COVID-19 Vaccine AstraZeneca is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. COVID-19 is caused by SARS-CoV-2 virus.
COVID-19 Vaccine AstraZeneca is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein from SARS-CoV-2.
COVID-19 Vaccine AstraZeneca does not contain the virus itself and cannot cause COVID-19.
Detailed information about this vaccine is available in the product information, which includes the package leaflet.
How is COVID-19 Vaccine AstraZeneca used?
COVID-19 Vaccine AstraZeneca is given as two injections, usually into the muscle of the upper arm. The second dose should be given between 4 and 12 weeks after the first dose.
Arrangements for the supply of the vaccine will be the responsibility of national authorities. For more information about using COVID-19 Vaccine AstraZeneca, see the package leaflet or consult a healthcare professional.
How does COVID-19 Vaccine AstraZeneca work?
COVID-19 Vaccine AstraZeneca works by preparing the body to defend itself against COVID-19. It is made up of another virus (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 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 it and be ready to defend the body against it.The adenovirus in the vaccine cannot reproduce and does not cause disease.
What benefits of COVID-19 Vaccine AstraZeneca have been shown in studies?
Combined results from 4 clinical trials in the United Kingdom, Brazil and South Africa showed that COVID-19 Vaccine AstraZeneca was safe and effective at preventing COVID-19 in people from 18 years of age. These studies involved around 24,000 people altogether. Half received the vaccine and half were given a control injection, either a dummy injection or another non-COVID vaccine. People did not know if they had been given the test vaccine or the control injection.
The Agency based its calculation of how well the vaccine worked on the results from study COV002 (conducted in the UK) and study COV003 (conducted in Brazil). The other two studies had fewer than 6 COVID-19 cases occurring in each, which was not enough to measure the preventive effect of the vaccine. In addition, as the vaccine is to be given as two standard doses, and the second dose should be given between 4 and 12 weeks after the first, the Agency concentrated on results involving people who received this standard regimen.
These showed a 59.5% reduction in the number of symptomatic COVID-19 cases in people given the vaccine (64 of 5,258 got COVID-19 with symptoms) compared with people given control injections (154 of 5,210 got COVID-19 with symptoms). This means that the vaccine demonstrated around a 60% efficacy in the clinical trials.
Most of the participants in these studies were between 18 and 55 years old. There were not enough results in older participants (over 55 years old) to provide a figure for how well the vaccine will work in this group. However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines; as there is reliable information on safety in this population, EMA’s scientific experts considered that the vaccine can be used in older adults. More information is expected from ongoing studies, which include a higher proportion of elderly participants.
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