Covid-19 vaccine (vidprevtyn beta, recombinant spike protein, adjuvanted)
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Vaccine containing COVID-19 vaccine (SARS-CoV-2 recombinant spike protein B.1.351, adjuvanted).
Drugs List
Therapeutic Indications
Uses
Coronavirus disease 2019 (COVID-19): Prophylaxis
COVID-19 vaccine (SARS-CoV-2 recombinant spike protein B.1.351, adjuvanted) is indicated as a booster for active immunisation to prevent COVID-19 in adult patients who have previously received an mRNA or adenoviral vector COVID-19 vaccine.
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
Adults
1 dose (0.5ml) at least 4 months after a previous COVID-19 vaccine.
Booster dose of COVID-19 vaccine (SARS-CoV-2 recombinant spike protein B.1.351, adjuvanted) can be given once as a booster to adults that have previously received prior vaccination series with either mRNA or adenoviral vector COVID-19 vaccines.
Administration
Administered via intramuscular injection only. The preferred site is the deltoid muscle of the upper arm.
Contraindications
Children under 18 years
Precautions and Warnings
Acute infection
Immunosuppression
Recent anticoagulant therapy
Severe febrile conditions
Coagulopathy
Pregnancy
Thrombocytopenia
Impaired response possible in immunocompromised patients
Vaccine may not be effective in 100% of patients
Do not mix with other vaccines in the same syringe
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Monitor patient for at least 15 minutes after vaccination
Follow national immunisation guidelines
Pregnancy and Lactation
Pregnancy
Use COVID-19 vaccine (SARS-CoV-2 recombinant spike protein B.1.351, adjuvanted) with caution during pregnancy.
The manufacturer does not recommend using COVID-19 vaccine (SARS-CoV-2 recombinant spike protein B.1.351, adjuvanted) during pregnancy unless the potential benefits outweigh any potential risks to the mother or foetus. At the time of writing there is limited published information regarding the use of COVID-19 vaccine (SARS-CoV-2 recombinant spike protein B.1.351, adjuvanted) during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/fetal development, parturition or post-natal development.
Lactation
COVID-19 vaccine (SARS-CoV-2 recombinant spike protein B.1.351, adjuvanted) is considered safe for use during breastfeeding.
The manufacturer states COVID-19 vaccine (SARS-CoV-2 recombinant spike protein B.1.351, adjuvanted) may be used safely during breastfeeding. The presence of COVID-19 vaccine (SARS-CoV-2 recombinant spike protein B.1.351, adjuvanted) in breast milk is unknown. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breastfeeding women to COVID-19 vaccine (SARS-CoV-2 recombinant spike protein B.1.351, adjuvanted).
Side Effects
Arthralgia
Bruising at injection site
Chills
Diarrhoea
Erythema at injection site
Fatigue
Fever
Headache
Itching (injection site)
Local pain (injection site)
Lymphadenopathy
Malaise
Myalgia
Nausea
Sensation of warm at injection site
Swelling (injection site)
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: January 2023
Reference Sources
Summary of Product Characteristics: VidPrevtyn Beta solution and emulsion for emulsion for injection. Sanofi. Revised December 2022.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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