"More safe and effective vaccines are coming to the market. We have just authorised the use of Johnson & Johnson's vaccine in the EU, following EMA positive review," Ursula von der Leyen, the president of the European Commission, wrote on Twitter.
The EU medicines regulator said earlier it was recommending the vaccine be authorised “after a thorough evaluation” of Johnson & Johnson’s data found it met the criteria for efficacy, safety and quality.
“With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens,” said Emer Cooke, executive director of the European Medicines Agency (EMA).
US pharma giant Johnson & Johnson (J&J) filed on February 16 for approval for the vaccine, developed by its Belgian subsidiary Janssen.
Its approval offers a boost for the EU's sluggish vaccination programme, even if reports say the first J&J shipments doses may not arrive in European countries until April.
Stella Kyriakides, the EU's health commissioner, said the vaccine's authorisation marked "another key step towards ensuring that all citizens can access safe and effective vaccinations as soon as possible".
The move comes as several European countries have suspended their roll-out of the AstraZeneca vaccine citing concerns about patients developing blood clots after receiving the jab.
The EU has so far approved three vaccines – Pfizer-BioNTech, Moderna and the AstraZeneca jab developed by the University of Oxford.
Three other vaccines are under "rolling review" by the Amsterdam-based EMA – Novavax, CureVac and Russia's Sputnik V.
As well as being the first that requires a single injection as opposed to two, the Johnson & Johnson vaccine is easier to store.
The J&J shot however appears less protective than Pfizer and Moderna's regimes, which both have an efficacy of around 95 percent against all forms of Covid-19 from the classic coronavirus strain.
(FRANCE 24 with AP, AFP)