- What is the COVID -19 Moderna vaccine and what is it used for?
The COVID-19 Moderna vaccine is a vaccine to prevent coronavirus disease 2019 (COVID-19) in people aged 18 and over.
The COVID-19 Moderna 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 COVID-19 Moderna vaccine does not contain the virus itself and cannot cause COVID-19.
Detailed information about this vaccine is available in the product information, which is included in the package leaflet.
- How is the COVID -19 Moderna vaccine used ?
The COVID-19 Moderna vaccine is given as two injections, usually in the upper arm muscle, 28 days apart.
Arrangements for the supply of the vaccine will be the responsibility of the national authorities. For more information on using the COVID-19 Vaccine Moderna vaccine, see the package leaflet or consult a healthcare professional.
- How does COVID -19 Vaccine Moderna work ?
The COVID-19 Moderna vaccine works by preparing the body to defend itself against COVID-19. It contains a molecule called mRNA and has instructions for the production of the protein spike. It is a protein on the surface of the SARS-CoV-2 virus that the virus needs to enter the body's cells.
When a person receives the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The individual's immune system will then recognize this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack.
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.
- What are the benefits of the COVID -19 Moderna vaccine according to studies?
A very large clinical trial has shown that the COVID-19 Moderna vaccine was effective in preventing COVID 19 in 18-year-olds.
A total of about 30,000 people participated in the study. Half received the vaccine and half received placebo. People did not know if they received the vaccine or placebo.
Efficacy was estimated in approximately 28,000 people aged 18 to 94 years who had no signs of previous infection.
The trial showed a 94.1% reduction in the number of symptomatic COVID-19 cases in people who received the vaccine (11 of the 14,134 people who were vaccinated received symptoms of COVID-19) compared with those who received sham injections (185 of the 14,073 people who received placebo injections received COVID-19 with symptoms). This means that the vaccine showed 94.1% efficacy in the trial.
The trial also showed 90.9% efficacy in participants at risk for severe COVID-19, including those with chronic lung disease, heart disease, obesity, liver disease, diabetes or HIV infection.
- Can people who have already been infected with COVID- 19 be vaccinated with the COVID- 19 Moderna vaccine ?
There were no additional side effects in the 343 people who received the COVID-19 Moderna vaccine in the trial and had previously had COVID-19.
There was not enough data from the trial to conclude how well the COVID-19 Moderna vaccine works for people who already have COVID-19.
- Can the COVID- 19 Moderna vaccine reduce the transmission of the virus from one person to another?
The effect of the COVID-19 Moderna 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 may still be able to transmit and spread the virus.
- How long does protection from COVID -19 Vaccine Moderna last ?
It is not known at this time how long the protection provided by the COVID-19 Moderna 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.
- Can children be vaccinated with COVID -19 Vaccine Moderna ?
The COVID-19 Moderna vaccine is not currently recommended for children. The EMA agreed with the company on a pilot project involving children at a later stage.
- Can immunocompromised people be vaccinated with the COVID- 19 vaccine ?
There are limited data on immunocompromised individuals (individuals with a weakened immune system). Although immunocompromised individuals may also not respond to the vaccine, there are no particular safety concerns. Immunocompromised individuals may still be vaccinated as they may be at greater risk than COVID-19.
- Can pregnant or lactating women be vaccinated with the COVID -19 Moderna vaccine ?
Animal studies do not show any adverse effects on pregnancy, however data on the use of COVID-19 Vaccine Moderna during pregnancy are very limited. Although there are no studies on breast-feeding, 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 COVID -19 Vaccine Moderna ?
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) have occurred. Therefore, as with all vaccines, the COVID-19 Moderna vaccine should be administered under close medical supervision, with appropriate medical treatment in case of allergic reactions. People who have a severe allergic reaction when given the first dose of the COVID-19 Moderna vaccine should not take the second dose.
- How well does COVID -19 Vaccine Moderna work for people of different nationalities and genders?
The clinical trial included individuals of different ethnicities and genders. High efficiency was maintained between the sexes and the racial and ethnic groups.
- What are the risks associated with the COVID- 19 Vaccine Moderna vaccine ?
The most common side effects with the COVID-19 Moderna vaccine in the trial were usually mild or moderate and improved within a few days after vaccination. They included pain and swelling at the injection site, fatigue, chills, fever, swollen or tender lymph nodes under the arm, headache, muscle and joint pain, nausea and vomiting. They affect more than 1 in 10 people.
Redness, urticaria and rash at the injection site and rash occurred in less than 1 in 10 people. Itching at the injection site occurred in less than 1 in 100 people. Swelling of the face, which can affect people who have had facial cosmetic injections in the past, and muscle weakness on one side of the face (acute peripheral facial paralysis or paralysis) is rare in less than 1 in 1,000 people.
Allergic reactions have occurred in people receiving the vaccine, including a very small number of cases of severe allergic reactions (anaphylaxis). For all vaccines, the COVID-19 Moderna vaccine should be administered under close supervision with appropriate medical care.
- Why did the EMA recommend the COVID- 19 Moderna vaccine ?
The COVID-19 Moderna vaccine offers a high level of protection against COVID-19, which is a critical need for the current pandemic. The main test showed that the vaccine was 94.1% effective. Most side effects are mild to moderate in severity and disappear within a few days.
The European Medicines Agency has therefore decided that the benefits of the COVID-19 Moderna vaccine outweigh the risks associated with it and may be recommended for EU approval.
The COVID-19 Moderna vaccine is recommended for “conditional marketing authorization”. This means that there is more information about the vaccine (see below) that the company must submit. 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 COVID -19 Moderna vaccine ?
Since the COVID-19 Moderna vaccine has been proposed for conditional release, the company marketing the COVID-19 Moderna vaccine will continue to provide results from the ongoing clinical trial for 2 years. This test and additional studies will provide information on how long protection lasts, how well the vaccine prevents severe COVID-19, how well it protects immunocompromised people, children and pregnant women, and whether it prevents asymptomatic cases.
In addition, independent studies on COVID-19 vaccines 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 the pharmaceutical quality of the vaccine as manufacturing continues to grow.
- What measures are being taken to ensure the safe and effective use of the COVID -19 Moderna vaccine ?
Recommendations and precautions to be followed by health professionals and patients for the safe and effective use of the COVID-19 Moderna vaccine are included in the product summary and in the package leaflet.
There is also a risk management plan for COVID-19 Vaccine Moderna and it contains important information about vaccine safety, how to gather further information and how to minimize any potential risks. A summary of the RMP is available.
Security measures for the COVID-19 Moderna vaccine will be implemented in line with the EU COVID-19 vaccine safety monitoring plan to ensure that new safety information is collected and analyzed quickly. The company that markets the COVID-19 Moderna vaccine will provide monthly safety reports.
For all medicines, data on the use of the COVID-19 Moderna vaccine are constantly monitored. Suspected adverse reactions reported with the COVID-19 Moderna vaccine are carefully evaluated and the necessary patient protection measures taken.
- Other information about the COVID- 19 Vaccine Moderna vaccine
The COVID-19 Moderna vaccine was proposed by the EMA Antitrust Commission (CHMP) on 6 January 2021 for a conditional 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.