COVID-19 vaccines: key facts

The COVID-19 vaccines authorised in the EU continue to prevent severe disease, hospitalisation and death linked to COVID-19.   

The SARS-CoV-2 virus keeps changing, as viruses do when they spread among people over time. When the virus becomes significantly different from the original virus, it is known as a variant. Therefore, the vaccines need to be routinely updated to target future virus variants and broaden immunity.

COVID-19 vaccines can be routinely updated in the same manner as flu (influenza) vaccines.

Flu vaccines are adapted every year in response to emerging virus variants. This ensures people remain protected over time, in particular vulnerable groups.

EMA expects future COVID-19 vaccination campaigns to take place once per year in the EU using updated COVID-19 vaccines, at the start of the cold season.

For more information, see: 

• EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants (06/06/2023)
• Global regulators agree on way forward to adapt COVID-19 vaccines to emerging variants (30/05/2023)

The World Health Organization (WHO) declared the end of the emergency phase of the pandemic in May 2023.

However, WHO highlighted that COVID-19 remains a health threat.

New virus variants can potentially still escape the body's immune system and cause infections, serious disease and even death.

COVID-19 still places a burden on healthcare systems and individual people whose immunity has decreased with time. 

In the EU, national authorities in the EU Member States will decide who should be offered COVID-19 vaccination and when, taking account of infection rates, hospitalisation rates, risks to vulnerable people, vaccination coverage and other factors. 

In the EU, each EU Member State is responsible for vaccination campaigns within its own territory.

Public health authorities in each EU country develop vaccination campaigns based on the spread of the virus and healthcare system capacity.

There may continue to be differences between how different EU countries use the COVID-19 vaccines at their disposal. 

EMA’s evaluations provide a scientific basis for national vaccination campaigns. They describe the benefit-risk balance of each vaccine in the different populations studied.

The benefits of all authorised COVID-19 vaccines outweigh the risks when used as described in the product information.

COVID-19 vaccination is estimated to have saved millions of lives in the EU and beyond.

Researchers have estimated that the first year of COVID-19 vaccination more than halved the number of deaths due to COVID-19 across the world, avoiding between 14 and 20 million deaths.

In May 2022, WHO estimated there were nearly 15 million excess deaths linked to the pandemic in 2020 and 2021 alone.  

Widespread vaccination also allowed the lifting of lockdowns and eased the pressure on healthcare systems, by protecting people against severe disease and hospitalisation.

For more information, see: 

• The Lancet: Global impact of the first year of COVID-19 vaccination: a mathematical modelling study
• WHO: 14.9 million excess deaths associated with the COVID-19 pandemic in 2020 and 2021
• WHO: Coronavirus (COVID-19) dashboard

A full list of side effects associated with each COVID-19 vaccine is found in the vaccine's product information.  

EMA and the EU Member States continuously monitor reports of suspected side effects with COVID-19 vaccines. This serves to detect any new safety issues.

Suspected side effects are medical events reported after vaccination by a vaccinated person or their healthcare professional. They are collected in the EU database of suspected side effects, EudraVigilance, and are available in a public database - adrreports.eu.

The fact that a medical event was reported as a suspected side effect does not mean that the vaccine caused it.  

When assessing the data, EMA and EU Member States look for any unusual or unexpected patterns, such as a medical event occurring more often in vaccinated people than in the general population.

They also consider other sources of evidence, such as studies and the medical literature.

If there is at least a reasonable possibility that a vaccine could have caused a suspected side effect, this is included in the vaccine’s product information.

The product information also indicates the likelihood of the side effect occurring and how to reduce the risk. 

For more information, see:

• Safety of COVID-19 vaccines
• EudraVigilance - European database of suspected adverse drug reaction reports 

EMA carefully reviews all safety data and can confirm that there is no evidence of an increase in deaths related to COVID-19 vaccination in any age group.

Data published by Eurostat have shown increased numbers of excess deaths in many EU countries over the past years. This largely coincided with waves of increased COVID-19 infections.

The medical literature shows that infection with SARS-CoV-2 can lead to serious health problems, such as heart attack and stroke, even several weeks or months after infection.  

Evidence gathered from hundreds of millions of vaccinated people confirms that the safety profile of COVID-19 vaccines authorised in the EU is very reassuring.

The vast majority of known side effects are mild and short-lived. Serious side effects may occur, but they are very rare.

Reports of deaths following vaccination are very rare.

