"Comirnaty" is a vaccine that helps protect against coronavirus infection (COVID-19 disease) in individuals over 16 years of age.
Vaccine “Comirnaty” contain genetic information (hereinafter referred to as mRNA) about the spike protein of the virus SARS-CoV-2, which causes COVID-19 disease.
The vaccine “Comirnaty” does not contain the virus itself, and it cannot cause COVID-19 disease.
"Comirnaty" vaccine is introduced in two injections, usually into the muscle of the upper arm. An interval of 21 days is made between injections.
The “Comirnaty” vaccine prepares the body to be resistant to COVID-19 disease.
The vaccine contains genetic information (mRNA) on the spike protein, coated with fine particles of fat that prevent the breakdown of mRNA.
When a person is given the vaccine, the cells in his body are able to "read" the genetic information encoded in the vaccine and begin to produce the spike protein. The human immune system recognizes this protein as alien to the body and activates T cells, stimulating the production of antibodies, which are part of the natural protection against foreign substances.
Later, if the vaccinated person's body is introduced to 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 terminate the virus, prevent its entry into the cells of the body and destroy infected cells, thereby helping protect yourself from COVID-19 disease.
A very large clinical trial showed that the vaccine “Comirnaty” effectively prevented the spread of COVID-19 disease among individuals over 16 years of age.
The study did not experience any additional side effects in 545 people who had already had COVID-19 disease
Currently, the “Comirnaty” vaccine is not recommended for use in persons under 16 years of age.
There is insufficient data on how the people with immune system problems react 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.
Laboratory studies on animals did not show any harmful effects on pregnancy, but there is very little data on the use of the vaccine “Comirnaty” during pregnancy or while feeding the baby.
A decision on the use of the vaccine in pregnant and lactating women should be taken only 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 the package information leaflet should not be vaccinated.
People who received the vaccine and have found allergic reactions (hypersensitivity). There have been very few cases of severe allergic reactions following the introduction of the vaccine in vaccination campaigns. As with all vaccines, the vaccine “Comirnaty” should therefore be administered under close medical supervision and appropriate treatment.
People who develop a severe allergic reaction when they are given the first dose of the vaccine “Comirnaty” should not take the second dose.
The main study involved people of different nationalities and sexes. The 95% efficacy of the vaccine remained the same between both sexes and racial and ethnic groups.
In the study, the most common side effects of using “Comirnaty” were mild to moderate, and human health improved within a few days after vaccination. People experienced pain and swelling at the injection site, fatigue, complained of headache, muscle and joint pain, chills and fever. These side effects occurred in more than 1 in 10 subjects in the study.
Redness at the injection area and nausea occurred in less than 1 in 10 people.
Itching at the injection area, limb pain, enlarged lymph nodes, sleep disturbance and malaise were uncommon side effects affecting less than 1 in 100 people.
The vaccine “Comirnaty” offers a high level of protection against COVID-19 disease, which is the basis for registering this vaccine. The benefits from it are significantly greater than the possible negative consequences.
Clinical studies have shown that the effectiveness of the vaccine is 95%.
As the conditional registration of the “Comirnaty” vaccine has been approved, the company will continue to provide the results of clinical trials lasting 2 years.
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 cases 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 “Comirnaty” have been included in the summary of product characteristics and the package information leaflet.
There is also a risk management plan for “Comirnaty” vaccine, 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 “Comirnaty” vaccine, all safety measures provided in the EU Safety Monitoring Plan for COVID-19 vaccines will be implemented. Vaccine manufacturers will report on a monthly basis.
As with all other drugs, data on the use of the “Comirnaty” vaccine will be constantly monitored. Each suspected side effect reported with the use of the “Comirnaty” vaccine is carefully evaluated and all necessary steps are taken to protect patients.