"Vaxzevria" is a vaccine that helps protect against coronavirus infection (COVID-19 disease) in individuals over 18 years of age.
"Vaxzevria" is made using another virus of the family of adenoviruses, which is modified to contain a gene encoding the SARS-CoV-2 spike protein. This vaccine does not contain the virus itself and cannot cause COVID-19 disease.
For more information about the vaccine, see the vaccine informational documents, including the package leaflet.
"Vaxzevria" is introduced in two injections, usually into the muscle of the upper arm. An interval of 4-12 weeks is made between injections.
National authorities are responsible for supplying the vaccine. For more information about using Vaxzevria, see the package leaflet or consul a healthcare professional.
"Vaxzevria" helps the body prepare to defend itself against SARS-CoV-2 coronavirus. This virus uses spike proteins in its outer layer to get into the cells of the body, thereby causing the disease. "Vaxzevria" is made using another virus of the family of adenoviruses, which is modified to contain a gene encoding the SARS-CoV-2 spike protein. The adenovirus itself is not able to multiply and therefore does not cause the disease. When the vaccine is administered, the SARS-CoV-2 gene enters the cells of the body, so that the cells in the body begin to produce the spike protein according to this gene. The human immune system recognizes this spike protein as alien to the body, so antibodies and T cells begin to be produced against it, which are the natural components of the immune system's defence. Later, if the vaccinated person has contact with the SARS-CoV-2 virus, his immune system is able to recognize the virus and is ready to fight it: antibodies and T cells, acting together, can kill the virus, prevent its entry into the cells of the body and destroy infected cells, thereby helping protect yourself from COVID-19 disease.
The results of four clinical trials conducted in the United Kingdom (UK), Brazil and South Africa showed that the Vaxzevria vaccine safely and effectively prevented the spread of COVID-19 disease among people over 18 years of age. Approximately 24,000 people were involved in these clinical trials. Half of them received the "Vaxzevria" vaccine and the other half received a vaccine to prevent diseases other than COVID-19. People did not know if they were given a "Vaxzevria" vaccine or an injection of another vaccine.
The safety of the vaccine has been demonstrated in four clinical trials. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) supported the calculations on the effectiveness of the vaccine from COV002 study (conducted in the UK) and COV003 study (conducted in Brazil). In the other two studies, fewer than 6 cases of COVID-19 disease were detected, so the number was too low to calculate the effectiveness of the vaccine to prevent disease. Also, as the vaccine should be administered twice and the second dose should be administered 4-12 weeks after the first one, the EMA CHMP focused on data from subjects who were vaccinated according to this standard vaccination scheme.
Studies showed that 59.6% of patients receiving the vaccine did not experience symptomatic COVID-19 disease (68 out of 5494 subjects had symptomatic COVID-19 disease in the "Vaxzevria" vaccine group compared to those receiving another medicine — 164 out of 5438 subjects who had symptomatic COVID-19 disease). This means that the effectiveness of the vaccine as measured in clinical trials is approximately 60%. You can find the latest information about the studies here.
Most of the participants in the above clinical trials were between the ages of 18 and 55. So far, there are not enough results yet to allow EMA to accurately assess the effectiveness of the vaccine in the elderly population. However, in view of the fact that an immune response is observed in the older population, and based on experience with other vaccines, the vaccine is expected to be effective in this population as well. There is also reliable information about the safety of this vaccine in this patient population, which is why EMA experts have decided that the vaccine can also be used to treat the elderly. More information is expected to be obtained in the near future from ongoing clinical trials involving more elderly individuals.
In 185 people who had already had COVID-19 disease, the study did not experience any additional side effects.
The study did not provide sufficient data to assess how well "Vaxzevria" works in people who have already had COVID-19 disease.
The effect of vaccination with Vaxzevria, in terms of the spread of infection in the community, is not yet known. It is not yet known how many vaccinated people may still be distributors of the virus.
At the moment, this is not yet exactly known. In a clinical trial, vaccinated people will continue to be monitored throughout the year in order to collect as much information as possible.
