Vaccination against an infectious disease caused by a pathogen prepares the humoral (antibody-based) and cellular (cell-based) immune systems for contact with the pathogen. The vaccination feigns contagion with the pathogen in the body without transmitting the infectious disease. Vaccination trains the immune system. When a vaccinated person comes into contact with the pathogen, the defence system is already equipped and can react quickly. Thanks to vaccination protection and immunity against the pathogen, the infectious disease either does not occur at all or has a milder course. Vaccine efficacy as well as quality and safety are tested during authorisation studies. A vaccine is only authorised if the benefit-risk ratio is favourable. Sufficient vaccination protection often needs to be built up by administering more than one dose of vaccine (primary immunisation). Many vaccinations wear off over time but can be extended by booster vaccinations or if necessary.
Updated: 11.09.2024
In an active immunisation, the immune system is stimulated by a vaccine to confer an immune response, which is developed through processes such as the creation of antibodies. Vaccines contain components of the pathogen (e.g. a virus) that trigger this immune response. These components are called antigens. The administration of antibodies, however, represents a passive immunisation. Antibodies can be used for prevention or treatment. Unlike active immunisations, which also trigger a memory function of the immune system and thus last for a longer period of time, the effect of passive immunisation depends on whether there is a sufficient amount of the specific antibodies (immunoglobulins) administrated. These immunoglobulins do not trigger a direct memory function.
Updated: 25.07.2024
Before a vaccine is placed on the market, it must undergo an extensive marketing authorisation procedure, either in Germany (national marketing authorisation) or at the European Medicines Agency (EMA) (centralised authorisation procedure by the EU Commission).
The quality, efficacy, and safety of the vaccines are thoroughly assessed and evaluated during the authorisation procedure in clinical trials with many study participants. A favourable benefit-risk assessment is a prerequisite for authorisation of a vaccine.
Before a newly produced vaccine batch may be placed on the market in Germany, this production unit (batch) is tested by an official medicines control laboratory (OMCL) independent of economic interests. These tests usually include experimental lab tests. The Paul-Ehrlich-Institut is an OMCL. The final step before a batch is released for Germany is carried out by the Paul-Ehrlich-Institut either after it conducts its own examination or after acceptance of the examination by another control laboratory of the European OMCL network.
From Vaccine Authorisation to Recommendation by the Standing Commission on Vaccination in Germany: Criteria for the Objective Assessment of Benefits and Risks (German only)
Vaccine Testing: The Challenge of Testing Complex Combination Vaccines (German only)
Updated: 11.09.2024
The Paul-Ehrlich-Institut offers a lot of information on the subject of vaccines on its website, including a list of all human vaccines authorised in Germany at www.pei.de/vaccines.
There is a table for each vaccine type. In far right-hand column of the tables, you will find links to pages where you can access the product information, such as the summary of product characteristics and the package leaflet. These resources contain all information, including specifics on composition, use, contraindications, and side effects.
Updated: 09.09.2024
The viral component or gene that provides protection against an infectious disease is called an antigen. In order to distinguish between the different types of viral vaccines, they are divided into live virus vaccines and inactivated vaccines, also known as dead vaccines. With the new mRNA vaccines came the addition of a third category, genetic vaccines.
Live virus vaccines contain an attenuated (weakened) form of the wild-type virus, which replicates in the body for a limited period after vaccination but cannot trigger the infectious disease associated with the wild-type virus. This form of the virus leads to long-lasting vaccination protection against the infectious disease. Examples of live attenuated vaccines are the vaccines against measles, mumps, rubella, and chickenpox (varicella). The vaccine against chickenpox is the only single vaccine in the group. The other three vaccines are only available in combination as one measles-mumps-rubella vaccine (MMR vaccine) or in combination with the chickenpox vaccine (MMRV). Thus, vaccination with the MMR or MMRV combination vaccines can protect against several infectious diseases at the same time.
