MIMS listing published for Pfizer/BioNTech COVID-19 vaccine

The mRNA vaccine, known as BNT162b2, does not have UK marketing authorisation but has been given authorisation for temporary supply by the DHSC and MHRA. The MIMS listing summarises the information for healthcare professionals approved by the MHRA.

The vaccine is embedded in lipid nanoparticles and must be stored at -80°C to -60°C. Once removed from the freezer, the multidose vials should be thawed at 2—8°C for up to 5 days then kept for up to 2 hours at room temperature before dilution. 

Two 0.3ml doses are given by intramuscular injection into the deltoid muscle, 21 days apart.

Following reports of allergic reactions, the MHRA has said the vaccine should not be given to people with a history of significant allergy to any drug, vaccine or food, and patients should be observed for 15 minutes after receiving the vaccine.

The vaccine should not be given to pregnant women or patients under 16 years.

The most frequent adverse reactions to the vaccine in clinical trials were pain at the injection site (> 80%), fatigue (> 60%), headache (> 50%), myalgia (> 30%), chills (> 30%), arthralgia (> 20%) and pyrexia (> 10%), which were usually mild or moderate in intensity and resolved within a few days. If required, symptomatic treatment with analgesic and/or antipyretic medicinal products may be used.