During mass vaccination campaigns, it is expected that some deaths will occur shortly after vaccination. This does not mean the vaccine caused the death.

Healthcare professionals can report any death that occurs following vaccination, even if it is unknown if the vaccine was the cause.

In very exceptional cases, deaths have been confirmed to be caused by a vaccine.

More information: 

• Safety of COVID-19 vaccines

COVID-19 vaccines have been used in hundreds of millions of people around the world and are subject to intensive safety monitoring.  

Long-term safety data on COVID-19 vaccines are very reassuring.

Data are available from studies in thousands of volunteers and from mass vaccination campaigns across the world over more than two years.

Moreover, safety monitoring of vaccines shows that any side effect usually occurs within two months of vaccination. 

EMA and the EU Member States will continue to closely monitor the safety of COVID-19 vaccines in the long term.

Scientific evidence increasingly shows that infection with SARS-CoV-2 can lead to a wide range of long-term symptoms, referred to as long COVID.

This can also happen in young people.

Symptoms include long-term organ damage, which can even lead to death several weeks or months after the initial acute infection. 

There is increasing evidence that vaccinated people who become infected with SARS-CoV-2 are less likely to report symptoms of long COVID than unvaccinated people, but more evidence is needed to establish the size of this effect.

More information: 

• The Lancet: Association of SARS-CoV-2 infection and persistence with long COVID
• Long COVID: major findings, mechanisms and recommendations

Several studies have shown that messenger RNA (mRNA) COVID-19 vaccines do not cause complications in pregnancy, either for expectant mothers or their babies.

On the contrary, COVID-19 vaccines protect expectant mothers and their babies. 

The data mainly come from studies with the mRNA vaccines Comirnaty and Spikevax (previously COVID-19 Vaccine Moderna) in more than 65,000 people at various stages of pregnancy.

The studies did not show any sign that the COVID-19 vaccines increased the risk of complications in pregnancy, miscarriage, premature birth or harm to the unborn baby. 

The data also confirmed that the vaccines reduced the risk of hospitalisation and death for pregnant people as much as for other people. 

Side effects in pregnant people are similar to those in other vaccinated people. They are mostly mild or moderate and resolve within a few days. 

Meanwhile, people infected with SARS-CoV-2 during pregnancy are particularly likely to become severely ill with COVID-19, especially in the second and third trimesters.

More information:

COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy (18/01/2022)

Data from many thousands of people who received an mRNA vaccine while breastfeeding found no risk of side effects in breastfed babies.  

Recent research has found tiny amounts of vaccine mRNA in breast milk during the first 48 hours after vaccination, but not afterwards.

Although more work is needed to understand the relevance of these findings, this amount of mRNA is very small and is not expected to cause any safety problem. 

There is also evidence that breastfeeding people who received an mRNA vaccine have antibodies against the SARS-CoV-2 virus in their breastmilk, which may help to protect their baby against infection.

More information: 

• JAMA paediatrics: Detection of Messenger RNA COVID-19 Vaccines in Human Breast Milk

COVID-19 vaccines are well tolerated in children, based on data from millions of children who have been vaccinated.  

The side effects are usually mild or moderate and go away in a few days, based on real-world evidence and clinical trials in children.  

Very rare cases of myocarditis and pericarditis (inflammatory conditions affecting the heart) have occurred in adolescents and adults after vaccination with certain COVID-19 vaccines. This risk is much lower in children aged 5 to 11 years.

These conditions usually clear up following treatment, as they do when unrelated to vaccination (for instance, as a result of a COVID-19 infection).

EMA continues to monitor data on safety in children in the long term.

The technology used to develop the mRNA COVID-19 vaccines had already been extensively studied for some twenty years in the prevention of other infectious diseases and in cancer treatment.  

Various mRNA vaccines against diseases such as influenza and Zika had already been tested in the laboratory, animal studies and early clinical trials.  

A wealth of scientific knowledge about viruses of the same family as SARS-CoV-2 also helped accelerate vaccine development.   

mRNA is a relatively small and simple molecule that is much easier to produce than more traditional vaccines. This means that producing mRNA vaccines for clinical trials, and then scaling up production for mass vaccination campaigns was faster than previously possible with other technologies. 

More information:

• Nature: mRNA vaccines for infectious diseases: principles, delivery and clinical translation
• Nature: The tangled history of mRNA vaccines
• US National Library of Medicine: Advances in COVID-19 mRNA vaccine development

Lipid nanoparticles are small fat particles used in mRNA vaccines to help the mRNA enter human cells.

