The EMA recommends the Janssen COVID-19 vaccine for approval in the EU

11.03.2021 15:19

The EMA has recommended granting conditional marketing authorization for the Janssen COVID-19 vaccine to prevent COVID-19 in people aged 18 and over. COVID-19 vaccine Janssen is the fourth vaccine recommended in the EU to prevent COVID-19.

After a thorough assessment, the EMA Committee for Medicinal Products for Human Use (CHMP) unanimously concluded that the data on the vaccine were robust and met the criteria for effectiveness, safety and quality.

“With this latest positive opinion, authorities across the European Union have another opportunity to fight the pandemic and protect the lives and health of their citizens,” said Emer Cooke, Executive Director of the EMA, adding: “This is the first vaccine that can be used as a single dose “.

Results from a clinical trial involving people in the United States, South Africa and Latin American countries found that the Janssen COVID-19 vaccine was effective in preventing COVID-19 in people aged 18 and over. Over 44,000 people took part in this study. Half received a single dose of the vaccine and the other half received a placebo (a dummy injection). People did not know whether they had received the Janssen COVID-19 vaccine or placebo. The study found a 67% reduction in the number of symptomatic COVID-19 cases after 2 weeks in people who received the Janssen COVID-19 vaccine (116 cases of 19,630 people) compared to people who received placebo (348 of 19,691 people). This means the vaccine had an effectiveness of 67%.

Side effects of the Janssen COVID-19 vaccine in the study were usually mild or moderate and resolved within a few days of vaccination. The most common were pain at the injection site, headache, fatigue, muscle pain and nausea.

The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.