The European Medicines Agency says it has received a request from Johnson & Johnson for its one-shot coronavirus vaccine to be authorised.
In a statement on Tuesday, the Amsterdam-based medicines regulator for the European Union said it could issue an opinion by the middle of March provided that company data on the vaccine's efficacy, safety and quality are sufficiently comprehensive.
It is the fourth COVID-19 vaccine to seek approval in the EU, after earlier shots made by Pfizer and BioNTech, Moderna and AstraZeneca were all given the green light. But unlike those vaccines, the J&J vaccine requires only a single dose.
Preliminary results from a large trial in the U.S., Latin America and South Africa suggested J&J's vaccine was safe and offered strong protection against moderate to severe COVID-19.
The shot is also being vetted by the U.S. Food and Drug Administration, whose expert panel will meet on February 26 to publicly debate the vaccine's data.