Inactivated viral vaccines, also known as dead vaccines, contain the entire virus in inactivated form (inactivated whole virus vaccines) or individual virus components in a more (subunit vaccines) or less (split vaccines) purified form. Recombinant protein vaccines, i.e. those produced by genetic engineering, usually contain a virus protein that is produced in cell culture without other virus components. Most commonly, subunit, split, and recombinant protein vaccines are mixed with an adjuvant in order to stimulate both the humoral and the cellular immune response. When the virus proteins spontaneously combine to form a structure that resembles a virus particle, these are referred to as "virus-like particles" (VLPs) and are used to produce VLP vaccines. The TBE vaccine, which protects against tick-borne early summer meningoencephalitis (TBE), is an example of an inactivated vaccine.
Genetic vaccines contain the nucleic acids DNA or mRNA with the blueprint for one or more virus proteins. These vaccines are produced using DNA that is unpackaged, packaged in lipid particles, or formed as part of the genome in viral particles (known as viral vectors) that are incapable of replicating. The nucleic acids are transferred to a small number of somatic cells. After reading the antigen blueprint (antigen gene), the antigen is produced by the host somatic cells and presented to the immune system. mRNA and vector vaccines are used to vaccinate against COVID-19. Vector vaccines, which, like live virus vaccines, are limited in the body and can only replicate for a short time, are also referred to as hybrid virus vaccines. An example of this vaccine type is the VSV-EBOV Ebola vaccine, in which the gene for the envelope proteins of the vesicular stomatitis virus (VSV) has been replaced by the gene with the blueprint of the Ebola virus envelope protein.
Updated: 11.09.2024
RNA vaccines contain the genetic information from messenger RNA (mRNA), which comprises the blueprint of one or more antigens. Antigens are components of the pathogen to which the immune system responds and develops a defence against. The genetic information from one or more antigens is directly used by somatic cells as a blueprint to produce the specific antigen in the somatic cells in which the mRNA has entered. The cells present this antigen to immune cells, which triggers the desired specific immune response. If the vaccinee comes into contact with the pathogen again, the immune system will recognise the antigen and will be able to combat the virus, and thus the infection, in a targeted manner.
Advantages of mRNA vaccines include the simple structure of the RNA and the possibility to produce several millions of vaccine doses within few weeks.
Updated: 25.07.2024
Vector vaccines contain parts of the pathogen’s genetic material. The genetic material in vector vaccines is incorporated into harmless carrier viruses that are injected as a vaccine. These vaccines can be made with carrier viruses that are either capable or incapable of reproducing.
The genetic material is the blueprint for one or more of the pathogen's antigens. The antigen is a component of the pathogen to which the immune system responds and develops a defence.
After this genetic information has reached some of the somatic cells of the vaccinated person through vaccination, it is read by the cells and the corresponding surface structures (proteins) of the virus are then produced. The immune system reacts to these antigens and produces defensive substances (including antibodies) against them. If the vaccinated person comes into contact with the pathogen later on, the immune system recognises the antigen(s) and can combat that pathogen specifically.
Vector vaccines against Dengue fever, Ebola, and COVID-19 have been developed.
Updated: 25.07.2024
The quality, efficacy and safety of a vaccine are only guaranteed if the vaccine has been properly stored. Each vaccine’s summary of product characteristics (SmPC) and package leaflet provides information on the required storage conditions.
The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, offers lists of vaccines authorised in Germany on its website (www.pei.de/vaccines). "Further information" links are provided in the far right-hand column of the lists. In the case of centrally authorised products, these links lead to the EPAR (European Public Assessment Report), which contains details such as the product information. For all other authorisations (national, decentralised, mutual recognition procedure), the links connect to the PharmNet.Bund database. After accepting the disclaimer and clicking on the name of the medicinal product, the product information or package leaflet can be downloaded by clicking on the "additional documents" (Zusatzdokumente) tab.
Updated: 09.09.2024
The Summary of Product Characteristics (SmPC) is one place where information on the substances contained in a vaccine can be found.
The "Guideline on Summary of Product Characteristics (SmPC)" from the European Medicines Agency (EMA) specifies what must be stated in each medicinal product's SmPC.
