FAQ on Vaccinations at the University Medical Centre

Practical Information on Registration and Carrying Out the Vaccination

How can I register for vaccination?

All those who have not yet received a vaccination and need two vaccination appointments can register at: https://ecampus.rwth-aachen.de/vo/rwthcoronaimpfung for a vaccination with the vaccine Comirnaty® (BioNTech/Pfizer). The appointment for the second vaccination will be scheduled automatically at an interval of 3 weeks.

If you only want to book a single appointment, this is possible at: https://ecampus.rwth-aachen.de/units/hsa

 

1.    Appointment for a second vaccination

  • as from 4 weeks after a Janssen vaccination (Johnson&Johnson) with Comirnaty® (BioNTech/Pfizer)
  • 3-6 weeks after a Comirnaty® (BioNTech/Pfizer) vaccination
  • 4-6 weeks after a Spikevax® (Moderna) vaccination

2.   Appointment for a booster vaccination

  • usually 6 months after the 2nd vaccination

3.   Vaccination after proven SARS-CoV-2 infection

  • Persons who have had a laboratory-diagnostically confirmed SARS-CoV-2 infection should receive 1 vaccine dose, no earlier than 4 weeks after falling ill.
  • For persons whose SARS-CoV-2 infection was laboratory-diagnostically confirmed after the 1st vaccine dose, the 2nd vaccine dose should be administered no earlier than 4 weeks after recovery.
  • Persons who have had a laboratory-diagnostically confirmed SARS-CoV-2 infection before or after the COVID-19 vaccination are currently not recommended for booster vaccination.

 

What needs to be observed when making an appointment?

The online tool for registering for a vaccination appointment permits the free choice of appointment within the opening hours of the vaccination centre.

 

However, it must be taken into account that in the double appointment booking tool, the follow-up appointment with Comirnaty® (BioNTech/Pfizer) is scheduled at an interval of three weeks. It is possible to postpone the second appointment on site (at the first vaccination) if there are compelling reasons. Therefore, when choosing the first appointment, please be sure that you will be able to keep the follow-up appointment.

As a rule, the booster vaccination should be administered 6 months after the initial immunisation consisting of 2 vaccine doses. Persons who have had a laboratory-diagnostically confirmed SARS-CoV-2 infection before or after the COVID-19 vaccination are currently not recommended for booster vaccination.

Each appointment is equivalent to one vaccine dose. Due to the short shelf life of the vaccines, please avoid multiple bookings and, if possible, appointment changes at short notice as well.

While there is no longer a vaccine shortage in Germany, the global situation is quite different. We, therefore, kindly ask you to handle the appointment resources responsibly, as we do not want to waste any doses.

If you are unable to come to your vaccination appointment, please contact the Vaccination Centre (+49 241/80-38777 or coronaimpfung(at)hsa.rwth-aachen.de) immediately.

Is it possible to have a corona vaccination and an influenza vaccination at the same time?

According to the recommendation of the STIKO, COVID-19 vaccinations and the administration of other so-called dead vaccines (inactivated vaccines that contain killed pathogens or only pathogen components, and that cannot multiply and cause illness) can be given at the same time. This applies, in particular, to the influenza vaccination if there is an indication for vaccination against both influenza and COVID-19. In this case, the injection should be administered to different limbs. When COVID-19 vaccines and influenza vaccines (including high-dose vaccines) are administered simultaneously, it should be noted that vaccine reactions may occur more frequently than when administered separately. Effectiveness and safety when administering different vaccines at the same time are generally the same as when each one is used on its own.

A minimum interval of 14 days should be observed before and after each COVID-19 vaccination when vaccinating with live vaccines (e.g. measles-mumps-rubella, chickenpox).

Where is the Vaccination Centre located?

The vaccination takes place in the Vaccination Centre set up for this purpose at the University Hospital RWTH Aachen Uniklinik, Spiegelsaal, Lift B2, Floor E, Corridor 03, Room 01.

Does the University Medical Centre pass on my personal data?

Within the framework of the "Digital Vaccination Rate Monitoring", the University Medical Centre passes on the following data to the Federal Printing Office (Bundesdruckerei): first name, surname, date of birth, gender, postal code, date of vaccination, batch number, vaccine, first and follow-up vaccination, entry date.

The data is temporarily stored here on behalf of the RKI (Robert Koch Institute) and is retrieved daily by the RKI.

Will I receive a digital vaccination certificate from the University Medical Centre?

You can get the digital vaccination certificate after the vaccination on site at the Vaccination Centre at the University Hospital Aachen or at a pharmacy. You can find out which pharmacy offers this service here, among other places. Please bring your vaccination certificate and an identity document with you.

You can find more information on the digital vaccination certificate on the website of the Federal Ministry of Health.
 

 

 

I was vaccinated outside the EU and my vaccination is not recognised as an equivalent vaccine by the Paul Ehrlich Institute. Can I nevertheless attend courses at the FH?

You can participate by providing a valid negative test certificate.

I was vaccinated outside the EU and my vaccination is not recognised as an equivalent vaccine by the Paul Ehrlich Institute. Can I be vaccinated all over again?

Since 17.09.2021, the Standing Committee on Vaccination (STIKO) recommends a renewed vaccination series for persons who have already been vaccinated abroad with COVID-19 vaccines that are not approved in the EU, in order to obtain the status of vaccinated persons in the EU. The vaccination series should be started at a minimum interval of ≥28 days.

With immediate effect, it is possible to register for two vaccination dates at this link. The date for the second vaccination will be scheduled automatically at an interval of 3 weeks. Both vaccinations are carried out with the vaccine Comirnaty® (BioNTech/Pfizer).

In such cases, there may be increased local and systemic reactions which should be reported to the Paul Ehrlich Institute (PEI).

 

 

Is there a choice of vaccines?

Yes, there is. When booking your appointment, you can specify which vaccine you would like to be vaccinated with.
Currently, the vaccine Comirnaty® (BioNTech/Pfizer) and Spikevax® (Moderna) are available at the Vaccination Centre.

As a rule, the initial immunisation is carried out with the vaccine Comirnaty® (BioNTech/Pfizer) and the booster vaccinations are carried out with a single vaccination of the mRNA vaccine Comirnaty® (BioNTech/Pfizer) or Spikevax® (Moderna). Persons under 30 years of age as well as pregnant women are vaccinated exclusively with the Comirnaty vaccine.

For the booster vaccination, the mRNA vaccine that was used for the initial immunisation should be used, if possible. For people under 30 years of age, the STIKO recommends vaccinating exclusively with the Comirnaty® vaccine (BioNTech/Pfizer) due to the higher risk of myocarditis. For people 30 years and older, there is no increased risk of myocarditis and pericarditis after vaccination with Spikevax (Moderna). 

