BDAR

Frequently Asked Questions

COVID-19 Vaccine Janssen is intended for all vaccine-eligible people ages 18 years or older to protect against coronavirus infection (COVID-19).

Currently, this vaccine is used in Lithuania only as a booster, i.e., it can be given to people who have already received Janssen COVID-19 Vaccine for the primary series. This decision is based on the fact that one dose of COVID-19 Vaccine Janssen is less effective compared to the other vaccines used.

Janssen COVID-19 vaccine is produced from another virus in the adenovirus family that has been modified to contain a gene encoding the SARS-CoV-2 spike protein. The vaccine does not contain the virus itself and cannot cause COVID-19 disease.

For more information about the vaccine, see the product sheets that include the package leaflet.

Last updated: 08 02 2022

Currently, this vaccine is used in Lithuania only as a booster dose.

The booster dose of this vaccine can be received 60 days (2 months) after completing the Janssen primary series.

Last updated: 08 02 2022

Currently, children (under 18 years of age) are not vaccinated with a booster dose of this vaccine.

Last updated: 08 02 2022

COVID-19 Vaccine Janssen is given as an injection, usually into the muscle of the upper arm.

The national authorities are responsible for supplying the vaccine. For more information about using COVID-19 Vaccine Janssen, see the package leaflet or consult your healthcare professional.

Last updated: 08 02 2022

COVID-19 Vaccine Janssen helps your body prepare for the SARS-CoV-2 coronavirus. COVID-19 Vaccine Janssen works by preparing the body to defend itself against COVID-19. It is made up of another virus (an adenovirus) that has been modified to contain the gene for making the SARS-CoV-2 spike protein. This is a protein on the SARS-CoV-2 virus which it needs to enter the body’s cells.

The adenovirus passes the SARS-CoV-2 gene into the vaccinated person’s cells. The cells can then use the gene to produce the spike protein. Human immune system will recognise the spike protein as foreign and produce antibodies and activate T cells (white blood cells) to target it.

Later, in the case of exposure to SARS-CoV-2 virus, the immune system will recognise the spike protein on the virus and be ready to defend the body against it.

The adenovirus in the vaccine cannot reproduce and does not cause the disease.

Last updated: 08 02 2022

Results from a clinical trial involving people in the United States, South Africa and Latin American countries found that COVID-19 Vaccine Janssen was effective at preventing COVID-19 in people from 18 years of age. This study involved over 44 000 people. Half received a single dose of the vaccine and half were given placebo (a dummy injection). People did not know if they had been given COVID-19 Vaccine Janssen or placebo.

The trial found a 67% reduction in the number of symptomatic COVID-19 cases after 2 weeks in people who received COVID-19 Vaccine Janssen (116 cases out of 19 630 people) compared with people given placebo (348 of 19 691 people). This means that the vaccine had a 67% efficacy.

Last updated: 08 02 2022

There were no additional side effects in 2 151 people who received COVID-19 Vaccine Janssen in the trials and had previously had COVID-19.

There were not enough data from the trials to conclude on how well COVID-19 Vaccine Janssen works for people who have already had COVID-19.

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The effect of COVID-19 on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not yet known to what extent vaccinated people may still be able to carry and spread the virus.

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Protection from COVID-19 Vaccine Janssen starts around 14 days after vaccination but it is not currently known how long the protection continues. Those vaccinated in the clinical trials will continue to be followed for 2 years to gather more information on the duration of protection.

Please note that this vaccine is currently used in Lithuania only as a booster dose.

Last updated: 08 02 2022

There are no data on immunocompromised people (people with weakened immune systems).  Although immunocompromised people may not respond as well to the vaccine, there are no particular safety concerns. Immunocompromised people can still be vaccinated as they may be at higher risk from COVID-19.

Last updated: 08 02 2022

Animal studies do not show any harmful effects of COVID-19 Vaccine Janssen in pregnancy. However, data on the use of COVID-19 Vaccine Janssen during pregnancy are very limited.

There are no studies of COVID-19 Vaccine Janssen on breast-feeding but no risk from breast-feeding is expected.