Detailed information is listed under the following points:
Elemental impurities in pharmaceuticals (e.g. metal traces) are considered acceptable up to certain limits. This is regulated in the ICH Q3D Elemental impurities guideline.
Tables A.2.1 and A.2.2 in the document show the PDE values (permitted daily exposure) in micrograms (μg)/day for different elements.
Quantities in excess of these values shall be justified by the applicant in exceptional cases. A level of elemental impurities above the specified PDE value (see Table A.2.1) may be acceptable in certain cases. These cases include intermittent (temporary) administration, short-term administration (i.e. 30 days or less), special indications (e.g. life-threatening diseases, unmet medical needs, rare diseases).
If doses of a vaccine batch (production unit) contain concentrations of elemental impurities that are too high and do not fall under the exceptions mentioned above, the vaccine batch does not receive a federal batch release for Germany from the Paul-Ehrlich-Institut.
Updated: 28.03.2024
No.
Vaccines can contain pharmaceutical excipients that are produced by the pharmaceutical manufacturer itself or purchased from other companies. Such substances are sometimes offered as laboratory chemicals for a wide variety of applications. The manufacturer usually provides the product information on these laboratory chemicals with a warning that they are not suitable for use in humans. This can lead to the erroneous assumption that they cannot be used in humans at all.
As soon as such substances are used in medicinal products, their suitability for use in humans must be carefully examined and evaluated by the manufacturer and within the framework of the marketing authorisation, e.g. by the Paul-Ehrlich-Institut. A marketing authorisation application contains corresponding information on quality and production. The above-mentioned testing was also carried out as usual for the authorisation of mRNA vaccines.
Updated: 22.08.2024
Since viruses require a live cell to replicate, a cell line (cell culture) from animals or humans is required to produce vaccine viruses. Depending on the virus type, various cell types or cell lines have proved to be particularly suitable for this purpose. For influenza vaccines, for instance, up to now, these have been primarily embryonised hen’s eggs. Measles viruses and mumps viruses are replicated on chicken fibroblasts, rubella viruses and chicken pox viruses on human diploid cells (MRC-5).
There are currently two cell lines from human lung tissue for the production of marketable vaccines in Germany. In 1961, the scientist L. Hayflick developed the cell line WI-38, and in 1966, the scientist J. P. Jacobs developed the cell line MRC-5 (Medical Research Council). These cell lines are described as human diploid cells (HDC).
With the development and authorisation of vector vaccines to prevent COVID-19 disease caused by the SARS-CoV-2 virus, two additional cell lines have been added.
These vector vaccines require an attenuated virus as a means of transport (vector) for a harmless portion of the genetic information of SARS-CoV-2 into a small number of somatic cells. AstraZeneca's Vaxzevria and Johnson&Johnson's COVID-19 Vaccine Janssen use adenoviruses for this purpose.
In the case of Vaxzevria, these viruses are propagated on the cell line 293 HEK (Human Embryonic Kidney), in the case of Johnson&Johnson's vaccine on the cell line PER.C6 (from human fetal retinal cells).
The cell line 293 HEK was developed in 1973 by Frank. L. Graham, a doctoral student of Alex J. van der Eb.
The PER-C6 cell line was generated in 1998 by Frits J. Fallaux, also in the laboratory of van der Eb, by an immortalisation of embryonic retinal cells. These came from a fetus aborted in 1985.
The term "cell line" means that this line has been created as a unique line, and has since then been replicated and frozen. The cells are cultured. No new foetuses are required, as can be frequently read. No foetus was aborted in any case to serve as starting material for the establishment of cell cultures.
Updated: 28.03.2024
No. All ingredients are listed in the relevant Summary of Product Characteristics (SmPC).
Updated: 28.03.2024
The currently authorised COVID-19 mRNA vaccines – Comirnaty and COVID-19 Vaccine Moderna – contain lipid particles in which the mRNA is encapsulated. On account of their size (< 100 nm), they are also referred to as lipid nanoparticles (LNPs). When using the term "particle", however, it should be noted that these are not non-degradable solid particles (metals, plastics etc.), but rather fat globules that, like biological cell membranes, are made up of a phospholipid layer. They act as carriers and protect the otherwise unstable mRNA. Above all, however, the LNPs ensure that the mRNA is absorbed into the cells after vaccination (especially around the injection site) and is then released within the cell where the mRNA is to be transcribed.
