European Commission authorises fourth safe and effective vaccine against COVID-19

(Credit: Unsplash)

This article is brought to you in association with the European Commission.


Today, the European Commission has granted a conditional marketing authorisation (CMA) for the COVID‑19 vaccine developed by Janssen Pharmaceutica NV, 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.”

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.”

The Janssen vaccine will be given 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.

Next steps

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.

Background

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.

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.

the sting Milestones

Featured Stings

Can we feed everyone without unleashing disaster? Read on

These campaigners want to give a quarter of the UK back to nature

How to build a more resilient and inclusive global system

Stopping antimicrobial resistance would cost just USD 2 per person a year

Europe should make voice ‘more heard’ in today’s ‘dangerous world,’ says UN chief

The revenge of the fallen

Syrian crisis is ‘clearest example’ of foreign investment in terrorism, Deputy Prime Minister says at UN

This Syrian national has been trapped at Kuala Lumpur airport for 3 months

European Commission calls on national political parties to join efforts to ensure free and fair elections in Europe

Back to the Basics: Primary Healthcare

Learning lessons from across Europe – the hidden costs of COVID-19 on lung cancer

Eliminating gender based bias in medicine: the role of medical students

MEPs propose more transparent legislative drafting and use of allowances

Out with the old: Young People transforming Humanitarian Action

Parliament adopts deal to improve quality of tap water and reduce plastic litter

Mergers: Commission clears acquisition of Eaton Hydraulics by Danfoss, subject to conditions

5 ways to #BeatAirPollution

Security spillovers from Trump’s trade wars: China, Germany prepare for global disorder

Iceland’s slowdown underlines the need to fix structural issues

Wirecard: MEPs call for new audit rules, protection for whistle-blowers and EU supervision

Why salaries could finally be on the way up

Estonia: use robust growth to improve income equality and well-being

More funds needed to counter ‘persistent and multi-faceted humanitarian problems’ in Ethiopia

EU prolongs economic sanctions on Russia by six months

New energy security framework will help meet growing needs in East Africa, sustainably – UN economic wing

Postal workers in France are helping elderly people fight loneliness

We are witnessing a revolution in genomics – and it’s only just begun

Why transparency in drug pricing is more complicated than it seems

COP21 Breaking News_04 December: Launch of CREWS, climate risk & early warning systems

Merkel: Nationalism and egoism must never have a chance again in Europe

More funding needed to combat locust swarms ‘unprecedented in modern times’

Global warming: our responsibility

Beware the fragility of the global economy

Commission provides 20 cities with funding for innovative security, digital, environmental and inclusion projects

WHO and UNICEF in campaign to protect 1.6 million in Sudan from cholera

Falling inflation urges ECB to introduce growth measures today

Why are the financial markets shivering again?

‘Great Pacific Garbage Patch’ clean-up project launches trial run: UN Environment

EU labour mobility: Inconvenient truths for everybody

European Parliament and Eurovision sign partnership for European Elections

EU attempts to make new deal with Turkey as relations deteriorate

Technophobe or technophile? We need more conversation about digital transformation

‘Emulate his example’ urges UN chief as world celebrates Nelson Mandela: a ‘global advocate for dignity and equality’

MWC 2016 LIVE: Qualcomm looks to pick up Hamilton’s winning ways

EP and EU ministers agree on Erasmus+ programme for 2021-2027

My experience living with depression and schizophrenia in Thailand

Building cybersecurity capacity through benchmarking: the Global Cybersecurity Index

3 ways to rebuild trust in how we regulate technology

First calls under Horizon Europe to be launched by the European Research Council

Philanthropy must face a reckoning on race in 2021

New UN finance panel to push Global Goals forward

Conditions deteriorating alarmingly in Yemen, warns senior UN official

Commission reinforces tools to ensure Europe’s interests in international trade

EU mobilises emergency assistance for Croatia in the aftermath of devastating earthquake

Commission concludes that an Excessive Deficit Procedure is no longer warranted for Italy at this stage

Better ID card security to curb document fraud

Can we automate our way out of the savings crisis?

5 lessons for the future of universities

Things are bad and getting worse for South Africa. Or are they?

This is why AI has a gender problem

Commission paralysed before the banking leviathan

The world must pull together to stem the urgent crisis in our ocean

Alice in Colombia

The recipe for creativity involves a lot of ideas, and a short break

More Stings?

Advertising

Speak your Mind Here

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s