Whereas the booster vaccination with Comirnaty®(BioNTech/Pfizer) is administered with the same dosage as for the initial immunisation, Spikevax® (Moderna) is used in a lower dosage (half dose, 50µg). Here, it is irrelevant whether the initial immunisation was carried out according to a homologous or heterologous vaccination scheme.
Persons with immunodeficiency, on the other hand, receive the identical dosage of the initial immunisation (100 µg) as a booster vaccination.

How is the vaccination carried out and who administers it?

The Vaccination Centre is run by the University Medical Centre.

Before you come to the vaccination appointment, please read the information sheet. Please bring along the completed consent form and your vaccination card for the vaccination.

The vaccine is injected into the muscle in the upper arm (intramuscularly) by a doctor or a medical assistant (MFA) with a vaccination permit. Afterwards, a quiet room (Café Lounge on the staff restaurant gallery) is available for a follow-up period of 15 to 30 minutes. Medical staff will be present here as well. Should any acute side effects occur, help can therefore be provided immediately.

Who can be vaccinated?

Is the vaccination against SARS-CoV-2 mandatory?

Vaccination against the SARS-CoV-2 virus is voluntary and free of charge for all citizens throughout Germany.

Why should I get vaccinated against the coronavirus?

10 reasons to get vaccinated against the coronavirus now

 

1. Prevention is better than getting sick
No one can predict whether an infection with coronavirus will turn out to be mild or severe. It is therefore best to avoid infection at all and get vaccinated against the SARS-CoV-2 virus. For this purpose, four approved vaccines are currently available in Germany, which verifiably protect against severe courses of the disease and the virus variants known so far. According to model calculations by the Robert Koch Institute, vaccinations have already prevented about 76,600 in-patient cases, about 19,600 intensive care cases and more than 38,300 deaths.

2. Younger people can fall seriously ill as well
It is not only older people who can become seriously ill with COVID-19; younger people can also develop serious courses of the disease and long-term consequences such as severe exhaustion, persistent shortness of breath, or neurological damage ("Long Covid"). According to an estimate by the German Society for Pneumology and Respiratory Medicine, one in ten people with COVID-19 suffers from late complications.

3. The corona vaccines are safe and effective
All vaccines approved in Germany have undergone the usual EU testing procedure and meet the high European safety standards. This means that the quality, safety and effectiveness of the vaccines were checked the same way as for all other pharmaceuticals - only this time it was quicker because all the relevant steps took place simultaneously instead of one after the other.

4. Vaccination poses fewer risks than corona infection
Some people are worried and fear vaccine damage as a result of a corona vaccination. However, the risk of a serious side effect after a COVID-19 vaccination amounts to just 0.02 percent. In contrast, the risk of encountering the virus unvaccinated is much greater: one in seven people who become infected must expect a severe course of COVID-19 (14 percent).

5. By now, vaccines are readily available
Meanwhile, there is enough vaccine available to offer vaccination within a narrow time frame to all adults as well as children and adolescents aged 12 years and older in Germany.

6. Vaccination protects you and others
The corona vaccination not only protects your own health. It also reduces the risk of transmitting the SARS-CoV-2 coronavirus to others. As a result, it also protects people who cannot be vaccinated - for example, people who cannot be vaccinated because of pre-existing conditions and children under 12 years of age for whom no vaccine has yet been approved.

7. Vaccination prevents the spread of the virus - and further lockdowns
Each vaccination helps keep the coronavirus in check and the pandemic under control. The more people are protected from infection with coronavirus through vaccination, the more frequently the virus comes into contact with people who can no longer be infected - and the more difficult it is for the virus to spread. This is also important in view of the dynamic infection events caused by the virus variants, as: The fewer infections there are, the less likely it is that new dangerous mutations will emerge.

8. Vaccination relieves the pressure on the health system
The more people are protected from severe courses of disease through complete corona vaccination, the fewer people infected with SARS-CoV-2 have to be treated in hospital (intensive care). This relieves the pressure on the health system. Furthermore, if fewer corona infections occur, contact tracing will be more successful and chains of infection can be broken more quickly.

9. Vaccination brings back normalcy to everyday life
From social distancing to working from home, studying at home and homeschooling, the pandemic has taken a heavy toll on everyone. Thanks to national vaccination progress, more normalcy has returned to our everyday lives. Nevertheless, no one should rely on the protection provided by more and more vaccinated people and the currently low incidence rates and forego vaccination. According to calculations by the Robert Koch Institute, at least 85 per cent of 12- to 59-year-olds must be vaccinated against COVID-19 in order to reduce the transmission of SARS-CoV-2 to such an extent that there is collective protection in the population. For those over 60 years of age, the figure would have to be as high as 90 per cent. Hence, the rule still holds: Each vaccination counts to end the pandemic!

10. Complete proof of vaccination makes travelling easier
Many countries make it easier for those who have been fully vaccinated to enter the country, and in many places the testing and quarantine obligation is no longer required with valid proof of vaccination. After all, the likelihood that fully vaccinated people will pass on the virus is significantly lower. There is no vaccine mandate, but the best protection is offered by a complete vaccination in combination with the AHA+A+L formula (=keep your distance, observe hygiene, wear a mask in everyday life, ventilate regularly and use the corona warning app).

Can people with an acute illness get vaccinated?

Anyone suffering from an acute illness with a fever above 38.5°C should not be vaccinated until they have recovered. However, a common cold or slightly elevated temperature (below 38.5°C) is not a reason to postpone the vaccination. Vaccination is possible as soon as you are free of fever and symptoms after the illness.

Can people with chronic illnesses be vaccinated?

Chronic illnesses such as high blood pressure, diabetes, asthma, cardiac or renal insufficiency or obesity are not a contraindication to vaccination. In these cases, neither a reduced protection effect nor an increased side effect rate is assumed.

Can people who take immunosuppressants, have an immunological disease, or a malignant disease be vaccinated?

Vaccination of immunodeficient persons is of particular importance, as they have an increased risk of severe courses of COVID-19. Therefore, vaccination is usually particularly advised here.

 

When administering the vaccination against COVID-19, it is important to note:

  • Immunosuppressive or immunomodulatory therapies can be continued even when vaccine administration is upcoming
  • However, it is recommended for the best possible vaccination effectiveness that immunosuppression is as low as possible at the time of vaccination, i.e. that the time of vaccination should be scheduled, for example, in the middle of the administration intervals of the immunosuppressive or immunomodulating medication.
  • In the case of planned antineoplastic therapy ("chemotherapy"), vaccination should take place at least 2 weeks before the start of the therapy in order to enable a sufficient immune response.

