Janssen Covid‑19 vaccine gets conditional marketing authorization in EU
The European Commission has granted a conditional marketing authorization (CMA) for the single dose Janssen Covid‑19 vaccine developed by the Janssen Pharmaceutical Companies of Johnson & Johnson.
The Janssen vaccine is the fourth Covid-19 vaccine authorized in the European Union (EU) after the vaccines developed by BioNTech and Pfizer, Moderna, and AstraZeneca.
Ursula von der Leyen – President of the European Commission said: “The Janssen vaccine is the fourth authorized 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.”
The Janssen Covid‑19 vaccine is authorized by the European Commission to be administered in one dose to adults 18 years and older.
The Covid‑19 vaccine from Johnson & Johnson is based on an adenovirus which is said to deliver the ‘instructions’ from the SARS-CoV-2 virus. This enables the body’s own cells to make the protein unique to the virus causing Covid-19.
The immune system of the human body recognizes that the unique protein should not be present in the body and for this, it responds by producing natural defenses against the Covid-19.
The adenovirus in the Janssen Covid‑19 vaccine cannot reproduce and does not cause disease, said the European Commission.
Results from the phase 3 ENSEMBLE study demonstrated that the Janssen Covid‑19 vaccine was well tolerated and had delivered a reduction of 67% in symptomatic Covid-19 disease in participants when compared to those who were given a placebo.
Paul Stoffels – Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, commenting on the Janssen Covid‑19 vaccine, said: “This vaccine is the result of more than a decade of investment in research and development and deep commitment by our scientists. We appreciate the collaboration and the support of the European Commission in this monumental effort.
“With this Conditional Marketing Authorization, we are proud to bring our single-shot vaccine to help protect millions of people across EU member states.”