Vaccination

In December, Belgium has started vaccinating against coronavirus. The vaccination is voluntary and free of charge for every citizen.

How does a vaccine work?

Why should I get vaccinated?

*At least 70% of Belgians should be vaccinated in order to maximise the effectiveness of the vaccine in the population and to create group immunity. Group immunity means that a sufficiently large group of people has built up resistance to the virus, making it difficult or impossible for it to circulate. In this way, the virus will no longer be able to spread on a large scale and cause a major epidemic with accompanying lockdown measures. It will also protect those who cannot be vaccinated (e.g. pregnant women, cancer patients in acute treatment or people with a severe allergic history to vaccines (anaphylactic reactions)).

If, on the other hand, few people are vaccinated, the virus will continue to spread and group immunity will become very difficult to achieve. As a result, more people will run the risk of getting infected. And this in turn causes an epidemic and lockdown measures.
The sooner we raise the level of vaccination, the sooner measures can be relaxed. After all, persons who are infected but vaccinated will be able to infect fewer other people.
However, this does not mean that everything will go back to normal again immediately at the start of the vaccination campaign. Measures can only be relaxed gradually, because not everyone can be vaccinated at the same time, but in different phases determined by the government. So, as long as a lot of people can still get infected, there is a serious risk of new waves and so the measures still have to be complied with.
We are striving for group immunity via the vaccine, step by step. Even then, it is good to be aware that there is always a risk of local flare-ups.
Moreover, an infection with COVID-19 is not risk-free for young, healthy people either. We have seen healthy people also getting seriously ill from the virus and suffering long-term consequences, such as lung damage.

What is a vaccine and how does it work?

A vaccine against a viral disease consists of part of the virus. When we vaccinate people, we insert the virus particles into the human body, usually through an injection (just think of the standard vaccines you get as a child against the hepatitis B virus, etc.). In this way our body produces antibodies against the virus whose particle has been injected.
This is how vaccines train the immune system. A vaccine administered into your body makes your body believe you’re carrying the virus. This will make you produce antibodies, among other things. In this way, the body and immune system are prepared for when the virus would actually attack. The advantage of vaccination is that you do not first have to catch the disease and therefore do not run the risk of the sometimes serious or even life-threatening complications that could occur.
All COVID-19 vaccines work more or less the same way in theory, but there are major differences in how they are formulated. They have one thing in common: they all train the immune system.

What vaccines against COVID-19 are available today?

It is very important that no vaccine will be administered in Europe that does not first pass the control of the European Medicines Agency (EMA). The EMA carries out very strict controls on all medicinal products administered in Europe. So also vaccines. Its strict controls focus on the safety of the vaccine, on its efficacy (does it really work?) and on its quality. If all vaccine data comply with the strict requirements, then a ruling of the European Commission will follow and these vaccines can be administered in our country.
On 21 December 2020, the EMA issued a positive opinion on the biontech/Pfizer vaccine and it was subsequently approved by the European Commission. On 28 December, this vaccine was administered for the first time in 3 Belgian residential care centres (located in Puurs, Brussels and Mons). From 5 January, this vaccination will be rolled out in all residential care centres. Currently, vaccines from two other companies, Moderna and Astra Zeneca/Oxford, are also undergoing the strict control of the EMA. The Moderna vaccine will be reviewed on 6 January 2021. If successful, the European Commission can give its final approval and green light for the use of this vaccine. Other potential vaccines will be examined later, including those from Johnson & Johnson or Curevac.

Will COVID-19 vaccination be compulsory?

No. Like most vaccines in our country, vaccination against COVID-19 will be completely voluntary.
Vaccination will be free of charge in Belgium.

Do I need to be vaccinated against COVID-19 every year?

Unfortunately, there’s no final answer at present. This is still being investigated.
The duration of protection is studied further in the Phase 3 studies of vaccinated volunteers and in practice.

How many doses will I get of the vaccine?

Most of the vaccines that have already been approved (Pfizer) or that are on the table today for approval by the European Medicines Agency (AstraZeneca/Oxford, Moderna and Curevac) involve 2 doses administered with a few weeks in between (3 weeks for the Pfizer vaccine and 4 weeks for the others).

Do I still need to be vaccinated if I have already had COVID-19?

