European Medicines Agency has recommended granting a conditional marketing authorisation for COVID-19 vaccine Janssen from Johnson&Hohnson to prevent COVID-19 in people from 18 years of age.
After a thorough evaluation, EMA’s human medicines committee (CHMP) published the consensus that the data on the vaccine were robust and met the criteria for efficacy, safety and quality. COVID-19 Vaccine Janssen is the fourth vaccine recommended in the EU for preventing COVID-19.
“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,” Emer Cooke, EMA’s Executive Director said, adding, “this is the first vaccine which 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 COVID-19 Vaccine Janssen was effective at preventing COVID-19 in people from 18 years of age. This study involved over 44,000 people.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
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.
This is the fourth vaccine recommended for use in the European Union. The first three include BioNTech/Pfizer, AstraZeneca, and Moderna.
It is noted that the vaccine is effective in combating other strains of the COVID-19 virus, including SARS-CoV-2 B.1.3511, found in South Africa.
The conditions of storage of a single-component vaccine comply with the conditions of standard vaccine distribution channels, which is a crucial factor in the context of the pandemic.