The European Union’s drugs regulator has recommended conditionally approving Johnson & Johnson’s (Janssen) single dose Covid-19 vaccine.
This European Medicines Agency (EMA) approval today clears the way for the European Commission to approve its use, possibly as soon as tomorrow.
“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,” This is the first vaccine that can be used as a single dose,” EMA’s Executive Director Emer Cooke said.
Results from a clinical trial involving people in the United States, South Africa and Latin American countries found that Covid-19 Vaccine Janssen was effective at preventing Covid-19 in people from 18 years of age. This study involved over 44,000 people. Half received a single dose of the vaccine and half were given placebo (a dummy injection). People did not know if they had been given Covid-19 Vaccine Janssen or placebo. (Link)
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 most common ones were pain at the injection site, headache, tiredness, muscle pain and nausea.
The company has committed to deliver 200 million doses to the EU this year. The vaccine was already been approved for use in the USA.