However, there is now clear evidence that the body's immune response is weaker, so that vaccination only offers reduced protection against COVID infection. Administering a third dose, known as a "booster vaccination", at least 6 months after completion of the full initial vaccination, can enhance vaccine protection (see question "What about booster vaccination?").

In the 11th update published in the Epidemiological Bulletin 39/2021, the STIKO comments on the COVID-19 vaccination recommendation for persons with immunodeficiency.

 

Can a person with allergies be vaccinated?

In principle, it is possible that allergic or anaphylactic reactions may occur in very rare cases (1 case per 100,000 to 1 million vaccinations) with every vaccination (not only against COVID-19). This can be caused either by the vaccine itself or by adjuvants/additives in the vaccine.

For patients with the following allergic/atopic disorders, there is no evidence of an increased risk (compared to the normal population) associated with COVID-19 vaccination when using the approved vaccines:

  • Atopic eczema (neurodermatitis)
  • Urticaria (hives)/angioedema
  • Rhinoconjunctivitis allergica (hay fever)
  • Bronchial asthma (asthma should be well controlled at the time of vaccination)
  • Nasal polyps
  • Food allergy (especially no problems for those allergic to chicken egg protein, as there is no chicken egg protein in the Biontech or Moderna vaccine)
  • Hymenoptera venom allergy
  • Pain medication intolerance
  • Antibiotic allergy
  • Contact allergy (e.g. nickel, fragrance or preservative allergy)

Please contact us if any of the following apply to you:

  • Severe allergic reaction to a previous non-COVID 19 vaccination.
  • Severe allergic reaction after taking medications (especially laxatives) or injections
  • Severe allergic reaction following intake of pharmaceuticals and known mastocytosis
  • Severe allergic reaction of unknown cause

Patients with a known previous severe allergic reaction to ingredients of the vaccine or to the first COVID19 vaccination must not be vaccinated. Among others, the following ingredients may play a role:

  • Polyethylene glycol (= macrogol)
  • Tromethamine/trometamol

(see also: What ingredients do the vaccines contain?)

Here is more information on concomitant therapies:
Patients receiving treatment for the above conditions (including antibody therapies such as Xolair®, Dupixent®, Nucala®, Fasenra®) may be vaccinated. At this time, it is recommended that the interval between treatment and vaccination be approx. 1 week.

A minimum interval of one week should be observed between the administration of subcutaneous hyposensitisation/specific immunotherapy (SCIT) and COVID19 vaccination, as with all other vaccinations. Clinical experience with regard to simultaneous protective vaccination (e.g. with the Biontech or Moderna vaccine) and SLIT treatment is not documented for many allergen immunotherapeutics. In order to distinguish possible reactions due to COVID-19 vaccination from reactions due to SLIT, according to allergological experience, SLIT should be paused at least 1-2 days after COVID-19 vaccination.

Can pregnant or breastfeeding women be vaccinated?

The STIKO recommends vaccination for unvaccinated pregnant women from the 2nd trimester onwards as well as for unvaccinated breastfeeding mothers. For them, a COVID-19 vaccination with two doses of an mRNA vaccine is recommended. Although no comparative safety data are available for Comirnaty and Spikevax with regard to the vaccination of pregnant women, STIKO recommends that pregnant women should be offered Comirnaty regardless of age when receiving a COVID-19 vaccination.

If pregnancy was determined after the first vaccination had already taken place, the second vaccination should only be carried out from the 2nd trimester onwards. The STIKO explicitly recommends the COVID-19 vaccination for women of childbearing age, especially those who wish to have children, in order to be optimally protected against this disease in the event of a future pregnancy from the time of conception. Close contacts of pregnant women should also be vaccinated against COVID-19 according to the vaccination recommendation.

  • Being pregnant in itself is a relevant risk factor for severe courses of COVID-19.
  • The COVID-19 vaccination protects both pregnant and non-pregnant women very well against symptomatic SARS-CoV-2 infections and against severe COVID-19 courses (which lead to hospitalisation).
  • According to current studies, severe side effects after vaccination during pregnancy (such as spontaneous miscarriage up to the 19th week of pregnancy, stillbirths, malformations) do not occur frequently.
  • After vaccination, a transmission of the mother's antibodies via the placenta to the foetus has been proven. Whether this can achieve clinically relevant protection for the newborn is not clear at this time.
  • There is no evidence that COVID-19 vaccination poses a risk to mother or child during breastfeeding.

Pregnant or breastfeeding employees are welcome to get personal counselling on this question via the hotline of the Vaccination Centre (38777).

 

Can women who wish to have children be vaccinated against COVID-19?

Yes, women who wish to have children can also be vaccinated against COVID-19. The available COVID-19 vaccines have been tested on adults - including women wishing to become pregnant - and have been found to be safe and effective.

Currently, misinformation is circulating. It says that vaccination can negatively impact fertility. This statement is false. In the extensive clinical trials that were carried out before the vaccines were approved, there is no evidence of infertility occurring. The misinformation is based on the fact that the protein encoded by the vaccines is structurally similar to a protein that is important for fertility. In fact, however, this similarity is limited to a few sections of the protein. These similarities, however, occur very frequently and are not specific to COVID-19 vaccination. If such a similarity were to make one infertile, then infection with COVID-19 would also make someone infertile. However, this has not been observed anywhere in the world. The Paul Ehrlich Institute assesses the safety of this as follows: "With this data situation, the best possible safety for the exclusion of damage to reproductive organs and of an impairment of reproduction in humans is ensured within the framework of a marketing authorisation for a medicinal product". Women who wish to have children can therefore be vaccinated against COVID-19.

Cycle disturbances following COVID-19 vaccination have been observed internationally and are currently being further researched. Such changes in the cycle are also known to occur with other vaccinations or through infection and are attributed to the activation of the immune system. A direct causal relationship is not known. Women should, however, be informed about this possible side effect of vaccination in order to avoid uncertainty.

The observed cycle disturbances are temporary, without pathological value and are not associated with infertility.


A study from Israel shows data from 36 couples who were undergoing fertility treatment for artificial insemination (IVF) during the time period of COVID-19 vaccination. The duration and characteristic parameters of ovarian stimulation, the number and quality of the eggs retrieved as well as the examined sperm parameters before and after vaccination were compared. It became apparent that there was no difference between these parameters in the observation period of 7-85 days after vaccination. In an American study that examined sperm parameters in 45 men, no difference was found before and after vaccination with 2 doses of an mRNA vaccine.