Updated: 22.08.2024
Both variants are possible. It is possible first to mix the mRNA and then to have it taken up in lipid vesicles or first to produce the lipid vesicles with the respective mRNA and then to mix the lipid vesicles.
Updated: 25.07.2024
Lipid nanoparticles (LNPs) are similar to the liposomes (fat cells) that have been used for over 20 years as delivery mechanisms for medicinal products (e.g. Myocet liposomal, Caelyx pegylated liposomal, DaunoXome, AmBisome). Another authorised medicinal product (Onpattro) contains therapeutic RNA molecules that are encapsulated in very similar LNPs. With these medicinal products, significantly higher amounts of lipids are administered intravenously compared to vaccination. There have also been authorised vaccines with a similar structure known as "virosomal vaccines", e.g. Epaxal for hepatitis A or Inflexal for influenza. Virosomes are also phospholipid vesicles that carry viral envelope proteins on their surface. These vaccines were in use for many years and they have a good safety profile. They are currently no longer on the market, but this is not due to safety concerns.
As with biological membranes, the structure of LNPs is formed by phospholipids with cholesterol stored in them. The various LNPs also contain other lipid components that impart special characteristics. As all lipids are identical or very similar to the body's own lipids, LNPs are considered to be "biodegradable", i.e. it may be assumed that they are broken down in the body enzymatically like dietary lipids and are largely incorporated into the body's own fat metabolism.
The potential toxicity of each of these novel vaccine preparations was tested in preclinical toxicity tests prior to marketing authorisation.
Updated: 22.08.2024
Many inactivated vaccines, such as vaccines against whooping cough, TBE (tick-borne encephalitis), meningococci, tetanus, and diphtheria contain aluminium compound adjuvants. Adjuvants are necessary in inactivated vaccines because this vaccine type contains only killed pathogens or parts thereof that do not sufficiently stimulate the immune system without an adjuvant. The adjuvant enhancer helps the immune system to build up effective immune protection.
The aluminium compound content in all vaccines authorised in Germany and Europe is well below the permitted limit specified in the European Pharmacopoeia.
Every day, every human being absorbs aluminium in the form of a chemical compound from the air, drinking water, and food. The additional uptake of aluminium compounds via vaccinations in a person's life is minimal by comparison.
Attenuated live vaccines do not require an adjuvant. These include vaccines against measles, mumps, rubella, and chickenpox (varicella).
Updated: 09.09.2024
The vaccines authorised in Germany today are thiomersal-free, which means they are free from mercury compounds. The only exceptions are pandemic and zoonotic inactivated influenza vaccines in multi-dose vials, which may contain organic mercury compounds as a preservative. These vaccines are not administered in non-pandemic times.
Updated: 09.09.2024
Typical vaccine reactions include redness, swelling, or pain at the injection site. General reactions such as fever, headache, body aches, and malaise can also occur. These reactions are an expression of the desired activation of the immune system and usually subside after a few days without consequences.
Vaccination side effects or vaccination complications are adverse drug reactions after vaccination. The frequency of such adverse reactions as identified in clinical trials can be found in each vaccine's Summary of Product Characteristics. Serious side effects are rare.
In general, the benefits of vaccination must outweigh any possible risks, otherwise a vaccine cannot be authorised. Information on the type and frequency of expected reactions can be found in each vaccine's Summary of Product Characteristics.
Updated: 08.08.2024
VAED stands for Vaccine-Associated Enhanced Disease. One trigger for VAED can be the occurrence of infection-enhancing antibodies (Antibody-Dependent Enhancement, ADE). It can also be caused by vaccine-associated hypersensitivity (VAH). These processes involve a shift in the balance between different immune cells, the type 1 and type 2 T helper cells, which in turn has consequences for the release of important immune system messenger substances.
