in preventing COVID-19–related hospitalization and death. These data are being reviewed by the US Food and Drug Administration to consider whether to grant an Emergency Use Authorization (EUA) to allow use of this vaccine.

Who should not get vaccinated

  • If you have had a severe allergic reaction (anaphylaxis) or an immediate allergic reaction—even if it was not severe—to any ingredient in the J&J/Janssen COVID-19 vaccine (such as polysorbate), you should not get the J&J/Janssen COVID-19 vaccine.
  • An allergic reaction is considered severe when a person needs to be treated with epinephrine or EpiPen or if they must go to the hospital. Experts refer to severe allergic reactions as anaphylaxis. Learn about common side effects of COVID-19 vaccines and when to call a doctor.
  • An immediate allergic reaction means a reaction within 4 hours of getting vaccinated, including symptoms such as hives, swelling, or wheezing (respiratory distress).

If you aren’t able to get the J&J/Janssen COVID-19 vaccine, you may still be able to get a different type of COVID-19 vaccine.

eudebates and celebrates Johnson & Johnson Vaccine in the EU

Share this debate with your friends!
Follow #eudebates on Google News and on Facebook
Tags: CoronavirusCOVIDCOVID19EU Health Security CommitteeEuropean Health UnionEuropean Medicines Agency (EMA)HealthcareHuman HealthPublic HealthStella KyriakidesUrsula von der LeyenVaccinationVaccinationsVaccinesWorld Health Organisation
Share52Tweet33

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.