 

The worry about possible infertility after COVID-19 vaccination is therefore unfounded. Women who wish to become pregnant can therefore be vaccinated against COVID-19.

 

Should the vaccination also be administered after a COVID-19 infection?

The STIKO recommends the administration of one vaccine dose for people who have already had a SARS-CoV-2 infection. The following recommendations apply:
1.    For persons with a confirmed symptomatic SARS-CoV-2 infection, STIKO recommends one vaccine dose usually 6 months after infection. In view of the increasingly better vaccine availability and the safety of vaccination after a SARS-CoV-2 infection, however, the administration of a vaccine dose is possible as early as 4 weeks after the end of COVID-19 symptoms.
2.    For persons with confirmed asymptomatic SARS-Cov-2 infection, the recommended single dose of vaccine may be administered as early as 4 weeks after laboratory diagnosis.
3.    Persons who have already been vaccinated once against COVID-19 and who were confirmed to have SARS-Cov-2 infection through direct pathogen detection after this vaccination should receive the 2nd vaccination usually 6 months after the end of COVID-19 symptoms or the diagnosis, respectively. In this case, the administration of a vaccine dose is also possible as early as 4 weeks after the end of symptoms.
4.    The STIKO currently does not recommend further vaccination with an mRNA vaccine for persons who have had a laboratory-diagnostically confirmed infection before or after a single vaccination with the Janssen vaccine.
5.    Persons who have undergone a laboratory-diagnostically confirmed SARS-CoV-2 infection before or after the COVID-19 vaccination are not recommended to receive a booster vaccination.

 

 

Why is one vaccine dose sufficient after a previous SARS-CoV-2 infection?

Due to the existing immunity after previous infection, one dose is sufficient, as this already allows high antibody concentrations to be achieved, which are not further increased by a second vaccine dose. Presently, it is not possible to say whether and when a second COVID-19 vaccination will be necessary at a later point in time. For persons with a reduced immune function, it should be decided on a case-by-case basis whether one vaccine dose is sufficient or whether a complete vaccination series should be administered. This significantly depends on the type and severity of the immunodeficiency. Even if more than six months have passed since the diagnosis, one vaccine dose is sufficient for complete initial immunisation.

The results of the studies that are available so far do not give any indication that vaccination after a SARS-CoV-2 infection would be problematic or associated with any dangers; this applies to the safety, effectiveness and tolerability of the vaccination. In the approval studies of the two mRNA vaccines, there were also participants who had already previously had a SARS-CoV-2 infection. The vaccination was not tolerated any worse by these persons than by primarily seronegative study participants. Local and systemic reactions after vaccination were even less severe in some cases. In some cases, local and systemic reactions after the vaccination were even less severe. The effectiveness of the vaccination is no different if a SARS-CoV-2 infection has already occurred. Against this background, there is no need to exclude the presence of an acute, asymptomatic, or undetected previous SARS-CoV-2 infection by laboratory diagnosis prior to COVID-19 vaccination.

Proof of SARS-CoV-2 infection can be confirmed by direct pathogen detection by means of PCR. The specific SARS-CoV-2 antibody tests, which are carried out in a laboratory that is accredited and/or works according to RiLiBÄK, have become so reliable that they are now, in principle, suitable for detecting a condition following SARS-CoV-2 infection. However, an antibody test cannot be used to prove the "recovered status" with the consequences deduced therefrom. The reason for this is that even highly specific validated antibody tests cannot provide information on the time at which the infection took place. The time of infection must be confirmed, as the "recovered status" is defined for the time period from at least 28 days to a maximum of 6 months after infection. For this time period, data are available that the person is sufficiently protected.
 
It is currently not known whether it is possible to favourably influence the course of the infection or prevent the disease by post-exposure vaccination after exposure to SARS-CoV-2.

 

What medical reasons (contraindications) are there against the COVID-19 vaccination?

There are only very few reasons (contraindications) why a person cannot be vaccinated against COVID-19, either permanently or for a limited period of time.

According to the RKI, only very few people (individual cases) cannot be vaccinated due to being allergic to components of the COVID-19 vaccines (see "Can people with allergies be vaccinated?").
As a rule, persons who cannot be vaccinated with one of the vaccine types (mRNA vs. vector-based) can be vaccinated with the other.

 

Furthermore, there are two rare contraindications for the vector-based COVID-19 vaccine Vaxzevria (AstraZeneca): a pre-existing thrombosis-with-thrombocytopenia syndrome (TTS) or a capillary leak syndrome. Both are very rare pre-existing conditions (individual cases). In these cases, mRNA vaccines can be used.

At present, children under 12 years of age cannot be vaccinated.

Infections with temperatures >38 °C are a temporary contraindication; vaccination can be administered after the fever has subsided.

Vaccination is generally not recommended for pregnant women before the second trimester.

 

Which vaccines are used?

Which vaccines are used?

In Germany, four corona vaccines are currently approved, one of which is currently being used at the Vaccination Centre at the RWTH Aachen University Hospital: Comirnaty® (BioNTech/Pfizer).

 

  1. The vaccine Comirnaty®, jointly produced by BioNTech and Pfizer. Comirnaty® was approved by the European Medicines Agency on 21 December 2020.
  2. The vaccine COVID-19 Vaccine Moderna® from the company Moderna, which was developed in cooperation with the US National Institute of Allergy and Infectious Diseases (NIAID) was approved by the European Medicines Agency on 7 January 2021.
  3. The vector-based vaccine COVID-19 Vaccine AstraZeneca® from the British-Swedish company AstraZeneca was approved by the European Medicines Agency on 29 January 2021.
  4. COVID-19 Vaccine Janssen from Janssen-Cilag International (Johnson & Johnson) was approved by the European Medicines Agency on 11 March 2021. Unlike the other three approved vaccines, it only needs to be vaccinated once.

What is an mRNA vaccine?

The vaccines are genetically engineered in a laboratory and consist of mRNA (messenger RNA) packed into small droplets of lipid or fat, so-called nanoparticles. The blueprint for a surface antigen, the so-called spike antigen of the SARS-CoV-2 virus, is located on the mRNA. If this mRNA gets into the target cell, it uses the body's own mechanism (ribosomes) to produce proteins, in this case for producing the viral surface antigen. The body then develops antibodies against these antigens in order to be able to protect itself accordingly upon actual contact with the virus. Moreover, viral proteins can trigger a T-cell response (CD4, CD8) (cellular immune response). T-cells support the immune system in fighting intracellular infections, and they can also kill the infected cells directly.

