Vaccines against COVID-19: Comirnaty® by BioNTech/Pfizer
BioNTech/Pfizer’s vaccine was the first to be globally authorised for use against COVID-19. An overview of important facts regarding safety and efficacy of coronavirus vaccination with Comirnaty®.
In 2020, BioNTech/Pfizer's Comirnaty® vaccine was developed by the German pharmaceutical firm BioNTech, in cooperation with the US pharmaceutical corporation Pfizer. On 21 December 2020, the European Commission issued a conditional marketing authorisation for the European Union – and therefore also for Germany. Read more information on the vaccine, its efficacy and possible vaccine reactions here.
The Biontech vaccine at a glance
- Name: Comirnaty® by BioNTech/Pfizer
- Authorisation holder: The German biotechnology firm BioNTech and the American pharmaceutical corporation Pfizer.
- Vaccine type + mode of action: An mRNA vaccine that introduces a blueprint for a feature of the SARS-CoV-2 virus (the spike protein) into the cells, enabling the body to produce the antibody itself so that the immune system is able to trigger a corresponding immune response.
- Efficacy: If the interval of six weeks between the two shots is observed, as recommended by the Standing Committee on Vaccination (STIKO), Comirnaty® provides an efficacy of up to 95 percent among vaccinated persons of all age groups.
- Vaccination recommendation: Based on the currently available data, the Standing Committee on Vaccination (STIKO) recommends the Comirnaty® vaccine for all citizens from the age of 16. The vaccine is also recommended for children and young people between the ages of 12 and 15 with specific pre-existing conditions as they are at a higher risk of severe COVID-19 infections.
- Typical vaccine reactions: Headaches, pain in the limbs and joints, pain and/or redness at the injection site, fatigue or flu-like symptoms, nausea
- Administration: By injection into the muscle of the upper arm (intramuscular)
- Vaccination schedule: Two doses 6 weeks apart
- Storage: Storage at -90 °C to -60 °C: up to six months. Undiluted, the vaccine can keep for a maximum of 31 days including the time for thawing and transport, if stored in a refrigerator at between 2°C and 8°C. At room temperature (max. 30°C), it can be kept (undiluted) for a maximum of two hours. Once thawed, do not refreeze.
How the vaccine works
As with the COVID-19 vaccine by Moderna, the Comirnaty® vaccine by BioNTech/Pfizer is a so-called mRNA vaccine. The “m” in this new vaccine technology's name stands for “messenger” and RNA for ribonucleic acid, a chemical compound found in body cells. The mRNA provides the blueprint for a small component of the coronavirus, specifically its spike protein. It is with this distinctive protein – we know it from the depictions of the virus as the spike on the virus’ surface – that the coronavirus penetrates human cells. The protein itself is perfectly harmless.
When a person is vaccinated with Comirnaty® by BioNTech/Pfizer, the spike protein blueprint enters the human muscle inside a protective coating composed of tiny fat droplets known as lipids. The body’s cells produce the protein themselves with the aid of the blueprint and present it to the immune system. The latter recognises the protein as a foreign body and develops antibodies and defence cells to fight it, thus generating a protective immune response.
If a “real” coronavirus enters the body in the wake of a subsequent SARS-CoV-2 infection, the immune system immediately recognises it due to its spike proteins and can quickly and effectively fight it. The mRNA contained in the vaccine, on the other hand, is broken down in the body within a matter of days. This then also concludes the body’s own production of spike proteins.
How effective is the vaccine?
The Comirnaty® vaccine by BioNTech/Pfizer is highly effective against the coronavirus. In vaccinated persons, the probability of getting COVID-19 after being infected falls by around 95 percent. The risk of transmission is also significantly reduced. The Robert Koch Institute assumes that, from the fifteenth day after the last vaccine dose, fully vaccinated persons have a lower risk of transmitting the coronavirus than persons with a negative test result.
However, owing to the residual risk, distancing and hygiene rules will continue to apply to vaccinated persons as well. Further studies are required to show how long the protection afforded by the vaccine lasts. Persons who still become ill despite vaccination can expect to have a relatively mild disease progression. To what extent boosters are necessary, as is the case with the influenza vaccine for example, is still unclear and will continue to be the subject of clinical trials.
Thanks to the platform technology used, mRNA vaccines are easier to manufacture and
guarantee the production of several million doses in only a few weeks. Using this technology, it is also possible to adapt the vaccine to modified virus mutations within a short space of time.
Recommended for humans from the age of 12
In June 2021, the coronavirus vaccine Comirnaty® by BioNTech/Pfizer was authorised by the European Medicines Agency (EMA) for persons from the age of 12. The STIKO currently recommends the vaccine for children and young people between the ages of 12 and 15 with specific pre-existing conditions, as they are at a higher risk of severe COVID-19 infections. The vaccine is generally injected into the muscle of the upper arm. Two vaccine doses are required for full protection. The interval between the first and the second vaccine should be between three to six weeks. The Standing Committee on Vaccination (STIKO)
recommends an interval of six weeks between the first and the second vaccine dose.
Vaccine reactions and adverse reactions
In principle, vaccine reactions and additional adverse reactions can occur with all vaccines, irrespective of the pathogen or the vaccine. The most frequent symptoms after vaccination include: pain at the injection site, fatigue, headache, muscle pain, joint pain and shivering. These symptoms are most often mild and are more likely to occur in younger people. Adverse reactions, in other words, symptoms that are worse than is customary with a vaccination, are very rare. Find important information on coronavirus vaccination using mRNA-based vaccines, and possible adverse reactions, in the fact sheet available for downloading and printing here.
Safety continuously monitored
If you have known allergies to ingredients contained in the vaccine, or have had a severe allergic reaction to the first vaccine dose, you should avoid taking a second dose. The corresponding product information containing the vaccine components of all authorised COVID-19 vaccines is available here. The safety of the vaccines is being monitored continuously. Indications of hitherto unknown, very rare possible adverse reactions are continuously examined and assessed to enable an immediate response if necessary. You can read the corresponding safety reports from the Paul Ehrlich Institute here.
This article also contains additional information on the coronavirus vaccination.