The European Commission today 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.
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 has been endorsed by the European Union (EU) Member States.
The President of the European Commission, Ursula von der Leyen, commented: "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, European Commissioner for Health and Food Safety, added: "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. 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 virus. The vaccinated individual's immune system recognises that this unique protein should not be in the body and responds by producing natural defences against COVID-19 infection. The adenovirus in the vaccine cannot reproduce and does not cause disease.
The Commission confirmed that, on the basis of EMA's approval, it verified all the elements supporting the marketing authorisation and consulted Member States before granting the CMA.
The Commission approved the contract with Janssen on 8 October 2020. With the CMA, 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 million doses of the BioNTech/Pfizer vaccine and the 460 million doses of the Moderna vaccine, as well as the 400 million doses of the AstraZeneca vaccine.