Currently, "Vaxzevria" is not recommended for vaccination of children. The European Medicines Agency has agreed with the company on a plan to conduct clinical trials including children later.
There is limited data on how people with immune system problems respond to the vaccine. Although such individuals may not respond so well to the vaccine, there are no special problems with the safety of the vaccine so far. These people can still be vaccinated because they are at a higher risk of developing COVID-19 disease.
Very little data has been obtained on the use of the “Vaxzevria” vaccine during pregnancy or during the feeding of the baby.
A decision on the use of the vaccine in pregnant and lactating women should be taken after consultation with a healthcare professional and considering the benefits and risks of vaccination.
People who know that they are allergic to any of the components of the vaccine listed in section 6 of the package leaflet should not be vaccinated.
People who received the vaccine and have experienced allergic reactions (hypersensitivity). There have been very few cases of anaphylaxis (a severe allergic reaction) after the vaccine was started for mass vaccination. Therefore, as with all vaccines, “Vaxzevria” should be administered under close medical supervision and appropriate medical care. People who develop a severe allergic reaction when they are given the first dose of “Vaxzevria” should not receive a second dose.
The main study involved people of different nationalities and sexes. The efficacy of the vaccine remained high in both sexes as well as in subjects of different races and nationalities.
In the study, the most common side effects of “Vaxzevria” were mild to moderate, and human health improved within a few days after vaccination. People experienced pain and sensitivity at the injection site, fatigue, complained of headache, muscle and joint pain, chills and fever, nausea and general feeling unwell. These side effects occurred in more than 1 in 10 subjects in the study. Vomiting and diarrhoea occurred in less than 1 in 10 people. Less than 1 in 100 people experienced decreased appetite, dizziness, sweating, abdominal pain and rash.
Like all vaccines, the vaccine “Vaxzevria” should be administered carefully, providing adequate health care.
“Vaxzevria” provides sufficient protection against COVID-19 disease, which is necessary in the presence of a pandemic. Clinical studies have shown that the effectiveness of the vaccine is 60%. Most side effects are mild to moderate and pass within a few days.
Therefore, the European Medicines Agency (EMA) has decided that the benefits of "COVID-19 Vaccine AstraZeneca" outweigh the risks and that it can be authorized and used in the European Union.
The EMA Committee for Medicinal Products for Human Use (CHMP) recommended that "Vaxzevria" be granted conditional authorization. This means that the company producing the vaccine will also have to provide further evidence on the safety, efficacy and quality of the vaccine. The EMA will review all new information received and update this review if necessary.
As the conditional registration of “Vaxzevria” has been approved, the company will continue to provide the results of the clinical trials that are taking place at the moment. These and other additional studies will provide information on how long the protection against COVID-19 disease lasts, how well the vaccine protects against severe symptom COVID-19 disease and new virus strains, and how well it protects people with weak immunity, children and pregnant women, and whether it prevents the way to asymptomatic cases.
In addition, independent studies of COVID-19 vaccines, coordinated by the institutions of the European Union, will also provide more information on the long-term safety and benefits of the vaccine to the general public.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of “Vaxzevria” have been included in the summary of product characteristics and the package leaflet.
There is also a risk management plan for “Vaxzevria”, which provides important information on the safety of the vaccine and specifies how to collect further information and how to minimize potential risks.
In order to ensure the collection and analysis of information on the safety of “Vaxzevria”, all safety measures provided in the EU Safety Monitoring Plan for COVID-19 vaccines will be implemented. The company will submit reports monthly.
As with all other drugs, data on the use of “Vaxzevria” will be constantly monitored. Each suspected side effect reported with “Vaxzevria” is carefully evaluated and all necessary steps are taken to protect patients.
The Committee of Human Medicinal Products, CHMP) approved the conditional authorization of "Vaxzevria" on 29 January 2021. Following approval by the European Commission, this authorization entered into force throughout the European Union.
Detailed guidelines for the use of this preparation are described in the preparation's information documents, which are published in English and are available in all the official languages of the European Union.