In the process, the mRNA remains in the cytoplasm of the cell and disintegrates there on its own after a short time. The mRNA does not reach the cell nucleus, where the cell's DNA is located. There is also no indication that the mRNA taken up by the body cells after vaccination is transcribed into DNA.  For this reason, there are no changes in the cell's genetic material.

What is a COVID-19 vector vaccine?

The "carrier or vector viruses" that are used in the AstraZeneca vaccine are adenoviruses (modified viruses that cause colds in chimpanzees), which are harmless to humans. The vaccine virus does not replicate (i.e. reproduce) in the human body and so cannot cause disease.

After vaccination, the vaccine virus with the SARS-CoV-2 gene finds its way into a few human body cells. The cells use the gene to produce the spike protein. The immune system recognises the spike protein as foreign and, as a reaction of the immune system, produces antibodies and T-cells that, ideally, protect against infection with the SARS-CoV-2 coronavirus.

In the case of natural infection with adenoviruses, no genetic alteration of human cells has been observed to date. Adenoviral vectors are generally considered non-integrating vectors, i.e. they do not integrate their genetic material into the cell genome. The genome of COVID-19 vector vaccines based on non-replicating adenoviruses, like that of other adenoviruses, remains outside the human DNA (extrachromosomal) in the nucleus of infected cells.

Furthermore, in view of the fact that the adenoviral vectors - unlike the natural cold viruses - do not replicate in the human body due to genetic changes and are quickly eliminated by the body, there is no risk of integration of the adenovirus vector DNA into the human genome based on the current scientific knowledge.

What ingredients do the vaccines contain?

In addition to the active agent (mRNA), the COVID-19 Vaccine Moderna® vaccine contains the following ingredients, as per the manufacturer's information:

 

  • the proprietary, ionisable lipid SM-102
  • 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 [PEG2000-DMG]
  • Cholesterol
  • 1,2-Distearoyl-sn-glycero-3-phosphocholine [DSPC]
  • Tromethamine
  • Tromethamine hydrochloride
  • Acetic Acid
  • Sodium acetate
  • Sucrose
  • Water for purposes of injection


In addition to the active agent (mRNA), the vaccine Comirnaty® from the company Biontech/Pfizer contains the following ingredients as per the manufacturer's information:

  • ALC-0315 = (4-hydroxybutyl)azanediyl)bis (hexane-6,1-diyl)bis(2- hexyldecanoate)
  • ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
  • DSPC= 2-distearoyl-sn-glycero-3 phosphocholine
  • Cholesterol
  • Potassium chloride
  • Potassium dihydrogen phosphate
  • Sodium chloride
  • Disodium hydrogen phosphate dihydrate
  • Sucrose
  • Water for purposes of injection

No adjuvant is included, nor is any preservative or chicken egg white.
According to the manufacturer, the stopper of the Comirnaty® vials is not made of natural rubber latex.

One dose (0.5 ml) of COVID-19 Vaccine AstraZeneca vaccine contains:

  • Chimpanzee adenovirus which encodes the SARS-CoV-2 spike glycoprotein ChAdOx1-S *, not less than 2.5 x 108 infectious units.

*Produced in genetically modified human embryonic kidney 293 (HEK) cells and by recombinant DNA technology. This product contains genetically modified organisms (GMOs).

The other ingredients are:

  • Histidine
  • Histidine hydrochloride monohydrate
  • Magnesium chloride hexahydrate
  • Polysorbate 80 (E 433)
  • Ethanol
  • Sucrose
  • Sodium chloride
  • Sodium edetate (Ph.Eur.)
  • Water for purposes of injection

 

Was the vaccine adequately tested before approval?

In January 2020, the genome of the SARS-CoV-2 virus was already completely decoded and the first vaccine candidates were already available by the end of December. This was made possible by telescoping the different test phases (I/II and II/III) and, simultaneously, forwarding all study results on a rolling basis to the approval authorities, where they were prioritised, so that, overall, a lot of time could be saved.

On top of that, there has never before been so much financial support for vaccine research worldwide, because it is clear to everyone that only effective vaccines that are available to a large part of the population globally can contain the pandemic in a timely manner.

The approval of the European Medicines Agency for the vaccine Comirnaty®, jointly produced by BioNTech and Pfizer, was granted on 21 December 2020, and on 7 January 2021 for the vaccine COVID-19 Vaccine Moderna®, produced by Moderna. On 29 January 2021, the European Medicines Agency approved the third vaccine, COVID-19 Vaccine AstraZeneca®, produced by the British-Swedish company AstraZeneca, in the EU. COVID-19 Vaccine Janssen from Janssen-Cilag International (Johnson & Johnson) was approved by the European Medicines Agency on 11 March 2021.

 

The two mRNA vaccines are licensed from age ≥ 12 years, the two vector-based vaccines from age ≥18 years.

Why do two vaccine doses have to be administered?

The second vaccination further stimulates the immune system already activated by the first vaccination to produce sufficient defences (antibodies) against the virus. We know from other vaccinations that this not only increases the production of antibodies, but also makes them last longer. For some infections, vaccination is administered even three times (e.g. hepatitis B or diphtheria).

Effects and Side Effects of Vaccination

What protection effect does the vaccination have?

From the approval study of the vaccine COVID-19 Vaccine Moderna® produced by Moderna, it is known that the protection effect in more than 15,000 vaccinated test persons was approximately 94 percent. This means that a symptomatic COVID-19 disease was observed about 18 times less frequently in the vaccinated test persons than in the unvaccinated study participants.

From the approval study of the vaccine Comirnaty®, jointly produced by BioNTech and Pfizer, it is known that the protection effect in more than 20,000 vaccinated test persons was approximately 95 percent; this means that a symptomatic COVID-19 disease was observed approximately 20 times less frequently in the vaccinated test persons than in the unvaccinated study participants.

Based on the current state of knowledge, the vector-based vaccine "COVID-19 Vaccine AstraZeneca" has a 70% effectiveness against COVID-19 disease in people.

Recent studies show that the available vaccines are also effective against virus variants. At present, Delta is the predominant virus variant in Europe. The Delta variant dominates the infection events while other variants have been replaced.

The living systematic review of the STIKO office shows that the effectiveness of the COVID-19 vaccines Comirnaty, Spikevax and Vaxzevria against any infection for the Delta variant is 10-20% lower than the effectiveness against the Alpha variant. There is also evidence that the effectiveness against Delta with respect to any infection decreases faster than the effectiveness against other variants.