It cannot be confirmed today that someone who has already come into contact with COVID-19 is also immune to the disease and for how long. In any case, there are reports of re-infections. Moreover, it is not feasible to check whether someone has COVID-19 antibodies in their blood and whether or not they should be vaccinated.
Vaccination is not mandatory, but it does ensure that you protect yourself and others. Vaccines train the immune system of healthy people in case the disease strikes for real or again.

Where can I find all the details about the efficacy and side effects of the vaccine?

As soon as the vaccine is approved by the European Medicines Agency, and enters the European market, the information leaflet is developed for the general public (in the packaging of the vaccine). In addition, there is a so-called scientific leaflet intended for, for example, doctors. This has now been done for Pfizer’s COVID-19 vaccine. The Belgian Federal Agency for Medicines and Health Products (the FAMHP) will publish these leaflets on its website (www.fagg-afmps.be) as soon as they are available in the three national languages and a number of additional languages.

Can I contract COVID-19 after vaccination?

As we do not check whether someone is already infected at the time of vaccination, a COVID-19 infection may occur shortly after the first vaccination. This is because the vaccinated person was already infected at the time of vaccination but did not show any symptoms. Moreover, as with other vaccinations, it takes 14 days before our immune system is sufficiently activated by the first vaccine. If we are exposed to the virus soon after such an initial vaccination, an infection may still occur.

Am I protected immediately after vaccination?

No, it takes 10 to 14 days after vaccination before your body starts to produce antibodies. Two weeks after the first vaccination, the efficacy is about 90%, and this increases to 95% after the second vaccination. In the meantime, it is very important that you continue to comply with the protective measures (keeping your distance, wearing a face mask, washing your hands, ventilating rooms sufficiently, etc.).
Even for those who are fully vaccinated, following the measures is still very important. After all, it will be some time before enough people have been vaccinated to achieve group immunity.

Is the corona vaccine safe?

What are the differences between the vaccines?

Scientists have developed different types of vaccines against COVID-19. All these vaccines are aimed at teaching our immune system to safely fight the coronavirus and to train our immune system. This is how the body is prepared in case the virus really hits you.

Different types of potential COVID-19 vaccines are being developed:

Inactivated or attenuated virus vaccines, which use a form of the virus that has been inactivated or attenuated so that it does not cause disease but still triggers an immune response.
Protein-based vaccines, which use harmless fragments of proteins or protein casings that mimic the COVID-19 virus to safely trigger an immune response.
Viral vector vaccines, which use a virus that has been genetically engineered so that it cannot cause any disease, but produces coronavirus proteins to safely trigger an immune response.
RNA and DNA vaccines, an advanced approach that uses genetically engineered RNA or DNA to generate a protein that triggers a safe immune response.

Which vaccines have been purchased by Belgium?

On 21 December 2020, the European Medicines Agency (EMA) issued a positive opinion on the biontech/Pfizer vaccine and the vaccine was subsequently approved by the European Commission. On 28 December, this vaccine was administered for the first time in 3 Belgian residential care centres (located in Puurs, Brussels and Mons). From 5 January, this vaccination will be rolled out in all Belgian residential care centres. Currently, vaccines from two other companies, Moderna and Astra Zeneca/Oxford, are also undergoing the strict control of the EMA. The Moderna vaccine will be reviewed on 6 January 2021. If successful, the European Commission can give its final approval and green light for the use of this vaccine. Other potential vaccines will be examined later, including those from Johnson & Johnson or Curevac.

Is the corona vaccine safe, given its rapid development?

The fact that the vaccine was developed so quickly is due to the fact that all global stakeholders (manufacturers, researchers and governments) made it their first priority. COVID-19 vaccines are being developed according to the same strict regulatory requirements for pharmaceutical quality, safety and efficacy as any other medication.

The different stages of the development of the vaccine are:

In a first phase, the developer subjects the vaccine to rigorous testing. This is when the quality of the vaccine is checked, more specifically its purity, the ingredients and the production process.
A scientific evaluation is then carried out by the regulatory authorities. These are the European Medicines Agency (EMA) and other regulators in the EU/EEA countries.
Next, the efficacy of the vaccine is tested by the developer. This is done through laboratory research.
If everything goes according to plan, the vaccines are tested on human volunteers. This is done during 3 clinical trial phases, with an increasing number of participants. This testing programme should be carried out in accordance with the procedures and protocols established by the regulators. This is also approved in each case by a Committee on Medical Ethics.
At the end of the testing programme, the developer submits the results to the European Medicines Agency (EMA). Ultimately, approval will only be granted if the EMA receives sound scientific evidence that the benefits of the vaccine outweigh its risks.

