The European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation for the single-dose Janssen (Johnson&Johnson) COVID-19 vaccine.
It comes as the company revealed to EU lawmakers that the vaccine will likely not be delivered until mid-April.
"After a thorough evaluation, EMA's human medicines committee concluded by consensus that the data on the vaccine were robust and met the criteria for efficacy, safety and quality," the EMA said in a statement.
"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," EMA's Executive Director Emer Cooke added.
The Commission authorised the use of the Janssen vaccine hours later.
The Janssen vaccine is the fourth one to be approved by the EU regulator, after Pfizer/BioNTech, AstraZeneca/Oxford University and Moderna.
The jab is made up of a virus modified to contain the gene for making the SARS-CoV-2 spike protein, which one injected, triggers the immune system into producing antibodies to counter it.
A clinical trial involving over 44,000 people in the US, South Africa and Latin American countries found it had a 67 per cent efficacy rate.
Side effects "were usually mild or moderate and cleared within a couple of days after vaccination," the EMA said in its statement. The most common ones were pain at the injection site, headache, tiredness, muscle pain and nausea.
EU chief Ursula von der Leyen welcomed the EMA's latest announcement, writing on Twitter: "More safe and effective vaccines are coming o the market."
She added that the Commission has "just authorised the use" of the Janssen vaccine.
The EU's contract with Janssen was struck in October 2020 and allows member states to purchase 200 million doses, with the possibility to acquire a further 200 million doses.
But despite the approval this month, the first doses are unlikely to be rolled out across the bloc until next month at the earliest.
"It's a good vaccine and it is possible to get protection with only one shot. But the problem is that definitely Johnson & Johnson will not deliver immediately like BioNTech/Pfizer did in December," German MEP Dr. Peter Liese told Euronews.
"They are speaking about mid-April and it's not sure, I hope they will make it. But they didn't give assurance that the promised delivery of 50 million doses in the second quarter will definitely be there.
"First of all, they should be faster. And second, they should deliver the 50 million doses as promised," he added.
The vaccine was authorised for use in the US on February 28. The company said that it would deliver 20 million doses to the US in March and a total of 100 million by the end of June.