The protection effect against a severe COVID-19 disease remains high for the vaccines Comirnaty, Spikevax as well as Vaxzevria, and the effectiveness against a symptomatic SARS-CoV-2 infection with the Delta variant is also good for all three vaccines.

A complete vaccination series is essential for a good protection effect.

The COVID-19 vaccines induce neutralising antibodies as well as T-cell immunity against many different regions (epitopes) of the spike protein of the SARS-CoV-2 virus. In other words, a polyclonal immune response is induced. As a result, individual mutations do not usually have a major impact on the effectiveness of the vaccines. Since all currently available COVID-19 vaccines code for the spike protein of the original Wuhan type, it can be assumed that the effects of mutations in the virus variants on the effectiveness of the approved vaccines are, basically, similar. However, should the effectiveness of the vaccines drop significantly as a result of further mutations in the viruses circulating here, it would be possible for the vaccine manufacturers to adapt the available vaccines accordingly within a few weeks. All manufacturers now have adapted vaccines in clinical development. The first approvals of these adapted vaccines are expected for the second half of 2021.

How quickly does this protection effect occur?

The full protection effect of the vaccination only develops after the second vaccination dose. Accordingly, high antibody titres should develop approximately two weeks after the second vaccination, i.e. approximately five to six weeks after the first vaccination. However, the approval studies of the two vaccines COVID-19 Vaccine Moderna® and Comirnaty® also show that the first dose of vaccine already has a certain protection effect.

The AstraZeneca vaccine achieved an effectiveness of 60% (41-73%) 28-34 days after the 1st vaccine dose, which further increased to 73% (27-90%) thereafter.

What about the "booster vaccination"?

The STIKO is updating its COVID-19 vaccination recommendation (18.11.2021) to recommend that all persons aged 18 years and older receive a COVID-19 booster vaccination with an mRNA vaccine.

 

The STIKO, however, confirms its recommendation to prioritise booster vaccination for the following groups of people:

  • Persons with immunodeficiency
  • Persons aged ≥ 70 years
  • Residents and assisted persons in care facilities for the elderly
  • Staff in medical and nursing facilities

The recommendation for booster vaccination also applies to pregnant women from the second trimester onwards.

Persons who have undergone a laboratory-diagnostically confirmed SARS-CoV-2 infection before or after the COVID-19 vaccination are currently not recommended for a booster vaccination.

Usually, booster vaccinations should be given at an interval of 6 months from the last vaccine dose of the initial immunisation. A shortening of the vaccination interval to 5 months can be considered in individual cases or if sufficient capacities are available.The objectives of expanding the existing booster vaccination recommendation beyond the previous indication groups are, in addition to upholding individual protection, the reduction of transmission of SARS-CoV-2 in the German population in order to mitigate infection waves and prevent additional severe cases of illness and fatalities.

If at all possible, the mRNA vaccine that was used for the initial immunisation should be used. If this one is not available, the other mRNA vaccine can also be used. Persons under the age of 30 as well as pregnant women should be vaccinated with Comirnaty® (BioNTech/Pfizer), even if the initial immunisation was carried out with another vaccine, since there are indications suggesting that the risk of myocarditis and pericarditis occurring in persons under 30 years of age after vaccination with Spikevax®(Moderna) is higher than with Comirnaty® (BioNTech/Pfizer).
The booster vaccination with Comirnaty® (BioNTech/Pfizer) is administered using the same dosage as for the initial immunisation. Spikevax® (Moderna) is approved for the booster vaccination of immune-healthy persons at half the dose (50µg).

 

Does it make sense to determine the antibody titre before the booster vaccination?

The STIKO does not recommend any testing of the vaccination success for COVID-19 vaccinations, neither after the first vaccine dose nor after the second vaccine dose.

So far, no uniform serological correlate has been defined for testing the vaccination success in vaccinated persons. As a result, there is no threshold value at which immunity can be assumed. A general serological examination of the immune response is therefore not recommended.

Besides, cellular immunity is built up after the vaccination regardless of the existence of antibodies. Whether a serological correlate for effectiveness can be defined later on is uncertain; even in the case of other vaccine-preventable diseases (e.g. pertussis), no reliable serological correlate for protection can be provided so far.

Does vaccination prevent the virus from being passed on?

The risk of virus transmission to other people is greatly reduced when there is full vaccination protection. However, it is assumed that, despite vaccination, some people become infected through contact with SARS-CoV-2 infected persons and secrete infectious viruses, but to a lesser extent than non-vaccinated persons.

A study by the Robert Koch Institute at the end of May 2021 concluded that, based on current knowledge, the risk of virus transmission by persons who have been fully vaccinated is lower from day 15 at the latest after administration of the 2nd dose than in the case of a negative rapid antigen test for asymptomatic infected persons ("Wie gut schützt die COVID-19-Impfung vor SARS-CoV-2-Infektionen und -Transmission? Systematischer Review und Evidenzsynthese", How well does the COVID-19 vaccination protect against SARS-CoV-2 infection and transmission? Systematic review and evidence synthesis).

 

Hence, there is no such thing as 100% sterile immunity, especially with the much more contagious Delta variant. Just as a negative test, especially a rapid antigen test, does not offer 100% certainty and the result can be false-negative or false-positive.

The extent to which virus transmission is reduced may also vary depending on the virus variant. Current studies show that vaccination provides protection against symptomatic and asymptomatic infections even with the currently dominant Delta variant being present. However, the protection seems to be slightly reduced compared to the Alpha variant.

This risk must be further reduced by compliance with infection protection measures. For this reason, everyone must continue to comply with the hygiene rules that are in force, both at work and in private life.

From a public health point of view, vaccination appears to reduce the risk of virus transmission to such an extent that vaccinated persons no longer play a significant role in the epidemiology of the disease.

 

 

Can vaccine breakthroughs occur and how frequent are they?

There is no vaccine that is 100% effective. The vaccines against the SARS-COV-2 virus show very high effectiveness, even against the much more contagious Delta variant.

 

Since the start of the vaccination campaign, the Robert Koch Institute has been continuously monitoring vaccine effectiveness.

A probable vaccination breakthrough is defined as a SARS-CoV-2 infection (with clinical symptoms) which is diagnosed in a fully vaccinated person with the help of PCR or pathogen isolation. Complete vaccination protection is assumed if at least two weeks have passed after a completed vaccination series.

Up to the RKI Situation Report 09.09.21, 30,880 probable vaccine breakthroughs had been identified in Germany, with 103,165,990 vaccine doses administered (54,890,847 fully vaccinated). (Source RKI Situation Report 09.09.)

 

What do these numbers mean in terms of vaccination effectiveness?

