The European Medicines Agency (EMA) has recommended a conditional marketing authorization for the Janssen vaccine (Johnson & Johnson) to prevent COVID-19 in people aged 18 years.

After a thorough evaluation, the EMA Commission for Human Use of Medicinal Products (CHMP) concluded that the vaccine data were strong and met the efficacy, safety and quality criteria. The Janssen vaccine is the fourth vaccine recommended in the EU to prevent COVID-19.

"With this latest positive opinion, Authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens," said Emer Cooke, Executive Director of the EMA. "This is the first vaccine that can be used as a single dose."

The results of a clinical trial involving people in the United States, South Africa and Latin America found that the Janssen vaccine was effective in preventing COVID-19 in people aged 18 years. This study included over 44,000 people. Half received a single dose of the vaccine and half received placebo (placebo injection). Participants did not know if they were given the Janssen vaccine or placebo.

The trial found a 67% reduction in the number of symptomatic cases COVID-19 after 2 weeks in subjects receiving the vaccine COVID-19 Janssen (116 cases out of 19,630 people) compared to people taking placebo (348 out of 19,691 people). This means that the vaccine was 67% effective in two weeks. Similar efficacy was observed at four weeks.

Side effects with the Janssen vaccine in the study were usually mild or moderate and disappeared within two days of vaccination. The most common were injection site pain, headache, fatigue, muscle aches and nausea.

The safety and efficacy of the vaccine will continue to be monitored as it is used throughout the EU, through of the EU pharmacovigilance system and additional studies by the company and the European authorities.

Where to find more information

Janssen Vaccine Product Information contains information for healthcare professionals, a leaflet for members of the public and details of the conditions for approval of the vaccine.

An evaluation report detailing the EMA evaluation of the Janssen vaccine and the full risk management plan will be published within days. Clinical trial data submitted by the company in the marketing authorization application will be published on the website clinical trials of the Agency in due course.

More information is available in a plain language overview of the vaccine, including a description of the benefits and risks of the vaccine and why the EMA recommended its EU approval.

How the Janssen vaccine works Covid-19

The Janssen vaccine works by preparing the body to defend itself against it COVID-19. It consists of another virus (an adenovirus) that has been modified to contain the gene for the production of the SARS-CoV-2 spike protein. This is a protein in the SARS-CoV-2 virus, which must enter the body's cells.

The adenovirus transmits the SARS-CoV-2 gene to the cells of the vaccinated individual. The cells can then use the gene to produce the spike protein. The individual's immune system will recognize the spike protein as foreign and will produce antibodies and activate T cells (white blood cells) to target it.

Later, if the person comes in contact with the SARS-CoV-2 virus, the vaccinated person's immune system will recognize the protein spike in the virus and will be ready to defend the body from it.

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

Conditional marketing authorization

The European Commission will now rapidly follow the decision-making process for the conditional marketing authorization for the Janssen vaccine, allowing vaccination schemes to be developed across the EU.

Conditional Marketing Authorization (CMA) is used as an accelerated approval process to expedite the approval of treatments and vaccines during an EU public health emergency. , what is usually required. This is the case if the benefit of the immediate availability of a drug or vaccine to patients outweighs the risk that not all data are yet available.

The CMA guarantees that the approved drug or vaccine meets strict EU standards for efficacy, safety and quality and is manufactured in approved, certified facilities to high pharmaceutical standards for large-scale production.

Once a CMA has been granted, companies must provide further data from ongoing or new studies within a pre-defined timeframe to confirm that the benefits outweigh the risks.

Monitoring the safety of the Janssen vaccine

In accordance with EU security monitoring plan for vaccines COVID-19, the vaccine COVID-19 Janssen will be closely monitored and subject to various vaccine-specific activities COVID-19. Although a large number of people have received vaccines COVID-19 In clinical trials, some side effects may occur only when millions of people are vaccinated.

Companies are required to provide monthly safety reports in addition to the regular updates required by law and to conduct studies to monitor the safety and effectiveness of vaccines as they are used by the public. In addition, independent studies for vaccines COVID-19 coordinated by EU authorities will provide more information on the long-term safety and benefit of the vaccine to the general population.

