The official website of the EMA reported on March 11.
“The EMA has recommended granting an interim marketing authorization for the Janssen COVID-19 vaccine for people over the age of 18,” the agency said in a statement.
The EU regulator, after an examination, concluded that the data on the vaccine are reliable and meet the criteria for efficacy, safety, and quality.
Janssen’s COVID-19 vaccine is the fourth vaccine recommended in the EU to prevent coronavirus infection. Earlier, the EU regulator has already approved the German-American vaccine from BioNTech / Pfizer, the British-Swedish vaccine from AstraZeneca, and the American vaccine from Moderna.
The vaccine, developed by the pharmaceutical company Janssen, which is owned by Johnson & Johnson and is based in Belgium, differs from other approved vaccines in that it requires only one dose.
The EU has already ordered 400 million doses of the vaccine.
According to the regulator, the vaccine is 67% effective.
The side effects of the Janssen vaccine during clinical trials were usually mild to moderate and disappeared within a few days after vaccination. The most common of these were pain at the injection site, headache, fatigue, muscle pain, and nausea.