At the present time, it can be established, even with regard to the patients treated in the University Hospital, that the vast majority of them have not been vaccinated.
The vaccination status has had to be included when reporting COVID cases for some time now.
A comparison of the proportion of fully vaccinated COVID-19 cases with the proportion of fully vaccinated persons in the population makes it possible to estimate vaccination effectiveness.

The RKI has come to the following conclusion about the estimated vaccine effectiveness against further COVID-19-associated endpoints (observation for the time period of the last four weeks ( CW 32-35):

  • Protection against hospitalisation: approx. 96 % (age 18-59 years) and approx. 94 % (age ≥60 years), resp.
  • Protection from treatment in the ICU: approx. 97 % (age 18-59 years) and approx. 94 % (age ≥60 years), resp.
  • Protection against death: approx. 100 % (age 18-59 years) and approx. 91 % (age ≥60 years), resp.

Moreover, statistically it is entirely to be expected that more and more vaccination breakthroughs will be recorded over time as more and more people are getting vaccinated. With an increased spread of the virus, the probability of coming into contact with the virus increases for all people, including those who have been fully vaccinated.

What side effects or complications may occur?

In general, a distinction must be made between mild but frequent vaccination reactions and rare but severe vaccination complications.

In this context, harmless, mild vaccination reactions are, in fact, a "good reaction", as they show that the body is reacting to the vaccination and that an immune response is developing. Frequent and harmless vaccine reactions described in the approval studies of the COVID-19 Vaccine Moderna® and Cominarty® vaccines include redness or swelling of the puncture site. Fever, fatigue, nausea as well as muscle and joint pain and headaches may also occur after vaccination. In very rare cases, swelling of the lymph nodes may also develop. Mild vaccination reactions occur more frequently in younger test persons and more frequently after the second vaccination. The vaccination reactions lasted for a maximum of one to two days and were reversible with no exception. In order to relieve possible discomfort, an analgesic / antipyretic medication can be taken in the recommended dosage.

Vaccination complications, on the other hand, are effects of the vaccination that go beyond the normal level of a vaccination reaction and significantly impact the health of the vaccinated person.
In the extensive clinical trials prior to approval, cases of acute facial paralysis were observed rarely (between 0.1% and 0.01%) after administration of the mRNA vaccines (Comirnaty : 4 cases after administration of the vaccine; Spikevax®: 3 cases after administration of the vaccine and 1 case in the control group). Facial paralysis regressed after a few weeks in all cases. These facial paralyses may possibly be causally related to the vaccination. Hypersensitivity reactions were observed in rare cases (between 0.1% and 0.01%): Hives or facial swelling after administration of Comirnaty and 2 cases of facial swelling after administration of Spikevax®. Since the vaccination was first introduced, anaphylactic reactions (immediate allergic reactions) have been reported in very rare cases. These occurred shortly after vaccination and required medical treatment.
They are also an extremely rare, but, in principle, life-threatening vaccination complication.
Please also read the section "Can people with allergies get vaccinated?".

Since the introduction of COVID-19 vaccination with the mRNA vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna), it has also been established that myocarditis and pericarditis have occurred in rare cases in younger people after these vaccines were administered. Current analyses of reports show that myocarditis and pericarditis were observed more frequently in boys and young men and in girls and young women under 30 years of age after vaccination with Spikevax than after vaccination with Comirnaty. For people 30 years and older, there is no increased risk of myocarditis and pericarditis after vaccination with Spikevax. Based on the safety reports available up to now, the acute course of vaccine-induced myocarditis and pericarditis is predominantly mild.


Vaxzevria®: The vaccination reactions most frequently reported in the approval studies were tenderness at the puncture site (more than 60%), pain at the puncture site, headache and fatigue (more than 50%), muscle pain and discomfort (more than 40%), increased temperature and shivering (more than 30%), joint pain and nausea (more than 20%). Frequently (between 1 % and 10 %), a reduction in the blood platelet count (thrombocytopenia), vomiting, diarrhoea, redness and swelling of the puncture site and fever were observed. Occasionally (between 0.1% and 1%), lymph node swelling, decreased appetite, dizziness, drowsiness, increased sweating, itching and a general skin rash occurred.

Since the vaccine was first introduced, blood clots (thromboses), associated with a reduction in the blood platelet count (thrombocytopenia), sometimes accompanied by bleeding, have been observed in very rare cases (less than 0.01%) after vaccination with Vaxzevria®. These included a number of severe cases with blood clots in different or unusual locations (e.g. in the brain as sinus vein thromboses or in the abdomen as well), together with increased clotting activity or bleeding in the whole body. The majority of these cases occurred within two to three weeks after vaccination and mostly in people under 60 years of age. Some of the cases described ended fatally or with lasting damage. Likewise, since the introduction of vaccination, cases of capillary leak syndrome have been observed very rarely (less than 0.01%) after vaccination with Vaxzevria®, some of them in persons who had previously fallen ill with capillary leak syndrome, and in some cases with a fatal outcome. Capillary leak syndrome occurred in the first few days after vaccination and it is characterised by a rapidly progressive swelling of the arms and legs, sudden weight gain as well as a feeling of weakness; it requires immediate medical treatment. Furthermore, very rare cases of Guillain-Barré syndrome have been reported after vaccination with Vaxzevria®, in some cases with a fatal outcome. Whether these cases are causally related to the vaccination is still being examined. Guillain-Barré syndrome is characterised by weakness or paralysis in the legs and arms, which can extend to the chest and face and which may require intensive medical treatment. Finally, complications must be mentioned which are not caused by the vaccine, but may be caused by the injection. As with any other injection, there is an extremely small remaining risk that bleeding, infections or nerve and soft tissue injuries may occur, even with an appropriate injection technique.