These measures will allow regulators to quickly evaluate data from a variety of sources and take the necessary regulatory measures to protect public health.

Evaluation of the Janssen vaccine

During the Janssen vaccine evaluation, the CHMP had the support of the EMA Safety Committee, PRAC, which evaluated the vaccine risk management plan. COVID-19 Janssen and the pandemic task force COVID-19 EMA (COVID-ETF), a team bringing together experts from across the European Medicines Regulatory Network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.

Everything you need to know

What is the vaccine? Janssen and what is it used for?

The vaccine COVID-19 Janssen is a vaccine for the prevention of coronavirus disease 2019 (COVID-19) to people aged 18 and over. THE COVID-19 caused by the SARS-CoV-2 virus.

The vaccine COVID-19 Janssen is made up of another virus (of the adenovirus family) that has been modified to contain the gene for the production of a protein found in SARS-CoV-2.

The vaccine COVID-19 Janssen does not contain SARS-CoV-2 itself and can not cause COVID-19.

Detailed information about this vaccine is available at product information, which includes the package leaflet.

How the vaccine is used Janssen;

The vaccine COVID-19 Janssen is given as a single injection, usually in the upper arm muscle.

Arrangements for the supply of the vaccine will be the responsibility of the national authorities. For more information on using the vaccine COVID-19 Janssen, refer to the package leaflet or consult a healthcare professional.

How does the Janssen vaccine work?

The vaccine COVID-19 Janssen works by preparing the body to defend itself against him COVID-19. It consists of another virus (an adenovirus) that has been modified to contain the gene for the production of the SARS-CoV-2 spike protein. This is a protein in the SARS-CoV-2 virus that must enter the body's cells.

The adenovirus transmits the SARS-CoV-2 gene to the cells of the vaccinated individual. The cells can then use the gene to produce the spike protein. The individual's immune system will recognize the spike protein as foreign and will produce antibodies and activate T cells (white blood cells) to target it.

Later, if the person comes in contact with the SARS-CoV-2 virus, the person's immune system will recognize the protein spike in the virus and will be ready to defend the body from it.

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

What are the benefits of the Janssen vaccine according to studies?

The results of a clinical trial involving people in the United States, South Africa and Latin America found that the vaccine COVID-19 Janssen was effective in preventing it COVID-19 in people aged 18 years. This study included more than 44.000 people. Half received a single dose of the vaccine and half received placebo (placebo injection). People did not know if they were given the vaccine COVID-19 Janssen or placebo.

The trial found a 67% reduction in the number of symptomatic cases COVID-19 after 2 weeks in subjects receiving the vaccine COVID-19 Janssen (116 cases out of 19.630 people) compared to people taking placebo (348 out of 19.691 people). This means that the vaccine was 67% effective at 2 weeks. Similar efficacy was observed at 4 weeks.

Can people who have already passed COVID-19 to be vaccinated with a vaccine COVID-19 Janssen;

There were no additional side effects in the 2.151 people who received the vaccine COVID-19 Janssen in trials and in the past have COVID-19.

There was not enough test data to determine how well the vaccine was working COVID-19 Janssen for people who have already received COVID-19.

Can the Janssen vaccine reduce the transmission of the virus from one person to another?

The effect of the vaccine COVID-19 Janssen on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not yet known how many vaccinated individuals may still be able to transmit and spread the virus.

How long does protection against the Janssen vaccine last?

Vaccine protection COVID-19 Janssen starts about 14 days after vaccination, but it is not yet known how long protection lasts. Individuals vaccinated in clinical trials will continue to be monitored for 2 years to gather more information about the duration of protection.

Can children be vaccinated with the Janssen vaccine?

The vaccine COVID-19 Janssen is not currently recommended for use in children. The EMA agreed with the company for one test plan with the participation of children in a later stage.

Can people vaccinated with immunocompromised people get the Janssen vaccine?

There are no data on immunocompromised individuals (individuals with a weakened immune system). Although immunocompromised individuals may not respond to the vaccine, there are no particular safety concerns. Immunocompromised individuals may still be vaccinated as they may be at greater risk of COVID-19.

