The vaccine will be assessed by the EMA Human Medicines Committee (CHMP). The opinion may be issued by mid-March 2021, provided that the research results provided by the company regarding the effectiveness, safety and quality of the vaccine are sufficiently comprehensive and reliable.
If EMA concludes that the benefits of the vaccine outweigh its risks, it will recommend conditional marketing authorization. Then, the European Commission will decide on the marketing authorization in all EU and EEA (European Economic Area) Member States.
This is the fourth application for authorization of a COVID-19 vaccine since the start of the coronavirus pandemic. Previously, preparations of the companies Pfizer / BioNTech, Moderna and AstraZeneca were authorized.
Janssen consists of another virus (adenovirus) that has been modified to contain the gene that produces the SARS-CoV-2 spike protein. This is a protein found on the surface of the SARS-CoV-2 virus that the virus needs to enter the body’s cells.
When administered, the vaccine delivers the SARS-CoV-2 protein gene to the body’s cells. A person’s immune system will recognize this protein as foreign and will make antibodies and activate T lymphocytes (white blood cells) to attack them.
If a person later comes into contact with the SARS-CoV-2 virus, their immune system will recognize the proteins of the virus and be ready to defend the body against it.
The adenovirus in the vaccine cannot reproduce and does not cause disease.