EMA recommends Johnson & Johnson COVID-19 vaccine for authorisation
After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the criteria for efficacy, safety and quality. COVID-19 Vaccine Janssen is the fourth vaccine recommended in the EU for preventing COVID-19.
This is the first vaccine which can be used as a single dose
, said Emer Cooke, EMA’s Executive Director.
Results from a clinical trial involving people in the United States, South Africa and Latin American countries found that COVID-19 Vaccine Janssen was effective at preventing COVID-19 in people from 18 years of age.
This study involved over 44,000 people. Half received a single dose of the vaccine and half were given placebo (a dummy injection). People did not know if they had been given COVID-19 Vaccine Janssen or placebo.
The trial found 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 as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.
How does COVID-19 Vaccine Janssen work?
COVID-19 Vaccine Janssen works by preparing the body to defend itself against COVID-19. It 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 SARS-CoV-2 virus which it needs to enter the body’s cells.
The adenovirus passes the SARS-CoV-2 gene into the vaccinated person’s cells. The cells can then use the gene to produce the spike protein. The person’s immune system will recognise the spike protein as foreign and produce antibodies and activate T cells (white blood cells) to target it.
Later, if the person comes into contact with SARS-CoV-2 virus, the person’s immune system will recognise the spike protein on the virus and be ready to defend the body against it.
The adenovirus in the vaccine cannot reproduce and does not cause disease.
The effect of COVID-19 Vaccine Janssen on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not yet known how much vaccinated people may still be able to carry and spread the virus.
Protection with COVID-19 Vaccine Janssen starts around 14 days after vaccination but it is not currently known how long protection continues. The people vaccinated in the clinical trials will continue to be followed for 2 years to gather more information on the duration of protection.
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