Can pregnant or breastfeeding women be vaccinated with the Janssen vaccine?

Animal studies show no harmful effects of the vaccine COVID-19 Janssen in pregnancy. However, data on vaccine use COVID-19 Janssen during pregnancy are very limited.

There are no studies on the vaccine COVID-19 Janssen on breast-feeding, but no risk of breast-feeding is expected.

The 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.

Can people with allergies be vaccinated with the Janssen vaccine?

People who are allergic to one of the components of the vaccine listed in section 6 of the package leaflet should not get the vaccine.

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

How well does the Janssen vaccine work for people of different nationalities and genders?

Clinical trials included people of different nationalities and genders. The vaccine worked in gender and ethnic groups.

What are the risks associated with the Janssen vaccine?

The most common side effects with the vaccine COVID-19 Janssen in the tests were usually mild or moderate and improved within 1 or 2 days after vaccination. The most common side effects are injection pain, headache, fatigue, muscle aches and nausea. They affect more than 1 in 10 people.

Cough, joint pain, fever, chills and redness and swelling at the injection site occurred in less than 1 in 10 people. Sneezing, tremor, sore throat, rash, sweating, muscle weakness, arm and leg pain, back pain, weakness and general malaise in less than 1 in 100 people. Rare side effects (seen in less than 1 in 1.000 people) are hypersensitivity (allergy) and pruritus ani.

Allergic reactions, including a case of rash (severe allergic reaction), have occurred in people receiving the vaccine. As for all vaccines, the vaccine COVID-19 Janssen should be administered under close supervision with appropriate medical care.

Why did the EMA recommend the Janssen vaccine?

The vaccine COVID-19 Janssen offers a good level of protection against it COVID-19 which is vital during the current pandemic. The main test showed that the vaccine is about 67% effective. Most side effects are mild to moderate in severity and last only a few days.

Therefore, the European Medicines Agency has decided that the benefits of the vaccine COVID-19 Janssen outweigh the risks associated with it and may be recommended for EU approval.

The vaccine COVID-19 Janssen is recommended for "conditional marketing authorization". This means that there is more information about the vaccine (see below), which is required by the company. The Agency will review any new information that becomes available and this review will be updated as needed.

What information is still pending about the Janssen vaccine?

As the vaccine COVID-19 Janssen is recommended for conditional marketing authorization, the company marketing the vaccine will provide results from ongoing clinical trials. These tests and additional studies will provide information on how long the protection lasts, the effectiveness of the vaccine against new strains of the virus, how well it protects the elderly, people of different ethnicities, immunocompromised children and pregnant women, if it prevents asymptomatic cases, and the results and timing of a second dose of the vaccine.

In addition, independent studies on vaccines COVID-19 coordinated by EU authorities will also provide more information on the long-term safety and benefit of the vaccine to the general population.

The company will also conduct studies to provide additional assurance on pharmaceutical quality and vaccine control as manufacturing continues to grow.

What measures are being taken to ensure the safe and effective use of the Janssen vaccine?

Recommendations and precautions to be followed by health professionals and patients for safe and effective use of the vaccine COVID-19 Janssen are included in the product summary and in the package leaflet.

There is also a risk management plan for the vaccine COVID-19 Janssen and contains important information about the safety of the vaccine, how to gather further information and how to minimize any potential risks.

Safety measures will be taken for the vaccine COVID-19 Janssen in line with the EU Vaccine Safety Monitoring Plan COVID-19 to ensure that new security information is collected and analyzed quickly. The company that trades the vaccine COVID-19 Janssen will provide monthly security reports.

Like all medicines, the data on the use of the vaccine COVID-19 Janssen are constantly monitored. Suspicious side effects reported with the vaccine COVID-19 Janssen are carefully evaluated and the necessary measures are taken to protect patients.

Other information about the Janssen vaccine

The vaccine COVID-19 Janssen was nominated by the EMA's Committee for Medicinal Products for Human Use (CHMP) on 11 March 2021 for a conditional marketing authorization valid throughout the EU. The European Commission will issue a decision shortly.

Detailed recommendations for the use of this product are described in the product information, which will be available in all official languages ​​of the European Union following a marketing authorization decision by the European Commission.