Tozinameran covid-19 mrna vaccine
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Vaccine containing tozinameran, a COVID-19 mRNA vaccine (embedded in lipid nanoparticles).
Drugs List
Therapeutic Indications
Uses
Coronavirus disease 2019 (COVID-19): Prophylaxis
For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.
Available at https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
Dosage
The 30micrograms/0.3ml dose is only indicated for treatment in adults and children aged 12 years and above.
The 10micrograms/0.2ml dose is only indicated in children aged 5 to 12 years.
The 3micrograms/0.2ml dose is only indicated in children aged 6 months to 5 years.
Adults
Primary dosing schedule
Two 30micrograms/0.3ml doses, administered at least 3 weeks apart.
Severely immunocompromised patients
A third 30micrograms/0.3ml dose may be administered at least 28 days after the second dose.
Booster dose
One 30micrograms/0.3ml dose, administered at least 3 months after primary course.
Children
Primary dosing schedule
Children aged 12 to 18 years
Two 30micrograms/0.3ml doses, administered at least 3 weeks apart.
Children aged 5 to 12 years
Two 10micrograms/0.2ml doses, administered at least 3 weeks apart.
Children aged 6 month to 4 years
Two 3micorgrams/0.2ml doses, administered at least 3 weeks apart. Followed by a third dose of 3micrograms/0.2ml administered at least 8 weeks after the second dose. Infants turning 5 years old between doses should complete the series at the same 3microgram/0.2ml dose schedule.
Severely immunocompromised patients
Children aged 12 to 18 years
A third 30micrograms/0.3ml dose may be administered at least 28 days after the second dose.
Children aged 5 to 12 years
A third 10micrograms/0.2ml dose may be administered at least 28 days after the second dose.
Administration
Administered via intramuscular injection.
If using the concentrate formulation, this must be diluted before use, see product literature.
Contraindications
Children under 6 months
Precautions and Warnings
Children aged 6 months to 12 years
Immunosuppression
Recent anticoagulant therapy
Severe febrile conditions
Coagulopathy
Immunodeficiency syndromes
Thrombocytopenia
Postpone immunisation if there is active or suspected infection
Advise ability to drive/operate machinery may be affected by side effects
Avoid second dose if anaphylaxis occurs with first dose
Avoid within 90 days after casirivimab and imdevimab therapy
Impaired response possible in immunocompromised patients
Not all available products are licensed for all age groups
Vaccine may not be effective in 100% of patients
Contains polyethylene glycol
Different brands may not be interchangeable
Do not mix with other vaccines in the same syringe
Do not use if solution is discoloured or particulates are apparent
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Some formulations must be diluted before use
Monitor patient for at least 15 minutes after vaccination
Advise patient to inform their physician if dyspnoea/chest pain occur
Advise patient to report any signs of cardiac arrhythmias
Advise patient to report signs or symptoms of myocarditis and pericarditis
Advise patient to seek medical attention if new onset of heart palpitations
Increased risk of myocarditis and pericarditis
Management of cases of shock should follow current medical standards
Follow national immunisation guidelines
If anaphylaxis occurs following the first dose of the vaccine, do not administer the second dose.
Healthcare professionals should consult specialists to diagnose and treat myocarditis and pericarditis. Very rare cases of myocarditis and pericarditis have been observed following vaccination with tozinameran Covid-19 mRNA vaccine. These cases have primarily occurred within 14 days following vaccination, more often the second vaccination, and more often in younger men.
Precautions should be in place to avoid injury from fainting should a psychogenic response occur from the needle injection.
If administering more than one non live vaccine at the same time, administer into different injection sites and preferably in different limbs. If more than one injection is administered in the same limb, separate by at least 2.5cm. Some live vaccines require further caution or time separation, see specific product literature.
The duration of protection provided by the vaccine is unknown. Individuals may not be fully protected until 7 days after their final dose of the vaccine.
Pregnancy and Lactation
Pregnancy
Tozinameran Covid-19 mRNA vaccine is considered safe for use during pregnancy.
The manufacturer advises tozinameran Covid-19 mRNA vaccine may be used safely during pregnancy.
Pregnant women should follow national guidance which suggests tozinameran Covid-19 mRNA vaccine is one of the preferred vaccine during pregnancy.
Lactation
Tozinameran Covid-19 mRNA vaccine is considered safe for use during breastfeeding.
The manufacturer states tozinameran Covid-19 mRNA vaccine may be used safely when breastfeeding.
Side Effects
Anaphylaxis
Angioedema
Arthralgia
Asthenia
Chills
Decreased appetite
Diarrhoea
Drowsiness
Erythema at injection site
Erythema multiforme
Facial paralysis
Facial swelling
Fatigue
Headache
Hyperhidrosis
Hypersensitivity reactions
Hypoaesthesia
Insomnia
Irritability
Itching (injection site)
Lethargy
Limb swelling
Local pain (injection site)
Lymphadenopathy
Malaise
Myalgia
Myocarditis
Nausea
Night sweats
Painful extremities
Paraesthesia
Pericarditis
Pruritus
Pyrexia
Rash
Swelling (injection site)
Urticaria
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: November 2022
Reference Sources
Summary of Product Characteristics: Comirnaty concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified). BioNTech Pfizer. Revised August 2022.
Summary of Product Characteristics: Comirnaty 3micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nuceloside modified). BioNTech Pfizer. December 2022.
Summary of Product Characteristics: Comirnaty 30micrograms/dose dispersion for injection 12+ years COVID-19 mRNA Vaccine (nucleoside modified). BioNTech Pfizer. Revised August 2022.
Summary of Product Characteristics: Comirnaty 10micrograms/dose concentrate for dispersion for injection Children 5 to 11 years COVID-19 mRNA Vaccine (nucleoside modified). BioNTech Pfizer. Revised August 2022.
Immunisation against infectious disease - The Green Book.
Available at https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
Last accessed: 08 November 2022
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 December 2022
The Joint Committee on Vaccination and Immunisation (JCVI)
Available at: https://www.gov.uk/government/news/jcvi-issues-updated-advice-on-covid-19-booster-vaccination Last accessed: 22 November 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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