A decision on whether to use the vaccine in pregnant women should be made in close consultation with a healthcare professional after considering the benefits and risks.

Last updated: 08 02 2022

People who have an allergy to one of the components of the vaccine listed in section 6 of the package leaflet should not receive the vaccine.

Allergic reactions (hypersensitivity) have occurred in people receiving the vaccine. One case of anaphylaxis (severe allergic reaction) has occurred in an ongoing study. As for all vaccines, COVID-19 Vaccine Janssen should be given under close medical supervision, with the appropriate medical treatment available in case of allergic reactions.

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The clinical trials included people of different ethnicities and genders. The vaccine worked across genders, races, and ethnic groups.

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The most common side effects with COVID-19 Vaccine Janssen in the trials were usually mild or moderate and got better within 1 or 2 days after vaccination. The most common side effects are pain at the injection site, headache, tiredness, muscle pain and nausea.  More than 1 in 10 people were affected.

Coughing, joint pain, fever, chills, as well as redness and swelling at injection site affected fewer than 1 in 10 people. Sneezing, tremor, throat pain, rash, sweating, muscle weakness, pain in the arms and legs, backache, weakness and feeling generally unwell affected fewer than 1 in 100 people.

Rare side effects (which affected fewer than 1 in 1 000 people) were hypersensitivity (allergy) and itchy rash.

Allergic reactions, including anaphylaxis (severe allergic reaction), have occurred in people receiving the vaccine. As for all vaccines, COVID-19 Vaccine Janssen should be given under close supervision with appropriate medical treatment available.

Last updated: 08 02 2022

COVID-19 Vaccine Janssen provides adequate protection against COVID-19, which is essential in the event of a pandemic. Clinical studies have shown that the vaccine had a 67% efficacy. Most side effects are mild to moderate and go away in a few days.

The EMA therefore concluded that the benefits of COVID-19 Vaccine Janssen outweigh its risks and that it can be registered and used in the European Union.

The EMA CHMP recommended that COVID-19 Vaccine Janssen be given conditional registration. This means that the company that makes the vaccine will have to provide subsequent evidence of the safety, effectiveness and quality of the vaccine. The EMA will review any new information received and this review will be updated as necessary.

Last updated: 08 02 2022

As the conditional registration of COVID-19 Vaccine Janssen has been approved, the company will continue to provide the results of ongoing clinical trials. This and other additional studies will provide information on how long protection against COVID-19 lasts, how well the vaccine protects against severe cases of COVID-19 and new strains of the virus, and how well it protects immuno-compromised patients, children, pregnant women and whether it prevents asymptomatic cases and the timing of a booster dose.

Furthermore, independent research into COVID-19 vaccines, coordinated by EU institutions, will also provide more information on the long-term safety and benefits of the vaccine for the public at large.

Last updated: 08 02 2022

The Product Characteristics and Package Leaflet contain recommendations and precautions that healthcare professionals and patients should follow in order to use COVID-19 Vaccine Janssen safely and effectively.

A risk management plan has also been developed for COVID-19 Vaccine Janssen, which provides important information on the safety of the vaccine, how to gather further information and how to reduce potential risks.

To ensure that information on the safety of COVID-19 Vaccine Janssen is collected and analysed, all safety measures provided for in the EU Monitoring Plan for the Safety of COVID-19 Vaccines will be implemented. The company will provide monthly reports.

As with all medicines, COVID-19 Vaccine Janssen will be subject to regular monitoring. Any suspected side effects reported with COVID-19 Vaccine Janssen will be carefully assessed and all necessary steps taken to protect patients.

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EMA Committee for Medicinal Products for Human Use (CHMP) approved the conditional registration on 11 March 2021. Once approved by the European Commission, it will be valid throughout the European Union. This will make it possible to expand vaccination coverage throughout the European Union.

Detailed instructions for use of this product are described in the package leaflet, which is published in English and will be available in all official languages of the European Union when the European Commission decides to register the vaccine.

Last updated: 08 02 2022