Why has the development of a safe, effective and high-quality vaccine been expedited?

What is different for COVID-19 vaccines is that the development and possible approval of a vaccine at all levels is given priority because of the public health emergency and is therefore completed more quickly.

Manufacture: The manufacturers have been given permission for the different phases in the development of the vaccines to overlap: for example, phase 3 trials can start at the same time as phase 2 trials. This does not mean that the vaccines are less safe, because all phases have to be completed correctly. Like all medication, COVID-19 vaccines are tested in a laboratory and in pre-clinical and clinical trials (Phase 1, 2 and 3). Of course, the same strict requirements apply at every step, as with all other medicines. They are also tested on a broad target group.
Approval: The European Medicines Agency (EMA) has set up a dedicated expert task force to prioritise COVID-19 evaluation procedures. In this way, companies' applications are evaluated quickly and at the same time solid scientific advice is guaranteed.
Globally: Due to the COVID-19 pandemic emergency, COVID-19 vaccines are being developed all over the world with absolute priority.
Extensive experience and knowledge: the development of COVID-19 vaccines is also accelerated by the knowledge gained in recent years in vaccine development for other SARS/coronaviruses. For example, some companies or research institutes start with existing constructions to make their vaccine.
More resources: moreover, more resources are being used and pooled while in a normal development they are spread over a longer period of time (both by pharmaceutical companies and competent authorities).

The process of developing and approving COVID-19 vaccines is therefore more efficient. The assessment does not skip any important steps and these vaccines have to meet the same requirements as all other vaccines. Only when there is sufficient evidence that the vaccine is of good quality, effective and safe, is a positive advice given for registration.

It's developed so quickly, do we know the long-term side effects?

First of all, it is important to know that a vaccine is only approved if its efficacy, quality and safety have been sufficiently demonstrated. This is why phase 3 of the clinical trials are so important.
During the clinical trials, the vaccine is tested in several phases on large groups of people, in the final phase (phase 3) this often involves tens of thousands of people. For the corona vaccine, the numbers are even higher than for most other vaccines, between 30,000 and 60,000 people. Thanks to these studies, we can see whether and what possible side effects may occur. Most side effects show up within six weeks after vaccination. They are then picked up during clinical trials.
The risk of major side effects occurring after the vaccine has been approved is therefore small. Still, we can never completely rule it out. This is not only true for the corona vaccine but for all vaccines and medicines. Therefore, even after approval, we keep a close eye on the vaccine.
A special European monitoring system has been set up for the corona vaccine. So we can intervene quickly if necessary.

What if side effects do occur?

Has a vaccine been approved? The Federal Agency for Medicines and Health Products (FAMHP) continues to monitor the vaccine and the studies. Just like it does for medication or other vaccines. Because all medication and every vaccine has side effects. Most are often mild or short-lived.
A special European monitoring system has been set up for the corona vaccine. So we can intervene quickly if necessary.
Someone develops side effects after vaccination that may or may not be mentioned in the leaflet? Then you can report this to the Federal Agency for Medicines and Health Products (FAMHP). FAMHP experts will evaluate these side effects. Such findings are also shared internationally. By compiling the data on a large scale, trends are detected more quickly.
What if a rare side effect occurs or something goes wrong with the quality of a medicine or vaccine? The FAMHP will assess the situation and take action where necessary. For example, by updating the leaflet or alerting healthcare providers. In extreme cases, the medication or vaccine is recalled from the market.

Do some vaccines change your DNA?

No. An mRNA vaccine does not change your DNA, but introduces a harmless variant with the same genetic code (mRNA) as the virus into the body. In this way, your immune system can create antibodies and your body reacts more quickly when you actually come into contact with the virus.
The variant with the genetic code contained in the vaccine cannot merge with the host genome, your DNA. After all, it is converted into spike proteins in cells in your body. The pieces of this protein become visible to the immune cells in your body, which then produce antibodies that will recognise the virus. Over time, the vaccine is broken down again naturally by your body. So it does not change anything in your DNA.

Will the vaccine still protect me if the virus mutates?

Viruses usually mutate. That means that the genetic material in the virus changes. For different viruses, this occurs at a different rate. Mutations do not necessarily affect how well the vaccine against the virus works.
Some vaccines remain effective for many years after their development and provide long-term protection, such as the ones against measles or rubella. On the other hand, viral strains for diseases such as flu can change and the composition of the vaccine needs to be updated annually to be effective.
The scientific community and regulators monitor whether the coronavirus changes over time and whether the vaccines can protect people from infection with new variants.
If it turns out that changes have to be made, science will provide an answer as it does for other viruses as well, where we have made changes too.