VAED arose in context with the development of a vaccine candidate against pneumonia in children caused by the respiratory syncytial virus (RSV) more than 50 years ago (1967). An increase in RSV with signs of inflammation in vaccinated individuals was noticed in the clinical trials. The development of the vaccine was stopped early as a result.
Updated: 23.08.2024
Influenza or flu vaccines offer protection against the genuine flu, a respiratory disease caused by an infection with the flu viruses. The vaccines are divided into two main categories:
The composition of these vaccines is adapted annually to the dominant influenza virus strains or variants. Seasonal flu vaccines are administered in autumn and winter to protect against the increase in flu cases that typically occurs in winter. They help to combat the dominant flu viruses in a particular season and reduce the severity of the disease.
A distinction is made in this category between zoonotic pre-pandemic influenza vaccines and pandemic influenza vaccines:
Zoonotic pre-pandemic vaccines contain a virus strain from the potential pandemic pathogen and can be used even before a pandemic breaks out in particularly vulnerable populations.
These vaccines may only be used in the event of a real pandemic, meaning a new influenza virus is spreading worldwide and a pandemic has been declared.
Pandemic vaccines contain a virus strain of a potential pandemic pathogen that is intended initially as a sample for marketing authorisation. Depending on when the authorisation was granted, the strains can vary greatly. Currently there are only pandemic influenza vaccines for the H5N1 subtype.
If a pandemic is declared, the virus strain contained in the vaccine (used as a sample for authorisation) is exchanged for the actual circulating virus strain that is causing the pandemic. This process is comparable to the annual strain update for seasonal influenza vaccines.
Updated: 19.09.2024
Influenza viruses continuously change the surface proteins to which the human immune system responds in a process known as drift. In order to ensure protection against influenza, manufacturers adapt the influenza vaccines every year to match the virus strains and virus variants that are expected to circulate.
Flu vaccines are first given an initial marketing authorisation. The marketing authorisation holder must then obtain an authorisation for the seasonal strain update from the competent authority in order for their vaccine to be placed on the market in Germany and the European Economic Area (EEA) during the flu season. Depending on the vaccine product's initial authorisation procedure, different responsibilities arise for the subsequent strain update authorisation:
The list of seasonal influenza vaccines authorised in Germany on the Paul-Ehrlich-Institut's website indicates whether a strain update has been approved by including the adaptation year in the name of the vaccine product. If an influenza vaccine product is included in the Paul-Ehrlich-Institut's vaccine list but their name does not include the current year, this indicates that the vaccine has been authorised but no seasonal strain update has been carried out. These influenza vaccine products are not allowed to be placed on the market or used in the current influenza season.
Updated: 06.09.2024
Seasonal influenza vaccines are adapted annually to the virus variants expected to be in circulation (known as the strain update). It is important that the virus components (antigens) contained in the vaccine are as close a match as possible to the virus strains and virus variants that are expected to circulate in the coming influenza season. This approach ensures the best possible immune protection.
The World Health Organization (WHO) continuously obtains data on the circulating influenza strains via the GISRS network (Global Influenza Surveillance and Response System). Based on this information, WHO updates its annual recommendations for flu vaccine composition for both the northern and southern hemispheres.
The influenza vaccine products approved for a given influenza season in Germany and the EU contain the antigens of the variants of certain influenza virus strains expected in Europe, as recommended by WHO and the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA).
Current Compostition of Influenza Virus Vaccines
Updated: 06.09.2024
Seasonal influenza vaccines are adapted annually to the virus variants expected to be in circulation (known as the strain update). Flu vaccines containing three different strains of influenza virus (trivalent vaccines) were common for many years. Starting with the 2018/19 season, the Standing Committee on Vaccination (STIKO) at the Robert Koch-Institut (RKI) began recommending tetravalent (also called quadrivalent) vaccines containing four different virus strains for use in Germany, following the recommendations of the World Health Organization (WHO).
