Johnson & Johnson's Janssen Submits Prospectus for EU-Approved Single-Dose COVID-19 Vaccine
Johnson & Johnson
Healthcare Product Manufacturers, Health Service Providers
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
Janssen Pharmaceuticals
Pharmaceutical R&D Developer
On March 12, the European Medicines Agency (EMA) announced on the 11th its assessment results for a COVID-19 vaccine developed by Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson, concluding that it demonstrates favorable efficacy and safety. On the same day, based on the EMA’s recommendation, the European Commission granted conditional marketing authorization for this vaccine in the European Union. This marks the fourth COVID-19 vaccine approved in the EU and the first single-dose COVID-19 vaccine, indicated for individuals aged 18 years and older.
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