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AS OF 1 JULY 2021 – NATIONAL EMERGENCY

Frequently Asked Questions

"COVID-19 Vaccine Moderna" is a vaccine that helps protect against coronavirus infection (COVID-19 disease) in individuals over 18 years of age.

Vaccine “COVID-19 Vaccine Moderna” contain genetic information (hereinafter referred to as mRNA) about the spike protein of the virus SARS-CoV-2, which causes COVID-19 disease.  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, amongst which is the package leaflet.

Last updated: 10 05 2021

"COVID-19 Vaccine Moderna" is given in two injections, usually into the upper arm muscle. A 28-day interval is made between injections.

National authorities are responsible for supplying the vaccine. For more information about using "COVID-19 Vaccine Moderna", see the package leaflet or consul a healthcare professional.

Last updated: 10 05 2021

"COVID-19 Vaccine Moderna" prepares the body to defend itself against 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, while 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.

The mRNA of the vaccine does not remain in the body and is broken down shortly after vaccination.

Last updated: 10 05 2021

A large-scale clinical study showed that "COVID-19 Vaccine Moderna" effectively prevented the spread of COVID 19 disease among subjects over 18 years of age. About 30,000 people participated in the study. Half of them received the vaccine and the other half was given placebo. People did not know if they were given a "COVID-19 Vaccine Moderna" vaccine or an injection of a placebo.

The effectiveness of the vaccine was estimated from data regarding more than 28,000 people (aged 18 to 94 years) who did not show signs of coronavirus infection. The study showed that 94.1% of subjects receiving the vaccine had no symptoms of COVID-19 (11 out of 14,134 subjects had COVID-19 symptoms) compared to those receiving placebo (185 out of 14,073 subjects had COVID-19 symptoms). This means that the effectiveness of the vaccine is 94.1%.

The study also showed approximately 90.9% effectiveness of the vaccine in those participants who are at risk of severe COVID-19 disease (persons with asthma, chronic lung disease, diabetes, HIV, high blood pressure or overweight).

Last updated: 10 05 2021

The study did not experience any additional side effects in 343 people who had already had COVID-19 disease

The study did not have enough data to conclude how well "COVID-19 Vaccine Moderna" works in people who have already had COVID-19 disease.

Last updated: 10 05 2021

The effect of vaccination with "COVID-19 Vaccine Moderna", in terms of the spread of infection in the community, is not yet known. It is not yet known how many vaccinated people are still able to spread the virus.

Last updated: 10 05 2021

At the moment, this is not yet exactly known. In a clinical trial, vaccinated people will continue to be monitored during 2 years in order to collect as much information as possible.

Last updated: 10 05 2021

Currently, "COVID-19 Vaccine Moderna" is not recommended for use for children. The European Medicines Agency (EMA) has agreed with the company on a plan to subsequently test the vaccine on children.

Last updated: 10 05 2021

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.

Last updated: 10 05 2021

Laboratory studies on animals did not show any harmful effects on pregnancy, but there is very little data on the use of the vaccine “COVID-19 Vaccine Moderna” 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.

Last updated: 10 05 2021

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 found allergic reactions (hypersensitivity). There have been very few cases of anaphylaxis (a severe allergic reaction) following the introduction of the vaccine in vaccination campaigns. As with all vaccines, the vaccine “COVID-19 Vaccine Moderna vaccine” 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 “COVID-19 Vaccine Moderna” should not take the second dose.

Last updated: 10 05 2021

The main study involved people of different nationalities and sex. The high efficacy of the vaccine remained present for both sexes, as well as all racial and ethnic groups.

Last updated: 10 05 2021

In the study, the most common side effects of using "COVID-19 Vaccine Moderna" 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. Some were sick with nausea and vomiting. These side effects occurred in more than 1 in 10 subjects in the study.

Redness at the injection area and rash occurred in less than 1 in 10 people. Itching at the injection area occurred in less than 1 in 100 people. Swelling of the face that may affect people who have previously undergone cosmetic injections, as well as muscle weakness on one side of the face (acute peripheral facial paralysis or paralysis) has been reported rarely, less than 1 in 1,000 people.

Allergic reactions have also been reported with "COVID-19 Vaccine Moderna", including very few severe allergic reactions (cases of anaphylaxis). As with all vaccines, "COVID-19 Vaccine Moderna" should be administered carefully with appropriate treatment.

Last updated: 10 05 2021

"COVID-19 Vaccine Moderna" offers a high level of protection against COVID-19 disease, which is necessary in case of a pandemic. Clinical studies have shown that the effectiveness of the vaccine is 94,1%. Most side effects are mild to moderate and pass within a few days.

Therefore, the EMA has decided that the benefits of "COVID-19 Vaccine Moderna" outweigh the risks and that it can be authorized and used in the European Union.

EMA approved the conditional registration of "COVID-19 Vaccine Moderna" This means that the company producing the vaccine will have to provide more evidence. The EMA will review all new information received and update this review if necessary.

Last updated: 10 05 2021

As the conditional registration of the "COVID-19 Vaccine Moderna" 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.

Last updated: 10 05 2021

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of "COVID-19 Vaccine Moderna" have been included in the summary of product characteristics and the package leaflet.

There is also a risk management plan for "COVID-19 Vaccine Moderna" 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 "COVID-19 Vaccine Moderna “vaccine, 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 the "COVID-19 Vaccine Moderna" vaccine  will be constantly monitored. Each suspected side effect reported with the use of the "COVID-19 Vaccine Moderna" vaccine is carefully evaluated and all necessary steps are taken to protect patients.

Last updated: 10 05 2021