Products
BNT162b2 from German biotechnology company BioNTech and Pfizer was approved in many countries on December 19, 2020, as the first representative of mRNA vaccines and Covid-19 vaccines (Comirnaty, frozen suspension). The vaccine was studied in 2020 in a large Phase III trial with more than 44,000 participants. Switzerland was the first country in which the vaccine was released through a proper regulatory process. The vaccine is stored frozen at -60 °C to -80 °C. Once thawed, the undiluted preparation can be stored in the refrigerator at 2 to 8 °C for 5 days. Before use, dilution with sterile sodium chloride solution 0.9% is required. The drug is available as a suspension. The official active ingredient name is tozinameran.
Structure and properties
BNT162b2 is a nucleoside-modified mRNA vaccine (modRNA). It is lipid nanoparticles containing the mRNA (messenger RNA) for the formation of the spike protein of SARS-CoV-2.
Effects
After administration, the mRNA is translated by endogenous cells to the spike protein (S) of coronavirus. This causes an immune response and triggers the formation of antibodies that protect against infection. Efficacy and safety have been confirmed in a large clinical trial (see above).
Indications
For prevention of covid-19 starting at age 16 years.
Dosage
According to the SmPC. The drug is administered as an intramuscular injection (0.3 ml). Two vaccinations are required at least 21 days apart (3 weeks).
Contraindications
- Hypersensitivity
- There are not yet sufficient data for use during pregnancy.
The study’s main exclusion criteria included covid-19 in patient history, immunosuppressants, and immunodeficiency. Immune response may be reduced in people with immunosuppression. Full precautions can be found in the drug label.
Interactions
No data are available on concomitant administration of other vaccines.
Adverse effects
The most common possible adverse effects include:
- Pain, redness, and swelling at the injection site.
- Fatigue, feeling sick
- Headache
- Muscle pain, joint pain
- Fever, chills
- Nausea
- Lymph node swelling
The side effects are normal immune reactions, which also occur with other vaccines. Allergic reactions and anaphylaxis were observed in the clinical trials. Tolerability will be further evaluated during vaccination programs.
