The European Commission granted a conditional marketing authorisation for the fourth COVID-19 vaccine, developed by Janssen Pharmaceutica NV.

This authorisation follows a positive scientific recommendation based on an expedited assessment of the vaccine safety, efficacy and quality conducted by the Human Medicines Committee at the European Medicines Agency (EMA).

The vaccine has been authorised to prevent COVID-19 disease in people from 18 years of age and to be used as a single dose.

In addition, a Paediatric Investigation Plan (PIP) was agreed between the agency and the company to assess the vaccine reactogenicity, immunogenicity and safety in the paediatric population from birth to less than 18 years of age.

Results from a clinical trial (NCT04505722) involving over 44000 people in the United States, South Africa and Latin American countries found that COVID-19 Vaccine Janssen was effective at preventing COVID-19 in adults.

The trial showed a 67% reduction in the number of symptomatic COVID-19 cases after 2 weeks in people who received COVID-19 Vaccine Janssen (116 cases out of 19,630 people) compared with people given placebo (348 of 19,691 people). This means that the vaccine had a 67% efficacy.

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 safety and effectiveness of the vaccine will continue to be monitored across Europe, through the European pharmacovigilance system and additional studies promoted by the company and the European authorities.

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