1. What is Comirnaty and what is it used for?
Comirnaty is a vaccine for the prevention of coronavirus disease 2019 (COVID-19) in people aged 16 and over.
The Comirnaty vaccine contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. The Comirnaty vaccine does not contain the virus itself and cannot cause it COVID-19.
Detailed information about this vaccine can be found in the product information, which is included in the package leaflet.
2. How it is used the Comirnaty vaccine?
The Comirnaty vaccine is given in two doses (two injections), usually in the upper arm muscle, at least 21 days apart.
The supply of the vaccine will be the responsibility of the national authorities. For more information about using the Comirnaty vaccine, see the package leaflet or consult a healthcare professional.
3. How does the Comirnaty vaccine work?
The Comirnaty vaccine works by preparing the body to defend itself against it COVID-19. It contains a molecule called mRNA and has instructions for the production of a specific protein. This protein is found on the surface of the SARS-CoV-2 virus, through which the virus enters the cells of the body.
When a person receives the vaccine, some of their cells will read the mRNA instructions and temporarily produce this protein. The individual's immune system will then recognize this protein as foreign and will produce antibodies and activate T cells (white blood cells) to attack it.
If, later, the person comes in contact with the SARS-CoV-2 virus, their immune system will recognize it and be ready to defend the body against it.
The mRNA from the vaccine does not remain in the body, but breaks down shortly after vaccination.
4. What benefits have Comirnaty studies shown?
A very large clinical trial showed that the Comirnaty vaccine was effective in preventing COVID-19 in persons over 16 years of age.
A total of approximately 44,000 people participated in the clinical trial. Half received the vaccine and the other half received a sham injection. Not all participants in this clinical trial knew whether they received the vaccine or the placebo injection.
Vaccine efficacy was estimated in more than 36,000 people over the age of 16 (including people over the age of 75) who had no evidence of a previous infection. The study showed a 95% reduction in the number of symptomatic cases COVID-19 in people who received the vaccine (8 of the 18,198 cases developed symptoms COVID-19) compared with people who received a sham injection (162 cases out of 18,325 showed symptoms of COVID-19). This means that the vaccine showed 95% efficacy in the clinical trial.
The clinical trial also showed approximately 95% efficacy in participants with a severe case COVID-19, including those with asthma, chronic lung disease, diabetes, high blood pressure or body mass index ≥ 30 kg / m2.
5. Can people who already have COVID-19 to be vaccinated with the Comirnaty vaccine?
No additional side effects were reported in the 545 patients previously diagnosed with COVID-19 and who received the Comirnaty vaccine in the clinical trial.
There was insufficient data from the clinical trial to determine how well the Comirnaty vaccine works in people who have already been infected with COVID-19.
6. Can the Comirnaty vaccine reduce the transmission of the virus from one person to another?
The effect of the Comirnaty vaccine on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not yet known whether vaccinated individuals can carry and spread the virus.
7. How long does protection from Comirnaty last?
It is not known at this time how long the protection provided by the Comirnaty vaccine lasts. Individuals vaccinated in the clinical trial will continue to be monitored for 2 years to gather more information about the duration of protection.
8. Can children be vaccinated with Comirnaty?
The Comirnaty vaccine is not currently recommended for children under 16 years of age. The European Medicines Agency (EMA) has agreed with the company for a new clinical trial of the vaccine in children at a later stage.
9. Can immunosuppressed people be vaccinated with Comirnaty?
There are limited data on immunosuppressed individuals (individuals with weakened immune systems). Although immunosuppressed individuals may not respond to the vaccine, there are no particular safety concerns. Immunosuppressed individuals may still be vaccinated as they may be at greater risk of COVID-19.
10. Can pregnant or lactating women be vaccinated with Comirnaty?
Animal studies do not show any adverse effects on pregnancy, however data on the use of Comirnaty vaccine during pregnancy are very limited. Although there are no studies on breast-feeding, no risk is expected during breast-feeding.
