Tozinameran

Intramuscular
Active immunisation against coronavirus disease 2019 (COVID-19)

Before dilution, verify that the correct vial and method of preparation is selected. Thaw vials prior to dilution in the refrigerator between 2-8°C; for immediate use, thaw for 30 minutes at room temperature between 25-30°C and dilute within 2 hours. Vial must reach room temperature before dilution. Before dilution gently invert the vial 10 times, do not shake. Vial with purple cap: Add 1.8 mL of preservative-free 0.9% NaCl into the vial. Vial with orange cap: Add 1.3 mL of preservative-free 0.9% NaCl into the vial. Equalise vial pressure by withdrawing 1.8 or 1.3 mL of air into the empty diluent syringe before removing the needle from the vial respectively. Gently invert 10 times to mix, do not shake. Vial with grey cap must not be diluted. It is recommended to use a low dead-volume syringe and needle to withdraw the dose for administration.

Incompatible with bacteriostatic 0.9% NaCl.

History of hypersensitivity following first dose or immediate allergic reaction (of any severity, occurring within 4 hours of administration) to any component of the formulation (e.g. polyethylene glycol [PEG]).

Patient with bleeding disorders (e.g. thrombocytopenia, haemophilia); history of any immediate allergic reaction to any other vaccine or injectable therapy; autoimmune conditions. Immunocompromised patients. Patients who have received dermal fillers. Defer vaccination in patients with moderate to severe acute febrile illness (with or without fever); known current SARS-CoV-2 infection or exposure, patient who develop SARS-CoV-2 infection before receiving any vaccine dose, or after the first dose but before the 2nd dose, until recovery from acute illness (if symptomatic) and/or no longer requires isolation. Defer vaccination in children or adults with history of multisystem inflammatory syndrome until resolution of illness or for ≥90 days after diagnosis. Defer 2nd dose in patients who experience myocarditis/pericarditis after the 1st dose; if 2nd dose is desired and is clinically appropriate, wait until complete resolution of signs/symptoms; those with history of myocarditis/pericarditis unrelated to mRNA COVID-19 vaccine may receive vaccination upon complete resolution of signs/symptoms. Not recommended for outbreak management or postexposure prophylaxis. Pregnancy and lactation; use only if potential benefits justify potential risks as there is limited data regarding the use of COVID-19 vaccines in pregnant and lactating women. 

It should be noted that:

- Tozinameran may be available as a formulation under an FDA approved brand or as formulations under an emergency use listing or authorisation in some countries. Registration status and or availability may vary between countries.
- The safety and efficacy of tozinameran for immunisation against COVID-19 continue to be evaluated, preliminary data suggest a high vaccine efficacy in preventing COVID-19 following a complete course of vaccination.
- The duration of protection against COVID-19 after a complete vaccination course has not been fully evaluated. Clinical trials and epidemiologic surveillance are ongoing to evaluate break-through infection in fully vaccinated individuals.
- COVID-19 vaccines are not interchangeable. It is recommended to use the same brand of vaccine for both doses to complete the series. There are no data available on the interchangeability of COVID-19 vaccines, guidelines may vary among countries.
- For traceability of biological medicinal products, the name of the vaccine, batch, or lot number of the administered product must be properly recorded (refer to specific country guidelines).
- Tozinameran is supplied in multiple formulations and vial presentations; the method of preparation, requirements for dilution, dose volume, and storage requirements may differ between formulations. Refer to individual product guideline.
- The FDA approved formulation of tozinameran and the formulations under the emergency use authorisation for individuals ≥12 years may be used interchangeably.
- Due to the potential of vaccine administration errors (e.g. dosing errors), ensure that the correct age-appropriate formulation is selected for administration. Vials with purple or grey caps should not be used for individuals 5-11 years and vials with orange cap should not be used for individuals ≥12 years.
- Recommendations and approval for booster doses may vary among countries. Refer to specific country guidelines.
- Defer vaccination (primary series) in persons with current SARS-CoV-2 infection until the individual recovers from acute illness and no longer requires isolation. It is recommended to delay booster doses by 3 months from onset of symptoms or positive test. Refer to detailed product guideline.
- To potentially decrease the small risk for myocarditis while possibly increasing the peak antibody responses and vaccine efficacy, a longer interval between the 1st and 2nd dose (8 weeks) may be optimal for certain populations ≥12 years, particularly males 12-39 years. Myocarditis risk after a 3rd dose of tozinameran has not been identified.
- Administration of antipyretics, antihistamines, aspirin or anticoagulants prior to the administration of COVID-19 vaccines for the purpose of preventing post-vaccination symptoms is not recommended. However, antipyretic/analgesic medications may be taken after vaccination to treat post-vaccination symptoms such as local pain or fever.
- Minimise any unnecessary co-medication whenever possible, given the lack of information about interaction risk.
- A person is considered fully vaccinated after receipt of the 2nd dose of the primary series. Recommendations and approval may vary among countries. Refer to specific country guidelines.
- Refer to your local health authority for the most up-to-date fact sheet when prescribing or administering tozinameran.
- To alleviate the risks of this unapproved drug during pandemic use, local regulatory agencies may require healthcare facilities and healthcare providers to comply with certain regulations for administration of tozinameran. Please refer to respective local regulatory agencies for further information.

