The European Medicine Agency (EMA) on Thursday recommended granting a conditional marketing authorization for the COVID-19 vaccine developed by Johnson & Johnson.
The vaccine developed by pharmaceutical Janssen, owned by the US' Johnson & Johnson, is the first COVID-19 vaccine that can be used as a single dose.
"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, the agency's executive director, in a statement.
The vaccine is the fourth vaccine recommended by the agency to combat COVID-19, after BioNTech/Pfizer, Moderna, and AstraZeneca.
"The trial found a 67% reduction in the number of symptomatic COVID-19 cases after 2 weeks in people who received COVID-19 Vaccine Janssen," said the agency.
While Janssen's efficacy rate is lower than other European-approved vaccines, health experts have touted the ease of its single dose as well as its not needing special refrigeration.
"The side effects with COVID-19 Vaccine Janssen in the study were usually mild or moderate and cleared within a couple of days after vaccination," the agency added.
The European Commission is expected to give quick final authorization for marketing the vaccine.
Janssen has promised to ship 200 million doses to the bloc between April and June, and a further 200 million doses are expected afterwards.
The news came as several European countries suspended use of the AstraZeneca vaccine over possible side effects in the form of serious or even fatal blood clots.
The addition of Janssen might speed up the bloc's vaccination campaign since it only needs to be administered once, while other jabs need a second dose.
The EU aims to vaccinate 70% of its adult population by the end of September.