The decision on whether to use the vaccine in pregnant women should be made in close consultation with the healthcare professional taking into account the benefits and risks.
11. Can people with allergies be vaccinated with Comirnaty?
People who already know they 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 been observed in people receiving the vaccine. A very small number of cases of rash (severe allergic reaction) were observed when the vaccine was used in vaccination campaigns. Therefore, as with all vaccines, the Comirnaty vaccine should be given under close medical supervision and with appropriate medical care. People who have a severe allergic reaction when given the first dose of Comirnaty vaccine should not take the second dose.
12. How well does Comirnaty work for people of different nationalities and genders?
The main clinical trial included individuals of different nationalities and genders. Approximately 95% efficacy was observed in both sexes, racial and other ethnic groups.
13. What are the risks associated with the Comirnaty vaccine?
The most common side effects with the Comirnaty vaccine in the clinical trial were usually mild or moderate and improved within a few days after vaccination. These include pain and swelling at the injection site, fatigue, headache, muscle and joint pain, chills and fever. These side effects affect more than 1 in 10 people.
Injection site redness and nausea occurred in less than 1 in 10 people. Itching at the injection site, pain in the limbs, enlarged lymph nodes, difficulty sleeping and feeling unwell were uncommon side effects (affecting less than 1 in 100 people). Muscle weakness on one side of the face (acute peripheral facial paralysis or paralysis) rarely occurred in less than 1 in 1.000 people.
Allergic reactions to the Comirnaty vaccine have occurred, including a very small number of cases of severe allergic reactions (anaphylaxis) that have occurred when the Comirnaty vaccine has been used in vaccination campaigns. As with all vaccines, the Comirnaty vaccine should be administered under close supervision with appropriate medical care.
14. Why did the EMA recommend the approval of the Comirnaty vaccine?
Comirnaty offers a high level of protection against it COVID-19, which is a critical need for the current pandemic. The main clinical trial showed that the vaccine is 95% effective. Most side effects are mild to moderate in severity and go away within a few days.
The Agency therefore decided that the benefits of the Comirnaty vaccine outweighed the risks associated with it and that it could be recommended for EU approval.
The EMA has recommended a conditional marketing authorization for the Comirnaty vaccine. 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 done whenever necessary.
15. What information is still pending about the Comirnaty vaccine?
As the Comirnaty vaccine is recommended for conditional marketing authorization, the company marketing the Comirnaty vaccine will continue to provide results from the clinical trial, which has been ongoing for 2 years. This clinical trial and additional studies will provide information on how long protection lasts, how well the vaccine prevents serious cases COVID-19, how well it protects immunosuppressed people, children and pregnant women and whether it prevents asymptomatic cases.
In addition, independent studies on vaccines COVID-19 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 about the pharmaceutical quality of the vaccine as manufacturing continues to grow.
16. What measures are being taken to ensure the safe and effective use of Comirnaty?
Recommendations and precautions to be followed by health professionals and patients for the safe and effective use of the Comirnaty vaccine are included in the product summary and in the package leaflet.
There is also a Risk Management Plan (RMP) for the Comirnaty vaccine and it contains important information about the safety of the vaccine, how to gather further information and how to minimize any potential risks. A summary of the RMP is available.
Safety measures to be implemented for Comirnaty vaccine in line with EU vaccine safety monitoring plan COVID-19, to ensure that new security information is collected and analyzed quickly. Comirnaty vaccine trading company will provide monthly safety reports.
For all drugs, data on the use of the Comirnaty vaccine are constantly monitored. Suspected side effects reported with the Comirnaty vaccine are carefully evaluated and the necessary measures taken to protect patients.
17. Other information about the Comirnaty vaccine
The Comirnaty vaccine was proposed by the EMA (Committee of Medicinal Products of Human use, CHMP) on 21 December 2020 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.