Is it safe if I'm pregnant or want to breastfeed?

The data available today is insufficient to make a statement about the safety of vaccines during pregnancy. It is therefore recommended not to administer vaccines during pregnancy. If you want to become pregnant in the coming months, it is also not advisable to take the first dose of the vaccine.
Women of childbearing age are advised to wait 2 months after the second vaccination before trying to get pregnant.
If you find out that you are pregnant after you have started with the vaccine, the pregnancy will take priority and you will not get the second dose as scheduled.Breastfeeding is also given priority and vaccination is postponed until after breastfeeding has stopped.

Can children get the vaccine?

COVID-19 vaccine research has only just started in children and therefore there are very limited data on safety and immunogenicity in this group. For this reason, COVID-19 vaccines are currently not routinely recommended for children and adolescents under the age of 16 (for the Pfizer vaccine).

Do you need to get vaccinated if you have developed COVID-19 and/or if you are HIV-positive?

It cannot be confirmed today that someone who has already come into contact with COVID-19 also remains immune to the disease.
Unfortunately, there are reports of re-infections and it is not yet known whether and for how long you will be immune if you have been ill.
Vaccination is not an obligation but it does ensure that you protect yourself and others. Vaccines train the immune system in case the disease really strikes (again). This way, the body and immune system are prepared in case the virus strikes again.
Moreover, it is virtually impossible ahead of the vaccine rollout whether someone has COVID-19 antibodies in their blood.
- The phase 3 clinical trials include broad target groups, including HIV-seropositive people. Analyses of the different groups will be presented and analysed in detail by the regulators.
Also in the Pfizer and Moderna phase 3 trials, COVID-19 positive participants were included with a similar side effect profile as the COVID-19 negative participants.

I am chronically ill, how do I know whether I am eligible for vaccination?

In Phase 3 clinical trials, the results of several patients with chronic diseases (diabetes, pulmonary disease, etc.) were analysed. The analysis of these groups will allow us to provide more specific responses later on. That is why an individual analysis of the benefits and risks must always be made for each patient. (zou ik weglaten) Just under 50% of participants in Pfizer’s COVID19 Phase 3 vaccination trial had a co-morbidity. The side-effects and efficacy (with the exception of people with cancer) in this group were very similar to those of the participants without co-morbidity. However, not all chronic diseases are represented in clinical trials.

Who will get the vaccine and when?

Will there be enough vaccines for everyone?

The vaccines will be produced continuously and quantity available will increase as they are delivered.
Pending their large-scale production, several steps should be planned to best protect the most vulnerable groups and gradually increase individual immunity.

Will the vaccine be available to everyone from the start?

No. The vaccines will be produced continuously and quantity available will increase as they are delivered. Pending their large-scale production, several steps should be planned to best protect the most vulnerable groups and gradually increase individual immunity. (see question “Who are the priority groups?")
At the moment, it is difficult to provide a precise schedule for the administration of these vaccines. Therefore, monitoring the progressive availability of the vaccine per priority group is crucial.

Can everyone be vaccinated at the same time?

No. The vaccines will be produced continuously and quantity available will increase as they are delivered. Pending their large-scale production, several steps should be planned to best protect the most vulnerable groups and gradually increase individual immunity. (see question “Who are the priority groups?")
At the moment, it is difficult to provide a precise schedule for the administration of these vaccines. Therefore, monitoring the progressive availability of the vaccine per priority group is crucial.

Who are the priority groups?

To increase the population’s immunity and to protect those most vulnerable from the virus, vaccination will take place in three phases, depending on the number of doses available.

GROUP 1a

First, the most vulnerable and exposed people will be vaccinated.

Residents and employees of residential care centres and collective care institutions: since the outbreak of the pandemic, COVID-19 has hit elderly people hard, especially those living in residential care centres. They will be vaccinated first, followed by the staff (including volunteers), followed by collective care institutions.
The medical staff from primary care and hospitals: they are in close contact with patients with Covid-19 on a daily basis. To protect them, they are vaccinated as a matter of priority.
Next, the other staff in hospitals and health services will be vaccinated, including organisations responsible for prevention activities, such as vaccination and cancer screening centres, ONE and Kind en Gezin.

