The Covid-19 vaccine being developed by Johnson and Johnson has been submitted for approval to the European Medicines Agency (EMA).
EMA’s human medicines committee will assess the vaccine, known as COVID-19 Vaccine Janssen, under an accelerated timetable which could see a decision being made on the single-shot vaccine by the middle of next month.
However, this is assuming the data relating to the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust, the EMA said.
In a trial of nearly 44,000 volunteers, the jab was shown to be 66% effective against Covid-19 and 100% effective in preventing hospitalisation and death.
Unlike the Pfizer/BioNTech and Moderna vaccines, the Johnson & Johnson vaccine does not require a second shot weeks after the first or need to be kept frozen.
Ireland has ordered 2.2 million doses of the Johnson & Johnson vaccine.
Johnson and Johnson's Covid-19 vaccine is made up of another virus (an adenovirus) 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 T cells (white blood cells) to attack it.
If, later on, the person comes into contact with SARS-CoV-2 virus, their immune system will recognise the spike proteins on the virus and be ready to defend the body against it.
The adenovirus in the vaccine cannot reproduce and does not cause disease.
South Africa is set to become the first country to administer the Covid-19 vaccine created by Johnson & Johnson as it begins rolling out the vaccine later this week.