COVID-19 Vaccine Janssen®: The most frequently reported vaccine reactions in the approval studies have been pain at the puncture site (more than 40 %), headache, fatigue and muscle pain (more than 30 %) as well as nausea (more than 10 %). Frequently (between 1% and 10%), fever, cough, joint pain, redness and swelling of the puncture site, and shivering have been reported. Occasionally (between 0.1% and 1%), tremor, sneezing, pain in the mouth and throat, a general rash, increased sweating, muscle weakness, arm or leg pain, back pain, general weakness and discomfort have occurred. In rare cases (0.01% to 0.1%), hypersensitivity reactions and hives have occurred. Furthermore, after vaccination with COVID-19 Vaccine Janssen®, blood clots (e.g. in the brain as sinus vein thrombosis or in the abdomen as well) associated with a reduction in the blood platelet count (thrombocytopenia) have been observed in very rare cases (less than 0.01 %), and in some cases with a fatal outcome. These cases occurred within 3 weeks after vaccination and mostly in persons under 60 years of age. Since the introduction of the vaccination, there have also been very rare ® cases of capillary leak syndrome after vaccination with COVID-19 Vaccine Janssen, some of them in persons who had previously fallen ill with capillary leak syndrome, and some of them with a fatal outcome. Capillary leak syndrome occurred in the first few days after vaccination and it is characterised by a rapidly progressive swelling of the arms and legs, sudden weight gain as well as a feeling of weakness; it requires immediate medical treatment. Furthermore, very rare cases (less than 0.01%) of Guillain-Barré syndrome have been reported after vaccination with COVID-19 Vaccine Janssen . These cases may possibly be causally related to the vaccination. Guillain-Barré syndrome is characterised by weakness or paralysis in the legs and arms, which can extend to the chest and face and may require intensive medical care. Since the introduction of the vaccination, there have been reports of very rare cases of immediate allergic reactions (anaphylactic reactions). These occurred shortly after the vaccination and had to be treated medically. In principle, as with all vaccines, it cannot be ruled out that in very rare cases there may be an immediate allergic reaction leading to shock or other previously unknown complications.

Why was vaccination with the AstraZeneca vaccine suspended?

In Germany and other European countries, vaccination with the AstraZeneca vaccine was temporarily suspended. This decision was made on 15.03.2021 by the Federal Ministry of Health at the recommendation of the Paul Ehrlich Institute, following an increased occurrence of cerebral venous thromboses in connection with the vaccination. In Germany, a total of seven people were affected, six of them women with so-called sinus vein thrombosis, three of whom have since died. At the time of the vaccination stop, it was not clear whether this was a coincidental accumulation or whether there was a causal connection to the vaccination; time was needed to examine the cases. On 18 March 2021, the European Medicines Agency (EMA) recommended that vaccination be continued because the benefits of vaccination outweighed the potential risks and since a causal link to cerebral venous thromboses and clotting disorders could neither be ruled out with certainty nor clearly established. The use of the vaccine was then continued in Germany and at the University Hospital as well starting on 19.03.2021. Another nationwide vaccine was available on 30.03.2021. Currently, there are no plans to use the AstraZeneca vaccine for further initial vaccinations at the University Hospital.

What should I do before and after vaccination?

Please inform the vaccinator before the vaccination if you fainted after a previous vaccination or any other injection, or if you have a predisposition to immediate allergies or have had any other reactions. This way, he/she can observe you for a longer period of time after the vaccination if necessary.

Please tell the doctor before the vaccination if you suffer from a clotting disorder or if you are taking anticoagulant medication. In compliance with simple precautionary measures, you can be vaccinated.

Please also tell the doctor before the vaccination if you had an allergic reaction or allergies after a vaccination in the past. Together with you, the doctor will determine whether there is any reason why you should not be vaccinated.

 

It is recommended that you avoid any excessive physical exertion or competitive sport in the first few days after the vaccination.

In case of pain or fever after the vaccination, analgesic / antipyretic medication may be used. Your GP can advise you on this.

If symptoms occur after a vaccination that exceed the above-mentioned transient local and general reactions that quickly pass, your GP is, of course, available to advise you. If you suffer from severe adverse effects, chest pain, shortness of breath or palpitations, please seek medical treatment immediately.

Is there insurance coverage for vaccination damage?

At RWTH Aachen University Hospital, only vaccines are administered that have been approved by the European Medicines Agency (EMA) and recommended by the Standing Committee on Vaccination (STIKO) at the Robert Koch Institute (RKI). Under these premises, it is guaranteed that the costs of vaccine damage will be covered by the public authorities.

Are there any data on long-term side effects?

Many years of experience with numerous vaccines have shown that most side effects occur within a short period of time, usually within a few days to a few weeks, after vaccination. Vaccines continue to be actively monitored by the Paul Ehrlich Institute even after they have been approved, so that more and more knowledge is being gained about long-term safety, especially very rare side effects, in different groups of the population.

Side effects that occur unexpectedly and not until a long time (e.g. several years) after the vaccination have not yet been observed with any vaccination and are also not to be expected with the COVID-19 vaccines. There were cases in the past where very rare side effects that occurred in vaccinated persons shortly after vaccination were not recognised by researchers until later. The reason for this is that a great many people have to be vaccinated in order to detect very rare side effects. This generally takes some time. The COVID-19 vaccines were administered to many people all over the world in a very short time. Therefore, very rare side effects can be detected and assessed more quickly than would otherwise be the case.

To date, the following side effects that occurred a short time after receiving the COVID-19 vaccine have been reported: After the approval of the vaccine Vaxzevria (AstraZeneca) and the COVID-19 Vaccine Janssen (Janssen-Cilag International), special forms of thrombosis occurred in vaccinated persons. So far, these side effects have been observed predominantly in women aged ≤55 years, but men and the elderly have also been affected. Very rare side effects in the form of (peri-)myocarditis have also been observed with the mRNA vaccines after their approval. These myocarditides are usually mild and heal without consequences. However, it is not yet known whether, in individual cases, myocarditis can also lead to late complications such as myocardial insufficiency.

The Paul Ehrlich Institute points out that there is no need to be concerned about so-called long-term side effects that only occur years after vaccination. The Paul Ehrlich Institute regularly evaluates suspected cases of side effects with COVID-19 vaccines in the safety reports and reports on them in its corona dossier.
Suspected cases of side effects can also be reported via the Online Reporting of Side Effects.

 

 

What should I do if there are suspected side effects?

If symptoms occur after a vaccination that exceed the above-mentioned transient local and general reactions that quickly pass, your GP is, of course, available to advise you. If you suffer from severe adverse effects, chest pain, shortness of breath or palpitations, please seek medical treatment immediately.

 

If you suffer from severe adverse effects, especially if you experience persistent headaches, shortness of breath or pinpoint bleeding of the skin 4-14 days after vaccination with the AstraZeneca® vaccine, you should seek medical attention immediately.

Who monitors vaccine reactions and how can side effects be reported?

Even with widespread use, the effectiveness, safety as well as the duration of protection of COVID vaccines are continuously being monitored and evaluated by the pharmaceutical company itself as well as by the Paul Ehrlich Institute and the competent committees at the European Medicines Agency (EMA). This means that we can react very quickly if there are indications of possible side effects. If you or your attending doctor suspect a side effect, you can report this to the Paul Ehrlich Institute (PEI) as the highest federal authority, to your local health authority, or in the PEI's "SafeVac" app.