Once the vaccine is injected into the muscle, the lipid nanoparticles fuse with the cell membrane which is also made up of lipids (fats).

This mainly happens in immune cells found around the injection site.

The immune cells that contain the lipid nanoparticles and the mRNA then move to nearby lymph nodes, where they stimulate an immune response. 

Lipid nanoparticles are also important in maintaining the quality of the vaccine during storage, for example by keeping the vaccine stable and making sure the vaccine components work properly.  

The use of lipid nanoparticles in medicines has been researched extensively. The first medicine using lipid nanoparticles was authorised in the EU in 2018. 

Messenger RNA (mRNA) is a type of molecule that exists naturally in the body and helps make proteins.

The cells in the body translate the information in the mRNA molecule to produce specific proteins. 

Animal studies for Comirnaty, in which much higher doses of mRNA were used than in the final vaccine given to people, found that the mRNA and lipid nanoparticles stayed mainly at the injection site and lymph nodes where they are able to stimulate the immune response.

In these cases, only small amounts of mRNA were shown to reach other tissues, mainly the liver but also the spleen, heart, kidney, lung and brain.

Levels of mRNA decreased over 6 to 9 days after injection, just like mRNA produced by the body.  

For Spikevax (previously COVID-19 Vaccine Moderna), animal studies were carried out using an mRNA vaccine that is similar to Spikevax.

The results only detected small amounts of mRNA in tissues beyond the injection site. After 1 to 3 days, the mRNA was found only at the injection site, the lymph nodes and the spleen. Based on these findings, at the time of authorisation, no build-up of mRNA or lipid nanoparticles in the organs was expected.

Since then, hundreds of millions of people have used the mRNA COVID-19 vaccines throughout the world. Intensive safety monitoring of COVID-19 vaccines has not detected any safety issue linked to the distribution of these vaccines in the human body.

More information: 

• Comirnaty: Assessment history
• Spikevax: Assessment history

Like all mRNA molecules, the mRNA in the COVID-19 vaccines is broken down by cell mechanisms and so spends a relatively short time in the body.

Animal studies in Comirnaty found that only small amounts of mRNA reached tissues beyond the lymph nodes, and the levels decreased over 6 to 9 days after injection. 

More recently, a study in vaccinated people suggested that mRNA and the spike protein produced are rapidly removed from the bloodstream but may stay longer in the lymph nodes. This is to be expected, as this is where the immune response starts.  

The companies marketing mRNA COVID-19 vaccines are carrying out more animal and laboratory studies to obtain additional data on how mRNA and the spike protein are distributed and broken down in the body. They will submit the results to EMA for assessment. 

More information:

• Cell: Immune imprinting, breadth of variant recognition,
  and germinal center response in human SARS-CoV-2
  infection and vaccination

The mRNA used in COVID-19 vaccines does not interfere with our genetic code. This is because: 

• mRNA does not enter the cell’s nucleus where our DNA is kept, but uses the cell’s machinery present outside the nucleus to make proteins, just like any other human mRNA;
• mRNA, in general, has a different chemical composition than DNA, and this prevents it from being able to directly integrate into a DNA strand.  

Although mRNA can be converted into DNA, this can only be done with a specific enzyme called reverse transcriptase, which is not normally present in human cells, nor is it present in the vaccine. 

No side effects linked to gene mutations, such as cancer, have been observed after vaccination with mRNA vaccines.

COVID-19 mRNA vaccines can sometimes contain truncated (shorter) or modified mRNA molecules. These are considered impurities and are not expected to affect safety or efficacy. 

There is no evidence that truncated mRNA is translated into shorter or modified forms of the spike protein.

Human cells have several processes ensuring that proteins are correctly produced and preventing the production of shorter or modified proteins from faulty mRNA.  

In the unlikely event that shorter or modified spike proteins were produced, they would not be expected to trigger unwanted immune responses. 

Although the risk of producing shorter or modified spike proteins is low, this risk will continue to be monitored as part of the long-term safety monitoring.

A vaccine against an infectious disease is not considered a gene therapy, as it does not aim to restore, correct or modify human genes. 

Therefore, mRNA COVID-19 vaccines are not considered gene therapies.

Instead, mRNA vaccines are classified and regulated as biotechnology medicinal products.