One of the four strains was the influenza type B Yamagata lineage. However, there has been little evidence of a natural case of influenza with this virus variant since March 2020, according to WHO. WHO has recommended switching from tetravalent to trivalent influenza vaccines without the B/Yamagata lineage since September 2023 to avoid the theoretical risk of B/Yamagata lineage viruses spreading again through the use of live attenuated vaccines. Inactivated influenza vaccines (dead vaccines) will also transition to three strains, so in the future trivalent vaccines will be the universal option. The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) followed the WHO's recommendation in March 2024.
An immediate transition was not possible for many manufacturers, however, so it was accepted that in the European Economic Area (EEA) for the 2024/2025 season only attenuated live vaccines would be offered as trivalent vaccines. These are the only vaccines in which live viruses are present. Since they no longer contain the Yamagata lineage, there is also no longer a theoretical risk that the Yamagata lineage will be preserved via the vaccines. All other influenza vaccines (dead vaccines) offered for the 2024/2025 season are once again tetravalent and have "tetra" added to their name. The trivalent flu vaccines do not have tetra in their name.
Updated: 05.12.2024
The Act on Protection against Measles and Strengthening Vaccine Prevention (Measles Protection Act) has been in force since 1 March 2020. This law is intended to provide better protection against measles, particularly for children. Information for parents and guardians, employees of community facilities and medical institutions, institution managers, and healthcare professionals is published at www.masernschutz.de. The German Federal Ministry of Health, the Federal Institute for Public Health, the Robert Koch-Institut, and the Paul-Ehrlich-Institut jointly developed the content.
Updated: 06.09.2024
Information on ingredients, excipients and additives, use, interactions, contraindications, and side effects can be found in the medicinal products' package leaflet and product information.
The Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines, offers lists of vaccines authorised in Germany on its website. "Further information" links are provided in the far right-hand column of the lists. In the case of centrally authorised products, these links lead to the EPAR (European Public Assessment Report), which contains details such as the product information. For all other authorisations (national, decentralised, mutual recognition procedure), the links connect to the PharmNet.Bund database (German only). After accepting the disclaimer and clicking on the name of the medicinal product, the product information or package leaflet can be downloaded by clicking on the "additional documents" (Zusatzdokumente) tab.
Updated: 06.09.2024
Mild vaccine reactions occur around six to 12 days after vaccination. These reactions often involve redness and swelling at the injection site and fever (in 5 to 15% of individuals) for one to two days. Headaches or fatigue may also occur. Approximately 5 to 15% of those vaccinated get a moderate to high fever that lasts for one to two days between the 7th and 12th day after vaccination. A rash (known as vaccine measles) can occur in about 5% of vaccinated individuals in the second week after vaccination. The rash can last for one to three days and is not contagious. About 1% of those vaccinated report joint pain after vaccination. The symptoms described only rarely occur after the second vaccination. Serious adverse vaccine effects are rare.
The repeated claim that the measles vaccination can cause inflammatory bowel diseases (such as Crohn's disease) or autism has long since been refuted by a variety of studies.
Known side effects of medicinal products, including vaccines, are listed in chapter 4.8 of the Summary of Product Characteristics and package leaflet.
Updated: 19.09.2024
The term "Post-Vac Syndrome" is used in connection with certain symptoms observed after COVID-19 vaccination, some of which are similar to Long COVID symptoms.
Currently there is no internationally recognised, standardised case definition for Post-Vac Syndrome. In the evaluations of suspected case reports of Long COVID/Post COVID-like symptoms after COVID-19 vaccination, it was not possible to identify an increased risk of these symptoms for such reports after COVID-19 vaccinations from Germany or from the Member States of the European Economic Area (EEA) and the non-EEA countries (worldwide) in which the centrally authorised COVID-19 vaccines were administered.
The Paul-Ehrlich-Institut would like to note that in each of the evaluations, as described in the statement dated 19 May, 2023, more than 50 percent of the suspected case reports came from Germany. However, less than 50 percent of all vaccine doses administered in the countries from which suspected case reports were submitted were administered in Germany.