In this first phase, this will require a special organisation and infrastructure (extremely low storage temperatures, multiple doses, etc.).

GROUP 1b : vulnerable people without acute medical problems but at high risk

In this phase it is expected that vaccines will become more widely available. It will then be possible to vaccinate larger groups of people. Priority will be given to people outside the hospital who are most at risk. These are the following groups:

People over 65: people over 65 are the first priority at this stage. If sufficient vaccine is available, all these people can be vaccinated at the same time. Otherwise we start with the oldest people and then work our way down.
People between 45-65 years of age with an increased risk: Then people between 45-65 years come with risk factors, such as:
- Diabetes,
- Hypertension, Chronic cardiovascular, pulmonary, kidney and liver disorders, haematological cancers up to 5 years after diagnosis,
- All recent cancers (or recent cancer treatments)
- Obesity (Body Mass Index ≥ 30).

This list will be updated and expanded in the light of scientific developments,

Essential professions: In this phase, people with essential social and/or economic professions are vaccinated. In this second phase, we can expect fewer logistical bottlenecks and organising the vaccination will be easier for these target groups.

GROUP 2 - general population

Thirdly, vaccine doses will be available in sufficient quantities to vaccinate the rest of the population.

At this stage it can be expected that the doses can be stored and administered like other vaccines such as the flu vaccine).

Vaccines in practice

Can I get my vaccine from my general practitioner (GP)?

Various scenarios are currently on the table. For phase 1a, a centralised approach will be adopted for vaccinating the residents and the staff of residential care centres, hospital staff and the primary care health workers (general practitioners, physiotherapists, home nurses, pharmacists, etc.). This is also the case for phase 1b, with the vaccination of over-65s and of people between 45 and 65 with co-morbidities, as long as they are sufficiently mobile. In phases 1b and 2, a combination of a centralised and decentralised approach is also possible, where general practitioners will become increasingly involved.
The main reasons for taking a centralised approach are the specific storage requirements for the vaccine, such as (very) low temperature and the delivery of the vaccine in a multi-dose package. This means that many hundreds of vaccines need to be grouped together in a relatively short period of time, taking into account the corona measures.
Just like in a number of neighbouring countries, including Germany, the Netherlands and France, we will roll out the vaccination strategy in the most efficient and controlled way possible. Maximum use will be made of existing structures such as hospitals and vaccination centres. A distinction is made between Phase 1a with centralised vaccination administration to the high priority target groups and Phase 1b with expanded target groups and increased availability of vaccines.
The widespread vaccination including low-risk groups can only be considered in phase 2. The start of each phase is determined by the availability and characteristics of the vaccine and the subsequent consequences in terms of distribution.

How are the logistics of distributing the vaccines handled?

The Task Force on the operationalisation of the COVID-19 vaccination strategy is in the process of developing a vaccination strategy in consultation with the Communities. Different scenarios are still on the table. Once the strategy has been clarified, it will also become clearer how the vaccines will be distributed in Flanders.

Will a vaccination centre be set up in my municipality?

This will be discussed with the federated entities. And in Flanders, the ELZ (primary healthcare zones) will take charge. This will only be relevant for phase 1b, when we can vaccinate on a larger scale. It is difficult to estimate at the moment when exactly we can start phase 1b because of the uncertainties involved in the deliveries. At present, it is impossible to estimate when phase 2 will start.

Where are the vaccines stocked?

The vaccines will be stored centrally with strict security measures in 41 hub-hospitals and vaccination centres throughout the country. The exact location cannot be disclosed for security reasons. As the first vaccines have to be stored at a very low temperature, appropriate cooling systems will be provided for this purpose.

Will all vaccines be here in time?

The orders for the vaccines have already been placed, so as soon as the approval from the European Medicines Agency comes in, these vaccines will be quickly available.
The entire logistics are currently being prepared by the task force ‘Operationalisation of the COVID-19 vaccination strategy’.

Research and development

Coronavirus has been the subject of much scientific research. Click here for more information about the research on coronavirus and the vaccine.

Information for caregivers

Would you like to help as a volunteer/caregiver in a vaccination centre? Students and pensioners are also more than welcome!

Flanders: https://www.helpdehelpers.be/
Brussels: send an email to covid-hyg@ccc.brussels
German-speaking Community: send an email to karin.cormann@dgov.be
French Community: the contact details will be provided asap.