Significant: Syncope, hypersensitivity (e.g. anaphylaxis), contralateral or ipsilateral lymphadenopathy, Bell’s palsy; temporary swelling at or near the site of filler injection. Rarely, myocarditis and pericarditis (particularly in young males).
Gastrointestinal disorders: Nausea, vomiting, diarrhoea.
General disorders and administration site conditions: Inj site pain, swelling, redness; malaise, fatigue, chills, fever.
Musculoskeletal and connective tissue disorders: Muscle pain, joint pain, arthralgia, myalgia.
Nervous system disorders: Headache.
Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria.

Fully vaccinated individuals (including those who have received a 3rd primary dose or booster doses) should continue to observe effective prevention measures (e.g. hand hygiene, wearing a mask, social distancing), please refer to your local health authorities.

Monitor for hypersensitivity reactions and syncope for 15 minutes after administration. Observe patients for 30 minutes for those with history of anaphylaxis due to any cause or an allergic reaction of any severity, within 4 hours after administration of a vaccine or injectable therapy; or a person with a contraindication to a different type of COVID-19 vaccine. Assess for signs and symptoms of myocarditis or pericarditis (e.g. acute and persisting chest pain, palpitations, shortness of breath).

Diminished therapeutic effect with COVID-19 directed monoclonal antibodies, derma fillers, and immunosuppressants. Antihistamines may mask the symptoms of anaphylaxis caused by COVID-19 vaccine (mRNA) which could lead to delay in diagnosis and management.

Description: Tozinameran is an investigational COVID-19 vaccine that contains messenger RNA (mRNA) encoding the viral spike glycoprotein (S) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The nucleoside-modified mRNA is encapsulated in lipid nanoparticles, that enable delivery of the RNA into host cells, to direct transient expression of the SARS-CoV-2 spike (S) antigen. It contributes to the protection against COVID-19 by allowing both neutralising antibody and cellular immune responses to the S antigen.
Synonym: vaccine, COVID-19 mRNA (BNT162b2).
Onset: Virus neutralising antibody activity: 7-14 days after the 2nd dose.

Vials with purple cap: Recommended storage for intact vials: Store between -90 to -60°C. May be stored between -25 to -15°C for up to 2 weeks. Protect from light. Transportation of frozen vials: If cannot be transported at recommended storage condition, vials may be transported and stored at -25 to -15°C for up to 2 weeks. Thawed vials before dilution: Store between 2-8°C for up to 1 month or up to 30°C for not more than 2 hours. Protect from direct sunlight and UV light. Thawed vials may be transported between 2-8°C for up to 12 hours. Do not refreeze. Diluted vials and pre-drawn syringes: Store between 2-30°C and use within 6 hours. Minimise exposure to room light and avoid exposure to direct sunlight and UV light. Do not refreeze. Vials with grey or orange cap: Store between -90 to -60°C. Protect from light. Alternatively, frozen vials may be transferred to the refrigerator between 2-8°C, thawed and stored for up to 10 weeks. Do not refreeze. If vials are received at 2-8°C, continue storing at this temperature (record and update the 10-week expiry date on the carton). During use of vials: Store between 8-30°C before dilution (vial with orange cap) or 1st puncture (vial with grey cap) for up to 12 hours; after dilution or 1st puncture, vials may be stored at 2-30°C for up to 12 hours. Transportation of vials: Transport between -90 to -60°C or 2-8°C. Minimise exposure to room light and avoid exposure to direct sunlight and UV light. Storage recommendations can vary depending on the available formulation (refer to specific guidelines).

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