The Paul-Ehrlich-Institut currently has no evidence from the scientific literature that could explain the triggering factors for the development of Long COVID/Post COVID-like symptoms.
It is now known that there were also numerous asymptomatic SARS-CoV-2 infections. In such cases, the Long COVID/Post COVID-like symptoms may also be a result of the undetected infection.
Updated: 23.08.2024
According to current knowledge, allergy sufferers or people who have already experienced a severe allergic reaction (anaphylaxis) can be vaccinated against COVID-19 with all authorised vaccines. There is no increased risk of serious adverse effects. An exception is a pre-existing allergy to an ingredient of the specific COVID-19 vaccine or a severe intolerance reaction to previous administration of the COVID-19 vaccine. In this case, allergological clarification is recommended and it is usually possible to switch to another COVID-19 vaccine.
As a general rule, severe allergic reactions can occur in very rare cases with all vaccines. Therefore, each person should be observed for 15 minutes after vaccination so that they can receive appropriate medical treatment in the event of an allergic reaction. If the person to be vaccinated has a history of anaphylaxis or severe allergic reactions following administration of medication or other vaccines, the observation time will be increased to 30 minutes if necessary.
It is not recommended to take anti-allergic drugs before vaccination, as a possible allergic reaction could be delayed and occur outside the monitoring period of 15 or 30 minutes.
In the rare case of a severe anaphylactic reaction after the first or second dose of vaccine, a further dose should not be administered.
Updated: 23.08.2024
Non-clinical studies of the authorised mRNA COVID-19 vaccines have produced no evidence showing that vaccination may impair female or male fertility.
Several studies on the potential toxicity to animals were carried out before human use, as is required in the EU marketing authorisation process. Potential adverse effects of repeated vaccinations on fertility, pregnancy and embryonic development were investigated in a special, very extensive study in female rats conforming to international guidelines in what is known as a DART (Developmental and Reproductive Toxicity) study. These studies show no evidence of impairment of female fertility caused by the vaccines. Furthermore,, no vaccine-related changes in female or male reproductive organs (ovaries or testes) were observed in the extensive fine-tissue (histopathological) examinations conducted in the toxicity studies with repeated administration of an increased vaccine dose ( repeat-dose toxicity study).
These data conditions ensure with the highest degree of certainty that damage to reproductive organs and impairment of reproduction in humans can be excluded within the framework of a medicinal product marketing authorisation.
The studies that have been conducted and their evaluations can be found in the published European public assessment report (EPAR) of the European Medicines Agency (EMA). The EPARs can be found in the right-hand column at www.pei.de/covid-19-vaccines. The Robert Koch-Institut reports on further studies in their report: "Does COVID-19 vaccination make men or women infertile?" (German only)
Updated: 23.08.2024
The answer is a clear no.
It has now been shown that the spike protein of the SARS-CoV-2 coronavirus, when in contact with human cells, causes the cells to fuse with neighbouring ones and partly die. Such fused cells were found in lungs of patients who had died of COVID-19.
With these findings, the question arose as to whether vaccines causing the formation of spike proteins might also cause such membrane fusions.
When the COVID-19 vaccines available in Germany (mRNA vaccines or vector vaccines) are used, a few body cells receive one batch of foreign genetic information. This information consists of mRNA (mRNA vaccines) or DNA transmitted by harmless cold viruses (vector vaccines). The genetic information is translated into protein by the affected cells. The cells generate the spike protein of the SARS-CoV-2 coronavirus. Unlike the SARS-CoV-2 coronavirus, the vaccines do not replicate, so the amount of spike protein will remain small and local. No clinical effects are to be expected because the number of cells that receive the genetic information for the formation of the spike protein via vaccination is so small.
Clinical studies in tens of thousands of vaccinated study participants have proven the safety of the vaccines. The regular public safety updates by the Paul-Ehrlich-Institut do not include any evidence of such vaccination complications either.
Membrane fusion is a natural process used by the cells to transport material such as hormones, neurotransmitters, and waste to the desired destination. Viruses also use this process to enter new cells.
Updated: 23.08.2024
