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AS OF 1 JULY 2021 – NATIONAL STATE OF EMERGENCY

Frequently Asked Questions

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

"COVID-19 Vaccine Janssen" 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, amongst which is the package leaflet.

Last updated: 10 05 2021

"COVID-19 Vaccine Janssen" is given in tone injection, usually into the upper arm muscle. 

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

Last updated: 10 05 2021

"COVID-19 Vaccine Janssen" helps the body prepare to defend itself against SARS-CoV-2 coronavirus. "COVID-19 Vaccine Janssen" 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 protein is located on the surface of the SARS-CoV-2 virus and is necessary for the virus to enter the cells of the body.

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 (white blood cells) begin to be produced against it.

Subsequently, if the vaccinated person has contact with SARS-CoV-2 virus, his immune system is able to recognize the virus and is ready to fight it.

The adenovirus itself is not able to multiply and therefore does not cause the disease.

Last updated: 10 05 2021

The results of a clinical study involving people from the United States, South Africa and Latin America showed that the "COVID-19 Vaccine Janssen" vaccine effectively prevented the spread of COVID-19 disease among persons over 18 years of age. More than 44,000 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 study showed a 67% reduction in symptomatic COVID-19 cases (116 out of 19,630 subjects had symptoms) in two weeks amongst people receiving the vaccine, compared to those receiving placebo (348 out of 19,691 subjects had COVID-19 symptoms). This means that the effectiveness of the vaccine is 67.1 %.

Last updated: 10 05 2021

The study did not experience any additional side effects in 2151 people who had already had COVID-19 disease

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

Last updated: 10 05 2021

The effect of vaccination with "COVID-19 Vaccine Janssen", in terms of the spread of infection in public, is not yet known. It is not yet known how many vaccinated people may still be distributors of the virus.

Last updated: 10 05 2021

Protection against COVID-19 disease begins approximately 14 days after vaccination, but it is not yet known exactly how long it lasts. In a clinical trial, vaccinated people will continue to be monitored during another 2 years in order to collect as much information as possible.

Last updated: 10 05 2021

Currently, "COVID-19 Vaccine Janssen" is not recommended for use for children. The European Medicines Agency has agreed with the company on a plan to conduct clinical trials including children later.Currently, "COVID-19 Vaccine Janssen" is not recommended for use for children. The European Medicines Agency has agreed with the company on a plan to conduct clinical trials including children later.

Last updated: 10 05 2021

There is limited data on how people with immune system problems how  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.

Last updated: 10 05 2021

Animal studies of „COVID 19 Vaccine Janssen“ have not shown harmful effects on pregnancy, but there are still very few data on the use of „COVID 19 Vaccine Janssen“ during pregnancy.

No data are available on the use of „COVID 19 Vaccine Janssen“ during lactation, but it is not expected that the vaccine may present any risk.

A decision on the use of the vaccine in pregnant women should be taken 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.

Allergic reactions (hypersensitivity) have been reported in people receiving the vaccine. One case of anaphylaxis (severe allergic reaction) has been reported in an ongoing clinical trial. Therefore, as with all vaccines, "COVID-19 Vaccine Janssen" should be administered under close medical supervision of a doctor and a possibility to provide appropriate treatment.

Last updated: 10 05 2021

People of different nationalities and both sexes participated in the clinical trials. The high efficacy of the vaccine remained present for both sexes, as well as all racial and ethnic groups.

Last updated: 10 05 2021

The most common side effects with the "COVID-19 Vaccine Janssen" vaccine were generally mild to moderate and human health improved within a few days after vaccination. Most often, people felt pain at the injection area, complained of headaches, muscle pains, fatigue, they were troubled by nausea.  These side effects occurred in more than 1 in 10 subjects in the study.

Cough, joint pain, fever, chills, redness and swelling at the injection area occurred in less than 1 in 10 people. Sneezing, tremor, sore throat, rash, sweating, muscle weakness, pain in the arms and legs, back pain, weakness and general malaise occurred in less than 1 in 100 people.

Rare side effects occurring in less than 1 in 1,000 people consisted of hypersensitive (allergic) and itchy rash.

Allergic reactions, including one severe allergic reaction (case of anaphylaxis), have also been reported with "COVID-19 Vaccine Janssen". As with all vaccines, "COVID-19 Vaccine Janssen" vaccine should be administered under close medical supervision of a doctor and a possibility to provide appropriate treatment.

Last updated: 10 05 2021

"COVID-19 Vaccine Janssen" offers sufficient protection against COVID-19 disease, which is necessary in case of a pandemic. Clinical studies have shown that the effectiveness of the vaccine is 67%. 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 Janssen" outweigh the risks and that it can be authorized and used in the European Union.

EMA CHMP recommended conditional authorization for COVID-19 Vaccine Janssen. This means that the company producing the vaccine will also have to provide further evidence on the safety, efficiency and quality of the vaccine. 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 Janssen" vaccine has been approved, the company will continue to provide the results of clinical trials that are being conducted 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, as well as the time for the second dose of the vaccine.

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 Janssen" have been included in the summary of product characteristics and the package leaflet.

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

Last updated: 10 05 2021

EMA Committee of Human Medicinal Products, CHMP approved a conditional authorization on 11 March 2021. Following approval by the European Commission, this authorization will be valid throughout the European Union. This will allow to extend the scope of vaccination throughout the European Union.

Detailed guidance on the use of this preparation is described in the information documents of the preparation, which are published in English and will be available in all the official languages of the European Union once the European Commission has taken a decision on the registration of the vaccine.

Last updated: 10 05 2021