Mid-March timeline for European approval of single-shot Janssen COVID-19 vaccine

The European Medicines Agency has set mid-March as a timeline for possible approval of the COVID-19 vaccine produced by Janssen.

Janssen says its vaccine only requires one shot, unlike those currently available on the market that require two shots taken a few weeks apart.

The company, an offshoot of Johnson and Johnson, filed an application for conditional marketing authorisation with EMA on Tuesday.

The European medicines regulator said its human medicines committee will assess the Janssen vaccine under an accelerated timetable.

“The Committee could issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust,” EMA said on its website.

It noted that such a short time for evaluation was only possible because EMA had already reviewed some data during a rolling review.

EMA has already approved three other COVID-19 vaccines for distribution in the European market – Pfizer/BioNTech, Moderna and AstraZeneca.

EMA said the Janssen vaccine works by preparing the body to defend itself against COVID-19. It is made up of another virus that has been modified to contain the gene for making the SARS-CoV-2 spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells.

Once it has been given, the vaccine delivers the SARS-CoV-2 spike protein gene into cells in the body. The cells will use the gene to produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate white blood cells to attack it.

The virus in the vaccine cannot reproduce and does not cause disease.